chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-Apr-2022 Reporter's comments: The patient received an expired dose of Engerix B. When asked regarding vaccination date, the healthcare professional reported not sure but she thought it happened in January. No details from patient or vaccine were available at the moment of the call. Pharmacist practically did not have any details regarding this situation and when asked about vaccination date that was she answered. No lot or expiration date available. The consent to follow up was given by email. Additional Supportive Information: The patient received expired dose of Engrix B, which led to expired vaccine used.
4/17/2021; Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  Dizziness, sweaty, and headache. Assessment: Time of assessment 09:09am. Alert and oriented, Anxious, Pallor, Diaphoretic and Headache. VAERS form obtained and completed by RN. At 09:09am- BP-134/101, P- 78, O2- 98%, given water, taken to stretcher, feet elevated, recheck VS at 0913am- BP - 128/78, P- 77, O2- 99%; Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. COVID-19 Vaccine 4/17/2021  8:40 AM 0.3 mL 12/11/2020 Intramuscular; Lot: ER8730; NDC: 59267-1000-2
3RD DOSE OF PFIZER COVID VACCINE GIVEN 11/22/21, LOT #FF8839;  pt admitted to hospital on 7/25/22 and dx with COVID, acute on chronic respiratory failure, pneumonia; tx with Remdesivir, ABX, O2 supplementation; eventually dc'd to home; 8/3/22 admitted to hospital with AMS and signs of respiratory distress; positive COVID test; O2  and steroids given; CTA showed lymphadenopathy, left upper lobe of lung with collapse and airway compression; ICU; ABX given; pt required BiPAP; condition deteriorated; family chose to transition pt to DNR, comfort care; pt passed away in the hospital
Non responsive, hypoxic, respirations shallow, decreased urinary output, hypotension, vomited, tachycardia, seizure like activity
1st dose did not have any real notable reactions. 2nd dose had extreme body-wide fatigue and inflammation (joints, muscles, etc). Unable to perform basic tasks for 2.5 weeks. Doctor was informed, but did not work with them much initially.  The pain began to dissipate, but still experiencing fatigue and brain fog. Later contracted delta variant of COIVID on July 25th, have recently recovered from that (after the vaccine). Took Percocet as needed (was recovering from hip replacement as well), did nothing for the pain. Nothing seemed to work. Consumed lots of fluid.
About 22.5 hours after shot, she experienced extreme dizziness.  She was shopping with husband and he had to drive home due to this dizziness.  She got home and went to bed and slept 4 hours and woke up without any further issues.  When she was dizzy she did experience some nausea.
No other AE reported; temperature excursion (11 C for 10 hrs), vaccine administered; This spontaneous report was received from a medical assistant and refers to a 15-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAR-2021 (also reported as yesterday), the patient was vaccinated with improperly stored 0.5 ml dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T007035, expiration date 01-MAY-2022 (the route of administration was not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 11 degrees Celsius for 10 hours. Data logger was involved. There were no previous excursions reported.  On 09-MAR-2021, an inbound phone call was received from a medical assistant (MA) who works with nurse practitioner (NP, correspondence contact). The MA was calling in response to the Merck correspondence received in the mail regarding the patient who had received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccinations after the vaccine had undergone a temperature excursion on 16-FEB-2021 for 10 hours. The lot number and expiration date were previously reported. The adverse event follow-up process was reviewed with both the MA and the NP and they verbalized understanding. The MA stated that she was the health care professional (HCP) who administered the vaccines to the four patients listed below. The MA states that she was certified and trained to administer these vaccines. The MA provided patient's age, gender and ethnic group. The MA stated that she would hold onto each letter in case there was additional information to report. Minimal information was obtained on that day, due to the HCPs being "very busy". At the time of the phone call, the patient had not experienced cellulitis, erythema, or swelling at the site of the injection. The vaccine was not available for return. Additional information is not expected.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T007035; expirationdate: 01-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001467: US-009507513-2103USA001526: US-009507513-2103USA001535:
A physician reported that a 35 month old female received Prevnar on 4/28/2000. On 4/29/2000, the pt developed an injection site reaction characterized by swelling and redness. Additional info received from the physician on 6/28/00 indicated that the pt recovered.
Rash; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
"Injection site on arm sore"; "Pain when lifting past parallel"; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female 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 20Apr2021 at 12:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. The patient did not receive any medication 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 on an unknown date as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced injection site on arm sore for a month after second shot and pain when lifting past parallel. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events "injection site on arm sore" and "pain when lifting past parallel" were recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received SHINGRIX. On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved. It was unknown if the reporter considered the headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the shingles vaccine and the same night she got the worst headache and body aches. She was just wondering how long side effects last. She could find nothing but saying what they were-no idea how long they would last. Hopefully it was very short lived.
Left arm redness and induration. Treated with warm compresses and Tylenol. Follow-up in 5 days as needed. Dx'd local reaction to Anthrax vaccine.
18 years old and right now she's experiencing a lot of pain; little fever going on it seems to be 101; lots of body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (18 years old and right now she's experiencing a lot of pain), PYREXIA (little fever going on it seems to be 101) and MYALGIA (lots of body aches) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (18 years old and right now she's experiencing a lot of pain), PYREXIA (little fever going on it seems to be 101) and MYALGIA (lots of body aches). At the time of the report, PAIN (18 years old and right now she's experiencing a lot of pain), PYREXIA (little fever going on it seems to be 101) and MYALGIA (lots of body aches) had not resolved.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Frozen vials, removed and transported at refrigerated temperature, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for maximum of 4 hours; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temperature, re-frozen at the time of arrival), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for maximum of 4 hours) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temperature, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for maximum of 4 hours). At the time of the report, PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temperature, re-frozen at the time of arrival), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for maximum of 4 hours) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported.  No treatment medications were reported.  It was reported that the vial was moved to fridge on 06-Oct-2021.  The storage condition of the vial at the time of the excursion was frozen storage/refrigerated storage/ambient room temperature frozen storage/refrigerated storage.  The state of the vaccine at the time of the excursion was reported as partially thawed/liquid.   The maximum or minimum temperature reached by the vial was 8 degree Celsius.  It was reported that the total duration of excursion at refrigerated temperature was for a maximum of 4 hours.  It was reported that the vials were re-frozen. Temperature fluctuations had occurred from frozen state to refrigerated state to being re-frozen.
Syncope resulting in pt fell to ground. Within 5 minutes of receiving vaccine. Unconscious for seconds then responsive to verbal stimuli.
Pt brought to urgent care, non responsive, seizure-like behavior. Pt transported by ambulance to hospital ER, then another hospital for overnight observation.
Temp 102 F, body aches, Wednesday. Temp 100F, 2:00 Thursday also had GI sx- diarrhea and pain.
Patient here at clinic today for her 2nd covid vaccine.  She denies having previous vaccine reaction.  She arrived in Covid Vaccine observation room after having receiving her 2nd dose of Pfizer Vaccine ER6206 at 1501.  She walked in with her father and was sitting for her 15 minutes.    She had been in the room about 10 minutes when she became diaphoretic.  Went to check on her and sent administrative help to find RN.   At her side she denied having any numbness, tingling or swelling  in her mouth at current time.   Said that she felt like her heart was racing.  And started shaking her right arm and leg at that time  and was not able to control movement. She told me she does not have any drug allergies. I put blood pressure cuff and pulse ox on her. RN in room.  BP at 1520 159/105 pulse 102 respirations 20, O2 100%.   RN sent me to get a provider.  She gave her Benadryl 25 mg and Pepcid 40 mg orally with water.  Her father had to hold the cup and give her the medicine.  She swallowed without difficulty.     MD in room at her side asking questions.  Admin person went to get patients mother.  RN on the phone with 911.     1525 bp 149/100, pulse 106, respirations 32 and O2 100%.   Father and mother stated she had 2 grand mal seizures at the ages of 5 & 7.  She does not take any medication for seizures currently.  And they told MD that she is under currently neurology care of a right hemisphere brain tumor.     Upon assessment she told MD that the feeling on right to left side was different.  She stated she was becoming numb completely on right side from face to her foot.  She started slurring her speech.  She was unable to squeeze with her right hand.   1532 bp 154/106, pulse 92, respirations 30 and O2 99%.  MD, RN and myself at her side with parents.   She said she did not want to go to the hospital but MD said she wanted her to go to be and examined and monitored.  Parents agreed.   Paramedics arrived at 1534.     MD gave them overview of what had been going on and they took over her care at 1536.  They did quick assessment and with slurred speech and not being able to hold right leg or arm up they decided to load her onto the stretcher.  RN and I helped them move her to the stretcher and secure her in.  They left with her at 1545 and said they were taking her to hospital.
Patient fainted after vaccination, remained seated in chair with assistance of mom and nurse using wet paper towels and cold packs.  Regained consciousness after about 45 seconds, slowly regained color.  Remained seated for 10 minutes, mom refused assistance when nurse offered to call 9-1-1. Insisted on walking to car, nurse followed to car to make sure patient was o.k. Mom assured nurse that patient was ok and that this always happens when he receives injections.
Received booster dose of Moderna COVID vaccine 1/2022 and in 2/2022 patient began with tingling and numbness in bilateral feet.  by 3/3 he reported weakness in bilateral lower extremities. He had to stop working and moved in with his grandmother because he was unable to go up/down stairs in his own home.  He was seen multiple times in walk in clinics during the month of March 2022, with MRI of the lumbar spine negative for acute pathology and did try a prednisone burst for five days during the month of March with minimal effect.  He was seen in the ER 4/15 and was admitted at that time with progressive lower extremity weakness to the point of inability to ambulate.  MRI at admission significant for T2 signal abnormality in the cervical and thoracic region.  Course now complicated by a provoked DVT from immobility.
This spontaneous report as received from a pharmacist via a company employee refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown). There were "bubbling" at the injection site immediately after vaccination. No treatment was given for the adverse event. The outcome of the event was unknown. Additional information has been requested.
Elevated blood glucose; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Elevated blood glucose) and HEADACHE (Pounding headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (Elevated blood glucose) and HEADACHE (Pounding headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pounding in head, at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (Elevated blood glucose) and HEADACHE (Pounding headache) outcome was unknown.            No concomitant medications were reported.
cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Full blood count: Unknown results; all kind of test: Unknown results.  Clinical course details: The reporter stated that they ran all kind of tests as the patient just got diagnosed with cancer not that long ago and then she got COVID. There was about 20 different test she has been going through. They did like a complete CBC, they did all kinds of things because they were getting ready to treat her for cancer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300155299 same patient/drug, different dose/event;US-PFIZER INC-202300155486 same patient/drug, different dose/event;
COVID-19 positive; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (COVID-19 positive) in a 91-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced COVID-19 (COVID-19 positive) (seriousness criterion hospitalization). The patient was treated with BAMLANIVIMAB at an unspecified dose and frequency and ETESEVIMAB at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 23.3. On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Study included patients with confirmed SARS-CoV-2 infection who received monoclonal antibodies (mABs) from 01-Sep-2021 to 28-Feb-2022. Total 66 patients were included in the study, out of which 44 were vaccinated. 6 patients had 2 doses of Moderna with median days of COVID diagnosis from last dose of vaccine 291 (205-322) and 3 patients had 3 doses of Moderna with median days of COVID diagnosis from last dose of vaccine 56 (16-61).  It was reported that patient had COVID 19 in Feb-2021 and Virus in Dec-2021 cannot sequenced. Patient was hospitalized due to weakness. Concomitant medication not reported.   Company comment: This is a literature non-study case concerning a 91year-old patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected event of COVID-19. The event occurred after the mRNA-1273 vaccine, received as the second dose of COVID-19 vaccination schedule (unknown latency) The patient was observed in a retrospective study with confirmed SARS-CoV-2 infection who received monoclonal antibodies during 01-Sep-2021 to 28-02-2022. Patient was hospitalized due to weakness and received monoclonal antibodies Bamlanivimab+Etesevina. Therapy with Rendenafir nor steroids wasn't received. On an unknown date, SARS-CoV-2 antibody test Ig was 23.3. The virus sequence wasn't done. The outcome of the event was reported as recovered. The Sponsor assessment was considered not applicable due to lack of biological plausibility. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report..   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2023: Live Follow up received by safety on 25-JAN-2023 has email with full text article received and contains significant information: Reporter information, lab data, seriousness, product details updated.