chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023; No adverse event; Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 14-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD) and PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023).    Concomitant medication information was not provided.  No adverse event had been reported and a dose of the Moderna bivalent vaccine was administered beyond the use by date of 13-Apr-2023.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
May have received 2 doses of Moderna at 9 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (May have received 2 doses of Moderna at 9 years old) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (May have received 2 doses of Moderna at 9 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (May have received 2 doses of Moderna at 9 years old) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-588901 (Patient Link).   Reporter did not allow further contact
Had Varivax vaccine on 11/14/06. Returned 11/16/06 with a 9.5 cm x 10 cm area of erythema on right arm at site of injection. There was also a 4 cm x 4 cm area of erythema and induration that was tender on palpation. Treated with Duricef 500 mg capsule - 1 capsule bid for 10 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperprolactemia" (unspecified if ongoing); "Thallasemia trait" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures (Paxlovid treatment start date: 04Oct2023, stop date: 09Oct2023) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331879 same patient, different drug/event;
irregular heartbeat; anxiety attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 13:00 (Lot number: EW0182) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset Jun2021, outcome "not recovered", described as "irregular heartbeat"; ANXIETY (non-serious) with onset Jun2021, outcome "not recovered", described as "anxiety attacks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular, anxiety.  Additional Information: Patient had not taken any other vaccination in four weeks and other medication in two weeks. Patient has not been tested positive for COVID-19 after the vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
low grade fever; significant fatigue ... mouth filled up with ulcers. I had a higher fever and some fatigue with the second dose, the ulcers were new this time. The fatigue was absolutely debilitating - much worse this time and lasted 3 days. Mouth sores took several days to clear.
Approximately 17 minutes after receiving Shingrix vaccine, patient came to counter stating feels like she is having a reaction to the vaccine. States throat feels tight although speaking normally, felt flushed, lightheaded. I walked her into the vaccine/home health care room where she received vaccine per her request for further assessment. No prior history of vaccine reactions. Allergies as noted.  EMS called due to compaints of throat tightness. They assessed her and recommended further evaluation in squad vehicle and then possibly to ER depending on findings. Patient stated was feeling better and wanted to go home. They advised against driving home until they further assessed her and she agreed.
No reaction 5 hours post vaccination.  24 hours post vaccination: 1.5" hard, raised, hot, red area around injection sites on thighs.  36 hours post vaccination:  Areas grown to 2"--all other attributes same.  Low-grade fever throughout episode.
Extreme nerve pain from scapula down to fingertips. Worst pain of life. Numbness in index and middle finger, but also shooting pain and the sensation of burns. Extreme pain in lats, and forearm and bicep as well. Muscle weakness. Had MRI and nerve test at neurologist in November. He diagnosed an autoimmune response to vaccine as brachial plexitis. The prognosis for nerve repair is not good. Damage may be permanent. PT will not help. If nerve repair occurs the rate at most is .5-1 mm per day stemming from spinal cord.
- R side HA and sinus congestion followed by left sided HA with sinus congestion - Fatigue - muscle and joint aches - resolved after 48hours.
patient was administered an expired dose of M-M-R II; No adverse effects; This spontaneous report was received from a nurse concerning a 51 year-old patient of unknown gender and race. There was no information about the patient's medical history, drug reactions, allergies, concurrent conditions or concomitant medications to be reported.   It was reported that on an unspecified date, the patient was administered an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot number: N010496 (expiration date: 31-MAR-2019) (strength, formulation, dose, route and anatomical location not reported) for prophylaxis (expired product administered). No adverse effects were reported. The outcome of this event was not reported. There was no product quality complaint (PQC) reported.
Sore arm 5 weeks later. Reported to pharmacy 10/6/2011. Has not seen physician yet.
Approx. 1min. post immunization, donor c/o lightheadedness and the room was spinning and then had an +LOC for ~3 seconds.  Donor placed in Trendelenburg position.  Donor sts she feels better but still a little lightheaded and also c/o weakness.  Donor sts she ate 2 oatmeal cookies and drank 3 glasses of water today.  She was counseled on proper solid and liquid intake for donating.  After ~15 min donor was + for ortho's with diaphoresis, pale skin and increased lightheadedness.  200cc fluid bolus given and 911 called.  Donor also vomited x1.
Had some swelling evening of 11/29/06, put ice on left arm. Has had increased pain in left arm since injection given.  No warmth or swelling in left arm at present.  Is unable to sleep because of severe pain in left arm when lying down.  Arm is painful when she lifts left arm.  Is taking Tylenol.  Saw physician on 12/8/06 - no treatment given.  Has not had a reaction to influenza vaccine in the past.
I had flat brown spots on my legs from sun damage and in beginning in November they became bumpy and raised and saw the dermatologist. I seen one dermatologist and she wasn't alarmed and seen another doctor and she was alarmed and they did a surgery and they were squamous cells detected. I am still seeing the dermatologist and she has prescribed Fluorouracil 5% cream. It is topical chemotherapy. I am to use this cream for 4 to 6 weeks and apply it 2x a day.
Swelling at injection site; temperature of 101.7; Bad Chills; Achy Muscles; Headache; Fatigue; Date of start of drug 21Sep2023 , dose number: 4/Date of start of drug 21Sep2023 , dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 01:45 as dose 4 (booster), single (Lot number: HF9275) at the age of 64 years intramuscular, in right arm for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2023 as dose 3 (booster), single (Lot number: GJ6742), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to peaches, cashews" (unspecified if ongoing); "Allergic to silver and nickel" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 19Sep2023, stop date: 19Sep2023. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Sep2023, outcome "unknown", described as "Date of start of drug 21Sep2023 , dose number: 4/Date of start of drug 21Sep2023 , dose number: 3"; MYALGIA (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Achy Muscles"; CHILLS (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Bad Chills"; FATIGUE (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered"; HEADACHE (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered"; INJECTION SITE SWELLING (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Swelling at injection site"; PYREXIA (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "temperature of 101.7". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site swelling, pyrexia, chills, myalgia, headache, fatigue.  Additional information: Swelling at injection site, temperature of 101.7, bad chills, achy muscles, headache, fatigue. No covid prior vaccination, no covid tested post vaccination.
Extreme dizziness and nausea near vomiting gagging. Dizziness still persisting as of 09/06/2012 but milder but very uncomfortable. Taking Promethazine 25 mg for stomach problems.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00621A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient came in pharmacy and reported and showed left arm red and swollen and vaccination area hurts and warm to touch. She has taken a dose of tylenol will repeat and i counselled as well on benadryl will see prescriber (ER or urgent care) if reaction still ongoing after 24hours from time of vaccine
Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.  This patient returned on 3/6/23 to be revaccinated; Moderna Lot#066H22A Exp:03/18/23
Left arm was very swollen and tender next day. He may have had low grade fever later the same day that he got it. Had sore throat, cough, some rhinorrhea, achiness which cleared by 10/26/2012.
there are bumps at the injection site; Vaccination site erythema; itching at the injection site; area around injection site is slightly swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (there are bumps at the injection site), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (area around injection site is slightly swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (there are bumps at the injection site), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (area around injection site is slightly swollen). The patient was treated with CORTISONE for Itching, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MASS (there are bumps at the injection site), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (area around injection site is slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Service member (SM) was in his usual state of excellent health prior to Aug 2006. He was diagnosed with Type 1 Diabetes Mellitus (T1DM) in Sep 2007. Looking back, SM recalls developing symptoms of hyperglycemia sometime between Aug and Dec 2006. Initially, his symptoms were subtle and he did not feel he was "sick", but his symptoms gradually increased and led to his diagnosis of T1DM in Sep 2007. SM received Yellow Fever vaccine in May 2006 and influenza vaccine in Dec 2006, which receipt of Typhoid vaccine in August 2007, shortly before his diagnosis. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Symptoms SM reports for months, maybe even a year prior to diagnosis were polyuria, polydipsia, fatigue, and weight loss. He had been losing weight by following the ATKIN's diet for a couple of years prior to symptom onset. His baseline weight in 2006 was about 200 pounds. At the time of diagnosis, his weight was down to about 160 lbs per her Med Records. SM did not experienced changes in sexual function until about 2 months before diagnosis, and he did not experience any visual changes until the week before diagnosis. In Sept 2007, SM was staying in a hotel during his week-end drill. After his wife attempted to call him and did not get an answer, she called the hotel front desk, who called the ambulance. The patient was unconscious and was admitted to hospital between 9/12/2007 and 9/19/2007. He was did not regain consciousness for 3 days and was placed on a ventilator. He believes his serum glucose level was >750 and he was in Diabetic Ketoacidosis (DKA). He suffered from renal insufficiency and almost went on dialysis. During his hospitalization, he developed pneumonia. During his hospitalization, he received hydration and electrolyte replacement, and insulin, as well as diabetes self management training were initiate. He was discharged on once daily LANTUS with additional supplementation for hyperglycemia using HUMALOG. Since diagnosis, SM has been followed through local civilian health care providers. He has been on an insulin pump for about 1 year. Following his diagnosis of T1DM, he had been diagnosed with peripheral neuropathy, ED, skin cancer, hyperlipidemia, right shoulder rotator cuff tear, and left knee ACL tear. Around the time of diagnosis, SM was told he had diabetic changes in left eye, which had later been noted to have resolved at a follow-up exam 2 months later. SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and met military weight requirements prior to diagnosis. SM has a sister with T1DM who was diagnosed at age 3. (He says he was tested around 1976 to see if the was at risk to develop T1DM and his mother was told he was not at risk.)
stomach cramps; upset stomach; sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0153, Expiration date: Unknown), via an unspecified route of administration in arm left on an unspecified date (at the age of 61-year-old), as a single dose for COVID-19 immunisation. The patient medical history and family history was reported as none. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that she had the first shot three weeks before the second shot and had stomach cramps on an unspecified date at 06:00 and stated stomach would not settle down. The patient stated that last week on thursday, she was in downward spiral and could not get out of it and was being careful with what she ate. The patient had pain in lower abdomen that started 10 days ago and gets upset stomach from time to time but that it has been pretty constant since the first week in May. The patient stated that sometimes she remembers things that amazes her and sometimes she cannot remember what happened yesterday and Stated that other factors were involved (memory) at that time that her husband was ill. The event did not result in Emergency Room/Physician Office. The seriousness of all the events was unspecified. The relevant tests were reported as none. The patient received mylanta as treatment for the events. The outcome of stomach cramps was reported as resolved 10days after started, upset stomach as resolved with sequel and sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday as unknown.  Follow-Up is needed for furthur information.
Right after the injection, I developed an itch and rash around the injection site. 15 minutes later my lips and throat swelled up.
Pt received the flu vaccine at half dose on 16 Nov 2010 because of her extended sxs following last year influenza vaccine. The next day she reports having low grade fever (100.5), chills, nausea, vomiting, body aches, and a severe headache. Quarters were required. The following day she continued with these sxs except for the vomiting and fever. Nausea and body aches, continued for 10 days. All sxs resolved now per pt. Case reviewed by the clinician group pt likely had a cytokine-based immune reaction to the influenza vaccination. Since the flu vaccines from this year and last are not the same antigenically, there is a concern for any vaccination received in the future. Although 2-3 days of flu-like symptoms are manageable, this pt's history of a prolonged fatigue syndrome, like that which occurred last year after the FLUMIST vaccination, is concerning. Recommendations: 1. Recommended pt receive no immunizations without input from the Vaccine Health Center. 2. Pt will be due for Td in 2011. Recommended tetanus titer be drawn and the HC subsequently consulted. 3. Will review eligibility for influenza vaccine in 2011 depending on length of time current systemic symptoms remain, health status in 2011, and clinical duty assignment. Follow-up as needed in the Health Center.