chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called today describing not feeling well right after she left our store. She had some breathing difficulty, hand swelling, heart irregularities and dizziness. She said that today 11-22-06 she is feeling better. I recommended that she see a physician if needed. Symptoms ended.
Pt had a sore and dry throat, with minor swollen lips for few minutes and blisters in her mouth
low grade fever; muscle weakness with 12 hours of getting their first shingrix vaccine; This case was reported by a non-health professional via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced fever and muscle weakness. On an unknown date, the outcome of the fever and muscle weakness were unknown.   It was unknown if the reporter considered the fever and muscle weakness to be related to Shingrix.  Additional details were reported as follows: Caller reported adverse event for a patient who got their Shingrix vaccination. Caller stated the patient developed a low grade fever and experienced muscle weakness with 12 hours of getting their fist shingrix vaccine. The reporter did not give consent to follow up.
7AUG92 mom reported mom reports she called MD; lt arm red, pt had fever; mom said gave APAP pt acting strange;
This spontaneous report was received from a pharmacist via company representative concerning to a 21-year-old female patient. The patient's concurrent conditions, medical history, drug reaction or allergies and concomitant medications were not reported. On an unspecified day in 2007 (reported as 12 years ago), the patient received a dose of GARDASIL (dose number, route of administration, lot# and expiration date were not reported). The pharmacist stated that he heard about a court case where the female patient died from arrhythmia after the administration of GARDASIL. It was unknown if an autopsy was performed. No additional information was provided. The causal relationship between de patient's death and GARDASIL was unknown.; Reported Cause(s) of Death: developed a heart arrhythmia that caused death.
Pain and swelling at injection site, 1cm x 8cm Red streak extending down left interior bicep and approx. #6 1-2 cm diameter red spots along medial / external bicep.  Streak and spots are painful but not itchy, reported to be warm yesterday but not today (2 days post injection).  Streak and spots are not raised and have diffuse edges, they appeared about 8 hours after injection and were dark red in the beginning fading to lighter red over the next 48 hours.  This was patients 2nd dose of Shingrix, she reported no adverse effects from the first dose.
This is a 82-year-old male with past medical history of hypertension, hyperlipidemia, type 2 diabetes mellitus, COPD/emphysema with chronic hypoxic respiratory failure requiring 2 L oxygen via nasal cannua every night, obstructive sleep apnea on CPAP every night, paroxysmal atrial fibrillation not on chronic anticoagulation due to history of intracranial bleed in 2020 , sarcoidosis, resident of assisted facility. He has been having symptoms for the last 2 days with cough and shortness of breath. Major symptoms the cough without any significant expectoration. He denies any subjective fevers but does have some chills. Denies any loss of taste or smell. Denies any chest pain or palp 8/14/2021 tested positive This is a 82-year-old male with past medical history of hypertension, hyperlipidemia, type 2 diabetes mellitus, COPD/emphysema with chronic hypoxic respiratory failure requiring 2 L oxygen via nasal cannula every night, obstructive sleep apnea on CPAP every night,  He has been having symptoms for the last 2 days with cough and shortness of breath. Major symptoms the cough without any significant expectoration. He denies any subjective fevers but does have some chills. Denies any loss of taste of smell. Denies any chest pain or palpitations. Denies any abdominal pain, nausea, vomiting, burning or panful urination, diarrhea. Patient reports that he has been vaccinated with Pfizer vaccine in March and April respectively.
sweats; low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (sweats), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 was not applicable
This spontaneous report was received from a consumer (patient's mother) refers to a 14 year old male patient. The patient's concurrent conditions included eczema and asthma. The patient did not have any drug allergies. On 22-OCT-2014, the patient was vaccinated with GARDASIL dose 1, intramuscular. (lot number was not reported). There was no concomitant medications reported. On an unknown date in November 2014 the patient was diagnosed with molloscom. The reporter stated that her son developed rash in November 2014. The patient had sought medical attention by consulting a dermatologist and a pediatric eczema specialist. The patient was treated with prednisone for the event. A wound culture, blood and skin testing were done on unspecified dates and the results were not provided. The patient received the second dose of vaccination on 22-DEC-2014. The rash got really bad by itching and bleeding and it had spread to the child's torso and extremities on 30-DEC-2014. There was no product  quality complaint involved. The outcome of molloscom was reported as recovering at the time of the report. The causality of the event was not reported. Additional information has been requested.
t104.9 on second day p/vax;local tenderness;pt did not walk x 24hr;
LIVER ISSUE/NUMBERS HIGH; STROKE; This spontaneous report received from a patient concerned a 63 year old male ,unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown ,expiry :unknown ) dose was not reported,one total, administered on 02-JUN-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number:Unknown ,expiry: Unknown ) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis; and methotrexate ( batch number: unknown expiry:Unknown, form of admin, route of admin, and were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  No concomitant medications were reported. On 06-JUN-2021, the patient experienced stroke. On an unspecified date, the patient experienced liver issue/numbers high.  Laboratory data (dates unspecified) included: Liver function test (NR: not provided) Numbers high (increased). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with adalimumab was not reported; and treatment with methotrexate was withdrawn. The patient recovered from stroke on 2021, and was recovering from liver issue/numbers high. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210726698-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Diagnosed with cancer; This case was reported by a other health professional via call center representative and described the occurrence of cancer in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cancer (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The patient was diagnosed with cancer and was in the hospital for a while. On 11th November 2019, the patient received 2nd dose with batch number P57AA and expiry date 5th July 2021, a year apart from the first dose due to the events. The reporter was not sure if the patient was immunocompromised or not.  No further information was available during call regarding cancer type or hospital details. The reporter inquired about regarding administration of a 3rd dose of Shingrix but didn't stated would administer a 3rd dose. The reporter consented to follow up.
Approximately 14 hours after receiving dose, I experienced pain under my armpit in my lymph node area.  I understand this is a common side effect; however, the severity of the swelling seems a bit extreme.  I have a visible tennis ball size lump under my arm that is tender to the touch.  The lump is the texture of a breast and is not thick or lumpy.  It is extremely uncomfortable to wear a bra or put arm down.  Also extremely uncomfortable to walk/run, as the lump shifts with motion causing discomfort.  I also had severe swelling to the lymph nodes after the first and second doses of the Pfizer vaccine that lasted for approximately 10-14 days.    I am aware this is a reported symptom; however, I wanted to report the severity and extent to which I am experiencing the symptom.  I do not feel the need to contact medical provider as this subsided within 14 days for my first two doses.  Did not have any long term effects.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 3 (booster), single (Lot number: EN5318) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ED140, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: SWELLING (non-serious), RASH (non-serious) all with onset 04Feb2021, outcome "recovered with sequelae" and all described as "Swelling and painful rash for about a week around the area". The events "swelling and painful rash for about a week around the area" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of swelling, rash. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Dietary supplement within 2 weeks of vaccination. The patient experienced Swelling and painful rash for about a week. Around the area. The pain on my left arm never stopped and still going on worse than ever. Prior to vaccination, The patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. Patient has no other medical history.
After administration of vaccine, we were notified by local Authority that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  As of this report, the patient has not come back for revaccination.
This report refers to a 42 year old female with a medical history of mitral valve prolapse since she was ver young, possibly a result of rheumatic fever. Now she has a prolapse with regurgitation. The pt has yearly echocardiograms, which now show slight thickening on the mitral valve leaflets. There were no concomitant medications reported. The subject received the first doses of havrix and Engerix-B on 09/18/2001. She received the second dose of Engerix-B on 10/16/2001. The subject complained of increasing fever and cough that lasted "for months." On 02/04/2002, the subject had blood cultures drawn which, as reported by the pt, grew streptococcus viridans. She was admitted to the hospital on 02/07/2002 for treatment with intravenous gentamycin and vancomycin. She was discharged on 02/11/2002 on oral ceftriaxone sodium. The subject's symptoms returned and she was readmitted on 02/21/2002 for treatment with vancomycin. She was diagnosed with bacterial endocarditis of the mitral valve. She was discharged on 02/25/2002. As of 03/14/2002, the event was reported as ongoing. An echocardiogram done on 03/19/2002 showed similar results to the one done in February, which showed bacterial endocarditis of the mitral valve. The investigator reported the vaccine possibly contributed. He clarified that there was no direct evidence for vaccine or vaccine administration as the cause of endocarditis, yet a possibility exists that the injection seeded the bloodstream in a person with preexisting mitral regurgitation. He could think of no way, short of contamination, to implicate the vaccine.
On 12/29/2022, I started experiencing some leg pain. I thought it was due to extensive walking. On 12/30/2022, I rested all day. On 12/31/2022, I also stayed home. By the evening of 01/02/2023, the pain was getting bad, but I still thought it was due to extra walking. From 01/01/2023- 01/03/2023, I was completely resting. I treated with Tylenol twice. The pain slowly started to wear off. When I took the Tylenol, I could feel the leg pain going away, but still had joint pain. By 01/05/2023, I was still having terrible joint pain. It was to the point that I could feel pain in each and every toenail and other joints. By 01/07/2023, the pain spread to my elbow and my hands. I am unable to lift anything with my left hand due to the pain in my hand and elbow. By Saturday evening, my right hand was feeling the same way. When I take over the counter medication, it eases for two to three hours, but once it wears off, the pain comes back. The pain is way worse in the night. I can't sleep or turn over. Mid-day is the best time of day, but I'm still feeling pain. By Tuesday evening, I had taken lots of Tylenol. I was taking it every six hours. I was able to feel my right hand again by that point. Today is the first day I have been able to return to work from the pain and I was only able to work partially due to the pain in my left hand. Today is better than the last four days. My dad provided me a medication for joint pain that he brought from another country, and it helped me a lot for three to four hours. However, now again, it's evening time and the pain is returning. I went to my doctor on Monday. She recommended some blood work and advised that I take only Tylenol until the blood work is back. She also explained some exercises that should help. They are helping but the pain is still there. I called my doctor's office when I saw that my results should have been in. The nurse in her office stated that the blood results looked alright and there was nothing she could do. She believes the pain is vaccine related and advised that I take no more COVID-19 vaccines and continue with the Tylenol and exercising. However, I am in terrible pain and cannot do my daily activity.
Pt inadvertently given ROTARIX via intramuscular (IM). Pt returning to office 10/8/15 to revaccinate ROTARIX PO
On evening of 10/27/14, pt reports injection site being very sore to touch. On 10/28/14 pt reports unusually large knot and redness at site. Reports symptoms gone by 10/31/14.
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of pruritus (itchy back) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included patchy rash (dry patches on his back from before the vaccine). On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pruritus (itchy back). At the time of the report, pruritus (itchy back) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications and treatment information not provided. Patient had an itchy back that did not come from the shot according to his doctor, since he had dry patches on his back from before the vaccine. This case linked to MOD-2021-379265, MOD-2021-379259 (patient link).
Headache, similar to a sinus Headache. Lasting approximately 24hrs Higher heart rate overnight, the night of the shot, 85 vs an average around 55. Hives covering neck and chest. Still bright, but not bad at joints at this time.  Lasting ?24hrs.  Similar symptoms as first shots, but more intense.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received SHINGRIX for prophylaxis. On 21st September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 23rd September 2018, the patient experienced injection site lump and injection site erythema. On an unknown date, the outcome of the injection site lump was not recovered/not resolved and the outcome of the pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site lump, pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient experienced soreness but then two days later a lump appeared on the injection site and it grown until it was a golf ball size and also red. It was appeared to be getting bigger. The pharmacist did not want to provide the date of birth for the patient. The pharmacist transferred to MI for additional assistance. This case linked with case US2018173608, reported by the same reporter for the same patient (for 1st dose of SHINGRIX).
arm became swollen and red, hot and itching for 10 days, then I started to forget or could not put words together (I knew what I wanted to say but could not find the correct words), extremely tired all the time, sleeping for hours, taking 2 or 3 naps a day, head began to "feel funny" like my brain was swelling but no headache, diastolic pressure was consistently high (86, 90, 100) systolic was around 110 to 105.  Passed out and hospitalized on Feburary 1, 2023.  Went to ER  February 14, 2023 feeling weak and dizzy with high blood pressure which was 181 over something at admittance and at release 155/76.
Consent Form populated with wrong birthdate in system indicated that patient to be 13 yrs old. So Pfizer adult dose(0.3ml) was administered as 1st dose of Pfizer on 2/17/22.  (Actual correct birthdate was (10 yrs) No sign of adverse event found when I was talking to Patient's Dad on 3/11/22 (we happened to find out on 3/10/22 when they came for 2nd shot.  Pt's dad recall was that patient only had mild sore arm, headache, low grade fever next day but all cleared up within 2 days==as common side effect for most of people.
MYOCARDITIS; This spontaneous report received from a consumer concerned multiple patients of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient's 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, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient's died from myocarditis. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  This case, from the same reporter is linked to 20230762281 and 20230756395.; Sender's Comments: V0: 20230754574- myocarditis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: MYOCARDITIS
Patient had been having normal side effects (fatigue, chills, body aches, mild headache) until late on 11/04/2021, around 10 PM.  His headache started to worsen.  He was sleeping and would wake up from the extreme pain.  He is a migraine sufferer, and said this pain was far worse than any migraine he has had.  He continued to wake up at 15-30 minute intervals and would complain of skull-splitting pain for at least 10 minutes each time.  Then, the pain would suddenly lessen and he could return to sleep.  This continued at increasing intervals of time until about 3 AM, then he slept through the rest of the night and woke with a mild headache.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received Moderna vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 12:41 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Feb-2022 at 12:41 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
Pt seen in ER day after vaccine given for local rxn at site of vaccine. Tx was ice and Tylenol.
Patient reports having her period and spotting for 3 weeks after her first dose of the Pfizer vaccine. She states that her period is always regular and it was not due yet, but started after the day she received her vaccine.