chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Agency and Clinic  that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility . The website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
After my first covid shot, my periods became immediately irregular. My periods have been extremely regular since starting at age 13. After the second covid shot, they continued to be irregular. After the third covid shot they became increasingly spaced apart, with the added symptoms of extreme fatigue, muscle weakness, nausea, constipation/diarrhea, headache, "brain fog", and weight loss in the 1-2 weeks leading up to my period. I have never had PMS symptoms like these before my booster shot.
Unstable diabetes mellitus; abd pain, n/v, generalized rash; pt hospitalized 3NOV cholecystectomy
flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) experienced flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of report.  There will be no information available on the batch number for this case.   Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) experienced flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of report.  There will be no information available on the batch number for this case.
body ache; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LCOA) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy, Food allergy, Thyroid disorder and Palpitations (due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM SUPPLEMENT WITH VITAMIN D) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever). At the time of the report, MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mentioned as Cilnidipine extended. No treatment information was provided by the reporter.
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An infant female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient swelled and turned red in seconds/ redness. It was also reported that the patient experienced 'hot and heat' (pending clarification). The patient was told to go home and put ice in the leg which later in the day was reported fine just leaving the area red. The outcome of the event 'turned red in seconds/ redness' was unknown; all other events was recovered on unspecified date. Information on the batch number has been requested.
8/12/2022: Soreness 8/13/2022: soreness, inflammation, redness at injection site, Tiredness, slight headache 8/14/2022: soreness, inflammation, redness at injection site, Tiredness, slight headache 8/15/2022: nausea, soreness, inflammation, redness at injection site,, 8/16/2022:  soreness, inflammation, redness at injection site, slight headache 8/17/2022: soreness, inflammation, redness at injection site. Swelling is approximately the diameter of  a nickel and slightly raised.
Severe fatigue. Sore throat. Sniffles. Phlegm in lungs.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent condition were not provided. On unspecified dates ("sometime") in October 2015 and November 2015, the patients might have been received possibly improperly stored PROQUAD (Merck) injection (lot number L031602, expired date 18-FEB-2017, dosage, strength and route were not reported). No symptoms were reported. The nurse also inquired for the temperature stability data. This is one of several reports from the same reporter. Additional information has been requested.
I did not have a reaction to the vaccine.  On 09/15/2022 I started to not feel well with a severe cough and feeling fatigued. On 09/16/2022, I tested positive with a home test for COVID-19. I went to an urgent care facility and had a test to confirm that I had COVID-19. I was given a prescription for Paxlovid. I felt really bad for about 5 days and stayed home in bed. The coughing and sore throat stopped in about 5 days. It took about a month before I started to feel more like myself.
Mother received VARIVAX on 9-27-2008 around birth of child. Mom broke out with 2-3 lesions1 week later. Child broke out chicken pox rash 3 weeks later. child's mother at 5 weeks of age. Mom had rash, left wrist and center back.
2 hours after receiving the vaccine, patient noticed blochiness  on chest and fever.  Last 2 hours and the went away.
Headache Mild arm soreness, and discomfort ,chills, fatigue, body aches, nausea. Narrative:
Body aches, chills, low grade fever for  24 hours for both COVID vaccine doses. Improved with rest, fluids, and DayQuil. Of note: as of 3/14 I am 6 weeks pregnant. Did not know I was pregnant at time of vaccination. No birth defects or congenital abnormalities known currently.
This spontaneous report as received from a registered nurse refers to a 19 year old male patient. Patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL, injection, 0.5 ml, intramuscularly. No concomitant medications were reported. On an unknown date the patient experienced an episode of syncope, accompanied by seizure-like activity (medically significant) and foaming at mouth which lasted briefly for only 10 seconds immediately after receiving the first dose of GARDASIL. At the time of the events, patient was in office and hence sought medical attention. No laboratory studies were performed. Patient lifted legs up to increase blood flow to head, as treatment for the events. It was decided that the patient would not continue the series of vaccination due to the events and hence he did not receive any additional doses of GARDASIL. Patient recovered from all the events. Causality assessment was not provided. Upon internal assessment seizure was considered to be medically significant. Additional information has been requested.
The patient had a couple hours of chills; felt like I was having a severe flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation, reaction(s): "soreness at the injection site with his arm being a little bit sore that evening". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "The patient had a couple hours of chills"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "felt like I was having a severe flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a couple days of fever and body aches which did subside.  But i am having persistent fatigue, pain on the whole side of the body of the vaccination, shortness of breath, inability to do my normal physical activities because of elevated heart rate and shortness of breathe.
Intermittent double vision side to side starting in mid June with right eye wandering out, Previously right eye would deviate only when tired. Vision worsened in July 2021 with much more pronounced strabismus and double vision prompting visit to ophthalmologist, Doctor., on 7/23/2021. Exotropia noted to be acute, severe, and very atypical; sent to the emergency room the same day for an MRI/MRA of brain, which ruled out acute third nerve palsy. Past medical history of Graves' disease more than 25 years ago noted. Condition has worsened and thyroid eye disease (TED) was diagnosed on 9/13/21 with elevated thyrotropin receptor antibodies. I have now been referred to a TED clinic for management.
Patient administered vaccine 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 (Patient administered vaccine after the manufacture date of expiration) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine 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.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
Unbearable pain in the right arm.  Unable to move arm, felt like a broken arm.  Pain radiating down the arm and up over neck and shoulders. Dr.s  office was called, they called in a muscle relaxer and precscribed a X-ray,   which I refused.
Two raised, reddened areas on left inner wrist and right upper forearm that expanded over time.  Also itched.
The pt received the MMR vaccine on 4/21/00. The pt developed a hard area around the injection site post 6 days. The pt made doctors appointment, site of vaccine injection was 4 x 5 cm area of erythema and induration. No fluctuance or axilla. Doctor determined pt developed cellulitis post vax. Pt refused IV antibiotics, prescription written for oral Cephalexin.
Pt recvd 3 booster doses of Engerix-B & was determined to be a non-responder;
acute cerebellar ataxia; vomiting; rectal temperature of "101" was recorded; it was mentioned that patient might have a viral infection; This spontaneous report was received from a physician via employee, referring to a 12-month old male patient. The patient's medical history and concurrent condition were unknown. Concomitant medication included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR).    On 01-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. Other suspect therapies included sterile diluent.   On 15-SEP-2020 (reported as about 2 weeks after vaccine administration), the patient experienced acute cerebellar ataxia and he had a hard time standing with unsteady gait. On an unknown date in September 2020, patient's mom reported to the physician that patient was vomiting. The physician referred the mom to an urgent care. On 18-SEP-2020, the patient visited urgent care, and then went to the emergency room (ER), possibly on the same date as 18-SEP-2020. In the ER, rectal temperature of 101 (unit unknown) was recorded. It was mentioned that patient might have a viral infection. A computerized axial tomography (CAT) scan was done at unknown date in September 2020, which turned up negative. Patient was sent home after CAT Scan. Patient's parent contacted the physician again, and physician recommended seeing a neurologist. On an unknown date in September 2020, the patient was admitted to the hospital where a virology panel would possibly be done. It was unknown if patient was still hospitalized. The outcome of all events was unknown. The causality between all events and suspect drug was not provided.
Diffuse, itchy erythemic rash to left upper outer arm Prednisone 40 mgs daily x 5 days F/u visit scheduled for one week
NAUSEA, STIFF NECK, FEVER, BODY ACHE, TENDER ARM,  NO APPITITE
Pt came to receive his booster shot (3rd)  for COVID-19, but is inadvertently received PFIZER-BIONTECH vaccine instead of Moderna vaccine . Pt was informed by nurse manager and was in observation area for 45 minutes. Pt denies any pain and discomfort.
Rec'd Menactra vaccine 8/1/07 developed tactile temperature and redness (evening) 8/2/07 seen in our office 8/3/07 Diagnosed with cellulitis post reaction to Menactra. Treated with Keflex
When I got the vaccine that's when the pain started in both shoulders. That was on Feb 4th 2021. The pain never went away. I went to the doctor a few months later that is when she gave Ibuprofen. The pain did not go away that is when my doctor gave me Cortisol shot. The shot does help a little.
The pt complained of both arms hurting, joint, muscle and bone pain. Can't lift heavy stuff. Finger joints also hurt.
SEVERE BODY ACHES; BOOBS GOT BIGGER; PAINFUL PERIOD; NUMBNESS IN ARM; MILD PAIN IN ARM; CHILLS; JOINT PAIN; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 patient experienced severe body aches, boobs got bigger, painful period, numbness in arm, mild pain in arm, chills, joint pain, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild pain in arm, severe body aches, and joint pain, and the outcome of chills, mild fever, boobs got bigger, painful period and numbness in arm was not reported. This report was non-serious.
Back and right hip pain and small rashes on right side, ended up diagnosticated with shingles.
2 days after injection, clients mother called to report child's arm red, hot and hard and swollen almost down to elbow.  Mother also reports she did place ice on the arm just 24 hours after injection and moist heat 2nd 24 hours after injection.  Client referred to PMD.  PMD reported 9.5x10cm area of redness and swelling and heat.  Supportive care recommended.
Pt was well 3JUL91 when immun given; fever w/sz occurred about 3 hrs later & was seen @ ER; 2nd sz occurred @ 12 noon 4JUL91 & pt was again seen @ ER; Pt seen again 5JUL91 by MD;
Patient developed swollen tender left shoulder about 4 hours after shot. Also had intermittent fever, chills, myalgia and skin sensitivity for about 24 hours after shot but felt better by day 4.
Troponin-I protein was 5.25 and is really high; heart beat is very fast cannot be down less than 110; felt very hard to breathe/breath become short; get tired; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Mar2021 as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date a few days after vaccination, patient reportedly felt very hard to breathe as her breath become short and she get tired very fast. On 30Mar2021, patient's Troponin-I protein was 5.25 and was really high and it was really dangerous for her life, her Troponin-I protein was normally 0.04; patient's heart beat was also very fast and cannot be down less than 110. The events "troponin-i protein was 5.25 and is really high" and "heart beat is very fast cannot be down less than 110" was reported as serious since it caused hospitalization; event "troponin-i protein was 5.25 and is really high" was also reported as life-threatening. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Patient received second anthrax shot on November 13, 2002. Patient noticed local reaction November 14, 2002. Reaction characterized by swelling of 5.5in redness, pain, and pruritis also present. Joints in arm feel stiff to patient, especially elbows.
No adverse event; Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Our medical organization administered a Moderna Bivalent vaccine that was 2 days past expiration).    This case contains information for the 2nd of 2 patients described by the reporter.  No concomitant drug was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had been administered a Moderna Bivalent vaccine that was 2 days past expiration.  The vial was un-punctured and was in the freezer until the day it was administered.  No prior temperature excursion.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730343 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730343:Patient 1
Severe swelling and redness surrounding right thigh site. Treatment: Ice, Tylenol and follow up with physician in 24 hrs.
terrible chills, fever 102-103, uncontrollable shaking for all that night , nausea, headache, fatigue took ibuprofen, stayed in bed. fever lasted 2 days. nausea lasted thru 1st night, headache and fatigue  lasting 3 days.
Joint pains throughout body Slight fever Injection site pain Swelling under left arm pit and along the left clavicle