chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The dose administered today had expired on 6APR2022, 6 days ago.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose administered today had expired on 6APR2022, 6 days ago.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose administered today had expired on 6APR2022, 6 days ago.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose administered today had expired on 6APR2022, 6 days ago.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was immunocompromised. No reported symptoms. No additional doses, medications or treatments have been administered in response to this administration error. Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-538601 (Patient Link).
I developed a rash within 24 hours of receiving my second dose, which has slowly developed into blisters that look like pox in certain areas of my body.  I experienced headaches, fatigue and muscle aches as well.  Some of the blisters have developed a crust.  I am concerned that this vaccine gave me a version of pox but I do not have medical insurance and so have not gone anywhere for testing.
Breakthrough COVID infection - muscle aches, chills, sore throat, congested cough, fatigue
infant, 4 mos died 24 hrs after vax in ofc 25 yrs ago; was critically ill in 1 hr;
osteomyelitis/ immune stimulation post-Shingrix /may have helped to reveal this underlying infection.; lower back pain prior to Shingrix/ Post one dose / extreme pain at the lower back; This case was reported by a physician via sales rep and described the occurrence of osteomyelitis in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included low back pain (ongoing prior to Shingrix vaccination).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced osteomyelitis (serious criteria GSK medically significant) and back pain aggravated. On an unknown date, the outcome of the osteomyelitis and back pain aggravated were unknown.   It was unknown if the reporter considered the osteomyelitis and back pain aggravated to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient's ESR (Red blood cell sedimentation rate) was a little elevated but no telling tales of an infection. Post one dose of Shingrix, patient developed extreme pain at the lower back that eventually revealed osteomyelitis. The patient and MD thought the immune stimulation post Shingrix vaccination might had helped to reveal this underlying infection. The consent to follow-up was granted.
Numbness and paresthesias of the right face and right upper extremity.  Urticaria.  Onset within 45 minutes of administration.
Hard lump, red warm area 4-5 cm at upper arm injection site.  Skin is now itching.  Size and pain have started to decrease.
11-09-06 Developed sore throat and cough.  11-10-06 Began fever in p.m. and body aches 11-11-06 Increased body aches and "high fever"- temp not taken 11-12-06 Seen in Hosp ER for fever, body aches and cough.  After care instuction sheet from ER  Dx - Fever unknown Etiology RX Loritab 7.5/500 1-2 tab q 4-6 hrs for pain.  11-13-06 Reports to health department clinic that she is feeling better but cough continues.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 19-NOV-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
VERY LITTLE RESPONSE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced very little response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very little response was not reported. This report was non-serious. This case, from the same reporter is linked to 20210948137.
Heplisav-B that Expired was Administered; Initial Report Received on 13-Oct-2021  A registered nurse reported that a 24 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   The patient has an allergy to Cipro (ciprofloxacin). No other relevant medical history was reported.    No relevant concomitant medications were reported.  On 13-Oct-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021, NDC # 43528-003-05, and serial # not reported) in the left deltoid. The patient had not reported any adverse reactions.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Approximately 24 hrs. after receiving vaccination ZOSTAVAX, pt. developed blisters, reddened, swollen skin around the injection site. Area was swollen "like a bee sting" but not itchy or sore. Pt. also said she developed chest pain/palpitations during this time as well. The rash seemed to get worse from Wednesday to Thursday when I spoke with her. She called Dr. and was going to see her PCP on Friday.
(L) arm with 9x9cm area of redness. Minimal warmth or swelling
Admitted to hospital with respiratory failure due to pneumonia and COPD exacerbation, ultimately trach placed 6/21. Also found to have lung mass and diagnosed with NSCLC which had not yet been staged.    Transferred to LTAC on 6/26 and initially did well with ventilator weaning. He was on 4h BID TCT, then experienced a cardiac arrest on 7/1 likely related to pulmonary emboli and right heart strain. He was more hypoxic after that time, with high ventilator requirements, and found to have multiple small infarcts on brain MRI on 7/6. His mental status did improve but ventilator requirements did not, and he expressed to his family he would not wish to be supported on machinery long term.  As a family his children decided to honor his wishes to not prolong his life, and he was transitioned to DNR comfort on 7/11 after which he passed quickly with withdrawal of ventilator support with his family at his side.
Patient presented to emergency department on 10/15/2021 with shortness of breath. She was unsuccess on outpatient treatment. She was found to be COVID-19 positive on 9/29/2021. She was admitted for further management and treated with dexamethasone and supplemental oxygen. She was discharged home on 10/20/2021 with home oxygen.
sore arm & swelling 25MAY94; better next day inc temp, lethargic, emotional 30MAY94; inc temp relieved w/APAP;;
Covid arm? soreness, red circle rash about 2 inches, swollen, painful and burning
tested positive for COVID-19 on 10/1/21. Symptoms included: cough, fever, body aches, runny nose, scratchy throat. Received Regeneron monoclonal antibody treatment on 10/1/21 at approximately 3 pm.  Symptoms improved within 24-36 hours.
5 days after receiving my 1st Moderna covid 19 vaccine my heart bate began flucuating from as low as 55 bpm and as high as100 bpm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (5 days after receiving my 1st Moderna covid 19 vaccine my heart bate began flucuating from as low as 55 bpm and as high as100 bpm) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE ABNORMAL (5 days after receiving my 1st Moderna covid 19 vaccine my heart bate began flucuating from as low as 55 bpm and as high as100 bpm). At the time of the report, HEART RATE ABNORMAL (5 days after receiving my 1st Moderna covid 19 vaccine my heart bate began flucuating from as low as 55 bpm and as high as100 bpm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) heart bate began fluctuating from as low as 55 bpm and as high as100 bpm..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
tested positive for alcohol; This spontaneous case was reported by a consumer and describes the occurrence of ALCOHOL TEST NEGATIVE (tested positive for alcohol) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078BNAS and 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHADONE and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for an unknown indication.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021 at 5:30 AM, the patient experienced ALCOHOL TEST NEGATIVE (tested positive for alcohol). At the time of the report, ALCOHOL TEST NEGATIVE (tested positive for alcohol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Alcohol test: positive (Positive) Alcohol test positive.         Treatment information was unknown.
nausea is reported in pt receiving 1 dose of flu vax; pt recvd flu vax on 29SEP93 & on 30SEP93; pt reported was exp above sx; this is 1 of 4 pts reported @ this site (out of 150 pts given fluogen);  pt recvd 1992 Fluogen vax last yr;
t104 R @ 4 hrs p/shot until 12 hrs later; real irritable, sometimes high pitched; glossy eyed next AM alert p/eating; leg sore;
Developed "hive" like rash on trunk of body.  1 week after 2nd dose of Twinrix.  Rash continues of this report 4/3/08.  No SOB, no difficulty swallowing, no fever.  Referred her to her primary care physician.
Patient presented to the ED on 3/17/21, 3/20/21, 3/22/21. He presented to the ED on 4/3/21 and was subsequently hospitalized.
Facial spasms on my right side just above my cheek bone. Started within hours of my first injection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 15:00 (Lot number: EW0183) at the age of 59 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known Allergies" (unspecified if ongoing). Concomitant medication(s) included: HYZAAR; PREVACID. The following information was reported: FACIAL SPASM (non-serious) with onset 25Jun2021, outcome "recovering", described as "Facial spasms on my right side just above my cheek bone. Started within hours of my first injection.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial spasm.  Additional information: The patient did not receive any other vaccine in four weeks of covid vaccine. Other medications received by patient within two weeks of covid vaccine: Hyzaar, stool-softener, multiple vitamins, and Prevacid. The patient was not diagnosed with covid-19 prior vaccination but tested for covid post vaccination. The patient had PCR test (Nasal Swab) resulted negative. The patient had known allergies.  No follow-up attempts are possible. No further information is expected.
Doctor's office called.  Given out dated vaccine MMR expired 2/25/08, 7 days expired.
Intussusception (barium enema diagnosed). Reduced with air contrast enema. Recovered without incident. Presented with vomiting & hematochezia.  12/02/08  Reviewed hospital medical records of 11/08/2008. FINAL DX: Intussusception, enema reduced. Records reveal patient experienced loose stools x 2 days that became bloody & nausea/vomiting, clammy, pale.  Admitted overnight for observation s/p enema reduction of IS.  D/C to home.
Dizziness, headache with pain into left ear, diarrhea with upset stomach and no appetite.
Information has been received from a Certified Medical Assistant (healthcare provider) via a company representative referring to two unspecified female patient of unknown age. Information about patient's concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with unspecified doses of GARDASIL 9 (lot#, dose, route not provided, for vaccination). On unspecified dates the patients experienced light headed and dizzy. The patients had sought medical attention via an unspecified office visit. The outcome of the event was reported as recovered on an unknown date. Additional information has been requested.
Yeast infection. Itching, burning and vaginal discharge. Yeast infection has since cleared. Feeling of nausea, stomach pains a cramps that continue as  of 11/21/12.
I received the second dose of the Pfizer vaccine on 1/22/2021. On Saturday 1/23/2021 I woke up with chills, headache, and some fatigue. Later that day I had started to get itchy everywhere. Later Saturday into Sunday chest pain occurred. Sunday the itching worsened throughout my entire body with some bumps which were possible hives. Other symptoms along with itching came Monday with swelling at joints, continued itching, eyes and lips swelling, along with lips tingling. Monday I went to the clinic and was prescribed a steroid prednisone for the allergic reaction and then continued to take over the counter allergy medications to help with the itching.
Diffuse hives. No airway swelling. 25 mg Benadryl taken. Hives persisted for two days
lack of efficacy/the patient did not have immunization against hepatitis B; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 75-year-old female patient who received HBV (Engerix B) (batch number 34NG2, expiry date 24th February 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Engerix B. On 14th August 2019, the patient received the 2nd dose of Engerix B. On 7th January 2020, the patient received the 3rd dose of Engerix B. On an unknown date, less than 2 years after receiving Engerix B, less than a year after receiving Engerix B and less than 9 months after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist asked for information for a patient that received all 3 doses of engerix B and after performing test, the doctor mentioned that the patient did not have immunization against hepatitis B. The reporter consented to follow up.
Valid vaccine doses were mixed with expired vaccine doses, which were not disposed of appropriately. Administering  tech is unsure which vaccine patient received. Offered patient to re-vaccinate per recommendation from clinic team.
Pt very anxious after receiving the pfizer covid vaccine c/o itchy throat and chest tightness.  VSS on RA color pink throughout.  Pt encouraged to take deep breaths and relax.  Given water to drink.  Tolerated well. Then given Benadryl 25 mg PO and observed for 15 mins more.  Pt calmed down and denied further symptoms and went home without issue.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:59 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.10 for dose administered on 28-Feb-2021 and 75.18 for dose administered on 28-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A administered on  with temperature 27 at 09.00 AM and 26 at 01.00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A administered on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Information has been received from a physician concerning a 2 month old female who was vaccinated with her first dose of 2 ml oral ROTATEQ. The patient received other vaccines on the same day as the ROTATEQ, but unspecified date or names of the other vaccines. The patient developed reflux and vomiting sometime later after the dose of ROTATEQ. The mother took the infant to the Emergency Room and intussusception test were performed. The patient was not hospitalized. The physician does not believe the event had been due to the ROTATEQ, and that the patient is doing "just fine now". NO product quality complaint involved. Additional information has been requested.
Moderna was given mistakenly instead of Pfizer, that is approved for this age group.
TEETH PAIN; JAW-LINE ON FIRE; RING-WORM LIKE RASH AROUND INJECTION SITE; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included familial mediterranean fever  (genetic variant). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JUN-2021, the subject experienced ring-worm like rash around injection site. On 06-JUN-2021, the subject experienced fever. On 06-JUN-2021, the subject experienced severe headache. On 07-JUN-2021, the subject experienced teeth pain. On 07-JUN-2021, the subject experienced jaw-line on fire. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, severe headache, ring-worm like rash around injection site, jaw-line on fire and teeth pain was not reported. This report was non-serious.
administered Quadracel to an underage patient with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient was administered Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an 0.5 ml total (1X) of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine Suspension for injection (lot number: U7452AA) (expiry date: 29-Jun-2024) (Frequency: once) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, A clinical director of operations reported that they have invertedly administered Quadracel to an underage patient and would like to know what to do moving forward. She said that she saw an article (abbreviation meaning not known) CDC (abbreviation meaning not known) from 2015 that if an underage patient was administered Quadracel, that dose would be counted. She would like to know to know what information we have in regards to this. This situation is reported as a medication error.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Hot and cold sweats every day since vaccine. Increased lower-back inflammation and all over the body. Intermittent nausea. Been in bed mostly, trying to recover.