chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(VAERS filed by HC- urticaria w/i 6-8 hrs post-vaccine receipt) 17 mo old girl who developed urticaria about 6-8 hours after vaccine receipt on 29 MAR 2013. Dtap, influenza split vaccine, and Hib vaccines all injected into her upper thighs. She tolerated the vaccines well without any immediate reaction or rash. Mother reported that night, patient developed hives on her right arm that lasted for about 2 hours and resolved before she went to sleep. They were raised lesions on an erythematous base. They were not pruritic. They did not leave a mark after they resolved. They returned the next day this time on her legs. PER CLINIC On March 30th: patient developed blanchable welts over her body. Mom reported that she has none on her face, no swelling of the lips or tongue, no difficulty breathing. Mom reported that she has had no fever, she doesn't seem bothered by the welts, but they are moving around and spreading. She has otherwise been well. PER ALLERGY HPI on 8 MAY: The lesions came and went and no individual lesion lasted longer than 24 hours. This lasted for 1 week. The injection sites remained clear without any rash or swelling. In addition, patient had gastroenteritis with vomiting and diarrhea during this time that began March 14, resolved within a week or so, but returned. Mother said her only medication at the time was probiotic. In addition, around the time of her vaccine receipt, she also had a cough about which mother spoke to PCM on April 1. She was ultimately diagnosed with otitis media April 5 and given amoxicillin. The rash had resolved around that time. She had no angioedema at any time during this period. Patient had had Dtap and Hib before, but this was the first time having the flu vaccine. She has never had urticaria before.
pt recvd vax 9OCT95 next day exp involuntary jerking;
Nurse gave a Moderna COVID-19 vaccine to today 16Sep2021 that was expired 3 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse gave a Moderna COVID-19 vaccine to today 16Sep2021 that was expired 3 days ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse gave a Moderna COVID-19 vaccine to today 16Sep2021 that was expired 3 days ago). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Nurse gave a Moderna COVID-19 vaccine to today 16Sep2021 that was expired 3 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, elevation in blood pressure-normally is 120/80, 146/98 at MD's office Narrative:
After my 2nd dose on May 3rd, I started bleeding during my menstrual cycle.   I have not bled on my menstrual cycle since October 2020.  I had an endometrial ablation in October 2020 and this causes me to still go through mensuration but left me unable to physically bleed.   And when I went through what would have been my menstrual cycle at the end of May, I bled heavily.   This also occurred during my menstrual cycle in June.   I have not had any bleeding since.   I told my doctor what happened and all I was told was that it was causing "weird" period symptoms but didn't know why or how this could happen.
Day of and for the next two days had soreness at the site of the injection.   Two days after, experienced flu-like symptoms of chills and a low grade fever.  Felt very lethargic throughout the day two days after.  It is now near the end of day 2 and the symptoms seem to be subsiding.  Temperature is normal.
Tingling, numbness on the lt side of body that began approx 2wk p/vax;has been seen by MD;pt has a MRI both cervical & brain, SSEP (sematosensory evoked potential);dx inflammatory myelitis;has mild low-grade inflamm high spinal cord;
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient briefly fainted post Covid vaccination. Spoke to her mother later that evening, feeling much better.
hospitalized for unrelated problems; Patient has not received 2nd dose\ first dose > 35 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of HOSPITALISATION (hospitalized for unrelated problems) in a female patient of an unknown age 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (hospitalized for unrelated problems) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Patient has not received 2nd dose\ first dose > 35 days ago). At the time of the report, HOSPITALISATION (hospitalized for unrelated problems) and INCOMPLETE COURSE OF VACCINATION (Patient has not received 2nd dose\ first dose > 35 days ago) 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 considered HOSPITALISATION (hospitalized for unrelated problems) to be not related. No further causality assessment was provided for INCOMPLETE COURSE OF VACCINATION (Patient has not received 2nd dose\ first dose > 35 days ago).    No treatment information was provided by the reporter. No concomitant medications were provided by the reporter. Patient received Moderna Covid Vaccine in April and was reportedly hospitalized for unrelated problems when it was time for her 2nd dose.  Very limited information regarding hospitalization has been provided. Yet, it is mentioned that patient was hospitalized due to unrelated problems. Based on reporter´s causality the event is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional Information received included no new significant Information.; Sender's Comments: Very limited information regarding hospitalization has been provided. Yet, it is mentioned that patient was hospitalized due to unrelated problems. Based on reporter´s causality the event is assessed as unlikely related to mRNA-1273.
After 5 hours I began to get a headache. By the next morning I had a migraine and was nauseated all day. The next morning after I had a slight headache but the nausea has subsided
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastric bypass" (unspecified if ongoing); "Lyme disease chronic" (unspecified if ongoing). Concomitant medication included: CEFDINIR oral, start date: 02Jul2022, stop date: 11Jul2022. Past drug history included: Doxycycline, reaction: "Allergy: Doxycycline"; Augmenting, reaction: "Allergy: augmenting"; Clindamycine, reaction: "Allergy: clindamycine"; Iodine, reaction: "Allergy: Iodine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included received Anti viral drug Paxlovid orally from 06Jul2022 to 11Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
LUMP IN THROAT  Narrative:  Presented back to vaccine clinic at 0930 reporting that she felt like  she had a lump in her throat. No diff swallowing, no shortness of breath, and  declined urticaria/itching. She received her first dose of Moderna at 0916. B/P  173/103 HR 88 no evidence of any respiratory distress,stridor, wheezing,  dyspnea, increased work of breathing, retractions, persistent cough, cyanosis,  signs of poor perfusion, abdominal pain, vomiting, dysrhythmia, hypotension upon  exam. Veteran is able to speak clearly. Respirations evan and nonlaboared with  clear breath sounds throughout 1015 reports that the lump in her throat has  resolved. She declines any shortness of breath/diff breathing, respiratory distress,  urticaria/pruritus and is able to speak in clearly without difficulty.
ZOSTAVAX administered SQ to the left upper arm on 1/22/13. Pt noted tenderness and redness to left arm injection site on 1/23/13. Pt states redness, puffiness, and tenderness worsened. Pt to clinic for eval of site on 1/24/13. Pt diagnosed with cellulitis of injection site and prescribed KEFLEX 500mg po BID x10 days. Pt instructed to follow up after antibiotics for eval or if symptoms worsen.
Information has been received from a physician concerning a female who was vaccinated with varicella vaccine. Subsequently the pt experienced varicella lesions. Unspecified medical attention was sought. It was noted that the physician was notified by the Pediatrics Immunization Dept and is requesting an analysis of PCR to determine if the rash is associated with the vaccine or not. Additional info has been requested.
Patient called into clinic to report symptoms started 9/13/21, and tested positive 9/20/21.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  Treatment information was not reported.
Patient felt dizzy and light headed. she also said she felt tingling in her fingers and cramping in her legs. We called 911. while waiting for paramedics, I sat with her. She was able to hold a conversation with me coherently the entire time we spoke. Paramedics arrived and checked her vitals. everything was normal. pt did not want to be transported to ER at that point. Paramedics felt comfortable with her decision. I spoke to her afterwards, she seemed fine and ready to go home
Pt was given expired diluent with the vaccine. The actual vaccine was not expired, only the diluent.
Pt with rash to right arm appearing 2 days post vaccination. Rash started just below vaccine  site and spread down arm towards hand. Eventually spread to trunk and back. Trunk and back rashes have since resolved, but rash to arm persists 2 months later. Rash appears raised with some hypopigmentation. Pt seen via virtual visit, and scheduled to be seen in person to better visualize and diagnose rash. No treatments given at this time.
Full body trembling, muscles jumping and shaky. Feeling of fullness in the lower legs, trembling through upper legs, torso. Feeling of being flushed but no fever. Comes in waves. I had the first reaction the night of my booster shot and then last night it presented again.  No warning sign just a wave a body tremors and shaking, increased heart rate from what I could tell.
Nausea, malaise, achy muscles, body soreness,brain fog, lack of energy, body pains. (Had malaise and lack of energy the most first 6 weeks post vaccine) Heart Palpitations. Flank  side pains, ab pain went to ED on  January 2022. February foot pain- Gout February 2022. urgent care SVT extreme tachycardia 04/17/2022 required 2 nights hospitalization  Covid-19 6/17/2022. Seen for heart palpitations 6/23/2022 in ER
This spontaneous case reported by a consumer, describes the occurrence of pruritus (felt a little itchy that day) and vaccination site rash (developed a rash on the arm where the injection was) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040B21A) for COVID-19 immunization. Previously administered products (used for unknown indication): Tetanus (she had a rash years ago from a tetanus shot). Past adverse reactions to the above products included rash with Tetanus. On Apr 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  unknown route; 1 dosage form. On Apr 8, 2021, patient experienced pruritus (felt a little itchy that day). On Apr 19, 2021, patient experienced vaccination site rash (developed a rash on the arm where the injection was). At the time of the report, pruritus (felt a little itchy that day) and vaccination site rash (developed a rash on the arm where the injection was) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Severe itching and redness 6d post vaccine. Spread of redness for the next 3-4 days with continued itching. Runny nose day of vaccine to 1 week post.
This spontaneous report was received from a registered nurse (reported as nurse practitioner) and refers to an unspecified patient. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 05-JUN-2017, the patient was vaccinated with an expired dose of VAQTA lot # M034893 with expiration date on 26-MAY-2017 (dose was not reported). No adverse effects were reported. Additional information has been requested.
No adverse event; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Spikevax) (batch no. AS1417B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.   On 08-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Dec-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On 12-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications were not reported.  The patient was administered a dose more than 12 hours after the initial vial puncture. It was punctured on 7DEC2022 and administered on 12DEC2022. Treatment medications were not reported.
MenA lyophilized conjugate vaccine component was reconstituted with Sterile Water instead of with MenCYW-135 liquid vaccine conjugate vaccine component provided in the same box. Upon discovered patient was notified but did not get back to the pharmacy until 06/27/2022. He was made aware of the situation and reported not having any adverse affects. Message was left with patient's provider and have yet to receive a call back.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with GARDASIL, lot # k010574, expiration date 08-APR-2017 (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Fever, Chills, Injection site soreness-left arm swollen Narrative:
Facility became concerned about our lack of a dedicated freezer for storing Moderna Covid-19 vaccine on 2/2/2023. I exlpained to them that when we enrolled in the fall of 2020 for the program I was informed that we did NOT need a dedicated freezer. We have been storing unopened cartons/vials in the freezer section of a "home" refrigerator/freezer combo. I have a dedicated freezer on order along with the required 2 DDLs to put in use. I have the email response from Moderna on file if needed for review.
FLU LIKE SYMPTOMS; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced flu like symptoms, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms and fatigue was not reported. This report was non-serious.
Report of varicella in a person that received 2 doses of the varicella vaccine.  Onset of rash was 7/5/2022- started by belly button and the went to armpits, chest and groin. Raised spots, some have started to scab over. Went to Urgent Care for diagnosis- no treatment ordered. Will keep home until all lesions are crusted over. No known contact with a case of varicella. Has had 2 doses of vaccine.
Parents report patient with fever 102.4F runny nose and cough, irritability night of vaccine administration.
patient contracted COVID; patient contracted COVID; This is a spontaneous report from a contactable consumer.  A non-pregnant 80-year-old female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, the first dose in 2020 and the second dose on 22Dec2020 11:00, both at a single dose for covid-19 immunization.  Medical history included heart, diabetes, obesity.  There were no concomitant medications.  The patient did not have covid prior to vaccination.  The patient contracted COVID on 04Jan2021 11:00. The patient was hospitalized for COVID-19 for 8 days.  The patient underwent lab tests and procedures which included: Nasal Swab: negative on 24Dec2020, negative on 28Dec2020, negative on 31Dec2020, positive on 04Jan2021.  Unspecified therapeutic measures were taken as a result of the event.  The outcome of patient contracted COVID was fatal.  The patient died on 12Jan2021.  It was unknown if an autopsy was performed.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: patient contracted COVID
A non-serious spontaneous report of FLUMIST administration to a pregnant 33-year-old female was received from a registered pharmacist. FLUMIST was administered on 15-Sep-2009. The patient's expected date of delivery was May 2010. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
left arm often has a quick pain when I move it a certain way, such al lifting it over my head; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 at 10:30 (at the age of 74-year-old) in left arm as dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot Number: EN6200) via an unspecified route of administration on 24Feb2021 at 10:30 (at the age of 74-year-old) in right arm as dose 2, single for covid-19 immunization. Medical history included high blood pressure (take medication) from an unknown date and unknown if ongoing. No other vaccine in four weeks. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included allopurinol (ALLOPURINOL); amlodipine besilate (AMLODIPINE BESILATE); losartan (LOSARTAN); atorvastatin calcium (ATORVASTATIN CALCIUM) all taken for an unspecified indication, start and stop date were not reported. The patient received his first shot in left arm. Three weeks later his left arm often had a quick pain when he moved it a certain way, such as lifting it over his head. The pain was not severe and usually went away quickly but seemed to get more frequent. The event started from 08Feb2021. The patient did not receive any treatment. The outcome of the event was not resolved.  Follow-up attempts completed. No further information expected.
Child had headache, neck pain (improved now 8/11/10). Injection site redness, pain, swelling which is improving also. Advised MOTRIN 300mg Q6, BENADRYL 25mg. F/u 1 month.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports received from the same source. Additional information has been requested.
1-11 days after the vaccination I had a series of events that came and went: muscle pain in arm opposite of my injection, hot flashes, joint pain, body ache, chills, night sweats, rash.
red rash starting on arms, legs & spread to face & stomach on 24SEP AM; seen @ ER 24 & 25SEP; dx erythema multiforme; tx DPH;
10 minutes after vaccine, patient experienced flushing to her face, chest, and L arm. Her initial vitals showed pulse Ox: 100%, HR: 123, BP: 138/82. Patient denies SOB, sore throat, or difficulty swallowing. On exam, she has some flushing of her face b/l and chest had some popular erythema. It was not pruritic and blanched. No evidence of urticaria. She did not have any rash involving her b/l arms, abdomen, and back. Her airway was patent, no stidor. She was given a benadyrl. After 20 minutes, her HR decreased to 101. Her rash on her chest improved as well as her facial flushing. Patient was advised to follow up with her primary care physician.