chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was hurting bad; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting bad), CHILLS (chills) and PYREXIA (fever) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was hurting bad), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm was hurting bad), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.   This case was linked to MOD-2021-022360.; Sender's Comments: 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.
Face numbness of unknown origin lately; an extremely heavy period that not only came two weeks early but still has yet to end; knot was red; burning feeling; knot was itchy; arm hurt; had a knot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face numbness of unknown origin lately) and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Face numbness of unknown origin lately) and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end). At the time of the report, HYPOAESTHESIA (Face numbness of unknown origin lately) outcome was unknown and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021 included additional AE information.; Sender's Comments: 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.
Lack of mobility. Unable to lift arm 7-10 days post vaccine. Mom reports incidents 8-29-16.
I began breaking out in hives and rashes all over my body and face. They are red and itchy. The hives and rashes come and go.
Vaccine was administered after expiration date - no advserse events exp. date was 12/2/13.
Patient woke up, removed bandaid from left deltoid, noticed injection site was warm to touch and tender. By 15Feb2015, site's tenderness had increased and developed a hardened ball like feeling at injection site. Patient reported to urgent care center on 15Feb2015, was prescribed Prednislone, Cephalexin 500mg every 12hr for 5days.
Reaction the day following the shot was flu-like symptoms: sore aching muscles, fatigue, head congestion, felt feverish but no fever.  Lasted all the day, then fine the following morning.
11:30am post vaccination reports difficulty swallowing w/ no additional symptoms or complaints reported; no apparent respiratory deficits. Medical monitoring w/vital assessment: BP 118/84 P79 RR 12 O2 sat 99% RA.  11:55am During monitoring reports all symptoms resolve; released from facility w/self.
arm was a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little bit sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore). At the time of the report, PAIN IN EXTREMITY (arm was a little bit sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  Patient put rubbing alcohol on a white tissue and applied it to the area is the treatment medication reported.   This case was linked to MOD-2021-021923 (Patient Link).
Pharmacist reported that unspecified 48 year old patient was administered GARDASIL 9; No adverse effect reported.; This spontaneous report was received from a pharmacist referring to a 48 years old patient of unknown gender. Information of concurrent condition, pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On an unknown date, the patient was administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (also reported as for "possible exposure to human papillomavirus (HPV)") (inappropriate age at vaccine administration). No adverse effect reported. The causality of the event was not provided.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed breakthrough chickenpox with 30 lesions. The lesions were described as itchy, vesicular, and excavated no mucous. The pt was afebrile.
There was no adverse event!!! Administration error as patient was supposed to get a KINRIX instead of PEDIARIX.
Patient developed severe urticaria and angioedema starting about 24-48 hours after getting HPV vaccine (First dose). Patient had two E.R. visits. Needs high dose steroids to control angioedema of throat. Problem lasted ten days.  5/1/07 Received med records from ER visit which reveals patient experienced rash on hip area which spread to extremities. Exam revealed urticarial rash on extemities & trunk.  Initially had mild SOB & tightening of throat.  Pt had recent DepoProvera injection as well as Gardisil.  Tx w/antihistamine & prednisone & d/c to home. ALLERGIES: Augmentin & sulfa FINAL DX: Urticaria.
The grandmother of a 1 month old male reported that the infant received injections of Prevnar (1st dose), Hib-Titer (1st dose), DTP, poliomyelitis vaccine and Hep-B vaccine on 12/10/01. At approx. 21:00 on 12/10/01, that the pt's apnea machine alarmed, his lips "turned blue" and his body was "very" pale. His arms and legs were noted to be "jerking" and he stopped breathing. Cardiopulmonary resuscitation was performed and he was revived. He was than transported to a hospital. He reportedly has a nasogastric tube in place and has "sleep, central and obstructed apnea".
Patient was given 0.2 ml of Pfizer-BioNTech 12 and older vaccine, instead of the pediatric 5-11 vaccine.
Patient received 2nd dose of the COVID-19 Pfizer vaccine, was observed in office x 15+ minutes, and released home. Pt and his son exited the building and when they got to the car, the pt shouted out "oh no!" and collapsed to the ground. The patient was unconscious experiencing agonal respirations, and unresponsive to painful stimuli. There is an Emergency Room at the same location. Their staff came out and helped to transfer the pt to the ED for further evaluation. It was found that the patient had a known  Anterior communicating artery aneurysm (7/28/2017) that seemed to have ruptured. The patient was stabilized and transported to our local hospital and upon arrival, he was effectively comatose with a GCS 3. CT Head notated an extensive subarachnoid and intraventricular hemorrhage most probably related to a bleeding anterior communicating artery aneurysm. Neuro-Interventional Radiologist dictation reads "Hunt Hess 5 Fisher grade 4 extensive subarachnoid hemorrhage with intraventricular hemorrhage and early hydrocephalus secondary to rupture of a known anterior communicating artery aneurysm.  Initial ICP after EVD placement noted to be in the 120s now 68 treatment complicated by aneurysm rerupture after admission and increased volume of blood although large volume of hemorrhage was seen on initial scan and no change in the patient's clinical exam on her scale was noted due to this rerupture.  Patient's exam and prognosis are poor giving extensor posturing lack of extraocular movements to doll's maneuver and weak pupillary reflex as well as cough and gag.  Follows no commands or instructions at this time with no spontaneous movement on ventilator set at 12 overbreathing at 14-16 at this time without any sedation." The family opted to discontinue any further treatment to include surgical intervention given the findings. The patient was given comfort care with son and daughter at the bedside. The patient was extubated and expired at 1545h on 2/13/2021.
Doesnot feel quite herself; kind of fogginess; Feels like if she sneezes; Might experience diarrhea; Nausea, nausea she is currently experiencing is on both sides of the; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesnot feel quite herself; kind of fogginess), SNEEZING (Feels like if she sneezes), DIARRHOEA (Might experience diarrhea) and NAUSEA (Nausea, nausea she is currently experiencing is on both sides of the) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 13-Nov-2018, the patient started TREPROSTINIL SODIUM (IV drip) .06 microgram/kilogram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Doesnot feel quite herself; kind of fogginess), SNEEZING (Feels like if she sneezes), DIARRHOEA (Might experience diarrhea) and NAUSEA (Nausea, nausea she is currently experiencing is on both sides of the). At the time of the report, FEELING ABNORMAL (Doesnot feel quite herself; kind of fogginess), SNEEZING (Feels like if she sneezes), DIARRHOEA (Might experience diarrhea) and NAUSEA (Nausea, nausea she is currently experiencing is on both sides of the) outcome was unknown.            Concomitant medication use was unknown No treatment was provided by the reporter.
Narrative: Documenting VAER as required for pt who died and received COVID vaccine months before
Sudden pain in the left lower part of of the abdomen, it started the next day at noon after the vaccine, it wasn't a continuous pain but more or less constant and suddenly and it kept me from doing what I was doing. Bloody diarrhea that's started 20 minutes after the initial stomach pain. I had about 6 bloody bowel movements during that day, the pain disappeared that same day during the evening, the bloody diarrhea stopped during the night and I had two more bloody bowel movements  between 7 and 9am on the 10th of June.
Lacrimation, respiratory distress (wheezing, decreased air entry), itching and facial rash. Given Benadryl. Solu-Medrol, and epinephrine.
Soreness in left arm at vaccine site, swollen lymph nodes under left arm, total body aches, brain fogginess
1.  Swollen left underarm on shot arm presumed to be swollen lymph nodes.   Did not go to Doctor.  Pain also in shoulder blade as if lymph nodes swollen there also.   Lasted over a week. 2.  I was going through early stages of menopause.  Hot flashes, night sweats, stopped ovulating, haven't menstruated in 8 months.  Since the 2nd shot, about 5 days post vaccination, I have not had a single hot flash or night sweat.  I also ovulated and it is to be seen if it brings my menstrual cycle back.   Not a bad event, just thought it may be needed to be known if some women are on hormones, etc, as it may affect that.
pt had a tonic-clonic sz 10mins p/vax;adm w/episode of apnea @ 15seconds, pt was able to inform NP that was ready to pass out, postictally pt was alert; BP 90/60 p/sz;extremities shook;pale, eye rolled back, apnea, dizziness;
Patient was in on 06/09/2009 for varicella and HIB vaccinations. Patient's mother brought the child for more immunization on 7/27/2009. There is no mention of any reaction to varicella vaccine. Then on 8/20/2009 mother brought patient for a well child exam and told Dr. that her child had a rash and a fever within 48 hrs from receiving the varicella.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) 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.
PT DESCRIBED AS "PUCKERY" LIPS (NOT PUFFY); NO TROUBLE BREATHING; CONTACTED HER PCP WHO SAID GIVE 50MG LIQUID BENADRYL PO AND IF NOT ANY BETTER W/N 1 HR GO TO ER; PT CONTACTED AFTER 1HR AND SAID NO MORE OF SAME SENSATION; FELT BETTER.
The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; Though pulled back; The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; Night stiffness; Pain in feet; Pain in feet, back and in soft tissues around bone joints; Pain in feet, back and in soft tissues around bone joints; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date in 2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included HBP (high blood pressure), high cholesterol but under control with meds and COVID-19 in Jan2021. Concomitant medications included atorvastatin and lisinopril. Historical vaccine included BNT162B2 (Lot number: Ek8737), dose 1 on an unspecified route in the arm left on 05Apr2021 at 02:00 PM (at the age of 52-years-old) for COVID-19 immunization in which the vaccine activated an autoimmune condition spondyloarthritis. The patient had no relevant past drug history. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient diagnosed with COVID-19 prior to vaccination. It was reported that the vaccine (1st shot) activated an autoimmune condition - spondyloarthritis. The second shot made so much worse. He did not realize what was happening. Though pulled back, cracked rib, etc. got worse and worse. Night stiffness. He was almost crippled, he had pain in feet, back and in soft tissues around bone joints. Finally, he got into a doctor and got on ENBREL and CELEBREX.  Which made him feel 99% back to normal. The patient mentioned that the shot crippled him and activated an autoimmune. He was tested positive for hla-b27, as he found out. And he also had covid early in Jan2021. So he had antibodies most likely already. He added that no one believed the shot caused it; but there was no doubt it did based on timeline and symptoms. The patient had not been tested for COVID-19 since the vaccination. The events' onset date was on 09May2021 with unknown outcome. No hospitalization/prolonged. Therapeutic measures were taken as a result of the events. The events resulted to doctor or other healthcare professional office/clinic visit    Follow-up attempts are completed. No further information is expected.
Healthy, well controlled blood pressure, active 48 year old woman, avid hiker of summiting elevation, supposedly training to summit Mt. June 2021, was cancelled d/t pulmonary embolism. Been hiking elevations up to 10,000-11,000 feet weekly to 2x/week before May 5, 6, 2021. Then, the final training was to Mt. May 5, 6, 2021. Got stung by a bee with mild erythematous reaction on the dorsal area of the right thumb. Hiked to Mt. but ended up only to Trail Camp, d/t to chest pain, SOB, abdominal pain. Initially thought to be caused by altitude sickness. However,  when the hike was over - went home. On May 7, went for a walk and could not walk even just 5 steps without getting SOB. Thought it was post altitude sickness. Went to Urgent care d/t increasing inflammation to the right thumb caused by the bee. Given antibiotic but told the doctor there that I was having chest pain. Immediately, pulmonary embolism workup started starting with EKG. Then, D-dimer. D-dimer showed it was elevated and immediately was advised to be admitted to a hospital. Went to the hospital. CT angio with contrast was performed and showed "MULTIPLE SUBSEGMENTAL FILLING DEFECTS ON ALL " my pulmonary branches except the left lower lobe. All clotting factors and immunoglobulin studies were all negative for clotting problems and allergy to bee venom. Was given LOVENOX and transitioned to Apixaban. The reason I am reporting this now is because given that I had "subsegmental filling defects " in my pulmonary branches made me think that these clots have been forming for awhile, and NOT acute. The clots were exacerbated by the getting stung by a bee and the altitude. All my medical providers cannot explain the exact science or the mechanism at to what happened. However, it makes sense that this clots have been forming for awhile. I am afraid, it started right after the PFIZER COVID vaccine. I would like to deny this event but this makes sense. Going to Mt. tipped me over completely. I ended up cancelling my Mt. hike. (Of note, I am a pediatric nurse practitioner as well).
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information
Full-body rash and hives- onset roughly 12 hours after injection.  Patient has gotten several seasonal flu shots over the last several years and had absolutely no problem.  Only change for this year was the addition of Cosentyx therapy.
Severe right arm soreness inability to have range of motion cannot pick up items over 5 lbs numbness and tingling and cooler fingers in rt hand
Patient was due for dose #2 of her Pfizer 5-11 series. She was instead given a dose of the Bivalent Booster, No adverse reactions reported, parent was contacted by the office and the PCP was given directives from Pfizer regarding revaccination recomendations.
HPI: 14-year-old female 1 minute post-vaccination developed 1 syncopal episode, lasting 5 seconds. Patient was caught by her father prior to falling off her seat and regained consciousness. She was able to verbally communicate and respond to commands. No falls or head trauma witnessed. Patient reported a similar episode with her first dose of Pfizer; she was seen at her PCP the following day and was told she could get her second dose. Patient denied shortness of breath, pruritus, difficulty breathing, fatigue, diaphoresis, tongue or lip swelling. Patient was fully assessed by medical staff and given PO fluids and cold compress. She was monitored for 30 minutes with no further progression of symptoms. Upon leaving the patient reported a full recovery of any adverse symptoms and was driven home by her father. Patient and parent were educated to call for EMS if symptoms returned and to follow-up with her PCP.  Physical Assessment: BP: 96/60 mmHg left arm, sitting position HR: 79 bpm RR: 18 breaths per minute SpO2: 97% RA Constitutional: No acute distress. Non-diaphoretic.  Lungs: Clear to auscultation bilaterally. Heart: Regular rate & rhythm. No murmurs, rubs, or gallops. Neurology: A&O x3. Normal speech and gait. Skin: Warm and dry.
10 cm localized redness on right thigh where Hep A was given on 2-10-2014, warm to touch. No fever. Symptom began on 2-11-2014 and noticed by mother, brought to clinic on 2-12-2014.
Woke up next day at 5:00am very nauseous. Threw up at 6:45 am and had to call off work. Felt chills and fatigue and weakness the whole day. Felt fine the next day. No symptoms in second dose.
Fever; Headache; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a certified medical assistant (CMA), concerning a female patient (date of birth 07-FEB-2007), who on an unknown date was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot # 659727/1771U). Subsequently the patient had a reaction described as "developed a single hive near the injection site". The outcome of the event was not specified. This is one of six reports received from the same source. The CMA requested a lot check. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released.