chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022) and NO ADVERSE EVENT (no adverse event) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022).    Concomitant product use was not provided by the reporter.   Medication expired on 28-Nov-2022. Physician and patient notified on 30-Nov-2022 as soon as the staff become aware of administration error. Patient did not experienced any symptoms at that time, and it was unknown that the patient experienced any additional symptoms/events.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live follow-up received: additional reporter, date of birth, suspect product name, dose, case narrative were updated.
Patient called to report that a few hours after recieving COVID vaccine she experienced tingling then numbness in the area of her eye. She reports she took benadryl last night and the problem has mostly resolved however she does have some residual tenderness in that area.
Information has been received from a 49 year old female patient with glaucoma, elevated cholesterol, triglyceride, sulfa and iodine allergy and a medical history of laser surgery for glaucoma, who on 08-FEB-2012, was exposed to VARIVAX (Merck) (dose and lot numbers not reported) through her daughter who was vaccinated on 27-JAN-2011. Concomitant therapy included NEURONTIN, KLONOPIN, baclofen, levothyroxine sodium (manufacturers unspecified) and unnamed eye drops. It was reported that on 08-FEB-2012, the patient developed red itchy spots on her chest, then upper back, scalp, face, legs and arms and stated her "unspecified" eye was red and itchy. She reported that on some areas the scabbing was falling off but new lesions were appearing. The patient believed she had contracted chickenpox from her daughter because she had touched one of the daughter's lesions. It was also reported that the patient was very tired, nauseated and was not hungry. The patient stated she probably had multiple sclerosis. The consumer took BENADRYL Liquid and calamine and CALADRYL topically for the lesions as treatment. The consumer reported that her cholesterol and triglyceride medication were held. It was noted that the consumer had not notified the doctor. At the time of the report, the patient outcome was unknown. Upon internal review multiple sclerosis was considered as another important medical event. This is one of the several reports coming from the same source. Additional information has been requested.
Pt's arm/shoulder started hurting right at the time of injection and was very sore for days, pain worsened and pt lost strength and range of motion. Called pharmacy after a few weeks to inquire and pharmacy instructed pt that the sore arm was a side effect. Months passed and the pain worsened and range of motion decreased so much so that the patient was unable to reach the top of their head to wash hair. Pt made an appt with ortho (11/2/2020), ortho completed a scan, determined that this was a SIRVA injury and gave steroid injection. Patient's pain was relieved immediately and stayed improved until 4/2021, now pain is increasing again and range of motion declining again.
This spontaneous report as received from a physician as a part of a marketing research program conducted by a marketing research agency, refers to a 75 year old male patient. The patient medical history and current condition are not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (reported as shingles vaccine) of unknown dose and frequency (Lot # and expiry date not reported). Other concomitant drugs were not reported. On an unknown date the patient suffered from shingles in his eye (apparently the eye area was affected seriously a day after receiving shingles vaccine). The outcome of the event is unknown. The reporter considered the patient suffered from shingles in his eye (apparently the eye area was affected seriously a day after receiving shingles vaccine) to be related to ZOSTAVAX. Upon internal review the event of shingles in his eye was considered as medically significant since it was stated as the eye area was affected seriously a day after receiving shingles vaccine. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 1 year old female patient. Pertinent medical history and concomitant medications were not reported. On 16-DEC-2016, the patient was vaccinated with M-M-R II (dosage regimen were not reported) lot # M008589 for prophylaxis and other suspect therapies included PROQUAD (dosage regimen were not reported) (drug administered to patient of inappropriate age, overdose and inappropriate schedule of drug administration). No adverse event (no adverse event) were reported. The outcome of drug administered to patient of inappropriate age, no adverse event, overdose and inappropriate schedule of drug administration were unknown. No additional information was provided. Additional information has been requested.
Feverish feeling with normal temperature.  Whole body aching and pain--extremities, torso, breasts, bones, joints.  Agitation.  Sleeplessness due to malaise.
Employee reports that she felt sudden onset of rapid heart rate and chest burning, this she know was due to the flu shot she took 10 days prior.
Patient received first Pfizer COVID vaccination 3 days ago at an outside facility and has presented today to our facility with chest pain found to be acute coronary syndrome.  Patient is daily smoker, BMI of 35.5, and drinks 5-6 drinks daily.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a female patient who received Influenza vaccine quadrivalent. On an unknown date, the patient received Influenza vaccine quadrivalent unspecified season. On an unknown date, less than a year after receiving influenza vaccine quadrivalent unspecified season, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to Influenza vaccine quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient noted that she experienced joint hurt time to time with the flu vaccine (manufacturer unknown). The patient got flu shot every year but it did not happen every year. The primary care physician had retired and would accept authorization form and provide healthcare professional if one known at the time of follow up. This case has been linked with case US2018060700, reported for the same patient, by the same reporter.
lump above right collar bone; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump above right collar bone ) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Apr-2021, the patient experienced AXILLARY MASS (lump above right collar bone ). At the time of the report, AXILLARY MASS (lump above right collar bone ) outcome was unknown. Not Provided          Concomitant Atorvastatin
Discharge Provider: PRIVATE MD Primary Care Provider: PRIVATE MD Admission Date: 11/18/2022 Discharge Date: Nov 24, 2022 COVID positive Date 11/16/2022   PRESENTING PROBLEM: Empyema (HCC) [J86.9] Acute respiratory failure with hypoxemia, resolved RML and RLL pneumonia with large loculated right-sided complicated parapneumonic pleural effusion status post chest tube placement and subsequent removal COVID-19 infection   HOSPITAL COURSE: Patient is a 71-year-old female with PMH significant for T2DM, HTN, GERD, UC, history of trauma related multiple right-sided rib fractures/pleural effusion thoracentesis (2015) presents to the hospital 11/13 with  11 day symptoms of dyspnea, nonproductive cough and pain between her shoulder blades that wraps around on the right side.  Patient did not have any fevers but did have sweats.  Patient was noted to be hypoxic needing supplemental oxygen, SIRS (tachycardia, leukocytosis and hypoxia).  COVID PCR was negative.  Chest x-ray showed right-sided consolidative pneumonia.  Patient was admitted to Hospital for CAP and started on Rocephin/azithromycin/vancomycin (discontinued with MRSA screen negative).  On third hospital day, patient was noted to feel poorly after initial improvement, diaphoretic,  soft blood pressures and body aches.  CT thorax obtained which showed loculated right-sided pleural effusion and hence was transferred to alternate Hospital for further evaluation. --patient's pneumonia was treated with Rocephin/azithromycin from 11/13, switched to Zosyn on 11/16 and then to Unasyn on 11/21.  Infectious Disease consultation was also obtained.  Patient has RML, RLL community-acquired pneumonia.  SLP evaluation was negative for aspiration. --patient was noted to have complicated right-sided loculated parapneumonic effusion.  She had IR chest tube placement on 11/18, fluid is exudative, with LDH > 1800 increasing suspicion for empyema however cultures remained without growth.  She also finished 6 doses of tPA/dornase on 11/21 with improved outputs.  A follow up limited CT thorax on 11/23 revealed a markedly improved pleural effusion.  Pulmonary and ID are recommended removal of chest tube which was done on 11/2020.  Patient continued to improve with very minimal pain or trouble breathing . Recommended 4 weeks course of Augmentin was closed Pulmonary, and ID follow-up on a follow-up CT scan in 4 weeks. Patient was subsequently weaned off oxygen and was satting well on room air.   The patient was noted to be positive for COVID-19 on a film array however patient was negative and a PCR at admit on 11/13.  This is of unclear significance.   The patient on antihypertensives at baseline, however due to soft/low normal blood pressures are antihypertensives were held.  This was subsequently resected appetite improving blood pressure.  Patient to resume blood pressure medications and renal function remained stable.   She was discharged home in stable condition with plan to follow up with PCP, Pulmonary and Infectious Disease.
Low fever most of afternoon Tuesday, Sept 21 2004 Wednesday, Sept 22, 2004 3:30 am.... high fever 102.3. Fever continued througout Wednesday am and Pm. Thursday, Sept 23, 2004 1:30 - 4:00.... continual inconsolable crying. Continued fussiness, fever, loss of vocal capabilities, abnormal sleep periods. change in temperment.
Pt experienced vasovagal syncope after 2nd dose of moderna vaccine today. After admininstration, pt was able to walk and sit in chair in waiting area to begin 15 min waiting period. After 1 minute I overhear pt tell husband she is getting dizzy. I go over and talk to pt and she states she is getting very dizzy, but states no issues breathing. Pt closes eyes and begins to mutter responses. I lay her down on the floor and have someone call 911 and code white at the store. I raise the patients legs while pt lays flat on the floor, pt begins to be responsive and regains full consciousness. She sits up and begins sipping on a bottle of water. Paramedics show up and evaluate her vitals. Her daughter is called and pt is able to leave with daughter and husband to return home.
Intussussception. 3/20/07 Received medical records from hospital which reveal patient experienced vomiting & bloody stools for 1 day.  Seen at outlying ER on 2/16 & tx w/air contrast enema for +IS then transferred for higher level of care.  Admitted to hospital 2/17-2/24/07.  Air contrast enema from outlying ER successful but f/u US of abdomen revealed IS had recurred.  Repeat air contrast enema reduced IS but again recurred & was so was taken to OR.  Stayed in PICU for several days observation & treated w/antibiotics & TPN.  Transitioned to oral feeds & antibiotics d/c 2 days prior to d/c home w/o further complication. FINAL DX: Intussusception, RLQ in cecum, adjacent to eleocecal valve.  Surgically reduced after failure of air contrast enemas x 2.  Exp lap; segmental resection of IS, ileal; & enteroenterostomy.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 12-OCT-2018, the patient inadvertently received VARIVAX (dose and frequency were unknown; lot number R00940 and expiration date was on 29-MAR-2020) subcutaneously for prophylaxis and PROQUAD (dose and frequency were unknown; lot number reported as R012417 and expiration date was on 28-OCT-2019) for prophylaxis (Accidental overdose). No adverse effects were reported.
stroke; heart attack; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 03-DEC-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the pt was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) inoculation: heart attack (Myocardial infarction) and stroke (Cerebrovascular accident). Outcome of the events was not provided.  Upon internal review, cerebrovascular accident and myocardial infarction were determined to be medically significant events.
Headache WEAKNESS; INJECTION SITE REACTON Narrative:  Other Relevant History:
nasty cough; slight headache; slight temperature; chills around the neck/chills around shoulders; feeling hot/cold; shortness of breath; A spontaneous report was received from a healthcare professional concerning a 64-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 105M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath was unknown.
seizure like symptoms; Dizziness; lethargy; fatigue; This is a spontaneous report from a contactable pharmacist.  A 16-year-old male patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 12:00 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was EN6205. Medical history and concomitant medications were unknown. On 02Mar2021 at 12:00, the patient experienced Dizziness, seizure like symptoms, lethargy, fatigue. It was unknown if the patient was treated due to the events. The patient recovered from the events in Mar2021. It was unknown if the patient had COVID prior vaccination; it was unknown if the patient was tested for COVID post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Seizure cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Hives on arm, hands and face.  After taking antihistamine, hives subsided within 2-3 hours.
Very sore arm day 1 Tired and achy starting around 10am day 2....fever of 101.4 as of 2:50 pm
Pt admitted on 12/16/21. Pt received hemodialysis on 12/17. RN found patient unresponsive and pulseless. CPR and ACLS started then MD notified staff that pt had just been made a DNR/DNI. Code terminated. Pt pronounced deceased on 12/17/21 @ 1813.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. Medical assistant reported that she administered a dose of M-M-R II on 31-JUL-2012 (from lot 666685/0742Z which had expired on 19-MAY-2012). No adverse effect was reported. No treatment information was reported. Additional information has been requested.
Covid vaccine was administered to patient past BUD date and therefore was not valid. Patient did not have any adverse event post vaccination.  12/12/2023
The patient received a 30mcg dose at age 11 (not approved for this age population). However, he did not experience any adverse events.
Pt has pro cellulitis at right thigh  (local reaction). Pt received four vaccines and unfortunately we didn't record what vaccines went into each leg. Two shots in right leg and the other two on the other leg. Started on 04/09/2002 and will follow up on 04/12/2002.
LOW GRADE FEVER, 99.9, MILD BODY ACHES, MILD MALAISE LASTED ABOUT 24 HOURS
Mother explained patient developed an initial wheal about 8pm the following day after vaccination. Mother showed a picture that looked like it developed right on top of where the MMRV was given subcutaneously to the left posterior upper arm, and mother described it as starting out as the size of a quarter. Throughout the night, patient developed several other welts around left deltoid vaccination site where Quadracel was given. Mother had given patient Tylenol, Benadryl, and applied cold compresses. Mother denied fever and any other symptoms. No anaphylactic reaction or s/s occurred as of this time.
Immediately after the injection went in, there was a blood trail. I took the bandaid off a couple of hours later and there was no bleeding. The next day I had a bruise at the injection site and it?s still there 4 days later.
Patient appear to have a mild seizure (faint, stiffness on the arm that got the vaccine injection, eye rolled) about less than 5 seconds. Patient became fully awake as being put to laying down on the floor. Patient was able to answer to all questions was asked. Patient stated that he was nervous and scared of getting the vaccine. Patient's mother stated  that he had  fainting history of seeing cut or bleeding. The event occur 30 seconds after received that vaccine.
Fever; Chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of injection site pain (first dose received on an unknown date and felt just the pain of the needle, refer case id US2023AMR052242).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever) and chills (Verbatim: Chills). The outcome of the fever and chills were resolved (duration 1 day).   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.     It was unknown if the company considered the fever and chills to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR052242   Additional Information: GSK receipt date: 07-Apr-2023  This case was reported by a patient via interactive digital media. The patient received second shot and experienced fever and chills for a day. The patient thought way better than getting shingles. This case had been linked with US2023AMR052241, US2023AMR052227 same reporter.; Sender's Comments:  US-GSK-US2023AMR052227:same reporter US-GSK-US2023AMR052241:same reporter US-GSK-US2023AMR052242:same reporter
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thyroidectomy, and concurrent conditions included: allergy (Unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 4383 and expiry: Unknown) dose was not reported, dose 1, administered in left arm on 25-FEB-2022 for covid-19 prophylaxis. Age at time of vaccination 48 years old. Concomitant medications included levothyroxine sodium. On an unspecified date in 2022, the patient experienced covid-19. The patient received non-company suspect Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, for treatment of covid-19 from 25-JUL-2022 to 29-JUL-2022. On 29-JUL-2022, after the 5 days treatment of Paxlovid, the patient had rebound Covid symptoms. On 30-JUL-2022, day 6th, the patient tested negative for covid-19. Laboratory data included: COVID-19 virus test Negative. On 06-AUG-2022, day 13th, the patient tested positive for covid-19 which was confirmed covid-19 infection and confirmed clinical vaccination failure. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and Paxlovid was not reported. The patient was recovering from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246751.; Sender's Comments: V0-20220832263-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.