chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Big blue spot on left arm; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Big blue spot on left arm) and VACCINATION SITE PAIN (Arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (Arm hurt). On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH MACULAR (Big blue spot on left arm). At the time of the report, RASH MACULAR (Big blue spot on left arm) and VACCINATION SITE PAIN (Arm hurt) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.
Lightheadedness, tingling of legs & arms & weakness. Tx: Benadryl 25mg po.
Platelet count: 01/28/2021 169 02/04/2021 130 02/11/2021 170 02/18/2021 134 02/25/2021 121 No bleeding or bruising issues noted
Redness, itchy, swelling at injection site 8 days after injection. Redness and itchiness radiated to bicep  6" x 4"
Issues with her mind come and go/Mind is not right, getting into arguments, and fighting/ Unable to hold down a job/ Anger is not controllable; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Issues with her mind come and go/Mind is not right, getting into arguments, and fighting/ Unable to hold down a job/ Anger is not controllable) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (Issues with her mind come and go/Mind is not right, getting into arguments, and fighting/ Unable to hold down a job/ Anger is not controllable) (seriousness criterion medically significant). At the time of the report, MENTAL IMPAIRMENT (Issues with her mind come and go/Mind is not right, getting into arguments, and fighting/ Unable to hold down a job/ Anger is not controllable) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  The patient was not well since after receiving the second shot of primary series.  Patients anger was not controllable and unable to hold down a job. The treatment medication was not reported.  Company comment: This spontaneous case concerns a female patient of unspecified age, with no medical history reported, who experienced the unexpected serious (Medically significant) event of Mental impairment that occurred in the context of second dose of mRNA-1273 vaccine in COVID-19 vaccination series. Latency could not be assessed as the exact date of vaccination and onset date of the event was not available. No further information regarding risk factors, clinical course, medical history, concurrent conditions, concomitant medication, additional vaccination details, investigations and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Taken to ER on 5/4/01 due to loose stools and fever and vomiting X 2 days. Taken to clinic on 5/5/01 and was admitted. Had blood in stool. 12 month old male child with a 3 days history of fever (max to 105.7F), vomiting and watery green, bloody, mucoid stools. He was put on amoxicillin 125mg po TID. Decreased appetite and inactive restless and fussy all night. No cough or runny nose. Discharged on 5/9/01, afebrile, good appetite and less frequent stools. Sent home on Augmentin and Bactrim, restricted activity and diet for age and follow-up with PMD. Dx: acute gastroenteritis (presumed bacterial enteritis), anorexia, dehydration and hyperpyrexia. On 5/31/01, seen due to injury to mouth with upper lip edema. Popsicles prn lip swelling, cold compresses to upper lip several times a day and Tylenol for pain. Also, grandmother said he felt warm to touch yesterday and he has been less active. Also, today mother said he does not want to take/drink fluids and seems as if his mouth hurts. He did not take his breakfast today. DX: tonsillitis and anorexia. Give fluids as tolerated. On 5/16/01, had rash on bottom x 3 days, treated with Nystatin ointment
Pt was a non-responder p/receiving a series of 3 Engerix-B vax; pt did not develop antibody titer when tested one month p/3rd vax & then one month subsequently;
pt recv vax 25FEB98 & 26FEB98 pt devel rash & swelling of face w/puffiness & mottling around face;also exp itching & burning;pt was treated w/DPH & on 27FEB98 recovered;
COUGH; CONGESTION; BODY ACHES; HAD TO MISS DAYS OF ACTIVITY; FEVER; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cough, congestion, body aches, had to miss days of activity, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cough, congestion, body aches and had to miss days of activity was not reported. This report was non-serious. This case, from the same reporter is linked to 20220102652 and 20220102250.
did not have vertigo or did not have the vertigo this severe with at least the first two doses of their Pfizer Covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 19Jan2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single and administration date 19Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "did not have vertigo or did not have the vertigo this severe with at least the first two doses of their Pfizer Covid vaccines".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101882222 same patient/drug, different dose/event.;US-PFIZER INC-202101883516 same reporter/drug, different patient/event.
Vaccine received at 4 pm - bottom of mouth and under tongue swelled. Called doctor, took 2 BENADRYL, subsided by morning.
Following 2nd vaccination administered on July 18, 2018. On July 31, 2018, I began to have redness, swelling, tingling and burning symptoms on the right side of my forehead, above the right eye, approximately one-half inch inside the hairline. Two photos were taken of the affected area on August 1 and 2, 2018.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 47 Patients in the exposed cohort experienced adverse events nos, while 58 of the unexposed cohort experienced adverse events nos. Of the 47 exposed patients age groups: 5 age 18; 37 age group 19-24; 5 age group 25-29. Sex: 19 female, 28 male. Of the 58 unexposed patients age groups: 7 age 18, 42 age group 19-24; 7 age group 25-29; 1 age group 30-34; 1 age group 35-39. Sex: 16 female 42 male.
Patient is not having an adverse reaction. Moderna booster #2 was given 4 weeks early. Writer did not see record that the patient had already received 1 of 2 boosters. This was done at a pharmacy.  Patient did not recall receiving a 1st booster. She was at a nursing home during this time. Moderna EAU called and informed. Patient does not need to repeat the dose. Patient informed with no concerns or questions.
Patient with apnea of prematurity (resolved) (discharged from NICU 1 week prior). Former 28 week premie CGA 36 wks. Had apneic/cyanotic episode while rooming in with hospitalized twin. Pt. then subsequently hospitalized.
This spontaneous report as received from a health worker refers to a patient of unknown age and unknown gender. On 16-OCT-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dosage information and lot number were unknown) and a dose of (Oka-Merck) PROQUAD (dosage information and lot number were unknown) (dose, frequency and route not reported). No adverse effect reported. Additional information has been requested.
malaise, hot, swollen arm, redness @ inject site & painful arm are reported in a pt receiving 1 dose of fluogen vax on 30SEP93 & next day devel malaise & arm swelling & feeling of hotness in the arm; pt cont to exp tenderness & pain;
denied her second dose (has not received it); rash the next day; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash the next day) and PRODUCT DOSE OMISSION ISSUE (denied her second dose (has not received it)) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included RIMEGEPANT SULFATE (NURTEC ODT) and ESTRADIOL (ESTROGEL) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH (rash the next day). On 28-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (denied her second dose (has not received it)). On 28-Aug-2021, PRODUCT DOSE OMISSION ISSUE (denied her second dose (has not received it)) had resolved. At the time of the report, RASH (rash the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided by the reporter. She was denied her second dose (has not received it). She went to go get her second dose today but the vaccination provider told her she needed to speak with her doctor.
3 days after the vaccine I got shingles; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 05Mar2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included heart issues from an unknown date. The patient did not receive any medications within two weeks of vaccination. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, three days after vaccination, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event, shingles which included treatment with steroids and anti-viral medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was resolved with sequelae at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache in PM of date of injection, low grade fever (99.5), sweats, chills, general body aches not limited to site of injection for full day after injection managed by tyleno 1/29l, continued headache 1/30 at time of filing report.
redness & swelling noted @ site of inject; redness has not subsided-still has marble sized knot;
Since March I have noticed an increase to my menstrual cycle flow, as well as increased cramping and spotting afterward.
Patient received a dose of vaccine that may be less than effective due to storage conditions.   No adverse effects noted.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 7th July 2018, the patient received the 2nd dose of SHINGRIX. On 7th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 1st August 2018, the patient experienced injection site vesicles. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site vesicles was unknown. It was unknown if the reporter considered the injection site pain and injection site vesicles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 73 or 74 years old. The patient received SHINGRIX on right arm. In 2018, the patient had soreness and pain at the injection when he received the vaccine. The pain did not go away until four days later and he said the pain came back about the first of August and seemed to get worse. The patient stated that, it started back slowly and intermittently and he believed that the weather, temperatures in the 90's or above, might had affected the change in the pain which had gotten worse. The patient stated that in his mind, it seemed a bubble was coming in where he received the shot. He thought that the liquid from the injection might have bubbled under the skin but was not certain. The patient did not see any bubbles under the skin. The pain aggravated at the site in which he could forget about it then it hurt when he paid attention to it and then he said that it should be considered an ache instead of a pain. The patient did mention this to a physician initially, only casually after discussion of other issues. The physician did not seem concerned by it experience. The patient did speak with the pharmacy where he received the injection just to let them know of his experience. The patient gave information about the physician that he spoke to and the pharmacy. The patient also spoke with the vaccine administrator who was a fill in pharmacist on the day the vaccine was given.
ITCHING OF LEGS; SWOLLEN FACE, LEFT ARM (INJ. SITE) AND BOTH LEGS, SWELLED UP AND COVERED FROM HEAD-TO-TOE; RASH; FREEZING; HEADACHE; TIRED; NAUSEA; FEVER (101F); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bowel obstruction, hernia, diabetes, non alcoholic, non-smoker, penicillin allergy, and levaquin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced freezing. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced tired. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever (101f). On 20-MAR-2021, the subject experienced itching of legs. On 20-MAR-2021, the subject experienced swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe. On 20-MAR-2021, the subject experienced rash. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, tired, nausea, and fever (101f) on 18-MAR-2021, was recovering from freezing, and had not recovered from itching of legs, swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe, and rash. This report was non-serious.
Moderna COVID-19 Vaccine EUA  Headache, fatigue, and myalgia - mostly 4/27 PM to 4/29 AM. Arm very sore on 4/28 to the point that anything touching that arm at all caused pain. Today, that is better. Local reaction - beginning 4/27 at end of day rash and peeling skin at injection site. Today, 4/29, rash and peeling skin are cleared up and just half dollar sized red raised circle at injection site that is warm to the touch and painful to touch.
15 minutes post injection pt complained of chest pain and tightness radiating to left arm and back. Pt rated pain 8/10. Pt also complained of shortness of breath making it difficult to catch breath. Vital signs checked, PCP notified. Per pcp orders; ASA 81mg administered, O2 administered via nasal cannula, and EKG performed. PCP met with pt. Per PCP orders, pt to be transported to hospital via ambulance. 911 contacted, pt transferred to nearby hospital.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 1820095 expiry: 02-OCT-2021) dose was not reported, administered on 14-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Low O2 saturation; This non-serious case was reported by a consumer and described the occurrence of oxygen saturation decreased in a 94-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On 20-SEP-2023, the patient received the 2nd dose of Shingrix. On 21-SEP-2023, 1 days after receiving Shingrix, the patient experienced oxygen saturation decreased (Verbatim: Low O2 saturation).  The outcome of the oxygen saturation decreased was not resolved.   It was unknown if the reporter considered the oxygen saturation decreased to be related to Shingrix.     It was unknown if the company considered the oxygen saturation decreased to be related to Shingrix.   Additional Information: GSK Receipt date: 25-SEP-2023 The reporter consent to follow up.
Pt recvd vax & exp diarrhea, stomach upset, h/a, dizziness & 8x8 mm induration @ site of inject; all events resolved; pt was given Engerix-B & reacted; again had an 8x8 mm induration @ site of inject;
she was told by her physician he thinks the first vaccine may have been inject too low on the arm; site of injection there were two red spots that looked like a bee had stung; feeling really really bad; muscle was tight; pain; swelling in the arm; itch under my attire, in the shoulder area, very itchy; slight headache; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm) and PRURITUS (itch under my attire, in the shoulder area, very itchy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Headache.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (slight headache). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm), PRURITUS (itch under my attire, in the shoulder area, very itchy) and VACCINATION SITE ERYTHEMA (site of injection there were two red spots that looked like a bee had stung). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she was told by her physician he thinks the first vaccine may have been inject too low on the arm). At the time of the report, FEELING ABNORMAL (feeling really really bad), MUSCLE TIGHTNESS (muscle was tight), PAIN (pain), PERIPHERAL SWELLING (swelling in the arm), PRURITUS (itch under my attire, in the shoulder area, very itchy), VACCINATION SITE ERYTHEMA (site of injection there were two red spots that looked like a bee had stung) and HEADACHE (slight headache) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she was told by her physician he thinks the first vaccine may have been inject too low on the arm) had resolved.            No concomitant medications reported by reporter.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information was received from the initial reporter: New event, second dose details and reporter comments were added. The patient received the second dose of the Moderna vaccine and did not have any problems with that dose.