chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the dose was of lot number 93CP5, which had an expiration date of 30Jun2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 93CP5, expiry date 30-JUN-2023) for prophylaxis.   On 19-OCT-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 19-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: the dose was of lot number 93CP5, which had an expiration date of 30Jun2023). 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: 20-Oct-2023 Medical Assistant reported that a dose of FluLaval QIV was administered to a patient one day before the reporting date.   The dose was pulled from carton lot number 82L45 (expiration date 30th June 2024), however when they went to enter the dose into the computer it was realized that the dose was lot number 93CP5, which had an expiration date of 30th June 2023.   The reporter stated that they did not had any remaining doses of last season's FluLaval on site, so she believed it arrived in the carton this way.   The product was ordered via wholesaler.   At the time of reporting, a repeat dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient received an expired dose of Flulaval QIV, which led to expired vaccine used.
Developed shingles; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient (pregnant: no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0168), dose 2 via an unspecified route of administration, administered in arm right on 11May2021 12:00 (age at vaccination: 62-years-old and pregnancy at vaccination: no) as dose 2, single for covid-19 immunisation. Medical history included osteoporosis and the patient was allergic to penicillin. The patient previously took with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), dose 1 via an unspecified route of administration, administered in arm right on 20Apr2021 at 11:30 AM (age at vaccination: 62-years-old) as dose 1, single for covid-19 immunisation. The patient's concomitant medications included alendronate sodium (FOSAMAX). On 14May2021 at 12:00, the patient developed shingles 3 days of the second vaccination. The patient read a report that states that 1% of the patients that received MRN vaccine were developing shingles. The patient was received treatment with anti viral and nerve support medications for the event of shingles. The patient did not receive any other vaccine within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the event was not recovered.
Itchy hands; Small hives; Itchy, watery eyes; Itchy, watery eyes; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19Mar2021 15:30 (at the age of 57-year-old) (Lot Number: EP7534) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies, mild asthma. Concomitant medications included allergy medicines. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 26Feb2021 (at the age of 57-year-old) (Lot Number: EN6203) as dose 1, single for COVID-19 immunization. The patient previously took bactrim and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced itchy hands, small hives, itchy, watery eyes on 21Mar2021. The patient did not receive treatment for the events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Saw hallucinations; Diarrhea; Dizziness; Shortness of breath; Vertigo; Fever dreams; Very upset / Very emotional; Cried; Paranoia; Fever; Nausea; Extremely cold; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Saw hallucinations) in a 39-year-old male patient who received mRNA-1273 (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Saw hallucinations) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), VERTIGO (Vertigo), ABNORMAL DREAMS (Fever dreams), EMOTIONAL DISTRESS (Very upset / Very emotional), CRYING (Cried), PARANOIA (Paranoia), PYREXIA (Fever), NAUSEA (Nausea) and FEELING COLD (Extremely cold). At the time of the report, HALLUCINATION (Saw hallucinations), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), VERTIGO (Vertigo), ABNORMAL DREAMS (Fever dreams), EMOTIONAL DISTRESS (Very upset / Very emotional), CRYING (Cried), PARANOIA (Paranoia), PYREXIA (Fever), NAUSEA (Nausea) and FEELING COLD (Extremely cold) outcome was unknown.            No concomitant medicines were reported. Treatment information included paracetamol for fever.  Company Comment: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.
Patient experienced dizziness and felt hot immediately after injection. Her injection site bled and required multiple bandaids and pressure held on area. During this, she felt like she was going to pass out. We provided a cold compress and water. I checked her blood pressure and she reported it being lower than normal (120/82). I re-checked in 5 minutes and it continued to drop to 105/65. I asked the patient if she would like us to call for additional medical attention to be evaluated and she said 'yes'. We called 911 and EMS arrived on the scene to further evaluate. Prior to EMS arrival, the patient's blood pressure was 130/90. The patient's blood pressure returned to normal about 30 minutes after injection and she did not go to the hospital.
sweat; kept waking up; Fever; little rash underneath; swollen in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (little rash underneath), VACCINATION SITE SWELLING (swollen in the injection site), HYPERHIDROSIS (sweat), PYREXIA (Fever) and INSOMNIA (kept waking up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On 14-Mar-2021, the patient experienced RASH (little rash underneath), VACCINATION SITE SWELLING (swollen in the injection site) and PYREXIA (Fever). On 15-Mar-2021, the patient experienced HYPERHIDROSIS (sweat) and INSOMNIA (kept waking up). At the time of the report, RASH (little rash underneath) and VACCINATION SITE SWELLING (swollen in the injection site) had not resolved, HYPERHIDROSIS (sweat) and INSOMNIA (kept waking up) outcome was unknown and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatments were reported.
Sore Arm at point of injection; This is a spontaneous report from a non-contactable consumer (patient). An 82-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included Known allergies: penicillin. The patient's concomitant medications were not reported. On 16Feb2021 18:00, the patient experienced Sore Arm at point of injection. The outcome of the event was recovering. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination.  Information about lot/batch has been requested.
Pt. states that she received HD influenza immunization and a day later, began having shortness of breath (pt is asthmatic), which later resulted in a hospitalization. Pt states that she hasn't had an "attack" in years and attributed the shortness of breath to the Immunization.
11/14/2022 @ 1600 Extreme fatigue, difficulty driving home, napped for 1 hour and had to sleep more than 9+ hours  on this day. Usually sleeps for 7.5 hours. Subsequently slept for 9 + hours. 11/15/2022  Persistent daily headaches of moderate intensity x 12 days. 11/16/2022 Onset brain fog, much harder to concentrate and focus 11/17/2022 Onset symptoms of a stuffed-up nose began with minor nose bleeds. No rhinorrhea is persistent and continues. Arthritic pain in wrist, hips, and knees. Moderate pain and generalized muscle weakness began. 11/18/2022 Onset dry cough, current and persistent at this time, chills and fever with 99.8 when the normal for the patient is 98.2, accompanied by early morning sweats and lasting another 7 days. Also, brain fog intensified on this date and lasted for another x7 days. 11/20/2022 Onset of skin rash on forelegs with urticaria and skin over body became very sensitive and painful to touch. The pain side effect persists, but the rash and urticarial have abated?Self-medicated with Atarax 10 mg 1 tab PO.  11/24/2022 Vertigo and labyrinthitis symptoms appeared but gradually abated over 48 hours. 11/25/2022 Temperature remained normal all day. Brain fog began to improve. Persistent symptoms:  The Dry cough continues at present. Bilateral hand pain and mild swelling persist. The painful and sensitive skin is still tender, but the rash is gone?no more urticaria. General muscle strength is still weaker, and the bilateral hand grip is only 60 % of normal.
Was tested for COVID per protocol prior to scheduled procedures and tested positive.  Procedures were then delayed 14 days.  Pt was asymptomatic for COVID as of 7/7.
Cough, Dyspnea, respiratory failure. Patient vaccinated with Moderna and is positive with Covid-19
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 08-JAn-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L016202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
on 8/3/14 - pt. reports not feeling well. 8/4/14 -> 8/8/14 Pt. reports fever of 102.9 degrees F. 8/9/14 -> 8/11/14 Pt. reports rash. 8/12/14 - Symptoms clear.
Information has been received from a pharmacist concerning a 12 month old healthy child who on approximately 9/30/04 was vaccianted with a dose of MMR. Concomitant therapy that same day included varicella virus vaccine live. On 10/7/04, the child developed a fever, adenopathy of a single inguinal node and neutropenia. It was unknown if the patient was admitted or just seen in the ER; however, it was noted on 10/8/04, the patient was admitted to the hospital. Treatment included antibiotics and an hematology consult which was to be scheduled. The outcome was not recovered. There was no product quality complaint involved. Unspecified medical attention was sought. The reporter noted the patient's experiences to be other important medical events (OMIC). Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Patient reports a red rash appearing around Sunday (7/7/19). The rash is itchy, slightly relieved by antihistamine (Benadryl).  When patient showed me his left arm, the lower portion just below the elbow was covered in a raised, papular rash which was oozing/bleeding from scratching.  He showed me his right arm which had very little bumps.  He said it also continues onto his left torso.  He said it has not gotten worse, but it has not improved.
Patient developeda rash 3-7-07. Papules with halos on arms legs face, sparce on trunk. Very itchy non febrile limited response to po Benadryl.Seen in office  3-8-07 dignosed with classic Gianotti-Crosti.
Horrible pain all night from shoulder blade to elbow. Ibuprofen not touching it. This morning I started with a very severe mid/upper back pain on the right side also.
.  He was recently evaluated at walk in to find that he had Bells Palsy.   E consult was placed to neurology with a recommendation to do a stat MRI and lyme titer.  Sent patient over to have lyme titer this am as he had not completed the testing.   Is scheduled for the MRI.   Facial symptoms have almost resolved but he continues to have a headache over his right eye.   Does note mild sinus symptoms.   He reported that he had received the covid vaccine prior to the symptoms on 11/22/21 with symptoms starting on 12/7/21.
Pharmacy intern accidentally administered an expired vaccine that was drawn up on June 1, 2021. We believe it is Moderna COVID-19 vaccine, but we are not absolutely certain. Patient could not be reached to let her know of the incident. We left her voice messages to come back to get the correct vaccine.
15MAY91 pt recvd DTP/OPV/HIB mom states t106r on 15MAY91 PM; tx APAP & Panadol; To MD on 16MAY91 no temp @ MD visit;
Continuing loose bowel movements without any abdominal discomfort; Loose bowel; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Continuing loose bowel movements without any abdominal discomfort) and DIARRHOEA (Loose bowel) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039A2EIP) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN and LOSARTAN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (Continuing loose bowel movements without any abdominal discomfort) and DIARRHOEA (Loose bowel). At the time of the report, FREQUENT BOWEL MOVEMENTS (Continuing loose bowel movements without any abdominal discomfort) had resolved and DIARRHOEA (Loose bowel) outcome was unknown.            Treatment information was not provided. Patient had a colonoscopy on ??-JULY-2021 and  discovered and removed some polyps.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant Follow up received contains - Patient demographics includes age, gender, DOB and reporter phone number , Concomitant medication updated. On 12-Aug-2021: Follow up received containsupdated event out come as recovered and resolved and medical history
her arm hurt for quite a while; little achy/it hurt like a "son of a bitch,"/little achy/it was very mild for 24 hours/her arm hurt for quite a while; she did not get a half shot, she in fact got a full dose and was fooled.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little achy/it hurt like a "son of a gun,"/little achy/it was very mild for 24 hours/her arm hurt for quite a while), ACCIDENTAL OVERDOSE (she did not get a half shot, she in fact got a full dose and was fooled.) and PAIN IN EXTREMITY (her arm hurt for quite a while) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Cancer. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced VACCINATION SITE PAIN (little achy/it hurt like a "son of a bitch,"/little achy/it was very mild for 24 hours/her arm hurt for quite a while) (seriousness criteria hospitalization and medically significant) and ACCIDENTAL OVERDOSE (she did not get a half shot, she in fact got a full dose and was fooled.) (seriousness criteria hospitalization and medically significant). On 02-Sep-2021, the patient experienced PAIN IN EXTREMITY (her arm hurt for quite a while) (seriousness criteria hospitalization and medically significant). At the time of the report, VACCINATION SITE PAIN (little achy/it hurt like a "son of a bitch,"/little achy/it was very mild for 24 hours/her arm hurt for quite a while) and PAIN IN EXTREMITY (her arm hurt for quite a while) outcome was unknown and ACCIDENTAL OVERDOSE (she did not get a half shot, she in fact got a full dose and was fooled.) had resolved.            Concomitant medications include Eliquis.  Company comment: This case involves a 69-year-old female subject with the medical history of hysterectomy and the concurrent medical condition of cancer who experienced the unlisted serious (hospitalization, medically significant) adverse events of Vaccination site pain, Accidental overdose and Pain in extremity on the day of her third vaccination respectively 24 hours later.   The benefit-risk relationship of mRNA-1273 was not affected by this report.  The benefit-risk relationship of mRNA-1273 was not affected by this report.   This case was linked to MOD-2021-206013, MOD-2021-022339 (Patient Link).; Sender's Comments: This case involves a 69-year-old female subject with the medical history of hysterectomy and the concurrent medical condition of cancer who experienced the unlisted serious (hospitalization, medically significant) adverse events of Vaccination site pain, Accidental overdose and Pain in extremity on the day of her third vaccination respectively 24 hours later.   The benefit-risk relationship of mRNA-1273 was not affected by this report.  The benefit-risk relationship of mRNA-1273 was not affected by this report.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29Oct2021 and administered on 05Nov2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29Oct2021 and administered on 05Nov2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29Oct2021 and administered on 05Nov2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant information was reported. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No Treatment information was reported.
Aside from experiencing typical vaccine side effects of fever, pain at injection site,  and joint pain, around 15 hours post vaccine I became nauseous followed by blurred vision, chest pain and ringing in my ears. I either fainted or had a seizure but no way to confirm which as I was alone at the time. I did awake on the floor after being unconscious though and was very confused for approximately 30 minutes or so.
big red shot below area of needle; the red are begin healing and turn dark; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 27Feb2021 (Batch/Lot Number: En6203) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation then from 23Feb2021 started cancer treatment with carboplatin (manufacturer unknown) intravenous at 50 mg; dexamethasone, diphenhydramine hydrochloride (BENADRYL), famotidine, ondansetron hydrochloride (ZOFRAN) all route of administration and dose were not reported; taxol via an unspecified route of administration at 100 mg. Medical history included asthma, chronic obstructive pulmonary disease (COPD), lung cancer, hypothyroidism, irritable bowel syndrome (IBS), allergies to penicillin, sulfa, and latex. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included pembrolizumab (KEYTRUDA) from 09Feb2021. The patient previously took the first dose of bnt162b2 (Lot number: El9261) in the left arm on 06Feb2021 for COVID-19 immunisation then erythromycin and aspirin [acetylsalicylic acid] and experienced allergies to both. On 23Feb2021, as a cancer patient, the patient started the chemo after the first vaccine. On 27Feb2021, the patient received the second vaccine in the right arm with no side effect. Until 2/4 two days after second chemotherapy treatment, the patient had big red shot below area of needle. This red are begin healing and turn dark. On 09Mar2021, the patient took the third chemotherapy treatment and the same area around previous area that had turn dark got red again and expanded. These events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient underwent lab tests and procedures which included nasal swab COVID test was negative on 05Mar202. The action taken in response to the events for carboplatin, dexamethasone, diphenhydramine hydrochloride, famotidine, ondansetron hydrochloride, and taxol was unknown. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Swelling, redness about 2", hot to the touch, hard lump, pain at inj. site. TX: BENADRYL.