chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time of the event, the pt was noncompliant with his diabetic medication metformin (Glucophage), had a blood sugar of 256 and may have been fatigued.  On the morning of 5/12/00, the pt received the 1st injection with Engerix-B. That afternoon, he experienced a seizure. The pt was brought to ER and became very agitated. He was given Haldol and the agitation came under control. The pt was hospitalized and treated with Dilantin. He was admitted to the ICU and suffered no further seizures. The next day, 5/13/00, the pt had confusion and experienced headaches. He also could not remember anything about the spell. The possibly of meningitis was considered and he was treated with Rocephin. He was reported to have had a new onset grand mal seizure. The pt was discharged from the hospital on 5/16/00 on Dilantin 400mg/day and glipizide (Glucotrol) o.5mg 2X/day. The hospital discharge summary and progress notes received on 7/27/00 reported the symptoms resolved. Progress notes state, "Neurologic evaluation failed to show a definite cause of the seizure, however, there was speculation that the seizure may have been the result of the Hep-B injection given earlier that morning". Neurology consult stated, "He probably had a seizure as a result of diabetes and a combination of fatigue, and his first Hep-B vaccine".
This spontaneous report received from a health care worker refers to 27 patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck) (dose, lot and route was unknown), which was improperly stored. No adverse effects were reported. The outcome of the events was unknown. This case is linked to MARRS# 1503USA007828 with the same reporter link. No further information was provided. Additional information has been requested.
Vomiting, 103 fever, chills. Joint swelling, malaise, soreness, congestion headache
PEDIATRIC FORMULATION WAS GIVEN TO PATIENT INSTEAD OF 12+ FORMULATION
Information has been received from a physician concerning a female patient who on 18-MAY-2007 was vaccinated with a dose of Zostavax. On 23-MAY-2007 the patient developed a rash on her face and  on her arm. It was reported by the physician that no pain was associated with shingles like rash. At the time of report, the patient was not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Bloating; Lethargic; tired; lower abdomen was tender to touch; loose stools with a lot of water; pain with stool; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 09:00 as 1st dose, single dose for covid-19 immunisation. The patient's medical history included Prediabetes and low d, thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID, 80mcg; take once daily by mouth, taking for 5 or more years) for thyroid disorder and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL], 125mg/5000IU; take once daily by mouth, taking for a year) for Prediabetes and low d and ongoing; multivitamin (taking for 10 years) takes once daily by mouth. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not visit to physician or emergency room. On 27Jan2021, patient experienced extremely tired. The patient went home, had lunch and slept for a couple hours, then when she got up she felt very lethargic, real tired, and noticed her lower abdomen was tender to touch. Patient had loose stools with a lot of water and when she tired to go to the bathroom there was pain in her abdomen with straining with stool. Patient still tender and felt good this morning but now she is not feeling as well, and she adds she feels bloated On 29Jan2021. The outcome of bloating was not recovered, while with other events was recovering.  Follow-up attempts are completed. No further information is expected.
racing heart; extreme heat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (racing heart) and FEELING HOT (extreme heat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, CANDESARTAN, NIFEDIPINE, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) and VITAMINS NOS for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PALPITATIONS (racing heart) and FEELING HOT (extreme heat). At the time of the report, PALPITATIONS (racing heart) and FEELING HOT (extreme heat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment was not reported.
Patient reported severe pain at injection site and shoulder following administration of BEXSERO for prophylaxis. Previously administered dose of BEXSERO given at pediatricians office on 09/06/18 produced a similar response. Patient described pain after second dose as more severe with significant impairment to range of motion and difficulty completing activities of daily ling X 1 day. States pain occurs only with movement. Pain was described as "burning" with a sensation of being "punched". Site was free of redness, swelling. Area was NOT tender to touch. Patient reported significant improvement to symptoms with use of OTC ADVIL and complete resolution to symptoms occurring with 48/hours.
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a 40-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included dialysis and kidney disease. On an unspecified date the subject received 1st dose of ENGERIX B (40 mcg, intramuscular, unknown details). Three days after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen positive. There were multiple discrepancies in the original report. The reporter stated that ENGERIX B was the first dose on the series; however, "serology done which came up negative." The subject was given ENGERIX B; however, the date provided for the vaccine administration was 19 April 2013 which was the day after reported to GSK. The reporter then stated that "3 days later tested again and results showed hepatitis B surface antigen." Attempts were made to clarify the dates of administration, dates of testing and lot number. The lot number was documented as AHBUC039AA which is not a valid GSK lot number for ENGERIX B. Clarification with the original reporter was attempted. Relevant diagnostic tests included serology testing. "Serology [was] done which came negative." The subject was tested again 3 days after administration of ENGERIX B. "Results showed hepatitis b surface antigen." At the time of reporting the outcome of the event was unspecified. Follow up was received from Quality Assurance on 10 June 2013. The lot number provided from the reporter, AHBUC039AA, was incorrect. The corrected lot number based on sales data was found to be AHBVC039AA.
Severe Site Pain, Soreness in Full Deltoid was immediate.  Following that about 3 hours later flu (covid) like symptoms set in.  Fever of 102 as of 9/13/21 @ 0600.   Fever persisted throughout day.   stayed in bed unable to work.  Felt like a moderate 24/36 hour flu.
Left arm sub q yellow fever/swollen/itches/redness/hot/site 50/50cirm./fevers/tenderness/
Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right eye and headaches that lasted couple days. His pain is exacerbated by extraocular muscle movement, particularly when looking to his left. Patient spent one night at the Hospital and they did a CT scan and blood work. His CT showed subtle retroocular inflammation, which correlates with his symptoms. Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS). After being seen at the ER and following up with his Ophthalmologist, patient was advised to report his case since it's very unique and unusual. Patient did his research he?s very concerned since there?s not much information about the syndrome, and since he never experienced eye problems for the past 63 years.
Localized erythema, edematous reaction at vaccination site. Pt c/o difficulty speaking, throat constriction, slight breathing problem, watering eyes, inflammation behind eyes, glottal inflammation. 500 NS 2 c 03mm Epinephrine 25 mg.
pt comes to the hosp with c/o congestion, cold sx, weakness; O2 sats 70s% on RA; placed on 15L HFNC; positive for COVID ; dexamethasone, remdesivir, baricitinib; placed on BiPAP; transferred to ICU; worsening renal function; suffered cardiac arrest, ROSC obtained; intubated; pt's condition worsened; status changed to DNR and pt died in the hospital
102.3 temperature taken at 11:15PM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 16:30 (Lot number: FK 5127) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 01Dec2021 21:00, outcome "unknown", described as "102.3 temperature taken at 11:15PM". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. It was reported that the patient was having 102.3 temperature which was taken at 11:15PM, the day after vaccination. The patient was sleeping and will wait till he wakes up to take further action.  No follow-up attempts are possible. No further information is expected.
9 HOURS AFTER DOSE NOTED ARM PAIN, FEVER,CHILLS, FOGGY AND BODY AHES X 24 OURS 1/12/21 NOTED FAIAL PARALYSIS, DECREASED VISIAL FIELDS
Patient made an appointment with our clinic reporting left arm red, swollen, warm to the touch and itchy after getting 2 vaccinations in the same arm from Pharmacy.
very painful @ inj site-painful to move arm up or down or from side to side;fever 101;had taken vanquish 2x before taking temp for the pain;
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 24 years old female patient who received an expired dose of vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 10-Jan-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5746AC (expiry date: Oct-2018) via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used. At the time of this report, it is unknown to reporter if the MENACTRA is continuing or if it is discontinued. It was unknown whether any adverse event occurred. No additional information was available at the time of this report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Vaccine used past its 30 day expiry date; Patient received vaccine past its 30 day expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine used past its 30 day expiry date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 2:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 2:35 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine used past its 30 day expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine used past its 30 day expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. ethnicity was reported and dose number was reported as Booster. It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the MFG expiry date of 04-Apr-2022. No treatments were reported.
Information has been received from a lawyer concerning a report of a professor's brother who was vaccinated with a dose of Recombivax HB. Subsequently, shortly thereafter he experienced flu-like symptoms. Within a few weeks after the second Recombivax (manufacturer unknown), the patient "was in bed mostly". At the time of this report there was no further information available. Additional information has been requested.
temp tx w/APAP;then distant-verbally quiet, speech capabilities much reduced, not able to focus attention to objects, visual discrimination off-not responsive to questions or look at person speaking;constipation;dx Landow Clefnor disorder
16 year old female instantly became dizzy,  was close to fainting and her face lost color.   She did not lose consciousness. Normal blood pressure reading after dizziness.   I stayed with my daughter in the clinic for about 15-20 minutes with the medical provider in the room.
I already had a sciatica flareup and pain at time of vaccination but about 8-10 hours after 2nd dose I experienced increased and very severe muscle pain in the same area (back of left thigh and down left leg) that night and into the next afternoon, to the point of being awoken from sleep and to tears.  It was back to normal by the next evening without treatment other than Tylenol and Ibuprofen.  (Pharmacist advised me to report my symptoms.)
TMJ problems jaw pain masseter  muscular pain  pain -  all pain  only on left side of face
became a little tired after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (became a little tired after the vaccination) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (became a little tired after the vaccination). At the time of the report, FATIGUE (became a little tired after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Non-significant follow-up appended. Reporter does not remember reporting an event for her brother-in-law
This solicited report was received from a patient's daughter regarding her 78 year old mother as part of a Market Research Program. The patient's concurrent conditions, historical conditions and concomitant medications were not reported. Approximately on an unknown date in 2016 (reported as in the spring of this year), the patient received ZOSTAVAX subcutaneous injection (dosage details and indication were not reported). It was reported: "I don't want to know the name and three weeks later (approximately in 2016) she got the shingles, explain that to me." The outcome of the event shingles and the causality with the suspect product was unknown. Additional information is not expected as the reporter did not give consent for further follow up.
A patient started having fever and pain on her left arm, neck, jaw, mid waist and her back at 2 am. on 10/22/2019. By 6 am. she had nausea, vomiting and diarrhea. She kept herself hydrate  took acetaminophen 1500 mg at 3 pm. Her nausea and vomiting stop sometime in the evening of 10/22/2019. She still having pain on her left arm and continue to have loose stools.
I had a sore throat, a slight headache, fairly bad muscle aches in my legs, and slight head cold symptoms without the congestion a couple of days after attending a birthday party. A couple of days after these symptoms, I had a loss of smell so I went to a drive-thru hospital testing site to receive for PCR test for COVID-19 on 09/02/2021, and the next day the results came back positive. I went and received Regeneron infusion after testing positive the next day on 09/03/2021.
Severe brain fog and ringing ears 3 full months after my 2nd shot.  The symptoms started within hours of getting the 2nd shot and have yet to subside.  I've been to my doctor twice, have had blood work and most recently a brain scan.  Still awaiting the results of the MRI brain scan.  I was prescribed Prednisone for a few weeks and I felt instantly great, which tells my doctor I have some swelling in my brain.
Pt given vaccinations on documented day to catch up on vaccinations. On day 10 pt began with maculopapular rash over torso and legs, and severe sore throat, general malaise, no fever. Seen by PCP on day 13, rapid strep negative, IgM drawn. Day 17 IgM positive at 3.5. Pt remains fever free, rash never became weepy, did spread to face and arms and was itching, pt never experienced a fever.
While I was in recovery during a reverse shoulder replacement I had a difficult time breathing. During the night you could not sleep and had to have VALIUM and breathing treatments. I could not catch a breath. This continued. I thought it could have been surgery but now I am wondering if it has something to do the the vaccine. I still do not feel completely normal. I get winded very easily. The day before surgery, I walked 2 miles on a treadmill. Now I can no longer do that. I also have low blood sugar. I am now on more medication.
Headache; This spontaneous case was received on 14-Oct-2022 from Med Communications (reference number: SEQW22-04542), reported by other non-healthcare professional (consumer) and concerned a 74-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  The patient stated he had not been sick for some time; he was taking precautions and was sensible in relation to health. The patient exercised and was not a smoker. His triglycerides value was usually around 50 to 60 g/ml. In addition, the patient stated that he usually did not get headaches,.   On 13-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose reported as 0.5 ml, anatomical location: left arm, route of administration: not reported) for active immunization against influenza caused by influenza virus subtypes A and types B contained in the vaccine. The batch number was not reported. The expiry date was reported as unspecified date in 2023.  On the same date, three or four hours after receiving Fluad Quadrivalent, the patient experienced a headache that then went away. The patient had to take half an Aspirin (acetylsalicylic acid) as treatment. The patient denied having injection site pain and fatigue.   The patient's triglycerides value is usually around 50 to 60 mg/dL.  On 13-Oct-2022, the patient recovered from the event of headache.  Next morning the patient also felt fine when he woke up.   The reporter considered the event as related to Fluad Quadrivalent. The patient stated that he had several vaccines over the time because of his career but this one probably hit a little harder than most.  The case was assessed as non-serious.  Company comment: The event of headache is assessed as related to Fluad Quadrivalent due to plausible temporal relationship.; Reporter's Comments: The patient stated that he had several vaccines over the time because of his career but this one probably hit a little harder than most.; Sender's Comments: The event of headache is assessed as related to Fluad Quadrivalent.
Loss of interest, lethargic, sleepy, fever, listlessness, change in personality, not as vibrant and energetic, bottom lip quivering, open and closing of mouth seeming involuntary, playing and twisting of tongue, fussiness and crankiness, moving lips, opening closing jaw, rapid breathing, rejection of food.
Was not aware of the vaccine containing eggs, I have a severe allergy to eggs. I?ve been breaking out in hives and have been in respiratory distress, I?ve been taking medications around the clock to prevent hospitalization.
Patient developed a rash after receiving vaccines. Patient  has a rash on his face, back, arm, hand leg, and abdomen. .
Narrative: Patient with two doses of the covid vaccine. Patient with terminal illness related to lungs. No further details of death noted. Reporting per facility instructions.
Headache, Myalgia, Fever, FLU LIKE SYMPTOMS Narrative:
Patient received vaccine through Clinic on 12/19/2020 into her L upper arm.   On 12/27 she first noticed swelling, itching, redness, and warmth in her poster L upper arm just superior to her elbow.   Due to swelling she initially could not move her elbow.   Taking benadryl for symptoms.   Gradually improving over the past three days but still with itching, redness, warmth, and now slight swelling.   No fevers.  No known injuries to her arm.
Devel fever of 105F on eve of 3AUG91 requiring trip to ER; Hosp MD dx ear/throat infect & placed on ATB; Unk relation to immun; Had been running fever of 102-103F from eve of 1AUG91 until it spiked on night of 3AUG91;
Soreness in his left injection site arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Soreness in his left injection site arm) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, 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 an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in his left injection site arm). At the time of the report, VACCINATION SITE PAIN (Soreness in his left injection site arm) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743491 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743491:2023-2024 dose