chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 01-APR-22, refrigerated on 04-APR-22 and administered on 11-APR; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-APR-22, refrigerated on 04-APR-22 and administered on 11-APR) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-APR-22, refrigerated on 04-APR-22 and administered on 11-APR). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-APR-22, refrigerated on 04-APR-22 and administered on 11-APR) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in refrigerator on 04-APR-2022. The vial did not undergo any temperature excursions. It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, however the vaccine expired on 01-Apr-2022. No concomitant medication were provided No treatment details were provided
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium
Redness at the injection site; Itchiness at the injection site; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2022, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's husband. The patient received the Shingrix vaccine in the left arm and at the time of reporting, she was experiencing redness, itching and pain at the injection site. The reporter was referred to healthcare professional.  The reporter provided limited information. The reporter gave consent to follow up with pharmacy.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 07-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
H Zoster eruption beginning day 2 after immunization.  Dermatome of H. Zoster L C-6.  Immunization also given L deltoid, although the area of zoster rash did not include the lateral deltoid
My sister had the new shot and still got the shingles/suspected vaccination failure; still got the shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's sibling. The age at vaccination was not reported. The reporter stated that the patient had the new shot (Shingles vaccine) and still got the shingles and did not had as much pain but still got them. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Swelling of deltoid area on same day that vaccine administered, swelling warmth abd pain continued til 11/24/2006, has not progressed ansd is a little better.
Began breaking out in hives 10/27/16 - used hydrocortisone cream. Doctor VS. 10/31/16 - ordered oral prednisone and BENADRYL. On oral prednisone at beginning of October 2016 for poison ivy.
Constant daily diarrhea for over a month - still ongoing.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration in left arm on 23Feb2021 at 10:00 (at the age of 76-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history was none. Concomitant medications included esomeprazole magnesium taken for an unspecified indication, start and stop date were not reported; olmesartan taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Reporter (Son) stated, he was called on behalf of his mom who was 77-year-old. She had the Covid vaccine back at early in Mar2021. She had diarrhea on 10Mar2021 at 15:00 for a month, it was still happening. She has had stool test, blood work, everything has been normal. She has had colonoscopy, it was normal. She had got her 'CAT' (Computerised tomogram) scan "today", but the doctors are not been able to find anything wrong, they said her everything was checked normally. The one thing we can think of was that almost 2 weeks prior to her coming down with the diarrhea was the fact that she still has "today". She had taken the first dose of the Pfizer vaccine and I do not know if you heard of diarrhea, the doctors are in little bit 'doubt' also. Doctor prescribed anti-diarrhea and anti-spasm drugs not helping much. The reporter was just called to see if any other 'accounts' of this reported. She was going to the CT scan "tomorrow". She had the colonoscopy last Friday that was normal, but she had diarrhea for 1 month, she still has diarrhea. It was pretty bad, so we just do not know what was going on so. The adverse event was resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test was normal, colonoscopy result was normal, 'CAT' scan (computerised tomogram): not been able to find anything wrong, stool test result was normal, tested for COVID result was negative (Tested for COVID 2x during the month while sick, was negative). The patient did not receive any treatment for the event. The outcome of the event was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Light headed and dizzy, sweating, passed out briefly. 15 seconds. This was 45 minutes after getting injection. I did not have trouble breathing or swallowing. Very similar to what has happened to me sometimes getting blood drawn but happens at time of appointment not after.  Reclined, deep breaths and started to feel better within 10 minutes.  An hour later feeling much better.
Date of Admission: 9/11/2023   Date of Discharge: 9/14/2023   Issues to be Addressed at Follow-up: COVID19 and UTI symptoms
Dr. referred him to get Pneumovax 23 at pharmacy. received Pneumovax 23 11-2-20. Awaken 11-3-20 with sore arm upon movement, swelling/redness/warmth along biceps down towards elbow. On 11-4-20 soreness in chest. He took ibuprofen which helped pain. He did not go to the doctor. Come to pharmacy 11-5-20. Was moving fine. Swelling/redness subsided.
13MAY pt recvd vax; devel jerking of rt arm & rt eye w/staring that noc; had several episodes over next 48 hr;
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unkonwn age and gnder. The patients' concurrent conditions, past medical history and concomitant therapies were not reported. On unknown dates in 2015 (reported as: since 03-JUN-2015) the patients were vaccinated with improperly stored GARDASIL (lot # K023432 exp. date 18-JUN-2016) (dose, frequency and route were not provided). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Leg pain, back pain, chills, fever, headache. Unable to walk or stand still for more than a minute. Unable to sit upright back pain travels to mid back.
IPOL was administered as a TB skin test in error with no reported adverse event; patient received IPOL intradermally with no adverse event; Initial information received on 10-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old female patient to whom vaccine IPV (Vero) [IPOL] was administered as a tb skin test in error, intradermally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Jul-2023, the patient received 0.1 mL dose of suspect IPV (Vero), Suspension for injection (batch number: V1B891M) (expiry date: unknown) via intradermal route in the left forearm as TB skin test (Tuberculin test) in error with no reported adverse event (wrong product administered) (incorrect route of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
Three days, post vax, the pt developed a fever, headache and ulcers in his mouth. The physician felt the pt's experiences were a viral reaction. The pt sought unspecified medical attention. The pt's parent told the nurse that she "heard that there was a new broadcast stating that there were cases of meningitis after RCV immunizations" (WAES00082197). The parents were quite concerned. On an unspecified date, the pt recovered. No further information is available.
This spontaneous report was received from a Licensed practical Nurse, referring to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II injection (Lot number, expiration date, strength, dose, frequency and route of administration were not reported) vaccine, for prophylaxis. Additionally, it was not reported if this excursion was detected due to a digital data logger. Temperature excursion was not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006813: US-009507513-1701USA006819.
I had a cough, congestion, I took a home COVID-19 test that came back negative.  I made an appointment with my doctor, I had a telehealth visit, we discussed my symptoms and negative test.  I was given Ciprofloxacin, Benzonatate, Albuterol Inhaler. I started taking the medication immediately, I am starting to feel better.
Pt. in observation line was feeling dizzy with palpations.  Paramedics assessed pt. vital signs normal.  Once symptoms subsided pt. was released to leave.
Headache starting 1 hour after vaccination. Chest pain, shortness of breath 10 hours after vaccination.  Patient's pain improved over the next few days. Significant family history of CAD, mother had MI in her 40s
Pt received a ZOSTAVAX vaccine 3/8/2011. On 3/10 she returned to the pharmacy. Injection site was red, warm to touch, raised & red. She was instructed to apply ice, take TYLENOL. 3/17 we followed up with phone call, area is still red, not warm, no raised area. We asked her to call if situation gets worse.
Swollen lymph nodes on right breast near armpit. Sore. Tender. Has been there for a couple of days so far.
DIFFICULTY SWALLOWING STARTED ON 1/22/2010 ABOUT 7:00PM.  IT FEELS LIKE A LUMP IS IN MY THROAT ALTHOUGH MY THROAT IS NOT SORE.  NAUSEA ALSO STARTED 1/25/2010 ABOUT 6:00AM.
systolic blood pressure has risen went to 110-115 over 65 to 70; pulse is elevated; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure has risen went to 110-115 over 65 to 70) and HEART RATE INCREASED (pulse is elevated) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Low blood pressure.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure has risen went to 110-115 over 65 to 70) and HEART RATE INCREASED (pulse is elevated). At the time of the report, BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure has risen went to 110-115 over 65 to 70) and HEART RATE INCREASED (pulse is elevated) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure systolic: 110-115 (High) 110-115 over 65 to 70. On 18-Mar-2021, Heart rate: (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not take concomitant medication and did not take medication to treat his symptoms.
COVID; COVID; fell/injured back down to buttocks; fell/injured back down to buttocks; fell/injured back down to buttocks; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4311759-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1156159) for rheumatoid arthritis. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "recovering" and all described as "COVID"; FALL (non-serious), BACK INJURY (non-serious), BUTTOCK INJURY (non-serious) all with onset Jan2022, outcome "recovering" and all described as "fell/injured back down to buttocks". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB)  The reporter's causality for the event(s) of COVID and Fell/Injured back down to buttocks onset in Jan2022 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Fell/Injured back down to buttocks onset in Jan2022 and Fell/Injured back down to buttocks onset in Jan2022 was not provided.  The reporter's assessment of the causal relationship of the (COVID, fell/injured back down to buttocks) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. Based on the current available limited information in the case provided, the causal association between the events fall, back injury and buttock injury and the use of suspect product BNT162B2 cannot be fully excluded.
pt recvd vax 9FEB between 2PM & 4PM & 10FEB95 between between 2PM & 4PM bgan to have sweats w/rash over chest, low back & arms w/itching all over body; discomfort, macular pap rash; allerg react to some component of the vax;
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced fainting with outcome of unknown.
Initial onset abd pain abt 6-7 PM with bad headache. 1 episode of dry heaves. Temp increased middle of noc 102.8. Mom gave TYLENOL, ibuprofen. Temp range 100-103 until AM 10/19/09. Also had c/o chest hurting in eve. MOC took to MD 10/20 AM because still coughing. MD said having "serum sickness" due to vaccine (nasal mist). Still tired and cough 10/22/09. 2 brothers who had nasal mist same day-also c/o severe headache, abd pain of short duration.
Patient given immunizations 2 weeks early, should have been given at 12 months. Patient will be re-immunized after birtdate.
Patient was given dose of Moderna COVID-19 vaccine after stating they had not previously been vaccinated for COVID-19. Son called a day later to say that he had received one dose of "a COVID-19" vaccine on 1/29/2021 but does not know which one. Father has dementia and did not remember that he had already had his first dose. This does not follow along with recommended protocol for Moderna vaccine second dose. No reported side effects.
Large redness and warmth in area over 4 cm medial to injection site.  Some induration and tenderness.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A 52-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 51, in left arm, Dec 2021, single dose, for COVID-19 immunization. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunization. Medical history not reported. No concomitant medications. Patient received the other medication in 2 weeks. The patient experienced ineffective drug (medically significant) and suspected COVID-19/treatment of COVID-19 (medically significant), with outcome of unknown. Therapeutic measures were taken as a result of ineffective drug and suspected COVID-19. Clinical course: Antiviral details: COVID-19 treatment started May 7, 2022 for both events. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Narrative:  Patient contacted telephone triage nurse today requesting to speak with PCP clinic for c/o rash. Patient states he had 2 injections on 4/15/2022, he is wondering if it could be a reaction. States the following day, he woke up and noticed a localized rash, L trunk area, "on my side.: States rash is "spotty, covers a size about the size of a football - blotchy - raised bumps - with some scabs." States some discomfort only with palpation. States no itching or redness. Has been applying eucerin cream, "think it's helping because it is getting better."
Information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11 and 19 who was vaccinated with a first dose of Gardasil. It was reported that the patient sat for a minute (after receiving the injection) and when she got up to leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however, the physician will forward other information including the lot numbers. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007.  Follow up information has been received from a health professional concerning the 12 year old female student with no medical history who on 30-APR-2007 received her second IM dose of GARDASIL, lot #657621/0387U.  The immunization was followed by a warm sensation all over.  The patient laid down for 10 minutes and felt better with no further incident. No treatment was necessary.  She was reported as recovered after an unspecified time.  Additional information is not expected.
Patient was accidentally given Trumenba instead of Tdap. She is under the age recommendation for administration of Trumenba to a health individual - though it is approved to be given as young as age 10 for those with risk factors.
Employee has previously received a three shot series of the Hepatitis B vaccine in 2009. Employee received first injection of  Hepislav-B on 9/23/2019 by trained staff. Employee states that she had only a slight headache when she received the vaccination. Roughly 8 hours after receiving the vaccination employee noted the injection site was sore, raised, red and warm to the touch. Roughly 12 hours after the shot employee states that she had a migraine, itching at the injection site, tingling in the right arm, nausea, fatigued, loss of appetite, and with chills. Employee took Excedrin Migraine and baclofen.  Employee presented to work to complete form. States that the injection site pain has stopped. The tingling in her arm and stopped but the redness remains. Employee now denies nausea and loss of appetite. Employee continues to complain of chills and  fatigue.