chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.; This vial was removed from the freezer to the refrigerator on 9/2/22.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.), PRODUCT STORAGE ERROR (This vial was removed from the freezer to the refrigerator on 9/2/22.) 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. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2022, 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 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (This vial was removed from the freezer to the refrigerator on 9/2/22.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.), PRODUCT STORAGE ERROR (This vial was removed from the freezer to the refrigerator on 9/2/22.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (This vial was removed from the freezer to the refrigerator on 9/2/22.).    No Concomitant medication was reported.  It was reported that vial was removed from the freezer to the refrigerator on 9/2/22.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661812 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Non-Significant Followup received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661812:Bivalent Case
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), on 03Apr2021 as dose 2, single (Batch/Lot number: unknown), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "carrier of IPEX syndrome with unspecified immune deficiency that is thought to be related" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN; DULOXETINE; OTEZLA; PANTOPRAZOLE; TRULANCE. Past drug history included: Etanercept, reaction(s): "Known allergies: etanercept"; Celebrex, reaction(s): "Known allergies: Celebrex". The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 12Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12Aug2022) Positive, notes: Tested positive again on 12Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
to ED c/o fever, cough, fatigue, myalgias, abd pain, elevated D-dimer 8.1, + pneumonia, probability of PE; TX: remdesivir, decadron, rocephin, doxy, maxipime, vit c, inhalers, lovenox; develops encephalopathy, discharged.
Information has been received from a medical assistant concerning a 72 year old patient who in May or June 2007, was vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot # 655766/0038U).  In May or June 2007, the patient experienced severe pain at the injection site and swelling.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Had severe chills when I went to bed. Woke up around 1:45am with severe pounding headache, fever, body aches, heart racing. 911 was called for fear of getting worse, however vital signs were stable so I stayed home and declined visit to ER.  I had COVID in September
cold; allergies; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6203) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, Lot Number: EL9669, Route, Anatomical Location: Left arm), administration date: 03Feb2021, when the patient was 77 years old, for COVID-19 immunization; Shingles vaccine (Manufacturer: UNKNOWN, Lot Number: UNKNOWN), for immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "cold"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergies"; COUGH (non-serious) with onset 2021, outcome "not recovered", described as "cough". The events "cold", "allergies" and "cough" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypersensitivity, cough.   Additional information: During the vaccine supplemental form caller provided that she had went to the doctor because she had a cold, she didn't have COVID, she was tested for that. The doctor gave her a Z-pack and something else for her allergies. This was all around the time of her last shot, the 3rd vaccine. She then went back, and she got another Z-pack because she still had a cough, and they gave her prednisone. The prednisone was just so many days and then when she went to get her vaccine, they said to wait 2 weeks, so they had rescheduled her. No history/ Investigations. She was on a medication that they had rescheduled her vaccine because of, it was an antibiotic, they wanted to make sure that it was out of her system. The AE(s) did not require a visit to emergency room and physician office.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
started getting sick; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. Caller said she got her first covid vaccine shot last on 19Jan2021 and started getting sick. HCP asked her to get tested with covid and on 29Jan2021 results came out positive. Wanted to know if it is possible for her to get the second covid shot that is scheduled 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 29Jan2021. The outcome of the events was unknown. Information on Lot/ Batch number has been requested.
My arm was visibly swollen , hot to the touch, itchy, burning,  sore, and very uncomfortable. I am still having mild symptoms. I found relief in rubbing it with a roller ball.
Pt c/o blurry vision. Pt waited 60 minutes following vaccine and double vision is now occurring. BP elevated at 160/90 and 150/96. Co-worker to transport pt to ER. Patient was seen and discharged from the ED. Concern for anaphylaxis.
Infection at site of injection (redness, tenderness, itching, swelling).  Treated with oral antibiotics.
Severe chills started 17 hours after shot.  20 hours after shot my heart started racing really bad and I was very breathless.  I tried to sleep, but kept jolting awake and felt like I had quit breathing.  I was lightheaded.  Arm/neck/shoulders really sore.   Chills went away after about 7 hours.  The chills came back 5 hours later (April 1 at 10:00 pm).  When I woke up on April 2, I felt better, but was extremely exhausted.  I felt really "off" through April 4.  (Off meaning:  breath kept getting caught in my throat, bouts of lightheadedness, slight tightness in right side of chest)
Upper arm swelling and pain.  Pain reaching to shoulder and neck.  Swelling and warm to touch with black/blue where shot given. Continued deep tissue pain off and on in shot area for 1 1/4 years.  Want pain to go away.
Patient reports feeling "ringing in ears, head spinning, and vision going dark" on vaccine floor. Upon arrival to observation area at 1632, patient appeared pale, alert and oriented. Vitals 1635 HR-65, RR-18, BP- 101/39, Pulse ox- 99%, 1641 HR-72, RR-18, BP- 100/53, Pulse ox- 99%, 1645- HR-65, RR-18, BP- 100/58, Pulse ox- 100%, 1648 (while standing)- HR-64, RR-18, BP- 104/51, Pulse ox- 100%. Patient stated he felt better. His mother stated she felt comfortable taking him home. Patient left accompanied by mother.
3 days following receiving vaccines soldier developed generalized rash.  Over upper torso.  Prescribed cortisone cream from medical provider.
Information has been received from a health professional concerning her 21 year old daughter who was recently vaccinated with the first two doses of GARDASIL (dates and lot numbers not reported). After each dose the patient developed abdominal cramping, similar to menstrual cramps. Subsequently, the patient recovered from abdominal cramping after each dose (dates not specified by reporter). The patient sought unspecified medical attention. Additional information has been requested.
RASH 3.5 X 2.5 CM IRREGULAR SLIGHTLY RAISED PINK PLAQUE ON L THIGH PER DR. NOTE/EXAM
joint pain in the shoulders and knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain in the shoulders and knees) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included Cholesterol medication and High blood pressure medication for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ARTHRALGIA (joint pain in the shoulders and knees). At the time of the report, ARTHRALGIA (joint pain in the shoulders and knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Injection site red, swollen, warm to touch and itchy after injection. Resolved in 4 days then returned on the 13th day. Headache has also been experienced since vaccination. Injection was administered lower than normal. Will contact pcp if symptoms do not resolve in a few days.
Cough came back and has not gone away/cough to be dry a hacking cough; Got sick after second dose; Could hardly hold her eyes open, slept a lot.; Fever; Fatigue was worse than anything; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough came back and has not gone away/cough to be a dry hacking cough), ILLNESS (Got sick after second dose), SOMNOLENCE (Could hardly hold her eyes open, slept a lot.), PYREXIA (Fever) and FATIGUE (Fatigue was worse than anything) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High), Diabetic (patient had pre diabetic,) and Allergy to antibiotic. Concomitant products included VALSARTAN (DIOVAN) for Blood pressure high, METFORMIN for Diabetic.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COUGH (Cough came back and has not gone away/cough to be dry a hacking cough), ILLNESS (Got sick after second dose), SOMNOLENCE (Could hardly hold her eyes open, slept a lot.), PYREXIA (Fever) and FATIGUE (Fatigue was worse than anything). At the time of the report, COUGH (Cough came back and has not gone away/cough to be dry a hacking cough), ILLNESS (Got sick after second dose), SOMNOLENCE (Could hardly hold her eyes open, slept a lot.), PYREXIA (Fever) and FATIGUE (Fatigue was worse than anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Tested positive for COVID in December2020 to JAN2021. In January 2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID in December2020 to JAN2021. In April 2021, Body temperature: 102.8 (High) fever 102.8.         Concomitant medications include vitamins. Treatment to the events not reported. Patient felt COVID symptoms after both doses, was nervous  last week the cough did Wake her up in the middle of the night. Patient made an appointment with a pulmonologist and was allergies to antibiotics so almost did not get vaccinated but checked ingredients and was told it was okay.   This case was linked to MOD-2021-322465 (Patient Link).
7/12/11 Immunizations et WCC. Infant dev. vomiting that pm. To ER et f/u at office. 6 month male vomiting, diarrhea (blood tinged), irritability (cyclic 10-15 minute every hour) 6 day prior to admission. 2 days prior to admission sx improved. Day of admission sx aggravated and patient was admitted to hospital. Barium enema was done for intussusception seen on CT scan. Repeat Xray and sono showed recurrent intussusception that spontaneously reduced during observation in PICU. Patient was feeling well with no irritability and discharged on HD #2.
Myalgia, Fever, Chills Narrative:  Bed rest times 2 hours
Fever 101; instructed to take Tylenol per instructions on bottle. Soreness and swelling right arm, deltoid area, instructed to apply cold compresses. Oct 30, 2002, 14:45 temp 100, swelling decreasing. Oct 31, 2002 resolved per TC.
Feeling weak; Real bad headache; Terrible chills; Felt heart skip a beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (Felt heart skip a beat), ASTHENIA (Feeling weak), HEADACHE (Real bad headache) and CHILLS (Terrible chills) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE ABNORMAL (Felt heart skip a beat), HEADACHE (Real bad headache) and CHILLS (Terrible chills). On 02-Feb-2021, the patient experienced ASTHENIA (Feeling weak). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 02-Feb-2021, HEART RATE ABNORMAL (Felt heart skip a beat), HEADACHE (Real bad headache) and CHILLS (Terrible chills) had resolved. At the time of the report, ASTHENIA (Feeling weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included beta blockers.
Information has been received from a physician concerning a 4 month old patient with a history of prematurity at 29 weeks of gestational age who on 01-APR-2008 was vaccinated with the first dose of ROTARIX. No symptoms were noted. There was no product quality complaint. No further information is available.
This spontaneous report was received from a healthcare worker referring to a 10 week old patient of unknown gender. The patients; concurrent conditions and medical histories were not provided. On 22-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Past digestion issues, Chronic Fatigue, Muscle loss, bone/teeth weakening, joint problems.....feels like body has been under attack for many years. Possible Auto Immune disorder, aches, pains, no muscle gain in late 20s early 30s could be severe in 50s 60s....All from Anthrax shot when immune system was already compromised as I was in recovery from a hepatitis B infection....I have battled on my own naturally with no help for over a decade.
Hives commencing 10/22/12 (date of vaccine) and recurring 3 more times to date.
My dad started having breathing problems and heart fluttering shortly after getting his first covid vaccination on April 9, 2021. He had contracted Covid back in October 2020. He never told us he was getting the vaccination until we got a call on his cell phone from Public Health the day after he died of a pulmonary embolism. When he started complaining of symptoms, his doctor referred him to a cardiologist at a Clinic. He had an appointment with them a few days before he died. Apparently, they didn't find any blood cllots, possibly because they were looking for heart issues. Either way, I believe that my dad died from side effects of the Moderna vaccine. My dad died on May 1, 2021 of a pulmonary embolism. The coroner and County Sheriff both said it was one of the biggest blood clots they had ever seen.  Since he had no history of blood clots, I thought it important that I report it.
This spontaneous report was received from a pharmacist, refers to a female patient in her 60's, via marketing research program, conducted by the planning shop, international. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with the first dose of ZOSTAVAX (strength, dosage and lot# were not reported). Concomitant therapy was not reported. The pharmacist informed that on an unknown date, the patient experienced injection site reaction, which was described as, red, itchy and inflamed. The outcome of the events was reported as recovering at the time of this report. Additional information is not expected because the reporter did not wish additional contact.
Fast heartbeat; Weakness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat), ASTHENIA (Weakness), FATIGUE (Fatigue) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat), ASTHENIA (Weakness), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, HEART RATE INCREASED (Fast heartbeat), ASTHENIA (Weakness), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
PT COMPLAINED OF THROAT SWELLING. NO ACUTE DISTRESS AT TIME OF COMPLAINT. WAS ESCORTED BY NURSE TO ER FOR EVALUATION AND OBSERVATION.
Eleven days and 10 days after #1 and #2 FLUMIST, developed hard barking cough in early AM hours. Fever up to 101 degrees at highest. No body aches, HA. PMD. Breathing tx's initiated, TID x 2 days, then BID x 2 days. Client recovered after 4 days. No further tx or medication needed. Like breathing "through a straw". No other family members ill.
64 yr/o  male past medical history of follicular lymphoma in remission  Fully vaccinated/boosted  Here today with chief complaint of cough shortness of breath all over body aches and dyspnea at rest, he is brought in by his daughter who is a pharmacist. she noted resting pulse ox of 91% and at that point decided to bring him in anticipating need for admission    He was first diagnosed January 6 so 10 days previously, has had a steady course of cough and fatigue with a dyspnea on exertion seems to have worsened in the last day or so.    His chest hurts from coughing, all over body aches and headache, decreased appetite increased burping  Has been taking a baby aspirin daily since his diagnosis   Hospital Course: Patient is a 64-year-old male who presented to the hospital complaints of fatigue and shortness of breath.  He was diagnosed with COVID-19 prior to admission and had been progressively getting more short of breath.  He had been vaccinated against COVID-19 and received his booster although given his history of B-cell lymphoma, he does have some immunocompromise state.  He was somewhat hypoxic on admission and was on oxygen temporarily during his hospital stay.  He was started on IV Decadron and Remdesivir with improvement of his symptoms over the next 24 to 48 hours.  He was weaned off of oxygen prior to discharge and a 6-minute walk did not show that he had any significant hypoxia, however he does get hypoxic at night when he sleeps and I feel that he would benefit from a short course of oxygen temporarily until he is fully recovered from his COVID-19 infection.  He will be discharged home on a course of Decadron as well and will be referred to the virtual hospital.
PT felt  hot and itching. Redness to right arm, ears and face.  Diphenhydramine 50mg/ml  IM given  RD.  After Diphenhydramine was given and 30 min of observation.  Client was free of reaction.
I developed a significant rash 3 days after my second Moderna vaccine. The rash began on my thighs and groin and have spread to my torso front and back. The rash then spread to my elbows and my calves. I also have a round rash several inches from the injection site.  The rash is consistent with previous rashes I have after a systemic reaction to something I've eaten of been exposed to, Typically I can trace a rash to a new supplement or body lotion, This time I have no other suspect beyond the vaccine as I have not taken or applied any new supplement or cream in the last 2 months,
4 days post yellow fever and Hep A vaccines she developed red itchy nodules at vaccine sites.
10/23/02 Diagnosed with PDD NOS. On 8/20/02 spun in circles on 3 occasions. Speech became delayed. At 18 mts - 2 yrs Mom had noted hand flapping and repetitive behaviors.