chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 18:15 as dose 4 (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), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Mar2023) Positive, notes: 5 days after finishing paxlovid, I tested positive again; (Mar2023) Negative. Therapeutic measures 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.
pt was given adult influx split Fluarix instead of Fluzone, no symptoms noted at this time.
Fluzone vaccine on 11/8/2006  Hepatitis A vaccine Havrix on 11/8/2006  Td vaccine on 11/8/2006  Vivotif (Live oral Typhoid) Started 11/15/06 and took one capsule every other day x four capsules.  Lariam generic (Mefloquine Hydrochloride) 250 mg. Started 12/21/06 and took one pill each week for a total of four weeks. Symptoms of dysphagia started about 1/1/2007 along with slurred speech(dysarthria), tongue twitch, and generalized weakness which have been present to varying degrees since 1/1/2007.  The other intermittent symptoms she has experienced over the course of the last six months are R occipital and parietal throbbing type pain, R ear pain, general headaches, R cheek droop once x 15 min, L facial numbness, balance/coordination difficulty, L arm numbness once x 15 min (like rubber band on it), tongue/cheek twitching, and a very, very mild L lower branch Bell's Palsy.  The symptoms are stable at this point in time. Currently the renaining symptoms are the dysphagia, tongue twitch, slurred speech and fatigue. She has been worked up from the ENT and Neurological perspective. Neuro initially thought neurologic paraneoplastic syndrome and then the ALS center gave her the diagnosis of amyotrophic lateral sclerosis (progressive bulbar palsy). She is being looked at now from the immunologic perspective since her symptoms seem temporally related to the vaccines and Lariam. Currently she is treating with a foriegn physician for paraneoplastic syndrome with reinfusion of her own Natural Killer cells, dendritic cells, phenylase and Rapakine plus some type of vaccine.She is also conferring with and being tested for immune dysregulation and possible mercury toxicity. Those results are not back yet. She has not been classified as permanently disabled as yet but her work has been affected. 7/5/07-records received for DOS 11/8/06-4/19/07-seen on 1/26/07- for C/O right ear pain times one week and slurred speech times 3-4 weeks. Symptoms consist of diplopia, slurred speech, numbness on left side of face, balance/coordination difficulty, swallowing difficulty, left lower facial weakness. Headaches localized in right occipital area, right parietal area. Recent travel to India. Patient had a cough and headache in India and returned feeling very weak. PMH: back apin, migraines and neck pain. Slightly elevated liver enzymes and elevated ESR could be thre tail end of viral illness acquired in India which is resolving. Seen on 4/2/07- C/O cough and cold. Dyspnea worse with moderate exertion. Neurology consult 4/13/07-Neuro exam demonstrated dysarthria accompanied by emotional lability, highly suggestive of bilateral corticobulbar tract lesion. Pseudobulbar palsy remains unexplained probably due to upper motor neuron degenerative disease. Seen by neurologist on 4/3/07-indicated that upon arrival in India on 12/26/06 family noticed her speech had changed. Two episodes of emotional upset that were accompanied by drooping left side of face. Laughs inappropriately during conversation with others. Fatigue, difficultly with swallowing. Seen on 4/18/07-Impression:unmistakable clinical features of bulbar amyotrophic lateral sclerosis (ALS).
I developed red,warm, hard spot about 2? long and 1? wide at the injection site that appeared over a week later. It was sore and tender after the shot but seemed to go away and now it is back.   I haven?t gone to the doctor about it, I just thought maybe it should be reported. I will continue to watch it.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medications were reported. Reporter has stated that the time from first puncture was 7 days. Reporter has stated that they were looking for a decision as to whether these doses can be counted or if the provider needs to contact the patients for re-administration of the doses.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant FU added.
pain in the joints; lot of pain at the back; The skin around the wound and the immediate area was infected; wound area was red in color; This case was reported by a other health professional and described the occurrence of joint pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leg injury (on 14th June 2019 while exercising.).   On 18th June 2018, the patient received the 1st dose of Shingrix. On 20th June 2018, 2 days after receiving Shingrix, the patient experienced joint pain, back pain, skin infection and erythema. The patient was treated with antibiotics nos (Iv Antibiotics (Nos)). On an unknown date, the outcome of the joint pain, back pain, skin infection and erythema were unknown.   It was unknown if the reporter considered the joint pain, back pain, skin infection and erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had leg injury and was an abrasion to her lower leg shin and below the knee. She struck her leg in that area on some exercise equipment. The wound area was an abrasion and when she got home it was not actively bleeding and was bandaged. The reporter was paramedic and cleaned the wound and rebandaged it.  The patient checked the wound and it was in the healing process.The wound was almost healed. The patient received Shingrix and day we checked her leg wound over, cleaned it and rebandaged the wound. The reporter checks the patient leg and the skin around the wound and the immediate area was infected and red in color. The patient was complaining of pain in the joints and took her to the emergency room for evaluation. At the emergency room they evaluated her problem situation. She was administered intravenous and was given prescriptions for antibiotics. She took the antibiotics for 3 weeks following the emergency room visit. After a few days on antibiotics her leg wound started to look better. She also had a lot of pain in the joints and back area after the vaccine. She received physical therapy for the pain but it did not produce any relief. The patient was due for her second vaccine my sister and did not allow her to get it.
Some of vaccine dripped on patient's arm; A spontaneous report was received from a health care professional concerning a 33-years old female patient, who received the Moderna COVID-19 Vaccine (mRNA-1273) and some of vaccine dripped on patient's arm (Incorrect dose administered).  There were no medical history concomitant medications provided by the reporter.  On 16-Jan-2021, the patient received the first of two planned doses of mRNA-1273 vaccine (Lot number: 025J20-2A) intramuscularly in the right arm for COVID-19 infection prophylaxis.   The HCP stated that, while the vaccine was being administered to the patient, a good amount of the vaccine dripped down her arm because the needle was retracted too quickly. No other adverse event was reported, and the patient provided consent for follow-up. No treatment information was provided for the event.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event some of vaccine dripped on patient's arm (Incorrect dose administered) was considered recovered on 16-Jan-2021.; Reporter's Comments: This case concerns a 33 year old female patient who experienced a non-serious unexpected event of Incorrect dose administered of the mRNA-1273 vaccine.
Pink raised area at injection site 2 inches by 1 inch lasting 8 days.
Had vaccination shot at Pharmacy at 2:15pm on 1/29/22. Around 6:30 started feeling extremely exhausted. Went to bed early with chills and body aches. Woke up at 6:00am, ran to the bathroom to vomit. Had extreme night sweats. Slept through the morning. with severe body aches. Attempted to eat a small amount of food. Went back to sleep on the couch, had a seizure. Woke up in a complete daze and confused state not knowing I was at my own home or knowing what day it was. Drool was on the couch, I'm not certain how long the seizure lasted. I was able to get up to go to the bathroom hours later, looked at my tongue and it had been bleeding with a large chunk out of it and was bruised with a lot of pain. Monday, 1/31/22 the body aches and chills had resided, however, it still feels as though I had a full body work out but had only slept the entire previous day and had not worked out within the last week.
Information has been received from a registered nurse concerning a 63 year old female patient with no pertinent medical history or drug reactions/allergies who on 20-MAY-2010 was vaccinated with a single dose of PNEUMOVAX 23 (Lot # 661739/1407X, expiration date 12-JUN-2011) 0.5 mL, IM. Concomitant therapy included ALEVE and amlodipine. On 20-MAY-2010 the patient developed leg and muscle pain after receiving PNEUMOVAX 23. The patient went to an emergency room but was later released. A cardiac panel, urinalysis and creatinine levels were performed without any results available. At the time of this report, the patient was recovering. Additional information has been requested.
March 10, 2021: 1st dose of Pfizer COVID-19 vaccine March 11: pleurisy-type symptoms and difficulty urinating began March 19: still symptomatic, urgent care visit with chest x-ray and blood draw March 20: told to go to ER, concern for pulmonary embolism. Sent home the same day, told to take pain medications and tamsulosin prescribed from urgent care visit. Received chest x-ray, blood draw, and CT scan.  March 25: another doctor visit, still symptomatic, prescribed prednisone and hydrocodone for pain and trouble breathing April 1: Seen by renal specialist, blood pressure medication dose changes, elevated potassium As of April 12, 2021, still symptomatic with pain (in the back), unable to sleep and taking pain relievers every 4 to 6 hours
Information was received from a medical assistant regarding multiple unspecified patient with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that an unspecified number of unspecified patients received improperly stored M-M-R II  lot# L012482/Expiry date: 10-APR-2017, L023386/Expiry date: 25-JUN-2017 and L033589/Expiry date:02-SEP-2017 on unspecified dates in 2016 (dosing details not reported). Temperature/time frame: 21-SEP-2016: 16.3F for 2 hours and 23-SEP-2016: 6.1F for 2 hours 15 minutes. The call was due to data logger. Prior excursions on 15-SEP-2016: 13.5F for 4 hours and on 16-SEP-2016: 63.1F for 4 hours. No product quality complaint (PQC) was involved. This is one of the three same reporter linked case. Additional information has been requested.
Had febrile seizure a few hours after vaccination (Temp 105), hospitalized at hospital.
Myalgias, arthralgias, headache, photophobia, sweats, chills lethargy all lasting twelve hours improved with ibuprofen
Lymph nodes in the right side of the neck are swollen; having side effects; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (having side effects) and LYMPHADENOPATHY (Lymph nodes in the right side of the neck are swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (having side effects). On 06-Dec-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in the right side of the neck are swollen). At the time of the report, VACCINATION COMPLICATION (having side effects) and LYMPHADENOPATHY (Lymph nodes in the right side of the neck are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment information was not provided.
ADMINISTRATION OF EXPIRED VACCINE(PAST 6 HOURS); INCORRECT PRODUCT STORAGE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: not reported) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced administration of expired vaccine (past 6 hours). On 24-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine(past 6 hours) and incorrect product storage was not reported. This report was non-serious.
Developed low grade fever and rash by 6/26/03. Mom called 6/27/03 AM with suspected seizure and facial grimacing/mouth smacking. Admitted to hospital and transferred to another hospital 6/27/03. Still hospitalized as of 7/8/03.
Shingles; This initial spontaneous report was received from a lawyer, regarding a case in litigation, concerning a female patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (strength, dosage regimen, route, lot number and expiration date were not reported) for the long-term prevention of shingles and/or zoster related conditions. On an unspecified date, subsequent to patient's inoculation, he experienced shingles and was treated by a health care provider due to the event. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses and damages in the future. At the time of the report, the patient had not recovered from the event. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Covid-19 symptoms starting 12/5/20;  diagnosis 12/7/20. Symptoms: Fever, chills, diarrhea, fatigue, malaise, headache, congestion. NO loss of taste or smell, NO cough, NO SOB. Recovered completely by 12/11/20. I decided to wait a few months before getting the covid vaccine.   Within 1 hour of receiving the vaccination on 2/12/21 (~3/3:30pm) I couldn't lift my arm past 45 degrees due to profound soreness. This was expected but felt like pain out of proportion and only worsened throughout the night. I couldn't sleep on my left side. Around 2am I awoke with shaking chills. I was profusely sweating and felt extremely cold and uncomfortable... I  knew I had a fever. I stood up out of bed to go get Tylenol and a thermometer, but I was lightheaded and dizzy that my that my knees gave out. I laid on the floor feeling so exhausted for a while and then crawled back into bed forfeiting the thermometer or tylenol. I laid in bed shivering until I fell back to sleep. I awoke around 9:30 am on Saturday 12/13 feeling fatigued, very congested (my first covid symptom), at this point my fever was 100.0. I took some tylenol and by 2pm on Saturday I was back to my usual self. It was short lived, but extremely scary to go through, scarier than when I had covid.
got shingles about a little less than a week ago; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (got shingles about a little less than a week ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-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 HERPES ZOSTER (got shingles about a little less than a week ago). At the time of the report, HERPES ZOSTER (got shingles about a little less than a week ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Chest tightness; She started to experience dizziness/ lightheadedness and was diagnosed with vestibular neuritis; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient. Other Case identifier: US2022AMR107598 (GlaxoSmithKline).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for COVID-19 immunisation; mepolizumab (NUCALA), since 2019 (Batch/Lot number: unknown) for asthma; budesonide, formoterol fumarate (SYMBICORT), (Batch/Lot number: unknown). The patient's relevant medical history included: "Severe asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 Vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 Vaccine (DOSE 2; MANUFACTURER UNKNOWN), administration date: Apr2021, for COVID-19 immunisation, reaction: "Thyroiditis". The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 28Apr2022, outcome "recovering", described as "She started to experience dizziness/ lightheadedness and was diagnosed with vestibular neuritis"; CHEST DISCOMFORT (non-serious) with onset 26Jul2022, outcome "recovered" (29Jul2022), described as "Chest tightness". The action taken for mepolizumab was unknown and post-therapy for budesonide, formoterol fumarate. Therapeutic measures were taken as a result of vestibular neuronitis. Clinical course: The patient received the booster dose of Pfizer vaccine on 18Apr2022 and 10 days later, she started to experience dizziness/ lightheadedness and was diagnosed with vestibular neuritis. She was taking ibuprofen for it. The patient was also taking SYMBICORT with NUCALA. She did not take SYMBICORT for a few days because she ran out of it and so, from 26Jul2022 to 29Jul2022, she was having some chest tightness. The patient attributed the chest tightness to maybe not taking SYMBICORT or due to receiving underdose of NUCALA.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201065278 same patient and drug, different dose and event;
It was discovered on 8/9/2023 that an expired dose was administered to the patient on 4/4/2023.  Manufacture was contacted to review the stability of the vaccine.  Report a stable and viable dose given.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with 2018SA295453 and 2018SA295455 (same reporter). This case involves a female patient of unknown age who received a 0.5 mL dose of FLUZONE QUADRIVALENT (lot UT6301LA and expiration date 30-Jun-2019) via unknown route in the left deltoid on 18-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the vaccine was reached -2 degrees C while administered. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
1st dose was 2 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose was 2 months ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose was 2 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose was 2 months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.