chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Spikevax COVID19 vaccine bivalent, the dosage given in ml was unknown to the HCP. HCP requested the list of information necessary for an assessment to be sent to her email since she did not have the info available at the time of the call and she would contact us again with that information. This case for patient 17 out of 100 patients. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
Had Moderna COVID-19 vaccine on 3/3/21, was fine at first.  But at 2 AM afterwards was awakened by upper back pain that was stabbing when she took a deep breath.  Also very fatigued.  Went back to sleep and the next day the upper back pain was better, but her ear cartilage was swollen bilaterally.  This resolved gradually over 24 hours.  She went to Patient First for her sx, was told her labs and CXR and COVID-19 test were all normal. She did test positive for COVID-19 on Dec 21.
Extremely fatigued, affected area swollen, itching and painful. Stiffness setting in the neck and back. Slept a deep and restless sleep that night. Awoke early next AM and upon arising I discovered that the pain had spread to the whole side of the body affected. I had pain even in my toes. My head felt 'fuzzy' and my affected arm had doubled in size. My NP suggested for me to take Tylenol and use heat on my arm to ease my discomfort but I'm allergic to Tylenol. I used ice every hour to ease my arm and it has worked!
p/recv vax pt devel pea-soup foul-smelling, green diarrhea; later pt devel fever of 102.2f & had 2 green stools; seen by MD who noted temp was 101.1f; stool specimen was collected, it tested positive for rotavirus antigens
03/01/2021, at around 8:00 pm, it started with a headache, chills fever. On 03/05/2021, I still had the headache, and began having GI symptoms with diarrhea, and vomiting at the same time, along with abdominal pains, bleeding during diarrhea, that lasted a day and half.
Same day as shot to current time, I got a tingly/numbness feeling in my left shoulder, neck, left arm, redness in my face, rashes on my face and back.  Saturday night the 24th, I went to the ER with tingling/numbness on the left side of my face, arm, and leg.
Pt experienced fever, chills, aches, and pain throughout her body. she has had fever and aches before with the vaccine but this was much worse.
About 12 hours after receiving the  Moderna  COVID-19 Vaccine EUA (11:30 pm) I spiked a temperature of 101.6. I had body aches, exhaustion, and I was shaking. I took some Advil and started to feel a little better. I woke up this morning and had no fever but still some body aches and fatigue.
34 year female presents for elective induction of labor at term (40 weeks 2 days) EDD 1/08/2022 No fetal heart tones were found and pt was diagnosed with an intrauterine fetal demise (stillbirth) Induction of labor occurred and patient delivered a nonviable female infant weighing 3446 grams on 1/11/2022 No gross anatomic fetal anomalies
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: CLL" (unspecified if ongoing), notes: Other medical history: CLL. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (22Sep2022) Negative, notes: Two days after finishing Paxlovid, I tested negative; (24Sep2022) Positive, notes: 4 days after finishing the Paxlovid, I relapsed with a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After 5 days of Paxlovid, She had a terrible metallic taste in my mouth and diarrhea. Two days after finishing Paxlovid, she tested negative. 4 days after finishing the Paxlovid, She relapsed with a positive test and had sick for the last 3 days with a very stuffy nose and cough.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Adult patient received a dose of pediatrix Havrix; Adult patient received a dose of pediatrix Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 17th June 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The adult patient received a dose of pediatrix Havrix, which led to underdose and adult use of a child product. The Health care professional did not want to provide patient's identifiers and stated that the nurse in charge will proceed administering a second dose of the pediatric Havrix to the adult patient to complete the dose. The reporter consented to follow up.
Pharmacist called patient to thank her for being a new customer and patient stated she believed she had a stroke and was on her way to ER, and she questioned if vaccine could have been cause. Patient stopped in 5/26/2012 to inform pharmacist it was a diagnosed stroke but cause was unknown.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 33-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was reported.
Very sore and weak left arm and mostly at the joint. I am a belly sleeper. Little soreness at the vaccination spot though.
Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal hygiene. Inability to perform previously routine tasks. Notable lack of concern about lost physical and mental capabilities.
FEVER, GENERALIZED BODY ACHES, ABDOMINAL DISCOMFORT, NAUSEA, DIARRHEA
Patient stated he typically runs fever after flu vaccine. Morning after his arm was very sore and became red and swollen.  Second day after since it was no better, he decided to go to urgent care to have it checked. Received rx for Keflex as precaution.
received an expired Havrix pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HAV (Havrix 720 Junior) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.   On 08-AUG-2023, the patient received the 2nd dose of Havrix 720 Junior. On 08-AUG-2023, an unknown time after receiving Havrix 720 Junior, the patient experienced expired vaccine used (Verbatim: received an expired Havrix pediatric dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2023 Adverse event (AE) was already reported to VEARS. The reporter consented to follow up.  The patient received an expired dose of Havrix pediatric, which led to expired vaccine used.
patient was given 0.5ml of moderna as a booster after receiving a jnj dose.  dose should have been 0.25ml  pt has had no side effects from it.
Sore lower back and hip on left side, Rash on lower left back near hip. Very tender sensitive skin at site of rash.
Injection ASTRAZENECA received Monday 16th August 4:30pm. Tuesday afternoon 17th August (24hrs post-vaccination): headache, malaise, pain at the injection site, injection site warm to touch Wednesday afternoon 18th August (48hrs post-vaccination): malaise, tiredness, muscular and joint pain, rash, pain at the injection site, fever, night sweats, loss of appetite Thursday afternoon 19th August (72hrs post-vaccination): malaise, extreme muscular and joint pain, swelling of extremities (hands/feet/wrists/ankles), unable to lift both arms, extreme pain in hip, pain at injection site, fever, night sweats, loss of appetite - these symptoms continued until escalation of pain approximately 11:30pm Saturday night.   Saturday 21st August 11pm: Patient screaming in pain.  Extreme pain in all joints and muscles.  Rash present on lower legs, inside thighs, abdomen (front and back), upper arms, underarms.  Patient still unable to lift arms. Called health advice line.  Transferred to ambulance line.  Ambulance transported patient to hospital just before 1am Sunday morning.  Hospital advised extreme allergic reaction to ASTRAZENECA vaccination.  Held for observation until just after 7am Sunday morning.  Discharged and advised to rest for a week and to make appointment with immunology clinic to assess if should receive another vaccine. Slight improvement of condition Wednesday 01st September - able to lift left arm but still unable to lift right arm.  Thursday 02nd September patient relapse with re-emergence of all symptoms previously indicated - cannot lift either arm, cannot close hands, swelling of extremities. Friday 03rd September 8am: Patient started screaming in pain shortly after waking up.  Extreme joint and muscle pain.  Admitted to hospital.  Receiving Endone (unknown dosage) and prednisone(?).  Some subsidence of pain and swelling symptoms at 3:30pm Saturday 04th September.
Hearing loss; This is a literature report for the following literature source(s): (Privacy).  A 53 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune inner ear disease" (ongoing), notes: 7+ years. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "hearing loss" was evaluated at the physician office visit.; Sender's Comments: Based on the available information in the case, the causal association between the event Hearing loss and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
shot given 3/11/21, on 3/16/21 a red rash that itched, burned and stung appeared from head to toe.  Dr. prescribed a steroid MethylPREDNISolone 4 mg tablets on 3/17 or 3/18 and about 3/22 the rash was gone.
T101 x 2 days; 1-1 1/2 hrs p/#2 DTP; no redness, swelling; no high pitch cry; just crabby x 2 days; dx ordered no more DTP's;
102 temp; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; could not even sleep; neck,shoulder,head ache so bad could not even sleep; flu symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillian" (unspecified if ongoing), notes: known allergies: Penicillian; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: LOSARTAN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Hycodan, reaction(s): "Known allergies: hycodan", notes: Known allergies: hycodan. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "102 temp"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "neck,shoulder,head ache so bad could not even sleep"; INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms"; INSOMNIA (non-serious), outcome "unknown", described as "could not even sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Every shot got worse. First shot 102 temp and neck, shoulder, head ache so bad could not even sleep plus basic flu symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reports onset of cough and shortness of breath on Tuesday, 11/30; she reports she came into contact known Covid positive patient on the bus.  Reports she went that same day, on 11/30 and received a positive Covid test.  She presents to the ED 12/2 after the onset of worsening shortness of breath and fever and chills.  She was vaccinated in March/April.  Denies loss of smell, taste, diarrhea.  12/14: 47-year-old female with PMH significant for CKD stage IV secondary to lupus nephritis, history of CVA with residual right-sided weakness and expressive aphasia 2012, history of lupus(on hydroxychloroquine, prednisone), HTN, seizure disorder, previously vaccinated for Covid was transferred from family medicine service to MICU for worsening hypoxic respiratory failure in the setting of Covid pneumonia. Symptom onset date 11/30.  Admitted to family medicine for worsening hypoxic respiratory failure requiring supplemental oxygenation, and was transferred to MICU for BiPAP initiation. Patient is s/p dexamethasone and tocilizumab. Remdesivir stopped early on 12/2 due to GFR <30. Holding hydroxychloroquine and CellCept. On 12/06 patient had increased resp fatigue and was intubated. Proning started 12/07. 12/09 patient was transfused 1 unit of RBC , Cr also increased so nephro consulted to place dialysis line on 12/09. Patient started on SLED for poor UOP and rapidly rising Cr. Worsening oxygen saturation prompted infectious workup on 12/11 with blood/urine cultures, QTL cultures, giemsa stain, PNA panel. Vanc and mero initiated on 12/11, stopped 12/13. RPP positive for adenovirus. On 40 iNO. Patient desaturated this AM after unproning and saturation dropped to 70%; increased slightly with change in ventilator settings to EPRV and repeat proning. Hgb this AM dropped to 7.0; FOBT positive; suspected internal bleeding. 1u PRBCs given with repeat H&H 1 hour afterwards. Comfort care conference today with family; patient's aunt, and both of patient's daughters opted to pursue comfort care. They understand that comfort care means stopping all life saving measures with the intention of keeping patient comfortable. They would like to begin that process soon; one of the family members would like to organize a zoom call before ETT tube is removed. She had no further questions. Will stop nimbex now and slowly wean sedation with ultimate removal of ET tube. Suspect patient will pass immediately with removal of tube considering the amount of ventilator support. Will call patient's aunt after patient passes.
Client does not speak English, daughter translated. Daughter stated client was experiencing tingling in the left arm. Daughter also stated client also experiences tingling since having surgery last year. Client was seen & cleared by EMS
Joint pain, chills and fever resulting in shaking and trembling for four hours, vomiting, headache
Tooth pain across the entire lower jaw that lasted for about 18 hours. Treated with ibuprofen.
When I woke up I felt my legs wouldn't hold me up. I passed out in the bathroom. Finally managed to get up and walk with the aid of a walker. I have no more memory of that day. Except for meals and bathroom use I remained lying down all day. I was very nauseous and severely weak, light-headed, and had brain fog, Except for the nausea I felt that way for 10 days. On the 10th day I felt able to stand long enough to take a shower.
Narrative:  Pt was an 80 YO Male with PMH of metastatic prostate cancer, OA, amputation, lung cancer, PVD, HLD, and tobacco use. Pt received Moderna COVID-19 vaccine on 3/1/21 and 3/8/21. No information in chart regarding patient's cause of death; death reported to agency by another agency. No evidence that death is related to COVID-19 vaccine.
heart arrythmia, unexplained positional drop in BP, dizziness, disorientation, mild difficulty articulating.  Started a couple of weeks after receiving vaccine.  Went to Dr, then to ED.  had stress test and MRI.  found nothing wrong with heart.  Believed to be neurological.  Lasted until about 10/2022.  went away fairly rapidly.