chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FIRST OF MANY SEIZURES NOTED 27 HOURS AFTER VACCINATION, FRIDAY 6/21/03, 5:30 PM. SECOND SEIZURE AT 6PM. SPOKE WITH DR. HE RECOMMENDED WAITING UNTIL MONDAY TO PURSUE APPT WITH NEUROLOGY UPON PARENTS DESCRIPTION OF SEIZURE ACTIVITY. PARENTS TOOK PT TO HOSP MONDAY MORNING AS SEIZURES CONTINUED THROUGHOUT WEEKEND. PT CURRENTLY ON PHENOBARBITOL WITH LITTLE IMPROVEMENT OF CONDITION. SHE IS STILL HAVING 3-6 SEIZURES PER DAY. HARD TO SAY IF THIS RESULTED IN "PERMANENT DISABILITY" AS IT HAS BEEN LESS THAN ONE MONTH. WE ARE HOPEFUL SEIZURES WILL SUBSIDE, BUT THEY HAVE NOT RESPONDED TO TREATMENT.
itchy rash; intermittent migrating urticaria/Every day an itchy rash appears on several areas of body (mostly arms and legs, but sometimes on torso and even head and neck) at various times throughout the day; itching/pruritus; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (intermittent migrating urticaria/Every day an itchy rash appears on several areas of body (mostly arms and legs, but sometimes on torso and even head and neck) at various times throughout the day), PRURITUS (itching/pruritus) and RASH PRURITIC (itchy rash) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     No known allergies. Type 2 Diabetes, well controlled on diet, exercise and oral medication.  Concurrent medical conditions included Type 2 diabetes mellitus (Type 2 Diabetes, well controlled on diet, exercise and oral medication) since 2005. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Diabetes, ASA for Primary prevention.   On 13-Jan-2021 at 8:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 8:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (intermittent migrating urticaria/Every day an itchy rash appears on several areas of body (mostly arms and legs, but sometimes on torso and even head and neck) at various times throughout the day). In February 2021, the patient experienced PRURITUS (itching/pruritus). On an unknown date, the patient experienced RASH PRURITIC (itchy rash). The patient was treated with DIPHENHYDRAMINE (oral) ongoing from February 2021 for Rash, at a dose of 50 milligram as required and HYDROCORTISONE (topical) ongoing from February 2021 for Hives, at a dose of 1 % as required. At the time of the report, URTICARIA (intermittent migrating urticaria/Every day an itchy rash appears on several areas of body (mostly arms and legs, but sometimes on torso and even head and neck) at various times throughout the day), PRURITUS (itching/pruritus) and RASH PRURITIC (itchy rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that rash usually recedes after 30 minutes, or so, but may reappear later in the day in the same area or a different area.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant FU Appended - narrative updated
Caller is pregnant and received the 1st dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine) in a 35-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 017c21a) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (3 drinks/week) from 01-Jan-2004 to 06-Apr-2021.   On 17-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Mar-2021 and the estimated date of delivery was 13-Dec-2021. On 17-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Prenatal screening test: low risk (Inconclusive) LOW RISK and normal (Inconclusive) NORMAL. On 04-Jun-2021, Ultrasound foetal: normal (Inconclusive) NORMAL.         Patient had Prenatal Vitamin (Oral) 1/day from 01-APR-2020 (Still taking) as concomitant medication. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was Not Applicable       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Added Lab information ,updated ethnic group, race and pregnancy information
MUSCLE TIGHTNESS; VEIN BULGED; MUSCLE BULGED; ARM SORENESS; INJECTION SITE TENDERNESS; This spontaneous report received from a patient concerned a female 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced muscle tightness, vein bulged, muscle bulged, arm soreness, and injection site tenderness. The action taken with covid-19 vaccine  was not applicable. The outcome of the muscle tightness, arm soreness, injection site tenderness, vein bulged and muscle bulged was not reported. This report was non-serious.
I received the first dose at approximately 11:45. I had no allergic reaction. I had lunch, then went home. As I drove, I started getting a sparkly effect in my vision (for me, this is usually a precursor to migraine), about 2 hours after the injection. After I got home, I started getting a minor headache, about 2.5 hours after injection. I sat for awhile, and the headache did not worsen and the sparkles dissipated. About 9 hours after the injection (and after preparing and eating dinner) I began to feel lightheaded, almost a feeling of inebriation. I quickly prepared for bed and went to sleep. About 2 hours later, I woke up with diarrhea. I continued to wake up twice more, about 2-2.5 hours apart, with diarrhea. I finally slept for about 4 hours and woke up feeling better.
8/25/10 PNEUMOVAX given right deltoid. 8/27/10 Pt c/o Rt arm achy - occ. shooting pain Rt upper arm - 1.5 cm x 7 cm, pale pink - slightly raised area ant. arm - Rt axilla - slight pink area - non-raised 2 cm x 3 cm. No warmth at area - slight ecchymosis at injection site.
Six hours later, i woke up with a terrible headache and took more Tylenol; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age (age: 72 ; unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included headache prior to vaccination. The patient's concomitant medications were not reported. The patient was experiencing a headache prior to vaccination. Patient received her first dose on 12Jan2021 and then took 2 TYLENOL five minutes later after vaccination. Patient wanted to know if that would lower her immune response to vaccine. Patient had headache before she got the vaccine, she did not take anything for her headache before the vaccine. She did take TYLENOL 5 minutes after getting the vaccine for her headache and is asking if that will interfere with the vaccine. Patient stated that six hours later in Jan2021, she woke up with a terrible headache and took more TYLENOL. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Intermittent hives, mild dermatographism managed with cetirizine  At time adverse event occured, patient ~ 8 weeks pregnant, estimated date of delivery May 2024
Mother reports child complaining of evening headaches for the last 7 days, child being given Tylenol as needed. Mother also reports swelling, knot redness and sore right deltoid.
Generalized sore, achy 1 hr after vaccine. Fever to 102 degrees F 2 hrs after vaccine. Fever to 103.5 18 hrs after vaccine. Fever to 102 24-36 hrs after vaccine. Extremely sleepy, temp to 100 degrees F to present. No localizing symptoms.
Patient experienced a red wheal around site of injection; localized reaction with swelling & mild heat produced. Patient did not experience any breathing difficulties.
This spontaneous report as received from an office manager refers to a 1 month old patient. The patient was inadvertently vaccinated with 2 doses of pediatric RECOMBIVAX HB (5mcg/0.5ml, lot number unknown) during one office visit on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
This solicited report as received from a patient's mother, as a part of market research program refers to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient was vaccinated with the first and the second dose of GARDASIL(dose, lot #, expiration date and route of administration were not reported). On an unknown date, after the patient received the third dose of GARDASIL (dose, lot #, expiration date and route of administration were not reported), she passed out. The outcome of the vent was not reported. The relatedness between the event and GARDASIL was not provided. Additional information is not expected as there was no consent for further contact.
Patient received ZOSTAVAX vaccine; area reported to be red, itchy, warm and bruised. Her daughter is a nurse said infected, I told her localized reaction
within hours: nausea, blurry vision, chills, fatigue within 48 hours: bells palsy
Patient developed diarrhea 4 days after vaccine administration date.  Mom wanted this reported because he had the same reaction after his first MMR, then developed a regression in milestones. He has since been diagnosed with autism.   Stool is described as liquid and grainy.  He will have liquid stools every few weeks now for a while.
Slightly sore arm, Aches, Migraine, nausea, chills for period from 18hrs after injection to 36 hrs.  Then general itching on back and torso beginning 4 days after injection.   Still ongoing itching.
Information has been received from a pharmacist concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt spiked a fever a day after the injection and developed a reaction at the injection site (red, warm area up to 7cm in diameter). The pharmacist reported that the pt's reaction continued to worsen, even after treatment with Tylenol and Benadryl to the point where the pt had trouble raising their arm. Upon internal review, the pt's injection site reaction (red, warm area 7cm in diameter) was considered an "Other Important Medical Event". The pharmacists also reported the experiences of 19 pts following vaccine with pneumococcal vaccine 23 polyvalent (WAES 01104731). Additional information has been requested.
Having been remission free for from Crohn?s disease for 30 years I had a flare soon after the vaccine. Please note that I had had a flare in March of 2020 but cleared that up with some small dietary measures. This time the flare was very much more severe and didn?t clear up even after treating with heavy doses of prednisone.  I raise this as a way to see if others with Crohn?s have seen such responses to the vaccine. I could not find this info anywhere in the internet.
Fluid on lungs; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PLEURAL EFFUSION (Fluid on lungs) and COVID-19 (COVID-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLEURAL EFFUSION (Fluid on lungs) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19) (seriousness criteria hospitalization and medically significant). At the time of the report, PLEURAL EFFUSION (Fluid on lungs) and COVID-19 (COVID-19) had not resolved.            No concomitant medication was provided by reporter.  On an unknown date, the patient experienced fluid in lungs, COVID-19 and might be Humira was no longer working. The patient had heath problems. The patient had fluid on lungs and was hospitalized for Covid-19. The physician had believed this might be the reason that Humira was no longer working. The patient was not enrolled in a COVID-19 vaccine trial.  No treatment drug was provided by reporter.  Causality for Humira: The reporters causality for the events of fluid in lungs, COVID-19 and might be Humira was no longer working was no reasonable possibility.  Company comment: This is a spontaneous case concerning a 49-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (hospitalization) unexpected events COVID-19 (AESI) and pleural effusion, on an unknown date after the second dose of mRNA-1273. Clinical course, diagnostic tests and hospitalization and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 49-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (hospitalization) unexpected events COVID-19 (AESI) and pleural effusion, on an unknown date after the second dose of mRNA-1273. Clinical course, diagnostic tests and hospitalization and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
co-administering Menactra with Covid-19 (with no reported adverse event); use of Menactra instead of the intended vaccine against meningococcal B (with no reported adverse event); Initial information received on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient who was co-administering menactra with covid-19 (with no reported adverse event) and use of menactra instead of the intended vaccine against meningococcal b (with no reported adverse event) while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included MENVEO on 17-JUN-2015  with first dose and MENVEO on 29-JAN-2020 with second dose. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 13-Jul-2022, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength, route: unknown) lot U7207AA, expiration date:08-Feb-2023, in the right arm as immunization.  On 13-JUL-2022 the patient was co-administering menactra with covid-19 (with no reported adverse event) (vaccine coadministration) and there was use of menactra instead of the intended vaccine against meningococcal b (with no reported adverse event) (vaccination error) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the events.  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 the guidelines. 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.
This spontaneous report was received from a company representative concerning a 67 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 millimeter (ml), subcutaneously. No concomitant medications were reported. On an unknown date, the patient experienced rash on her arm, the injection site was swollen and hot and there was a little bit of a hole where the needle had been inserted into her arm. No treatment was provided. The patient was not recovered from the events as all the events were still present at the time of reporting (also provided as unknown). Relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
I had a painful swollen lymph node in my left armpit for 3-4 days and now I've had a rash and swelling at the injection site for 2 days.
Large 10 cm erythematous local reaction suspected allergic. Benadryl - will Rx with Keflex if worsening.
Explosive Diarrhea; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received first dose BNT162B2 (PFIZER, Formulation: Solution for injection, Lot: Number: EN5318) via an unspecified route of administration on 06Feb2021 08:30 AM at single dose for covid-19 immunization. Vaccine location was left arm; facility where the most recent COVID-19 vaccine was administered was other; did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient's medical history included inflammatory bowel disease (IBS) (being treated with unspecified treatment) and hypertension. Allergies to medications, food, or other products: No. Concomitant medications included ciprofloxacin and lisinopril. On 10Feb2021 evening 08:30 PM, the patient experienced explosive diarrhea which may be due to being treated for colitis, but doctor said to report it. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient received a round of FLAGIL and CIPRO prescribed and no soli. Prior to vaccination, was the patient diagnosed with COVID-19?: No; Since the vaccination, has the patient been tested for COVID-19?: No. Outcome of the event was recovering. Vaccine Facility information, ethnicity information and race information was available.
Fever the morning after receiving the third dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 at 14:15 as dose 3 (booster), single (Lot number: FL8095) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 2, single , lot number FK5618, Anatomical location: Left arm), administration date: 28Nov2021, when the patient was 9-year-old, for Covid-19 Immunization; BNT162b2 (dose 1, single, lot number FK5127), administration date: 05Nov2021, when the patient was 9-year-old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 04Jun2022, outcome "recovering", described as "Fever the morning after receiving the third dose.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Patient underwent lab tests and procedures which included on 04Jun2022 Sars-Cov-2-test: negative (nasal swab). Patient did not have known allergies. Patient did not receive other medication within 2 weeks. Patient did not receive other vaccine in four weeks. Prior to vaccination patient was not diagnosed with Covid-19. Patient was tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
ice pick headache upon injection (3hr duration), nausea (36hr duration), fever 103F (8hr starting at 03:00 of day following injection), throbbing in arm of injection (36hr duration), chills (8hr starting at 03:00 of day following injection)
Itchy bumpy red rash across chest and abdomen of patient. Treated with cortizone for about 1 week.
Tinnitus and swelling the size of tennis ball. Swelling lasted for 4day and Tinnitus is ongoing. Tiredness, drowsy and is ongoing. Benedryl,  Tylenol, B-12 injection once a month. Helped about a week but still tired. 75lbs. lost since April(Gastric Sleeve) and cholesterol was down but after the 3rd shot jumped 75points.
slight fever; chills; Diarrhea; Feeling Achy; shakes; left side tender to touch; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy) and TREMOR (shakes) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy), TREMOR (shakes) and TENDERNESS (left side tender to touch). At the time of the report, PYREXIA (slight fever), CHILLS (chills), DIARRHOEA (Diarrhea), PAIN (Feeling Achy), TREMOR (shakes) and TENDERNESS (left side tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2020: Follow-up received on 31 Mar 2021 included no new information; Reporter's Comments: A spontaneous report concerns a 22-year-old, female patient, who experienced non-serious events of slight fever, chills, shakes, diarrhea, "feeling achy", and left side tenderness. The event occurred 1 day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). No treatment was provided, and outcome was unknown. Based on the information provided, which indicates a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Fever and chills are consistent with the known safety profile of mRNA-1273 vaccine.