chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (burning mouth) 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 ORAL DISCOMFORT (burning mouth). At the time of the report, ORAL DISCOMFORT (burning mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product information was  provided. No Treatment information was  provided.
Moderna COVID-19 .  The following morning after receiving the vaccine i experienced a brief vertigo when getting out of bed. Lasted less than 15 seconds. Having never really experienced vertigo, I didnt give much thought to it. However it happen the morning after that as well very similarly. On Friday 4/16 during my sleep, when I changed positions I woke up to the same vertigo. On Saturday, when getting out of bed felt vertigo again lasting a bit longer of 30 seconds. Each time the vertigo happened,  It went away and was not bother. On 4/18 when getting out of bed, i had a very severe vertigo experience. This time so severe I could not walk, could not get out of bed, fell to the floor from toilet. Got back to bed and had violent vomiting.  This happened 4 more times.  I could not get out of bed until 1:00 p.m. after trying to get up at 7:00 a.m. . The severe vertigo subsided after performing the Epley maneuver. On 4/19 5 days post 2nd injection, i feel very week with a mild sense of being dizzy but nothing like earlier. It has persisted all day. I went to a health clinic on 4/19 to insure that I did not have an ear infection as i felt perhaps that could be the cause of vertigo and ongoing dizzy feeling. The practitioner examined my ears and throat and reported no infection. It was at this time that i felt it necessary to report should be made.
STROKES; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical histories or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced strokes. Reporter stated that "Strokes are way up among my extended acquaintance." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of strokes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220207120.; Sender's Comments: V0: 20220207981-COVID-19 VACCINE AD26.COV2.S- strokes. 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).
After receiving the wrong formula patient noted w/ temp of 101 and vomiting and diarrhea. Possible reaction to vaccines.
Information has been received from a LPN concerning a 17 year old female with asthma who on 16-JAN-2007 was vaccinated with a first dose of Gardasil vaccine (yeast). On 16-JAN-2007 the patient experienced burning in her chest and lungs. The patient was seen at an Urgent Care facility and her lungs were found to be clear and her oxygen saturation was within normal limits. The Urgent Care physician's impression was that the patient experienced some type of allergic reaction. The patient was treated with Tylenol and Benadryl and instructed to come back if the symptoms did not improve or if they exacerbated. The LPN felt that there was a possibility of hospitalization at the time, however, at the time of this report, the patient was recovering and improving on treatment. No product quality complaint was involved. The reporter felt that allergic reaction was an other important medical event. Additional information has been requested.
On 1/8/2007 client was given Varicella, adult Td and Menactra vaccines in p/m. On 2/5/07 she reported that within 24 hrs of vaccines given she experienced right shoulder, elbow, wrist and finger joint pain and swelling. Symptoms also began on left side, and also included hips and knee joints, one day later, but not as severe.  Client states she has been taking tylenol and motrin with little relief and today continues to complain of bilateral wrist,finger and knee pain, unable to fully extend fingers of her right hand. Client denies any other symptoms.  She did not seek a physicians care.
18 patients received single dose of HPV vaccine; This literature marketed report has been received from the authors of a published literature article, and refers to 18 female patients of an unknown age. No information regarding patients' pertinent medical history, drug reactions or allergies and concomitant medications was reported. The patients took part in the study from March 2012 to December 2014.  On an unknown date, the patients were vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis or with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis. The patients received single dose regimen of the suspect vaccine (considered as inappropriate schedule of vaccine administration).  A copy of the published article is attached as further documentation of the patients' experience.   This is one of two reports derived from the same literature article (cross referenced with # 1908USA007784).; Sender's Comments:  US-009507513-1908USA007784:
patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that on 04-Nov-2021, the vaccine was initially stored in the refrigerator. Date of administration of vaccine to the patients was on 05-Nov-2021 and 12-Nov-2021. And also stated that the vial did not undergo any temperature excursions. No treatment medications were reported.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 75-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308:
0.3ml of dose given initially and error discovered in need for additional 0.2ml and 0.2ml dose Moderna  same lot administered
C/o being "light headed", slumped over in chair. Appeared to pass out then stiffened with rapid arm and feet movement. Patient easily aroused. BP 100/60.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20 and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. patient said his arm was only slightly sore and went away in a day or so. He is feeling fine now. No further FU needed.   This case was linked to MOD-2021-060547, MOD-2021-061044 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: patient is feeling fine now.No further FU needed.
Patient got very faint and passed out. Patient came to shortly after. 911 was called and they took patient to hospital.
Today at about 3:30 pm, I was nauseous, headachey, fatigued, chills, temp of 99 degrees, and feeling like I had the flu.  I napped for an hour and a half.  Previously, on the first 3 days after the shot, I had tenderness at the injection site, sore arm, and had headaches.
Right arm had severe swelling and erythema, 10cm X 9 1/2cm.
I am having serious blood clots each month during my period. Very heavy and long periods. The clots are huge each month and last the majority of each period.  I also now get my period every 20-22 days.
Parent reports rash (L) sd of body and at injection site, shortness of breath, throat felt as if closing. Body aches & weakness, parent reports s/s resolved spontaneously.
Apparent rebound of COVID infection. Mild symptoms.; Apparent rebound of COVID infection. Mild symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EN6205), on 20Apr2021 as dose 2, single (Lot number: EN0150), on 01Dec2021 as dose 3 (booster), single (Lot number: FJ8757) and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; PANTOPRAZOLE; BUPROPION [BUPROPION HYDROCHLORIDE]. The following information was reported: COVID-19 (medically significant) with onset 29Jul2022, outcome "recovering", described as "Apparent rebound of COVID infection. Mild symptoms"; VACCINATION FAILURE (medically significant) with onset 29Jul2022, outcome "recovering", described as "Apparent rebound of COVID infection. Mild symptoms.". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment of Paxlovid, Treatment start date-20Jul2022, Treatment stop date-25Jul2022, lot number- GC8123, indication: Treatment of COVID-19. No follow-up attempts are needed. No further information is expected.
Eye lashes falling out; Stye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101587181 (Pfizer).  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 15:30 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stomach pain" (ongoing); "Constipation" (ongoing). Concomitant medication(s) included: MIRALAX taken for constipation (ongoing); PEPCID AC taken for abdominal pain upper (ongoing). The following information was reported: MADAROSIS (non-serious), outcome "not recovered", described as "Eye lashes falling out"; HORDEOLUM (non-serious), outcome "unknown", described as "Stye".  Additional information: The patient has been on Pepcid for about a week. Caller states that she is calling about the Pfizer Product: Covid Vaccine for Children. States that her daughter got the first dose of the vaccine a week ago Saturday and now her daughter's eye lashes are falling out. Caller states that she is taking her daughter to the eye doctor today. Says that she didn't read out this being a side effect. Caller asks if this is a side effect? Has anyone else reported this? Eye lashes falling out: Caller states this has been occurring for the last day or so. Stye: Caller states that her daughter had a stye in one eye, she believes it was prior to the vaccine. States that she is concerned because the stye was only in one eye, but the loss of eye lashes is in both of her daughter's eyes. Caller verifies date of her daughter's vaccine as 06Nov2021. Caller does not have her daughter's vaccination card available at this time. Caller doesn't know the NDC, Lot Number, or expiry date for her daughter's vaccine. Caller states that her daughter has been dealing with chronic stomach pain and constipation and takes Miralax daily for the past 2 months. Caller states that her daughter also started taking Pepcid for this condition about a week ago. Pepcid Lot Number: WP7E or WP2E as reported by the caller. Caller denies any other labs, testing, or treatments relevant to these events. Vaccination Facility Type: Pharmacy. Patient did not required emergency room and physician office visit. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and AE(s) following prior vaccinations. Caller states that she's hoping it is just something short term, like an eye infection or something. She is hoping that it is nothing that will have long term effects on her daughter. Agent states that for the past last day her daughters eyelashes have been falling out and the caller is taking her daughter to the eye doctor today. The caller would like to know if this has been a reported side effect to the vaccine? Caller confirms daughters eyelashes have been falling out the past last day after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning a male who was vaccinated with MMR II. Three weeks after receiving MMR II the patient was diagnosed with PPD. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. No further information is available.
Follow-up information concerning a male pt with a history of natural chickenpox who developed herpes zoster in an unknown time frame post exposure to an individual who was vaccinated with varicella virus live. The vaccinee did not experience a post vaccination rash. Shortly after exposure to the vaccinee the pt developed herpes zoster.
pt recv vax 21AUG95 & 9FEB98 pt devel 10 pox lesions w/itching & a low grade fever;tx w/calamine & pramoxine & zinc acetate;27FEB98 pt recovered;
Titer negative After 2 Shot Series; Initial Report Received on 17-Nov-2021.   A registered nurse reported that a couple of patients (age, gender, race and ethnicity not provided) received the 2 shot series of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had negative titers.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site.   On an unspecified date, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site.   On an unspecified date, a couple of people that recently had the 2 shot series had negative titers. The number of patients and individual details were not specified.   No adverse reactions were reported. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient had upper palate and throat scratching and the sensation of throat closing. Administered Benadryl and EPI but continued with symptoms. EMS brought in and patient transported to ED. BP 150/110, P 86, O2 sat 96%
Experienced 1-2 hives on my body every day; This is a spontaneous report from a contactable Nurse. This 23-year-old non-pregnant female Nurse reported that she had received first dose of COVID 19 received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EK5730), dose 1 via an unspecified route at Left arm administration on 29Dec2020 as single dose for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EL1283) on 19Jan2021. Patient medical history reported as GERD and seasonal allergies. Patient concomitant medications included as Allegra, Zyrtec, Accutane, Flonase, Minastrin. Patient had not received other vaccine in four weeks. Patient stated that two weeks after her first dose, on 10Jan2021 she experienced 1-2 hives on her body every day. she worked for an allergist who thought it may be an immune response and recommended her still receive her second dose. 3 days after her second dose, her hives increased severely. The patient had full body hives that are extremely itchy that had not yet resolved and it had been over 4 weeks since her final dose. Her injection site got super red and itchy the day after her second injection, that lasted several days as well. The full body itchiness was unbearable and does not resolved with multiple antihistamines being taken. She had several pictures of the hives that she was willing to share if someone contacted her. Outcome of the event was not recovered.
Pt experienced syncopal episode about 10 minutes after her injections on her way out of the clinic. She had loss of muscle tone and vision.  Pt was monitered for 20 minutes following.  Vital were stable, pt. felt fine, and pt. was discharged home.
Pt was given Moderna COVID vaccine on 18 Mar 2021 for his first dose, however this vaccine was no longer available at the clinic after April 2021.   The clinic switched to using the Pfizer vaccine.  Due to the exceptional situation/unavailability of the same series vaccines for both doses,  pt was given Pfizer for his second dose.    "In exceptional situations in which the mRNA vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the second dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time. Such persons are considered fully vaccinated against COVID-19 ?2 weeks after receipt of the second dose of an mRNA vaccine."  Pt tolerated well/No reported side effects.
Information has been received from a registered pharmacist concerning a 70 year old male patient with no medical history and concurrent condition who on 02-JUL-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck), 0.65ml. There was no concomitant medication. The pharmacist mentioned that in June 2012, the patient developed redness and pus at the injection site. The patient contacted pharmacist for seeking medical attention. There was no lab performed. At the time of the report, the patient was not recovered. Follow-up information has been received from the pharmacist concerning a 70 year old male patient, who on 02-JUL-2012 was vaccinated with the first dose of ZOSTAVAX SQ in right arm (lot # 671660/1254AA, Exp: 01-NOV-2012). The pharmacist reported that the patient called and reported that on 03-JUN-2012 the injection site started to get red and sore and slightly swollen. The patient said he would call his doctor and notify him. The patient did not seek medical attention. The pharmacist called the patient back after 3 days and he said it looked better. The patient did not anymore voiced other complaints. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date in 2011, pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to this inoculation, on an unknown date, pt was treated by a healthcare provider at a local medical office for shingles (herpes zoster). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffering 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 included 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 reporting time, pt was not recovered from herpes zoster and it was related to zoster vaccine live (ZOSTAVAX).
pt told to come to ED due to blood sugars over 500; when got to ED his O2 sats where 59% on RA; increasing SOB; positive for COVID; placed on BiPAP; eventually required intubation and tracheostomy; O2 status continued to worsen and his sats went down; he went into cardiac arrest twice; CPR was done; family decided to stop CPR and pt expired in the hospital; Acute hypoxic respiratory failure secondary to COVID pneumonia; acute renal failure; DMT2; MI.
About 45 minutes after injection, my lips started to tingle and my face was blotchy. This did not last long ( subside as I was driving back to the injection site).Approximately 8 days after administration of 1st vaccine my arm started itching and the air of infection became hard, swollen and hot to the touch. The size of the rash was initially 3 inches in diameter and had grown to 5 inches in diameter. I feel fatigue, but unsure if it's related. I'm chuckling rash diameter reach day. I still have the rash as of reporting.