chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; 4th dose is Moderna vaccine, 5th dose is pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 033K2124), 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 included: "Known allergies: wheat gluten" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing); "Known allergies: Opiates" (unspecified if ongoing); "Recent severe weight loss from GI" (unspecified if ongoing); "Recent severe weight loss" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2022, outcome "not recovered", described as "4th dose is Moderna vaccine, 5th dose is pfizer vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 using Paxlovid from 04Jul2023 to 08Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250591 same reporter/patient ,different drug/event;
I reacted to it by having a high temp, and my arm, became extremely sore, and bright red and hot to the touch. The doc felt, that because of my allergy to latex. I reacted quite severely.
Pt received multiple vaccines in preparation for a job and initial had flu-like symptoms that progressed to chronic fatigue, myalgias, arthralgias, weakness, memory loss and headaches. She was seen by rheumatology in June 2010 and diagnosed with fibromyalgia. On 11/24/09 she received AVA #1, H1N1, yellow fever and primary SPV in preparation for a job in Jan. Within 4-8 hrs, she felt she had come down with the flu (body aches, malaise, fatigue). Stayed in bed the next day because she continued to feel poorly. Discussed with MD and was told it would resolve in a month's time and to treat symptomatically. Into December noticed increase of symptoms including muscle and joint aches, increasing fatigue, generalized weakness, disruption to sleep pattern, mental fog (forgetfulness, poor concentration) HA on R side of head. Left for job in Jan 2010. She continued to have symptoms at time of job, feeling like she a really bad case of the flu, had to force herself to go to work, couldn't sleep at night, hard time working due to poor concentration and forgetfulness, difficulty walking due to muscle and joint pain and weakness. Pt received AVA #2 on 1/30/10 and she felt as if she had a worsening of her symptoms, especially increasing joint and muscle pain and fatigue, more disruption to her sleep cycle. She was sent back from job in Feb 1010 because she was unable to function at her job. Was told at one time that her symptoms were due to depression. Saw a rheumatologist in June and was diagnosed with fibromyalgia. Has seen neurology for HA, which got progressively worse.
Exuberant left axillary adenopathy, painful. Myalgia and fatigue for 36 hours was expected and resolved after 48 hours, but the adenopathy is new.
This spontaneous report as received from a physician assistant refers to about 17 years old, non-pregnant female patient. Patient's medical history and concurrent condition were not reported. In approximately 2014 ("about a year ago"), the patient was vaccinated with a third dose of GARDASIL (lot number, Expiry date, dose, route were not reported). Concomitant medications were not reported. Subsequently on an unknown date, the patient experienced seizures. The patient sought medical attention- she went office visit. The outcome of the event was not reported. The relatedness between the seizures and GARDASIL was not reported. Upon internal review the event "seizures" was considered to be medically significant. This one of two reports received from the same reporter. Additional information has been requested.
Original symptoms included fever, cognitive decline, psychosis, vomiting, loss control of his bladder, lost his normal ability to use his legs and pain shooting down his legs. The outcome is he never regained the full use of his legs, control of his bladder or his normal cognitive ability.
Donor received vaccination this morning IM to right deltoid. Presented at 3:10 pm complaining of feeling nauseated, and he appeared pale in his face. States nausea started as he was leaving for lunch at 1:30-1:45.  Called at 3:15 pm. Clinic recommends eating something,  however, client feel this will not be helpful at present, and knows how he feels when his blood sugar is low.  Requesting to go home at present.   3:48 pm client feels the nausea is subsiding,
After 2nd shot I went into AFib about 5/6 days later. This lead to a heart attack about 17 days after 2nd covid shot.
tired; stool was black night of after cramping; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and FAECES DISCOLOURED (stool was black night of after cramping) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired) and FAECES DISCOLOURED (stool was black night of after cramping). At the time of the report, FATIGUE (tired) and FAECES DISCOLOURED (stool was black night of after cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This study case was received from the investigator on 13 April 2012. A 22-year-old male subject who had no significant medical history was found to have non-specific myocarditis 15 days after receiving an injection of ACAM2000 (lot of number, route and site of administration not reported) on 07 February 2012. On 17 February 2012 the subject had an abnormal troponin I level of 4.37 and an abnormal electrocardiogram. The subject had an echocardiogram on 19 February 2012 was normal. The diagnosis of non-specific myocarditis was made on 22 February 2012. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Menstrual cycle restarted. I am in menopause. Also having issues in my lower digestive tract.
new onset of ventricular premature contractions and right bundle branch block approximately 6 weeks following the second dose of vaccine.
11-2-09 vaccinated with H1N1 vaccine at 4:30 PM. Developed hives on chest and forearms at 9:30 PM-advised by doctor on 11-3-09 to take BENADRYL PO until hives resolved.
Shortness of breath, forcing me to use my resue inhaler once or more a day.  I have not had to use my rescue inhaler for appox. 2 years prior to this time
24SEP92 1045PM-25SEP92 230AM; emesis p/taking bottle; took H20-emesis p/H20; t101.2 APAP given for fever; dry heaves x2;
Pt received 2-dose COVID-19 vaccine (unsure if Moderna or Pfizer) received second dose in February.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
Diarrhea, nausea, Temp 102, body achestx with Ibuprofen  with some relief
One week and one day after injection I started getting a red, firm bump at the injection site. The bump has grown slightly in size in the last 24 hours and is about 2 inches wide, and slightly itchy and hot
doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Patient developed a rash approx 10/1/13 and was seen for this on 10/14/13, at this time she also received her 2nd HPV vaccine. In addition she requested referral to dermatology. I diagnosed her with folliculitis and treated her on 10/14 with topical triamcinolone and Benadryl. She then saw a dermatologist in Nov who treated her with addition of oral prednisone and did a punch biopsy showing spongiotic dermatitis. The rash got better but more recently worsened after discontinuation of steroids. She has also continued with oral antihistamine, hydroxyzine. She saw an allergist in Nov and had extensive skin testing done which revealed allergies to cats, grasses, weeds and molds. Recommendation was to use Zyrtec. She was then seen here 11/17/13 for abdominal pain and had been to the hospital for this complaint a few days prior. I felt that the pain was primarily due to dysmenorrhea but entertained a broad differential, this pain improved but has returned off and on. Patient sought care at ED on 1/7/14 for myriad of concerns including pruritis, rash, fatigue, abdominal pain, joint pain, heavy and irregular periods, attention and memory difficulties, dizziness, tingling of R arm and leg, chest pain, difficulty walking, almost impossible to get up stairs. She had been visiting father who has PhD in organic chemistry and he became concerned that her symptoms are due to Gardasil. Specifically he thinks she could have poisoning or reaction to the aluminum or boric acid used in the vaccine or that she is having a reaction to the active components of the vaccine. MOC also feels her daughter's symptoms are due to the vaccine.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. The nurse reported that an unspecified number of patients may have received VAQTA (25/0.5 U/ML, dosing information and route were unknown), RECOMBIVAX HB (dosing information and route were unknown) and ROTATEQ (dosing information and route were unknown) exposed to 19F and 59F for a total of 15 months. Nurse stated the minimum and maximum were never cleared off of the facilities monitoring device, so he is unable to provide how long the vaccines were exposed to each out of range temperature. All products were found to be unsupported by in-house stability data. The nurse was unable to provide dates of administration as well as product lot number/expiration dates for the vaccines in question. No adverse symptoms reported. Additional information has been requested.
Patient was administered Bivalent booster instead of 1st dose of COVID vaccine in initial series.
Arm painful within 5 hours after shot.  By the next day couldn?t move it.  Missed 2 days of work from it.
patient reported bruising that spread from the  shoulder where the vaccine was applied down to his palms.
itchiness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and RASH (Rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (itchiness) and RASH (Rash). At the time of the report, PRURITUS (itchiness) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  The patient reported scratching at the itchy rash. No treatment was reported for the events.   On 04-May-2021 the patient endorsed feeling much better.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Initial additional
Sudden, moderate to severe headache pain  back of head between both ears began around 10:50 am the day following vaccines.  Began to feel nauseous and lightheaded, dizzy.  Fainted approximately 11:10 a.m.  Husband was in the same location and did not see me fall, but heard me.  About 20 seconds after he heard me, he found me on the ground with eyes open, looking to the left with convulsive tremor of right hand.  I was responsive and able to call dr. from the ground a few moments after the fall, but very off balance and out of sorts for several hours afterward.  Had telemedicine visit same day 2:00 p.m. and advised to go to Emergency Room, which we did.
I did not have a reaction to vaccine. I was diagnosed with a respiratory illness on 02/07/2023. I was given a prescription for steroid and cough medicine with codeine. I had a constant, dry cough for about a week without a fever. As of today, I am feeling better and walk most days.
Accidentally mixed the buffer second and the live virus first of the Vaxchora medication, and drank it; Spontaneous report received on 04JAN2020.  A male consumer reported that he "accidentally mixed the buffer second and the live virus first of the Vaxchora medication, and drank it" (PT: Wrong technique in product usage process). He was receiving oral Vaxchora for immunisation. The consumer stated that he got Vaxchora and accidentally mixed the buffer second and the live virus first while preparing the suspension and then drank it. Action taken with Vaxchora with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer accidentally mixed the buffer second and the live virus first of the Vachora medication, and drank it (Wrong technique in drug usage process). Reconstitution of Vaxchora should be done by mixing buffer component first and then the active component. Considering the nature of the event, the causality of the event is assessed as not applicable to Vaxchora.; Sender's Comments: A consumer accidentally mixed the buffer second and the live virus first of the Vachora medication, and drank it (Wrong technique in drug usage process). Reconstitution of Vaxchora should be done by mixing buffer component first and then the active component. Considering the nature of the event, the causality of the event is assessed as not applicable to Vaxchora.
Painful chest/lung tightness and labored breathing 4 hours after going to bed. Awakened from sleep by growing pain.  Pain started at top of chest, traveling down chest/lung cavity. Slowly resolved w/i 2 hrs.
REDNESS Narrative:  Questionable if it was cellulitis. After antibiotics were administered rash/cellulitis rapidly improved after 1 days. 7 days completed.
Itching all over. Throat itching. Symptoms getting worse over the next 5-10 minutes. Patient had a seizure about 20 minutes after vaccination administration.
flu like symptoms; feeling bad; in bed all day; feeling of sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling bad), BEDRIDDEN (in bed all day) and MYALGIA (feeling of sore muscles) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling bad), BEDRIDDEN (in bed all day) and MYALGIA (feeling of sore muscles). On 15-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling bad), BEDRIDDEN (in bed all day) and MYALGIA (feeling of sore muscles) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.    This case was linked to MOD-2021-089348 (Patient Link).
TINGLING SENSATIONS IN ARM AND FEET; NUMBNESS IN BOTH FEET; This spontaneous report received from a patient concerned a 56 year old male. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced tingling sensations in arm and feet. On SEP-2021, the patient experienced numbness in both feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensations in arm and feet, and numbness in both feet. This report was non-serious.
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding an 8 year old male pt who experienced fever of 101 deg F, stuffy nose, cough and acting "hyper".  At 8 years of age, the pt received a dose on 12/13/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  On 12/15/03, 2 days post-immunization, the child had a low grade fever and was sent home from school on 12/16/03, with a fever of 101 deg F, stuffy nose, acting "hyper" and cough.  He was treated with Tylenol.  No additional information was available at the time of this report. Follow-up information received from the child's mother provided an additional symptom of a rash behind her son's knees which started on 19-Dec-2003. On 19-Dec-2003, the child developed a rash behind his knees, which appeared worse on 21-Dec-2003. The rash is currently being treated with Benedryl cream (diphenhydramine). No additional information was available at the time of this report.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-JUL-2015, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (lot # J008441, expiry date 09-JUL-2015, strength reported as 1350 U)(dose and route of administration unspecified). There were no concomitant therapies reported. The patient did not report any adverse experience. Additional information has been requested.
typical soreness; flu like symptoms; weak; tired; he administered the Pfizer-BioNTech COVID-19 Vaccine second dose to 3 Patients but he has drawn more than the required volume (0.5mL instead of 0.3mL).; This is a spontaneous report from a contactable pharmacist. This Pharmacist reported similar events for 3 patients. This report is for 1st of 3 patients. A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302; Expiration Date: 28May2021), via an unspecified route of administration on 26Feb2021 as DOSE 2, 0.5 ML SINGLE, on 05Feb2021 (Batch/Lot Number: EL3302; Expiration Date: 28Mar2021) as DOSE 1, SINGLE for covid-19 immunisation. No prior vaccination within 4 weeks. The patient medical history was not reported. There were no concomitant medications. On 26Feb2021 the patient experienced he administered the pfizer-biontech covid-19 vaccine second dose to 3 patients but he has drawn more than the required volume (0.5ml instead of 0.3ml), weak, tired, on an unspecified date typical soreness, flu like symptoms. On an unknown date in 2021 the outcome of other events were recovered. The outcome of he administered the pfizer-biontech covid-19 vaccine second dose to 3 patients but he has drawn more than the required volume (0.5ml instead of 0.3ml) was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223835 Same reporter/drug/event, different patient.;US-PFIZER INC-2021223836 Same reporter/drug/event, different patient.
Encounter Background Information: Within 12-24 hours following TDaP vaccination to left deltoid on 22 Mar 2007 she began to notice left deltoid swelling, pain at site and pain moving left arm overhead, subjective fever/chills, headache to frontal lobes. She reported her husband noted by 8pm day of vac, her left shoulder looked like she had been lifting wts...area markedly swollen and pushing cloths out. She slept but awoke if touched left arm, took Motrin 400 mg (causes sleepiness) and used warm compress to site as instructed during vac administration. The next day her left axilla was swollen with increased edema to left deltoid.  She denied redness to arm except at injection site. C/o deltoid tenderness, pain, no paresthesia. On 3/23/2007 she was dx with Lt pink eye and sent home.  On 3/24 increased diff moving lt arm from swelling and pain. 3/25 decreased swelling deltoid, but increased to axilla. 3/26 seen by Occupational Health, dx AE TDaP, light duty/wt restriction given, f/u HC.   To continue Motrin use and warm compress, arm exercises reviewed.
My HBP rise up to 49 points 169/96, headache (not normal  because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr  drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my  BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time  with it.