chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 22 September 2009 from a Healthcare Professional. An 17 month old female patient, with no known allergies and no medical history, received an intramuscular injection of FLUZONE (lot number not reported) in the left thigh on 18 September 2009. The patient had received a 0.5 ml dose instead of 0.25 ml. She had no illness at the time of vaccination and had received TYLENOL before vaccination. Prior vaccinations included influenza vaccination the previous year and an intramuscular right thigh injection of PENTACEL (lot number C3376AA) on 07 August 2009. On 19 September 2009, the patient developed vomiting and a rash was noted at the injection site. On 21 September 2009, the rash generalized throughout the body including on the ears, forehead, trunk, etc. The patient's hands and feet were also swollen. She was taken to the emergency room where BENADRYL was suggested. At the time of the report, the patient had not recovered. Follow up information received on 16 October 2009 from a health care professional who reported that the patient received a second dose of FLUZONE (lot number U3186AA) on 18 September 2009. The day after vaccination, the patient vomited four times. Two days post vaccination, the patient's mother noticed raised, red spots on the patient's body including right thigh, left arm, and the belly. The patient also had a low grade fever. Three days post vaccination, the patient's mother noted swelling in the patient's feet and hands and the red spots had spread all over. The patient's mother decided to take the patient to the emergency room. The patient was diagnosed with STEVEN JOHNSON Syndrome and was treated with BENADRYL. Per the progress notes, the patient experienced a runny nose in addition to the other symptoms, however an onset date was not clear. The patient's mother stated that the patient was doing well. The patient was reported as recovering at the time of the report. Based upon new information received, this case has been upgraded to serious. List of Documents held by Sender: none.
ulcerative Colitis flare up; Fatigue; body aches; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4412684-00 (Abbvie).  A 19-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) and second regimen (Batch/Lot number: unknown) at increased dose (1 in 1 week), all subcutaneous for colitis ulcerative. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "body aches"; COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "ulcerative Colitis flare up". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "ulcerative colitis flare up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "fatigue" and "body aches" related to BNT162b2 (probable).  The reporter causality for the event(s) of Fatigue, Ulcerative colitis flare up and body ache was not provided for Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of fatigue and body aches. Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported event of colitis ulcerative.
Small amt redness & swelling noted per mom to Lt upper arm of patient starting 5-16-08 at 2100.  Mom states by Saturday night 5-17-08 at 2200-Lt arm was bright red, swollen, hard to touch, with blisters, from Lt shoulder to Lt elbow.  Mom took patient to ER.  Today 5-19-08, Lt upper arm still red, firm to touch around deltoid.
patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now; passed out; chest burning; leg pain; severe pain on one side; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in an 80-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.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), CHEST PAIN (chest burning), PAIN IN EXTREMITY (leg pain) and PAIN (severe pain on one side). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now). On 02-Jan-2021, LOSS OF CONSCIOUSNESS (passed out), CHEST PAIN (chest burning), PAIN IN EXTREMITY (leg pain) and PAIN (severe pain on one side) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received Dose 1 of the Moderna COVID-19 vaccine in 01Jan2021 and not received 2nd dose till now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pediatric dose given to adult; Pediatric dose given to adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 24-MAR-2023, the patient received Engerix B pediatric. On 24-MAR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given to adult) and adult use of a child product (Verbatim: Pediatric dose given to adult). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-Mar-2023 The reporter consented to follow up via email. A pediatric dose of Engerix-B was administered to an adult patient which led to underdose and adult use of a child product.
Swelling, redness and discomfort at injection site. Patient advised to apply warm compresses.
Hives began 4/9/21 in the am, noticeably worsening around 11am
Post vax, the pt had onset of redness and blistering at site of tetanus injection. Area of redness was 12 cm x 8 cm on upper arm. Blister area was 2 x 1 1/2 cm with approximately 20 smaller blisters inside the erythematous area.
noticed giant welts over the chest, upper arms, both thighs, and stomach; noticed a bright red coin shape lesion around 3 inches in size.; right arm was swollen; second dose given 42 days after first; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (right arm was swollen), URTICARIA (noticed giant welts over the chest, upper arms, both thighs, and stomach), ERYTHEMA (noticed a bright red coin shape lesion around 3 inches in size.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 42 days after first) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 42 days after first). On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm was swollen) and ERYTHEMA (noticed a bright red coin shape lesion around 3 inches in size.). On 04-Mar-2021, the patient experienced URTICARIA (noticed giant welts over the chest, upper arms, both thighs, and stomach). On 17-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 42 days after first) had resolved. At the time of the report, PERIPHERAL SWELLING (right arm was swollen), URTICARIA (noticed giant welts over the chest, upper arms, both thighs, and stomach) and ERYTHEMA (noticed a bright red coin shape lesion around 3 inches in size.) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.
Swelling at injection site...pain traveled up arm; no shortness of breath of swelling of throat.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml (0.5 ml, lot # L044475, expiration date 12-MAY-2017, route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Realized after the patient was vaccinated that he was under 18 years old. Pt had no side effects for the 15 minutes of observation and has not reported any since the vaccination.
New Onset High Ringing tinnitus in both ears equally.   No treatment yet prescribed.    No change or improvement by Day 3 post vaccination, shot #2 of 2.
Right arm pain Deltoid area red & hot difficulty moving arm went to Emergency room approx 6:00 PM - was prescribed Benadryl; Prednisone; Tramadol & Pepcid. 11/04/14 Office visit with Dr - right deltoid area painful; red; hot to the touch 17 cm x 8 cm (bean shaped) area with decreased ROM @ right shoulder; good ROM @ elbow - Ice compresses & Percocet & Naprosyn for pain prescribed advised rest; return to office if symptoms worsen; ER if office is closed.
This person was given the vaccine at his workplace. It was reported to RN, on 1-9-18 from that workplace, that the person had a reaction to the vaccine on the same day he received it: 10-2-17.
7 year old patient received inappropriate dose of DTAP.  Pt should have received Td instead.  She  had no adverse reaction.
I received the injection the evening of 9/9/2021 my arm felt sore and the next day I had a headache 9/10/2021.  I took 500 mg Tylenol at 12:00 p.m.,  at 5:30 p.m. I noticed a lump on the left side of my neck above my collarbone it is sensitive to the touch. I do not have any bump or lump on the other side opposite. This is new. My neck also feels sore going towards my shoulder on the left side same side as the injection sight.
Pt recvd 2 doses of recomvivax-HB on 8SEP89, 9OCT89, & 1 dose of Engerix-B on 29MAR90 & was found to be a non-responder;
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 5-month-old patient of unknown gender. On 02-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date: 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
High fever (102.9F), SOB & rash 3 days after receiving Pediarix, hib, Prevnar.  Evaluated in ER 11/6/08 at Hospital.  Patient admitted for 1 week due to dehydration & fever would not break.  No diagnosis made.  2/5/09 MR received for DOS 11/18-21/2008 with D/C DX:  Rotavirus Gastroenteritis.  Dehydration.  Oral Thrush. Reflux. Infant presented to ER with 2 day hx of vomiting, diarrhea, irritability, abdominal tenderness and poor po intake.  Fever intermittently since shots 11/2/08.  Rapid breathing, nasal congestion and chills since 11/14/08. Decreased activity. PE (+) for sunken eyes, dry lips, tachycardia, macular rash on back and papular rash on forehead. Tx with IVF and Nystatin for thrush.  By day 3 tolerating PO and d/c next day. 1/27/09 ER visit 12/28/08 for cough and fever. (+) wheezing and retractions noted. DX: Viral illness.
Student recives H1N1 FLUMIST at approximately 1415 on 11/12/09. At 0800 on 11/13/09 student presented with vomiting and 100.4F temperature. Student was sent home for emesis and increased temp. At 1019 98.6 ty. Unsure of status on the weekend. 11/16/09 0730 student seen for c/o HA.
blood clot in left eye which left her blinded; blood clot in left eye which left her blinded; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 73-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 27Mar2021 at 10:45 am (Lot Number: EN6203, unknown expiration) as dose 1, single for COVID-19 immunization.  Medical history included diabetes, AFib, and known allergies. Concomitant medication included rivaroxaban (XARELTO). No other vaccine in four weeks. The patient experienced a blood clot in left eye which left her blinded in Mar2021 (pending clarification). The events resulted in emergency room/department or urgent care visit. The patient underwent many tests and received treatment for the events. No COVID prior vaccination and was tested for COVID via nasal swab post vaccination on 18May2021 with negative result. The patient had not yet recovered from the events. The events were assessed as serious (hospitalization for 4 days and disability or permanent damage).  No follow-up attempts are possible; information about batch number was already obtained.
Urticaria, lip swelling, itching -> given Benadryl PO -> resolution of symptoms started within 10 minutes of Benadryl, and complete within 30 minutes.
Narrative:  COVID infection following COVID vaccine series 02/17, Pfizer, dose #1 03/10, Pfizer, dose #2 08/01 pt cc: cough, dyspnea , rhinorrhea, fatigue, exposure: unknown 08/13 COVID swab, result: detected
Approximately 20 hours after the injection I was sick with much fatigue and body aches. At about 30 hours had fever, 102 temp with face and injection sites hot to touch. Fatigue and aches lasted the next 24 hours.  I also developed about 4 cankers sores in my mouth within about 30 to 48 hours and they continue today 6/27 at 1400 hours.   Also have fatigue and aches but less severe than the 24-48 hours following the vaccine.
Patient received flu shot at unknown pharmacy 6 months ago.  Felt immediate pain in Left lateral upper arm, and pain has persisted to the present day.  No loss of motor function.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were unknown. The reporter considered the fever and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to check the incidence rates of adverse events and commented that 3 patients who received SHINGRIX did report injection site pain or low grade fever. At the time of call, the health care professional did not have patient or vaccine information. The reporter was unsure if anything was done to treat the symptoms and if the symptoms were resolved, etc. This case has been linked with US2018GSK082721 and US2018GSK082722, reported by the same reporter.
After this shot, that night I had a lot of chest pain, like a lot of weight was on me squeezing.  This continued on and off for several weeks occasionally but not as bad or long.  I also got itchy hives in various parts of my trunk and arm and hand.  I had hip bursitis flare up badly after this and it is still bothering me a lot.  Never had it very bad before.  After the second shot July 21, I had the same symptoms flare up and my lips swelled noticably and I got hives as well as covid arm.  I took a bromelian and all symptoms are better quickly, except my hip bursitis which is better but still very bad.
Macular raised rash over entire body x 3 days.  Advised to use Benadryl elixer.
Heart racing, itchy and hot feeling on throat trouble swallowing. Chest pain when taking a deep breath, body rash.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Moderna COVID-19 vaccine administered to patients post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 62nd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:master case
Received Tdap 7/28/06 right deltoid, 5X began 7/29/06 fever 101-102, nausea, swelling and erythema small vesicle at injection site. MD at her worksite stated it was a reaction to Tetanus. Sx still present 7/31/06.
I got the two shots in January and I?m early February I had a painful period with lots of dark red discharge, which is especially bad because I had a hysterectomy over one year prior so I shouldn?t be having periods at all with no uterine lining. I do have endometriosis and had experienced a little spotting in the year precious to the vaccine, but there was a ton right after the vaccine and it was repeated in March and April. I went to my surgeon who was confused. I went to my OBGYN and she was confused. I am now seeing another OBGYN expert to talk through my continued endometriosis issues. I have pictures of what the discharge looked like. I have heard of others having bad periods after the vaccine but none have had a hysterectomy like me, so I am writing to share my experience. I am glad I got the shot but would like to see more research be done around this issue and have it be said as a warning to others.