chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received expired vaccine administered >12(US)/ hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12(US)/ hours post puncture) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12(US)/ hours post puncture). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12(US)/ hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.  The vial was initially stored in the refrigerator on 29-Oct-2021 and was first punctured on 13-Dec-2021. Therefore total amount of time the vial was exposed to room temperature was 17.5 hours.   This case was linked to MOD-2021-414574 (Patient Link).
patient complained of tingling in lips & tongue. Vitals taken; airway checked - no signs of swelling.  Onset @ 1235, 8 minutes after injection. Lasted for ~ 10 mins then subsided.  No rash/itch. Agree with assessment unlikely to allergic rxn
On day seven after receiving the vaccination, a rash appeared on the back of the neck that progressed around the entire neck by day eight.  On day nine rash appeared on the back of both arms and significant left arm pain distal to the injection site accompanied by inflammation.  The inflammation appears to be present all over.
Serum Sickness: Hives, nausea, vomiting, lymphadenopathy, swelling of hands and feet, angioedema.
I haven?t had vertigo before this, but I believe I had an episode of vertigo - the room spun around me, I felt nauseous and like I might faint, and I had a headache  (not terrible) for the rest of the day.
Symptoms began with headache, blurred/distorted vision, tingling sensation on left side of body, numbness in face. Proceeded to tightening of muscles on right side of body. Speech was impaired. Exhibited stroke like symptoms. Went to ER, CT scan was done. Was admitted to hospital. MRI was done following morning. Approx. 5:00 pm, was discharged and went to Medical Center. Had lumbar puncture. All tests came back fine. Was referred to another Medical Center for further testing. Still do not know what happened, no diagnosis. Nothing has come back on any of the testing.11/12 and 11/13/2009 ED, MR for DOS 10/27-10/28/2009, Pt c/o headache, blurred vision, tingling, weakness of extremities, slow speech and unsteady gait.  Neuro exam abnormal. Impression: Neurological spell.  12/1/2009 Lab test results: ASO titer: 211 IU/ml: normal.   01/12/10 MR received for DOS 10/28/09. Pt c/o numbness of L side of body and weakness, peripheral vision problems, confused, difficulty ambulating, headache, slow speech. On neurological exam: normal. Dr. considered this event as possible underlying seizure.  Pt scheduled for EEG to evaluate possible sz.
I am too sick; Lips are numb; Excruciating headache; Have rash on parts of my body; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that patient was too sick, lips was numb, excruciating headache, had rash on parts of body. The clinical outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Generalized urticaria that later evolved into dermographism. From the start date to the date of this report the patient has to take a 10mg ZYRTEC every 24 hours because otherwise the symptoms return.
Arm was swollen from shoulder to elbow, red and warm to the touch. Also reported fever.
red, swollen, hot, solid rash from shoulder to elbow  coming on 1 week after injection lasting one week.  Still itching.
Numbness in hands and feet ankle and joint pain and tingling in toes neck pain and stiffness eye sight problems fatigue rash nightsweats nightmares balance and clumsy ? ear ringing and buzzing.
HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fever was not reported. This report was non-serious.
times are approximate unless otherwise noted: 10/8 1:30pm injection received 2:00pm facial itching began 7:00pm noticed redness on face and neck in same locations as itching (sides of nose, and around mouth), applied topical hydrocortisone 1% to areas itching 8:00pm redness appeared as hives covering chest, neck, and face from forehead to chin, more hydrocortisone applied 10:00pm took first dose of Benadryl  10/9 3am awoke b/c of discomfort (itching), hives worsening in appearance locations the same, both eyes had swelling around eyes especially upper eyelids - took second dose of Benadryl  7am puffiness around eyes slightly decreased but rest of face appeared puffy as well. Hives remain on chest, neck, and face. took 3rd dose of Benadryl. reapplied hydrocortisone topical. 10am hands began to shake, face, neck and chest, noticeable redder, and facial puffiness was increasing 10:30am phoned on call nurse line - advised to seek medical care within one hour. 11:15am arrived at urgent care center 12:50pm seen by doctor. Given 12mg Dexamethasone in clinic, advised to take Zyrtec up to 3 times daily until reaction resolved Symptoms improved with medication, but not resolved. 10/10 facial itching and redness from chest up to forehead remains.
Pregnant; throat felt uncomfortable to swallow; throat felt uncomfortable to swallow; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable to swallow) and DYSPHAGIA (throat felt uncomfortable to swallow) in an adult female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (3 drinks monthly). Concurrent medical conditions included Environmental allergy. Concomitant products included SUMATRIPTAN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 18-Jul-2020 and the estimated date of delivery was 19-Apr-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable to swallow) and DYSPHAGIA (throat felt uncomfortable to swallow). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYTREC) at a dose of 1 dosage form. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), OROPHARYNGEAL DISCOMFORT (throat felt uncomfortable to swallow) and DYSPHAGIA (throat felt uncomfortable to swallow) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Blood glucose: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants: Prenatal vitamins was reported Estimated date of conception was 27 Jul 2020.
Scratchy/itchy throat. Benadryl given. Feeling mostly normal by 3pm and discharged.
SPOT ON MY FOREARM POP UP; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced spot on my forearm pop up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spot on my forearm pop up. This report was non-serious.
Provider ordered in error and patient was given the Pfizer/BioNTech monvalent as a booster.  No adverse reactions to the vaccine.    We do not have the Bivalent available yet.
yearly vaccine; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2110USA007820), concerning an approximately 60-year-old male patient. Concurrent condition, medical history and concomitant medication were not reported.  On an unknown date in 2008, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose, route, lot#, and expiration date were not reported). The vaccine was administered yearly to present (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2110USA007820:
After receiving the vaccine I experienced a severe runny nose and itchy throat that will not go away. I also was met with a severe headache a few hours after receiving the vaccine as well as stomach and full body aches. As the night went on i began to have the chills throughout my whole body.
My menstrual cycle has always been a little irregular but it has gotten substantially worse since the vaccine and I am unsure if it is related so erring on the side of caution and reporting. On may 9th I had profuse mid-cycle bleeding and was going through super tampons every 15 minutes for at least 6 hours. I went to the emergency room and tested negative for pregnancy (thus not a miscarriage) and my IUD was in place so my IUD that I have had for 2 years was not the cause of the bleeding. My period came back 2 weeks after that bleeding episode and has lasted for 13 days.
Moderna Covid-19 Vaccine EUA  On the day of the vaccine my arm (where the vaccine was injected) started to hurt in the evening. That night I was laying in bed and when I moved it felt as if the muscle was hanging off my arm. The next day the pain was worse and my arm was very swollen and looked like a ball where they injected the vaccine. My arm was also red and felt hot. My joints hurt and I felt tired. Throughout the day the redness began to travel down my arm to my elbow. I couldn't move my arm or do anything with it due to the pain. I took 1K miligrams of Tylenol with breakfast that day and felt a relief in joint pain and I didn't feel tired anymore. That Monday my arm began to itch sometimes. The pain, redness, and swelling was still there. On Thursday there was less swelling and less redness. To this day my arm is still itchy sometimes and still a bit red.
Intense pain at injection site, throbbing pain with numbness. Causes sleep interruptions due to pain.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No medical history or concurrent conditions were reported. The reporter stated that the patient received his first dose of ZOSTAVAX on 11-DEC-2013. However, on 18-NOV-2015, the patient was inadvertently administered a second dose of ZOSTAVAX with lot # L021602 and expiry date 10-SEP-2016. No concomitant therapies were reported. Additional information has been requested.
101 Fever; Chills; Vomiting; Diarrhea; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 17:00, the patient experienced 101 fever, chills, vomiting, diarrhea and body aches. On the same day, the patient under went body temperature test and the result was found to be 101 (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with TYLENOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101 fever, chills, vomiting, diarrhea and body aches were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
hissing and ringing in her ears; This case was reported by a consumer and described the occurrence of ringing in ears in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: This reporter reported for her neighbor patient. The age at vaccination was not reported. The patient received Shingrix last week and experienced the hissing and ringing in her ears There were no further details for this patient. This is 1 of the 7 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR222005:same reporter US-GLAXOSMITHKLINE-US2020221335:same reporter US-GLAXOSMITHKLINE-US2020AMR230569:same reporter US-GLAXOSMITHKLINE-US2020AMR230567:same reporter US-GLAXOSMITHKLINE-US2020AMR230553:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter US-GLAXOSMITHKLINE-US2020221342:same reporter
Cold chills - so bad that my whole entire body shakes. At same time, covers piled on top of me. Still having the cold chills now. It just happened yesterday and it doesn't stop for hours and when it happens, the following day  that I'm worthless - just tired. On the third day after the chills occur, I feel better. And then with fever: 97.2 is normal but then it goes up to 101.6 - 5 times - that has happened about every three weeks. (five times since March with the fever). I went to the doctor 5/25/2021 and she said she didn't have a clue as to what caused it. All looked normal with bloodwork.
Pt stated she received the vaccine went home and felt her arm very sore. she laid down and started feeling chills and fever that night. She hadn't been able to eat or sleep to much since the vaccination 2 days ago. She has spent the last couple days in bed as she has been unable to get out. She stated today was the first day she was able to get out of bed.
pt recvd vax;was inadvertently vaxed w/ 2nd dose of HIB;at time of report no problems noted;
Started out with red area at injection site and was sore. Developed high fever (103.2 orally), headache, chills, sore throat, and very pale in middle of the night. Will take her to the doctor in the morning if not better. Treating with Ibuprofen and Tylenol.
Limited soreness at injection site.; This is a spontaneous report from a contactable consumer. A 34-years-old male patient received bnt162b2 (BNT162B2,solution for injection,lot Number was EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:45 as DOSE 1,SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Feb2021 17:00 the patient experienced limited soreness at injection site.The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the event was recovering.    Follow-up (21MAY2021): Follow-up attempts completed. No further information expected.
approximately 24 hours post vaccine Patient developed a low grade fever of 99.5 and had increased fatigue. 48 hours later she had decreased neurological functioning. 02/23 she had difficulty swallowing. 02/23 She was admitted to hospice services. 02/26 she passed just before 10 am.
patient received expired TENIVAC with no reported adverse event; Initial information received on 17-Mar-2023 regarding an unsolicited valid  non-serious case received from  Other Health Care Professional.  This case involves a 22 years old female patient who received expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 16-Mar-2023, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, Suspension for injection (strength - standard, frequency - once, lot U6922AA, expiry date  - 22-Jn-2023) via intramuscular route in the deltoid NOS for prophylactic vaccination (Immunization) that was expired with no reported adverse event (expired product administered) (Latency: same day)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sleeping like crazy but not good sleep; Woke up with a sharp lower back pain, like a kidney related pain on both side of her back; Feels like a truck ran over her (rolling back and forth over her body); Could not produce enough urine; Swollen lymph node under her neck; temperature was mildly hiked; Unable to eat; Massive headache; Nausea; Chill; Vomited; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Sleeping like crazy but not good sleep), URINE OUTPUT DECREASED (Could not produce enough urine), BACK PAIN (Woke up with a sharp lower back pain, like a kidney related pain on both side of her back), FEEDING DISORDER (Unable to eat) and MYALGIA (Feels like a truck ran over her (rolling back and forth over her body)) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver disorder.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FEEDING DISORDER (Unable to eat), HEADACHE (Massive headache), NAUSEA (Nausea), CHILLS (Chill), VOMITING (Vomited), VACCINATION SITE PAIN (Sore injection site) and PYREXIA (temperature was mildly hiked). On 01-Apr-2021, the patient experienced URINE OUTPUT DECREASED (Could not produce enough urine) and LYMPHADENOPATHY (Swollen lymph node under her neck). On 02-Apr-2021, the patient experienced BACK PAIN (Woke up with a sharp lower back pain, like a kidney related pain on both side of her back) and MYALGIA (Feels like a truck ran over her (rolling back and forth over her body)). On an unknown date, the patient experienced SLEEP DISORDER (Sleeping like crazy but not good sleep). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, SLEEP DISORDER (Sleeping like crazy but not good sleep), URINE OUTPUT DECREASED (Could not produce enough urine), BACK PAIN (Woke up with a sharp lower back pain, like a kidney related pain on both side of her back), FEEDING DISORDER (Unable to eat), MYALGIA (Feels like a truck ran over her (rolling back and forth over her body)), HEADACHE (Massive headache), NAUSEA (Nausea), CHILLS (Chill), VOMITING (Vomited), VACCINATION SITE PAIN (Sore injection site), LYMPHADENOPATHY (Swollen lymph node under her neck) and PYREXIA (temperature was mildly hiked) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Ice coffee as a relief for headache.
"On 1/5/21, I was febrile (101.9) with severe body aches, weakness and dead arm.  Symptoms were present for 4 consecutive days.  On 1/9/21, all symptoms subsided, afebrile.  "
4-5 days after first dose, feeling sinus pressure, pressure in ears and constant high pitch ringing