chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the first shot I got the symptoms on my legs and on my calf I would say on the side of the muscles between the legs; on the side of the muscles between the legs, they were like not going on my veins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EP7534) at the age of 58 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VASCEPA; BABY ASPIRIN; FENOFIBRATE. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "On the first shot I got the symptoms on my legs and on my calf I would say on the side of the muscles between the legs"; MUSCLE DISCOMFORT (non-serious), outcome "unknown", described as "on the side of the muscles between the legs, they were like not going on my veins". Therapeutic measures were not taken as a result of limb discomfort, muscle discomfort.  Additional information:Consumer stated, "He got two shots of the Pfizer. On the first shot he got the symptoms on his legs and on his calf, he would say but, on the side, not on the back of the muscles but on the side of the muscles between the legs, they were like not going on his veins. Other medical condition: Consumer stated, "Just triglycerides are high." Patient said that person who gave me the vaccine that he takes all those 3 medications like blood thinners. Those medications were prescribed by his doctor." Consumer added, "he doesn't know what happened. he talked to his doctor, and he said it is going to my stomach also and he feel like an aneurysm or something like that.Treatment in response to event: Consumer stated, "No. This was the thing from last 10 days after the second shot. With the first shot it gave me the same reaction.  No follow-up attempts are possible. No further information is expected.
Period was over a week late following both vaccines. My cycle shot up to 39 and 35 days long, respectively. Second vaccine was administered on September 28th 2021. My cycle is always normal, around 25 days.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported.
Mild headache; injection site swollen and sore. Swollen lymph node on left side of neck with mild tenderness.
This male subject was enrolled in a study. On 30 November 2009, he received a dose of H1N1 PANDEMIC INFLUENZA VACCINE, 3.75 mcg adjuvanted with AS03A or 15 mcg without adjuvant. This subject received H1N1 15 mcg without adjuvant. The subject's past medical history included anxiety. Medical conditions at the time of the event included severe bilateral leg pain, depression, erectile dysfunction and premature ejaculation. On 14 August 2010, eight months after the dose of Blinded vaccine, this 34-year-old subject developed multiple sclerosis. The subject was hospitalised. The subject was treated with gabapentin. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the multiple sclerosis may have been caused by investigational product and that the event was possibly due to the subject's medical condition of severe bilateral leg pain. Investigator Comments: Subject was hospitalized from 14Aug2010 to 18Aug2010 and diagnosed with multiple sclerosis. The patient has started taking gabapentin 300 mg TID and continues to follow-up with primary care physician. Prior to diagnosis, the subject had severe bilateral leg pain for several weeks. At this time, the subject does not authorize the release of medical records. Without having medical records for further information, the primary investigator feels that there is a reasonable possibility that the SAE may have been caused by the investigational product.
low grade fever; sore arm; stiffness in the neck and back; stiffness in the neck and back/became very stiff my back, very pain; could not get warm although she had 3 dawn comforters on overnight; headache; horrible gastro-intestinal upset; nausea; vomitting; dry heaving; became very stiff my back, very pain; Gastrointestinal upset; I cannot drink water; cannot do anything; Fever; felt really horrible; been up for the whole night; I just tremble; dry heat; I just do not feel well that is severe; I have been sick all night; terrible chills; began to get very swarthy injection site; shivering; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for COVID-19 immunization and experienced low grade fever, sore arm and felt little sore. On an unspecified date, patient experienced low grade fever, sore arm, began to get very swarthy injection site, stiffness in the neck and back/became very stiff her back, very pain, headache, terrible chills, could not get warm although she had 3 dawn comforters on overnight and was just shivering then in the middle of night woke up vomiting and went this nausea and horrible gastro-intestinal upset, dry heaving, cannot drink water, cannot do anything, fever, felt really horrible, been up for the whole night, patient just tremble, dry heat, patient just did not feel well that was severe and patient had been sick all night. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
After the vaccine brain fog. Apr2021 - bloodwork done - elevated CRP inflammatory, Elevated still. Aug 2021 in routine check ups. In August mammograms on right breast had a small lump and been removed and hv to get early stage - after removing it had cancer cells.
The patient sustained a small burn to the left arm 3/26, and was seen in burn clinic 4/15.  There was a local reaction to tape on the left arm around the burn site.  She was treated with a silver impregnated foam dressing, and given TDap immunization, uncertain of her immunization status.  She noticed a rash and itch the next day.  The rash maximized about 4/18, on face, neck, left peri auricular, chest, with scattered on arms and legs, not at the injection site.  A crusty rash formed on the burn site.  Today the rash has not subsided.
Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous report from a contactable nurse report for self. This 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, Expiry Date: Apr2021) Intramuscular injected in right deltoid on 24Jan2021 12:00 at single dose for COVID-19 immunization. Patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Diabetes surgically induced in 2013. None prior vaccinations within 4 weeks. She takes flu vaccine each year and never has any problems. None vaccines administered on the same date with BNT162B2. There were no concomitant medications. Patient got the first vaccine on 24Jan2021 and was fine. The next day on 25Jan2021 patient experienced discomfort on right arm injection site, and at 18:00, she was very tired, she wanted to just go to bed and not get up. On 26Jan2021 18:00, she started having a big echo in her right ear, the nurse considered "Big echo on right ear" was medically significant. She could hear herself talking to herself. Since then, she has a difference in her ears. She heard people from a distance if she closes right ear. Right now, it echo's so bad. She did not have a problem with her ear before the vaccine. The ear has improved but persisted. Some noises are intolerable and some are ok. She is going for second dose in 3 weeks. Workplace clinic visit on 28Jan2021. They looked at her ear and had no medical intervention. Events outcome was recovering. Relatedness of vaccine to all events reported "related".; Sender's Comments: By close temporal relationship and absence of factors which may provide an alternative cause the events reported as tinnitus, vaccination site discomfort and fatigue, may be attributed to suspect product BNT162b2;  the event vaccination site discomfort is consistent with the known toxicity profile of the suspect product.  The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), in Apr2020 as dose 2, single (Lot number: Er8735), in left arm and in Apr2020 as dose 3 (booster), single (Lot number: Ep6955) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Plaxovid from 02Apr2023 to 07Apr2023 for the treatment of COVID-19. The patient had no known allergies.
After administration, it was realized patient was a minor. After contacting mother, it was determined this was their 2nd flu shot this season. A first flu shot was given at the PCP office on 9-10-2021.
This spontaneous report was received from a pharmacist refers to a 64 year old female patient. The patient has had prior reaction to vaccines. On 27-APR-2014, the patient was vaccinated with ZOSTAVAX one time lot # J013135. On 27-APR-2014, 1 day after onset of therapy the patient experienced golf ball sized lump at the injection site. On 27-APR-2014, the patient also experienced redness and itchiness. The patient did not sought medical attention. The patient was told to take BENADRYL. The outcome of the event was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Pain down upper arm at time of injection and then continuous ache in shoulder and upper right arm with weakness and inability to raise arm above level of shoulders without increase in pain.
ED to Hosp-Admission Discharged   9/13/2021 - 9/18/2021 (5 days)    Last attending ? Treatment team Odynophagia  Principal problem Chief Complaint Patient presents with ? Chest Pain   Asymptomatic Covid infection -Patient could have contracted Covid from visiting her husband in the hospital for the past several days however this is unclear -Has received 2 vaccines in the past -Patient denies any fever, shortness of breath or cough, satting mid 90s on room air -- > currently no indication to start treatment for Covid infection -Supportive care -Incentive spirometry   Substernal chest pain -Most likely related to possible esophageal/gastric inflammation or ulcer versus ACS -Troponin 0.04, continue to trend,  -EKG 9/13: Sinus rhythm, occasional PVCs, supraventricular premature complex -Stress test pending -Echo pending given cardiomegaly noted on chest x-ray -Patient without any active chest pain on admission therefore heparin drip not initiated -Continue home aspirin and statin -Monitor on telemetry, EKG.   Odynophagia Unintentional weight loss -GI consulted, spoke to doctor 9/13, recommending esophagram which they have ordered -PPI IV for now -Hold home Pepcid as it is not working per patient -N.p.o. for esophagram   COPD -Stable -Became very emotional after she found out she had Covid and she was visiting her patient who is currently admitted to hospital and is concerned he may contract Covid from her as she did get some on his cheek several times in the past several days -Patient received inhaler treatment which resolved her dyspnea which was only because she became very emotional, she denies any shortness of breath in the past 1 to 2 weeks, occasionally has dyspnea on heavy exertion -Continue home inhalers   OSA -Nightly CPAP   Hypertension -Continue home amlodipine, losartan     o Nutrition: N.p.o. o VTE prophylaxis: Heparin o Full Code   Updated patient's daughter at bedside 9/13, she agreed with above plan.   Patient is an 77 y.o. female with history of COPD, hypertension, prediabetes, sleep apnea on CPAP, presents to hospital 9/13 with complaint of substernal chest pain burning in nature worse after eating meal however also states it radiates to left arm occasionally and started approximately 3 days ago.  Also states 5 to 7 pound weight loss in the past month.  Denied any lightheadedness or dizziness, palpitations or shortness of breath, confusion or headache.  Denied abdominal pain, nausea or vomiting, dysuria or hematuria.  Denied fever, cough or myalgia.  Has never had a EGD.  Denies NSAID use.  Had a C-scope many years back.  Denies any melena or hematochezia or hemoptysis or hematemesis.   On admission patient is alert and oriented x3.  Sitting calmly upright in her bed in no acute distress.  Daughter at bedside.  Denies any active chest pain during my evaluation.  On admission setting 94 to 95% on room air, afebrile, heart rate 94, blood pressure 142/103.
Swelling, redness, pain and itching at site of TRIPEDIA injection- (RIE suggested). Dr. stated to mom-mild reaction. Called 7/17/09 12N Mom says slowly better.
Information has been received from a nurse concerning a 11 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 18-JAN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M024261, expiration date, dose and route unknown) for prophylaxis. The vaccines were stored at 11.6 degree Centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree Centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1702USA010448.
Severe headache and fever lasted about 12 hours. Max fever was 102.7 until otc acetaminophen was taken. Moderate symptoms continued to the next day and was unable to work or manage daily routine. Other moderate/mild symptoms included chills, joint and body pains.
Symptoms began Saturday November 26th at two AM, they include up to 102 degrees, headaches, body aches chills slight congestion and then around eight PM the same I experienced confusion and ringing in the ears. Sunday November 27 2022 I took a home COVID-19 test that resulted in positive. On Monday 28 2022 I contacted my PCP who prescribed an antiviral I began taking the antiviral on Tuesday November 29 and began to see a reduction in symptoms by Thursday December first symptoms had dissipated other than a loss of taste and smell.
This spontaneous report as received from a registered nurse refers to 2 unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. The nurse reported that, on an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, expiration date and route were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
No adverse side effects reported; an expired dose of VARIVAX was accidently administered to a patient today, 1/20/23. The vaccine expired on 12/9/22; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 20-JAN-2023 (also reported as "today"), the patient was accidently vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), 5 milligram (mg), administered subcutaneously (sq), (lot # T041505, has been verified to be a valid lot number for varicella virus vaccine live [oka/merck] [VARIVAX], expiration date reported and upon internal validation established as 09-DEC-2022) for prophylaxis (Expired product administered). An sterile diluent was used to reconstitute the expired vaccine (lot# T018894, has been verified to be a valid lot number for the sterile diluent, expiration date reported and upon internal validation established as 02-MAR-2023).  No adverse side effects were reported.
Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes noticed eye sensitivity and headache. When symptoms did not pass after an additional 10 minutes she came back into the office. While waiting when her husband was checking her in, she "passed out." Episode lasted less than 1 minute.  She was easily oriented to person, place and time. It was noted that she had some swelling to bilateral eyes. Patient was brought back to room, VS were checked and all were normal. She denied any chest pain, shortness of breath, wheezing, tongue swelling, itching, or tickling sensation to back of the throat. She was able to tolerate sips of water without difficulty. 50mg benadryl IM was given in the left deltoid. Approximately 5 minutes after IM injection patient again "passed out." She was seated at the time and slumped to her right, resting her head on her husband and did not fall from chair. She aroused after approx 2 minutes, and was a/ox4.  VS were rechecked and were O2 99% on RA. HR 101, BP 124/88, RR20, temp 98.5/oral.  Patient stayed at the clinic for an additional 45 minutes after which her eyesight was reported to be back to normal, her headache had improved and the lower eye edema had resolved.   It should be noted that both the patient and the husband were not concerned with her "passing out." She states it happens because of pain and she was fearful of the injections. Patient also states that her neurologist told her that when "she is in too much pain, she will pass out."
102.2 degrees fever, chills, aches, lethargy, headache, sore throat, felt sick for about 21.2 day, took ADVIL, bedrest.
Bloody stools, crying spells, abdominal pain crumps, decreased appetite, diarrhea.  Per mom
patient has been breast feeding x 22 months, and has not had a menses.  2 days after her second Pfizer shot she got her menses and is concerned.
Information has been received from a consumer concerning a couple of her friend's children who were vaccinated with MMR II (lot# not provided) and other vaccines (unspecified) and were later diagnosed with autism. Upon internal review, autism was considered to be an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful.
Headache, Myalgia, Arthralgia, Fever,  Chills Narrative:
Within 24 hours the pt experienced an extremely painful left deltoid. Unable to touch and couldn't raise arm for more than 5 days, the arm was red with moderate achiness. The pt experienced malaise and felt like she had the flu. Lymphadenopathy - neck swelling, and pin with touch. The pt had swelling in the face and neck which lasted more than 5 days.
Ran a fever of 104 on 1/6/2021 and then miscarried the next day.
Vaccine event: higher volume given. Approx 0.6 to 0.65 ml given to patient for Janssen vaccine instead of 0.5 ml. Currently no adverse consequences reported.
Hot thighs and cold hands; no fever.  Fatigue.  Brief chills.   Took 2 Tylenol and went to sleep unusually early.
Left arm with redness from upper arm to elbow.  Warm to touch, some swelling noted.  To do cool compresses Ibuprofen and Benadryl.
Foot started hurting really badly; Regular aches; Foot almost feels swollen; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Foot started hurting really badly), PAIN (Regular aches), PERIPHERAL SWELLING (Foot almost feels swollen) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Foot started hurting really badly), PAIN (Regular aches), PERIPHERAL SWELLING (Foot almost feels swollen) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Foot started hurting really badly), PAIN (Regular aches), PERIPHERAL SWELLING (Foot almost feels swollen) and HEADACHE (headache) outcome was unknown.
Tachycardia ranging from 100 bpm to 120bpm ( possibly higher around 3-4AM 2/28/21) from 2/28 1AM continuing through 3/1/21 approximately 10:00pm.
Patient reports right arm obtained a quarter dollar sized red/swollen rash after receiving the ZOSTAVAX vaccination. Patient says rash seems to be worsening.
April 3, 2021, 4 weeks after my second vaccine, I  was admitted to the hospital then transferred to  another hospital with a the diagnosis of Lacunar Stroke.  I was told that I did not have the usual risk factors for a stroke.