chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MUSCLE WEAKNESS AND FATIGUE STARTED A FEW HOURS AFTER RECEIVING THE SHOT,  MIGRAINE STARTED 24 HOURS AFTER RECEIVING THE SHOT, DIARRHEA STARTED THE MORNING OF THE 2ND DAY AFTER RECEIVING THE SHOT.
Site: Pain at Injection Site-Mild, Additional Details: Paint had vasovagal reaction and fainted after administering shot
no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-MAR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011859: US-009507513-1905USA011860: US-009507513-1905USA011861:
These started 31 hours after injection.  Chills, Headache, low grade fever of 99.9 body aches, sore arm. On 3 rd day after vaccine, injection site became red, hot to the touch and swollen. A separate area from the injection site also became red, swollen and hot to the touch. 4 th day, injection site and random site became more swollen and began to grow together with intense itching.  Still hot to the touch and red.
Chills and low grade temp of 99.9 Friday evening.  Reports extreme dry mouth, headache, and body aches.   Motrin taken on Saturday and Sunday with improvement.
Two days after vaccine pt. reports a "different rash at a different spot every morning and at night when I go to bed".  "I have a red ring and a big knot at the shot site"  "The rash itches like crazy." "I take Benadryl for the rash."  "the Benadryl seems to help."
underdose/"3-4 days" ago a female patient received a dose of Arexvy that leaked out the needle during administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: underdose/"3-4 days" ago a female patient received a dose of Arexvy that leaked out the needle during administration). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 23-Oct-2023 A pharmacist was at home during the report and did not had patient information or exact vaccination details during time of report.  The reporter consented to follow-up via email. About 3 to 4 days ago a patient received a dose of Arexvy that leaked out the needle during administration, which led to incomplete dose administered.
Vaccines were stored after beyond use date and CDC expiry date; Vaccine administered to patient past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 5th of 45 female patients described by the reporter.  No concomitant medication was reported.   It was reported that patient took vaccine on 08-Apr-2022, after the expiration date i.e on 02-Apr-2022.The BUD date was reported as 02-Apr-2022. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided.  Date Stored in Standard Freezer for the lot 068H21A was 2 degrees F high, -1 degrees F low on 04-Jan-2022.   No treatment medication was reported.
tested positive for Covid via PCR test on 28Mar2021; tested positive for Covid via PCR test on 28Mar2021; This is a spontaneous report from a Non-contactable Consumer (Patient). The female patient of an unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot and batch number not reported), via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. patient received both doses of the Pfizer BioNTech Covid 19 vaccine, second dose on 21Mar2021. She then tested positive for Covid via PCR test on 28Mar2021. She was calling to see if she needs to get a booster shot. (AE due to potential lack of efficacy) (possible PQC due to potential lack of efficacy). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My wife has had 5 Covid shots. The first three were Pfizer with no adverse reaction. The fourth was Moderna with fatigue that lasted a day as the reaction.  The fifth shot, yesterday, was Pfizer. The adverse reaction was  sufficient to cause me to  now report it. My wife spent hours last night shaking uncontrollably. The shaking was quite scary since for the 50 years we?ve been married, she has never been sick. She remains at 9am exhausted from  the experience.
Prior to vaccination, my menstrual cycles increased in frequency. I would get my period every 4-5 weeks then beginning in January it increased to every 2 weeks and now is at least weekly, sometimes starting again after only 3 days.
myoclonic jerking of all four extremities with mydriasis and ocular clonus; mydriasis; ocular clonus; fever 39.1; This is a spontaneous report from a contactable Physician.   A 16-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via intramuscular route on 08May2021 as dose 1, single (age at vaccination 16 years) for covid-19 immunisation. Medical history included depression and anxiety since an unknown date. The patient did not have any known allergies. The patient did not have covid prior vaccination. The patient did not get any other vaccine in four weeks. Concomitant medication included fluoxetine hydrochloride (PROZAC) since an unknown date. The patient presented with fever 39.1 and myoclonic jerking of all four extremities with mydriasis and ocular clonus on 09May2021 at 21:00. The events resulted in emergency room/department or urgent care. The patient received therapeutic treatment for the events with PO Diazepam. The patient underwent lab tests included body temperature: 39.1 centigrade on 09May2021. The patient was tested for covid post vaccination via nasal swab, (PCR/NAAT) with result as negative on 09May2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. came in 4 days after vaccine with swelling, redness, warmth at injection site, fever. Pt. went to Dr. the following day to see if it was cellulitis, Dr. told her she didn't think so and if it didn't get better in a few days to check back. Followed up with patient the following week and she said it was better and she did not go back to Dr.
fever 101 began about 6PM (same day vaxed); fever cont even w/APAP; began vomiting & became listless 25MAY94; fever inc 103.5 seen in er & adm for 5 hrs as an observation;
Patient received one shot of COVID-19 vaccine (Moderna) and the next day had a raised red itchy rash on left leg from knee to ankle.  The next day she experienced a headache beginning behind her left eye that then travelled down the back of her head, neck and into lower back.  She had pain in lower back so much so that she couldn't sit comfortably.  The next day she had bubbling and rolling stomach.  The next two days she had severe diarrhea, then a spot on her face (cheek).  The next day she had pain in her right foot and couldn't walk on it for a while.  Her shot was administered in her right arm and she has a history of anaphylaxis with a Penicillin shot.  She hasn't had anymore symptoms for about a week as of 3/15/2021.
I developed significant swelling of the lymph nodes under the arm and skin discoloration in the same area.
HEADACHE; SEVERE SHAKES; BODY ACHES; SEVERE CHILLS; FEVER; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced severe shakes. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced severe chills. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021 08:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe shakes, severe chills, and fever on 26-MAR-2021, body aches on 28-MAR-2021, and headache on 27-MAR-2021. This report was non-serious.
Case number PHEH2014US000906 is an initial spontaneous report received from a consumer on 08 Jan 2014. This report refers to a 27 years old pregnant female patient. Her medical history and concomitant medications were not reported. She was vacconated with first dose of FLUVIRIN (batch number: 13461P) intramuscularly on 15 Nov 2013 when she was pregnant. No adverse event was reported following the maladministration. She was further vaccinated with a second dose of FLUVIRIN (batch number: 13461P) intramuscularly on 08 Jan 2014 (see related case number: PHEH2014US001495).
Pt. recieved vaccine greater than 12 hours after being drawn up. MD contacted pt. no adverse event. no need for revaccination.
SkinRash  Chest tightness  Narrative:  Due to history of LATEX ALLERGY carrying EpiPen, immunization done in ER. Almost immediately developed chest tightness extreme fatigue and erythema off chest & face; pt says she was told by staff she was "Red as a Lobster" O2 Sat fluctuated 87-93% Treated with Benadyl 50-mg IM. Discharged with Prednisone 20-mg po daily x 3 and Benadryl 50-mg PO TID prn. Today feels normal.
Initial report received from literature on 17 May 2014. A 39-years-old female patient, has not received any concomitant, received TDAP (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. It was reported that within 24 hours of receiving TDAP vaccine, the patient noted several areas of pruritus and swelling on her distal lower extremities. During the next 24 hours these areas enlarged and developed into tender red nodules. The painful nodules persisted and she sought dermatologic medical attention. Correlation of the patients medical history, clinical symptoms, and lesion morphology were compatible with a diagnosis of Tdap vaccine-related erythema nodosum; however, the differential diagnosis also included an Arthus like phenomenon induced by immunization and erythema nodosum secondary to another etiology with immunization being associated by chance. Several circumstances favored Tdap vaccine-related erythema nodosum. Specifically, the patient had not been receiving any topical or systemic medications. Also, she had no recent streptococcal pharyngitis or systemic conditions such as Crohn's disease, sarcoidosis, or tuberculosis. Therefore, the temporal association between her recent Tdap vaccination and the development of the skin lesion suggested that the development of her erythema nodosum was related to her receiving Tdap vaccine. On cutaneous examination, 7 day after receiving Tdap vaccine, revealed tender erythematous nodules on her legs. There was a large, 12 by 8 cm, erythematous nodule on distal pretibial left leg. Multiple, individual and grouped, nodules were present on her right leg; they were located on the distal lateral thigh (4.0 by 2.5 cm), the proximal lateral calf (6.0 by 3.5 cm), the distal lateral calf (2.0 by 2.0 cm), and the distal lateral leg proximal to the ankle (each of 3 lesions measuring 2.5 by 2.5 cm). Symptomatic treatment was initiated oral ibuprofen 600 mg four times daily. Since a drug induced etiology was suspected, daily oral systemic therapy with an antihistamine and a corticosteroid, 180 mg of fexofenadine and prednisone (60 mg for 4 days, followed by 40 mg for 3 days, and followed by 20 mg for 2 days). Her symptoms began to improve and the nodules started to flatten within 3 days. One of the nodules proximal to her right ankle was smaller, yet palpable with mild erythema of the skin. All other nodules had completely flattened and there was macular hyperpigmentation at the sites. At the time of this report the patient was recovered from the event. Documents held by sender: none.
This spontaneous prospective pregnancy report as received from a pregnancy nurse refers to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies. On 05-DEC-2013 the patient was vaccinated with dose one of GARDASIL (lot # H021608, expiration date 13-AUG-2015), intramuscular and was found out a few hours later to be pregnant. No concomitant medication was reported. The patient became pregnant with last menstrual period (LMP) of 08-NOV-2013 and Estimated Date of Delivery (EDD) of 15-AUG-2014. The pregnancy outcome was outcome pending. No treatment was given. The patient underwent urine test. Nurse also reported that patient currently had an unspecified infection as well, and would be treated with an unspecified antibiotic. The events outcome was unknown. Additional information has been requested.
Pain in left arm night of injection. Next morning 8/18/2018, left arm very painful, redness, swelling, area felt hot. About 1230 PM 08/18/2018, I felt like I was coming down with the flu. Muscle and joint pain, massive headache, absolutely no energy. Drank fluids, took some Ibuprofen, ate a light meal about 430 PM. I felt like I had a temperature during this time. I took more Ibuprofen about 930 PM, and by this time, I started feeling better, still had a headache. It is now 130 AM 08/19/2018 and I'm feeling almost back to normal. Left arm still aches, painful and red.
Pain-10-14 days Bright red and warm-10-14 days Itching, burning, prickling-14-21 days
Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 26-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The  temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Patient returned to pharmacy with more serious local injection site reaction, needing medical attention/antibiotics. I referred to PCP and contacted staff.
Within 2 hrs had runny nose, a week later had stye, then a few days later vaginal infection. Following started the week of vaccine and is now resolving. Same with cough. Still has runny nose and never struggles with that before. B/P is up lately. Green nasal discharge.
no adverse event; Administration of vaccine outside of Prescribing Information recommendations. Initial dose of vaccine given in 2020 and second dose given 03Feb2022.; This spontaneous report has been received from a nurse via a company representative regarding a 50-year-old patient of an unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.   On unspecified date in 2020, the patient received the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, anatomical location, lot#, and expiration date were not provided) as prophylaxis.   On 03-FEB-2022 (reported as "today"), the patient received a second dose of polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, and anatomical location were not provided) as prophylaxis (inappropriate schedule of product administration). No further adverse event (AE) information was known.  Follow up information has been received on 10-FEB-2022, from another unspecified reporter.  The reporter asked about if there were any other patient demographic information available, as the only available information was the patient's age, the reporter stated that they would get in contact with the primary reporter to see if they can identify the patient. No further information was available.
Headache, Diarrhea & Nausea Vomiting Narrative:
fever; A spontaneous report was received on 12 Mar 2021, from a consumer concerning a unknown aged female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever.  The patient's medical history was not provided. Concomitant medications were not reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving mRNA-1273, the patient developed fever. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event fever was not reported.
More than 35 days since first shot.He has had the first shot already in april; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since first shot.He has had the first shot already in april) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since first shot.He has had the first shot already in april). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since first shot.He has had the first shot already in april) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
The next day and for two weeks, the patient experienced significant rectal bleeding in the toilet with each bowel movement.  There was no pain.  The patient went to Urgent Care to be examined, and had a colonoscopy after the bleeding ceased.  The colonoscopy yielded material for biopsy, which came out negative.
FEVER; Full body soreness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER), MYALGIA (Full body soreness) and INJECTION SITE PAIN (injection site pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 12-Mar-2021, the patient experienced PYREXIA (FEVER) and MYALGIA (Full body soreness). On 13-Mar-2021, PYREXIA (FEVER) and MYALGIA (Full body soreness) had resolved. At the time of the report, INJECTION SITE PAIN (injection site pain) had not resolved. Not Provided          concomitant medication was not reported treatment information was not provided Action taken with mRNA-1273 in response to the event was not applicable. No further fu needed as per patient.  Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: TCR document attached: event outcome and event updated