chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. Date the vial was initially stored in the refrigerator was 04-Nov-2021. 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. The patient did not experience any adverse event. No treatment information was provided by the reporter.
Left shoulder pain, possible tendonitis. Symptoms started 4 days after immunization, has been worsening. No loss of range of motion or strength, but exam suspicious for rotator cuff tendonitis, no history of injury or prior tendonitis.
Twin pregnancy, due date 7/4/2021. Twin B born on date diagnosed with moderate sized mid muscular VSD at birth
Information has been received from a Pharm.  T.  concerning a 23 year old female with sulfonamide allergy and a history of birth control who on 16-MAR-2009 was vaccinated with the first 0.5ml dose of GARDASIL.  Concomitant therapy included YAZ.  On 21-MAR-2009 the patient developed injection site pain.  The patient was not recovered at the time of reporting.  The patient sought unspecified medical attention.  No further information is available.
Employee received COVID vaccine #2 at 0830.  By 2200, employee had temp of 102.6 and bodyaches.  Continues to have temp 24 hours later.
Headache; Pain; Administrated a first dose of Shingrix only the adjuvant without the powder; Administrated a first dose of Shingrix only the adjuvant without the powder; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced headache, pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the headache, pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that the patient administrated a 1st dose of Shingrix only the adjuvant without the powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The patient reported pain and headache. The reporter consented to follow up. Pharmacist didn't know who she gave just the adjuvant. The case had been linked with US2020203921 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203921:same reporter
COVID-19 Vaccine  Severe Joint Pain  left Shoulder for 5 days - Started 4 Hours after vaccine. Severe Joint Pain in both knees for 2 weeks - Started next day Bad Neck and Head Pain for 2 weeks - Started next day Joint Pain Left  Shoulder,  Both Elbows, Both Wrists,  Both Knees,  and Left Ankle for 2 weeks - Started next day Migraine, Nausea started  24 hours later and lasted for two days.  Headache for 2 weeks.
Headache, Weakness, Fatigue, Sore arm . I had a fall.
Sinus headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120A) for COVID-19 vaccination.   The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ACETYLSALICYLIC ACID (ASPIRINE) and ROSUVASTATIN for an unknown indication.  On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced SINUS HEADACHE (Sinus headache). At the time of the report, SINUS HEADACHE (Sinus headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received 2 shots. covid had no reaction but patient had swelling 3 days after with veins turning darker tracking toward torso/heart
30 seconds after injection felt clammy, lightheaded and had tingling fingers.  Still symptomatic at 15 minutes post injection but symptoms improving.  Light headedness resolved after 10 minutes.
Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash from chest down it was a burning and itching and red spots. They took me to ER and gave me medicine. Within 40 mins I felt better so I left to go home. I have been feeling really tired and weak. I went home on the 4th with weakness and I did vomit 1 time. I felt sick to my stomach all day. I came back to work today still feeling nausiated."
Patient reported that he went to ER and was told Sugar level was at 500 and had to received Insulin... Hasnt been to work in over a month and he is Bloated badly and is taking medication for
Severe aches in joints (hips, knees) for two to three days. Nausea any time I moved injection arm even slightly for several days -- more like what you would expect from a break than a shot. Redness and slight swelling around injection site. Dizziness. Complete loss of appetite for two and a half days. Nausea for two days. Slight vomiting, mostly bile. Extreme fatigue for two to three days; lesser fatigue for another two. Liquid, nearly clear diarrhea morning of 3/29. Had the sense that I was running a fever but thermometer was in storage, so no proof.
This spontaneous case reported by a consumer, describes the occurrence of severe chills for 2 to 3 hours, fatigue and arthralgia (joint pain) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006M20A and 012L20A) for COVID-19 immunization. The patient's past medical history included blood cancer. Concurrent medical conditions included immunocompromised. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 16, 2021, patient experienced severe chills for 2 to 3 hours and fatigue. Feb 16, 2021, patient experienced arthralgia (joint pain). On Feb 16, 2021, severe chills for 2 to 3 hours) resolved. At the time of the report, fatigue and arthralgia (joint pain) outcome: unknown. No concomitant medications or treatment information provided. Reportedly, patient had no adverse reactions after the first Moderna COVID-19 vaccine. This case linked to MOD-2021-375478 (patient link).
Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K026387(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
nausea; diarrhea; excessive sweating; chills; hot flashes; shortness of breath; chest tightness; elevated liver enzymes; blood pressure and heart rate were high. BP was approx 180/120; heart rate were high; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Mar2021 08:15 (Batch/Lot Number: ER2613) as a single dose for covid-19 immunisation. Medical history included asthma, IBS (irritable bowel syndrome), and allergies to shellfish, fish and seafood. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included glucosamine and cetirizine, all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The COVID 19 vaccine was received in a hospital. Approximately 12:15 AM on 21Mar2021, the patient began to experience chest tightness, shortness of breath, nausea, diarrhea, excessive sweating, chills and hot flashes. The patient took himself to the emergency room (ER) on 21Mar2021. The patient also mentioned that his temperature was normal, but his blood pressure (BP) and heart rate were high. BP was approximately 180/120 (unit unspecified). The ER ran Chest X-Ray, EKG, CBC, CMP, Protime-INR, Magnesium, Troponin, Partial Thromboplastin Time and TSH. The results were normal ranges besides high heart rate and elevated liver enzymes. The adverse events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events received treatment for the adverse events which included albuterol-ipratropium, aspirin and IV fluids. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
severe allergic reaction to flu vaccines; Initial information was received on 27-Feb-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional via Social media.  This case involves patient (unknown demography) who experienced severe allergic reaction to flu vaccines (hypersensitivity), while the patient received INFLUENZA VACCINE.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. Medication Details and reason for taking the medicine: Not Provided The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious severe allergic reaction to flu vaccines (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  Reporter stated that, get yours and you can have mine too. The patient had a severe allergic reaction to flu vaccines. It is unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown.  There will be no information available on the lot number for this case.
Vaccine left at room temp for over 2 hours after being punctured and administered to Pt.  Pt received vaccine about 2&1/2 hours after puncture.
Rash, cold sores, canker, joint pain, Left elbow feels like pulled tendon or sprained and have not. Migraines every day. All over body aches, lower back nerve pain. Valtrex prescribed.
Miscommunication of patients birthday, patient was given janssen vaccine while still 17 years of age. No actual adverse reaction occured
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-DEC-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart murmur" (unspecified if ongoing); "latex allergy" (unspecified if ongoing), notes: Known allergies: latex. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Other medication in 2 weeks was reported as yes. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 29Dec2022 and stopped on 02Jan2023, Indication: Treatment of 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: Based on the information provided in the narrative, a causal association between the events Drug Ineffective, COVID-19 and the suspect drug cannot be completely excluded.
HEARING LOSS IN RIGHT EAR; VERTIGO; POOR QUALITY OF LIFE DUE TO THE HEARING LOSS; This spontaneous report received from a patient concerned a young female of unspecified age, race and ethnicity . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in good health prior to the vaccine administered. The patient received covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced hearing loss in right ear, vertigo, and poor quality of life due to the hearing loss. It was reported that the hearing tests/evaluation was ongoing and the outcome was unknown at the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hearing loss in right ear, vertigo and poor quality of life due to the hearing loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211229639-COVID-19 VACCINE AD26.COV2.S-Hearing loss in right ear. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Initial report received from a consumer (the patient) on 12 March 2014. An 89-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of TETANUS TOXOID (TETANUS) (Manufacturer unknown, batch number, dose number, route and site of vaccination unknown) on an unspecified date. On an unspecified date, the patient experienced an allergy to tetanus with the reaction of "pain". Lab data and corrective treatment was not provided. At the time of this report, the outcome was unknown. Document Held by Sender: None.
Pt reported to office with possible reaction to vaccine. 9-10 cm red, warm area to upper (R) arm. Pt was given BENADRYL in office, area circled to document change. Pt called in later that day and reported increase in size of redness outside the circle placed in office. KEFLEX called in however for possible infection.
Pain in injection site Nausea 4 hours after vaccination that subsided alone Breastfed 20 month old increased breastfeeding following day, experienced low grade fever and fussiness starting 24 hours after vaccination. Unknown if related to mother's vaccination.
pt recv vax 7MAR95 & w/in 30 days of vax pt exp pain in mult joints throughout body, swelling & tenderness of mult joints, fatigue, loss of appetite & weight loss,Limited ROM in mult joints;stiffness, swelling;arthritis;genetic disposition
12/20/21 - I received the Pfizer COVID booster shot at the pharmacy at approximately 11:40 AM. 12/22/21 - I felt a tightness in my stomach, as if there was a tight band around it. 12/23/21 - I had numbness and tingling from my stomach down to my ankles which made it very difficult to walk, stay balanced and get up from a seated position. 12/24 - 12/26/21 - I had trouble standing, walking, walking up/down steps and getting up from a seated position. 12/26/21 - 1/5/22: I went to Urgent Care at approximately 8:00AM and was told to go to emergency room immediately.  I went to the Hospital and was admitted.  According to multiple Neurologists they determined it was an atypical case of Guillain-Barré Syndrome and Acute Transverse Myelitis; typically both diagnoses start from the feet and work their way up, but mine did not - so the doctors were not fully sure of the cause. I was given a couple of different treatments that typically help with GBS and ATM.  Treatments I received were 3 doses of gamma globulin injections, as well as 5 doses of Dexamethasone steroids.   I received both physical and occupational therapy to help build my strength but since I did not have feeling in my knees and legs, I had randomly fallen while standing with a walker or while exercising.   1/5/22 - 2/4/22: I was then transferred to Rehab on 1/5/22. I was seen by their neurologist and team of doctors while receiving physical and occupational therapy.  Starting on 1/8/22 I received 5 doses of Prednisone Steroids for Acute Transverse Myelitis.   The neurologist could not exactly pinpoint what diagnosis I have but they believe that it is Acute Inflammatory Demyelinating Polyneuropathy / Paresthesia of the Lower Extremities which is a type of Guillain-Barré Syndrome.   2/4/22 - Present: I left Rehab on was working with Home Care PT / OT from 2/4/22 - 2/16/22.  I am going to outpatient neuro-PT, two times a week at (Privacy) Rehabilitation (my parents will be driving me), as well as exercising at home to regain strength.  I am still feeling the numbness/tingling in my legs and knees, along with having back pain, difficulty going up and down stairs, difficulty walking smoothly with the walker, not being able to get up from a seated position, (especially seats without armrests), difficulty balancing and being unable to drive.   I have not returned to work due to these circumstances and do not know when I will be able to return.
Urticaria, across right side of neck, jaw, and torso; This spontaneous case was received on 26-Oct-2023 from other non-healthcare professional (consumer) via Pfizer (reference number 202300323410) and concerned a patient of unknown demographics.  The patient's concurrent conditions included prolactinoma. The patient's concomitant medications included cabergoline, used for unreported indication.  On 26-Sep-2023 the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v, anatomical location: left arm, dose, indication and route of administration: not reported). The batch number was not reported.  On the same date the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent (active ingredients: not specified; anatomical location: right arm; dose, route of administration and indication: not reported). The batch number was not reported.  On 06-Oct-2023, ten days after receiving Afluria Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient experienced urticaria, across right side of neck, jaw, and torso.  On an unspecified day in Oct-2023, the patient received loratadine and hydrocortisone cream as treatment.  At the time of the initial reporting on 26-Oct-2023, the patient had not recovered from the event.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: The event of urticaria is assessed as unassessable to Afluria Quadrivalent due to unsuggestive temporal relationship.; Sender's Comments: The event of urticaria is assessed as unassessable to Afluria Quadrivalent due to unsuggestive temporal relationship.
NO ADVERSE EVENT; Incorrect storage PEDV AX HIB was administered to (3) patients on 7/6/2021; This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. THe patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 06-JUL-2021, the patient was vaccinated with improper storage haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T026961, expiration date 02-APR-2023 (dose, frequency and route were not provided), for prophylaxis. No additional adverse event reported.  Temperature (8.6F) Time frame 45 minutes Previous temperature excursion? N Was call because of a "data logger"? Y  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2107USA002009: US-009507513-2108USA001448:
SECOND DOSE ADMINISTERED ON DAY 14 RATHER THAN THE RECOMMENDED DAY 21. PATIENT WAS TIRED AND HAD CHILLS.
Patient was evaluated in the clinic by his PCP on 9/1/2021 for cough, fatigue, chills, shortness of breath and nasal congestion that had an onset 3-4 days prior. His pulse oximeter was 68-72% on room air, advised to the ER for further evaluation. Upon arrival to the ER he was hypoxic to the mid 80s and placed on supplemental oxygen.  Admitted to the hospital for further treatment of COVID infection.  No prior COVID infections.