chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incomplete course of vaccination; possible low grade fever; fatigue; achiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 11th July 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, fatigue and pain. On an unknown date, the patient experienced incomplete course of vaccination. On 15th July 2019, the outcome of the fever, fatigue and pain were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, fatigue and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced possible low grade fever, fatigue and achiness. Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. The patient planned to follow-up with her physician on an unknown date. Consented to follow up. This case has been linked with case US2020075688 and US2020075693, reported by same reporter.
no additional AEs reported; the vial used to administer the third injection was not rolled or shaken; the vial used to administer the third injection was not rolled or shaken and concerned if the dosage was good; the vial used to administer the third injection was not rolled or shaken and concerned if the dosage was good; This spontaneous report was received from a medical assistant calling on behalf of physician and refers to a male patient There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (reported as the age of 38), the patient started the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Approximately in March 2019 (reported as around), the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose for prophylaxis (route of administration, lot # and expiration date were not reported). It was reported, that the patient received all doses at the scheduled interval times (exact dates were not provided).   It was reported, that the health care professional (HCP) that administered the third dose of vaccine did not shake the contents in the vial prior to administration. The patient expressed concerns to physician, that the vial used to administer the third injection was not rolled or shaken like the first two doses and he was worried if the dosage was good. The medical assistant reports, that the patient was unable to provide details in regards to the appearance of the contents in the vial. No additional adverse events (AEs) were reported.
HEADACHE; FEVER STARTED  24 HOURS LATER; COMPLAIN OF LEFT ARM PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAR-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced complain of left arm pain. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced fever started 24 hours later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of fever started 24 hours later and complain of left arm pain was not reported. This report was non-serious.
1/22/2010  ED visit: Right sided facial drooping onset 2 days ago, Lagophthalmos OD. Pneumonia
(This history was obtained during a telephone interview with the service member on 1/28/06). Service member describes his health prior to 1/06 as "very good". He received a smallpox vaccine (primary) on 1/17/06-15 jabs in his left arm. On 1/24/06, he noted left axillary lymphadenopathy and redness and tenderness around his vaccine site. That evening, he also began experiencing left shoulder and neck pain ("round collar bone"). During that evening, he could not move his head due to the constant pain made worse with movement. Initially, he thought he had a pulled muscle. After dinner, he began experiencing substernal chest pain and sought evaluation in the ER. At that time, the pain was both substernal and in the area of the left clavicle. The pain was constant, but the intensity varied between a level 4-5/10 (at onset) and 8-9 (at time he went to ER). The pain was described as aching. He denied any accompanying symptoms that day or evening such as fever, chills, shortness of breath, palpitations, cough, headache, fatigue or body aches. The pain was made worse with movement and coughing and sitting up made the pain feel better. In the ER, the service member had x-rays and Cr scans completed and was treated with Morphine. There was concern regarding abscesses, as the pt had a history of neck abscesses X 3. After evaluation, he was told the pain was probably musculoskeletal. Upon discharge from the ER (morning of 1/25/06), the pain had decreased sufficiently to allow him to sleep. He was resting at home on 1/25/06 when he received a call saying that there was an abnormality on his CT scan requiring further evaluation. He had a Chest CT completed on 1/25/06, which showed a small pericardia effusion. By this time, pt reports continued substernal chest pain and neck/shoulder pain, but was also short of breath ("winded") and noted a "racing heart" with minimal exertion. On Friday, 1/27/06, he was evaluated by Internist and had ECG and ECG completed. He was placed on restricted duty for 3 months and started on Indocin and a medication to "protect his stomach". At time of interview, chest pain and shortness of breath could be elicited at 3 METS (walking slowly for 1 or 2 blocks). He describes his current health as "Fair". He has a follow-up appointment with the MD on 2/21/06 and has a pending Cardiology evaluation. Lymphadenopathy, axillary. Comment: left axilla; chest pain; sub-sternal; dyspnea (shortness of breath); tachycardia sensation of heart racing and pounding hard with minimal exertion. Findings suspicious for smallpox myopericarditis. He has been taking Motrin PRN, instructed pt on keeping anti-inflammatory doses of NSAID's at all times. Rx'd naproxen bid with Prilosec for GI prophylaxis. He was later prescribed Percocet for the pain.
Swollen, feverish, pink rash; Swollen, feverish, pink rash; Swollen, feverish, pink rash; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable and the patient had allergy to sulfa drugs and surgical stainless steel. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and diphenhydramine hydrochloride (BENADRYL), all taken from unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 11:00, ninth day after the vaccination, the patient experienced swollen, feverish, pink rash approximately 3.5" in height by 2.25" in width. By 06Apr2021, it was approximately 4" in height, 2.75" in width and in lighter pink color. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen, feverish, pink rash was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient had syncopal episode after receiving HPV vaccine at approximately 1013. The HPV vaccine was administered after the meningococcal vaccine - patient was seated on exam table and did not have a fall. He initially slouched forward and then was laid back on exam table with knees elevated by CMA -patient reports he "fuzzed out" and remembers feeling the left arm tingling where he received the HPV vaccine -no trouble breathing, just feelings of nausea/weakness -continuous SpO2 placed on finger at 1018 -initial BP 90/60, HR in 50's. Vitals taken at 1018 (supine), 1023 (supine), 1030 (supine), 1034 (reclined 45 degrees), 1040 (reclined 45 degrees), 1046 (reclined 45 degrees), 1049 (sitting), 1054 (sitting), and 1100 (sitting)-patient left clinic at 1103 and was continuously monitored by provider and CMA since 1013 -patient instructed to seek emergent medical care should he have trouble breathing or isn't feeling well. Patient verbalized understanding.
Developed hives 10 days after booster shot. Hives were on legs, arms, neck, chest - moved around body.  Extremely itchy. palms of hands and bottom of feet also itchy. Itchiness subsided after 50mg Benadryl. Saw general practitioner and went on prednisone for 10 days - did not stop hives. Hives came and went for the next 2 weeks, diminished time and intensity.
I developed blood clots and a hematoma in my right leg.  I was hospitalized for four days.  I am being treated with Lovenox injections and pain medication.  My prognosis is that I should be able to walk again after a month of treatment.  Unsure about being able to resume teaching tennis.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event ) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event ) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event ) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient 's age was reported as 18 year 7 months.  No concomitant medications were reported.  ID was reported as 80777027399.  It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2022: Live Followup received contains completion date and patient age month updated.
Low grade fever (99.9) Extreme bone, joint, muscle aches - much as experienced when I had the COVID virus in September Fatigue Symptoms began to abate about 24 hours after their onset
This spontaneous report was received on 03-OCT-2016 from a 69 year old male consumer regarding himself. In November 2015, the male was vaccinated with ZOSTAVAX subcutaneously. Medical history and concomitant medications were not provided (patient refused to provide as he felt they were not relevant or connected to his symptoms). He developed a rash a few days after the vaccination. He has also since been experiencing nerve pain throughout his body which has not dissipated. He had to go to the doctor each subsequent month since the vaccination. The outcome of the rash was unknown. The incurred as a result of the ZOSTAVAX. Additional information has been requested.
It started with "electrical shocks" in right side of face, occasionally. It has progressed to "shocks" non-stop in the right side of my face, skull, down both sides of neck, both ears and other various parts of body.
patient reports cellulitis to right arm from injection site to wrist.  Right arm swollen, red and painful
arm is sore; inside of her arm looked bruised in appearance of green and purple / about ten small bruises; about ten small bruises; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), CONTUSION (inside of her arm looked bruised in appearance of green and purple / about ten small bruises) and ADMINISTRATION SITE BRUISE (about ten small bruises) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is sore), CONTUSION (inside of her arm looked bruised in appearance of green and purple / about ten small bruises) and ADMINISTRATION SITE BRUISE (about ten small bruises). At the time of the report, PAIN IN EXTREMITY (arm is sore), CONTUSION (inside of her arm looked bruised in appearance of green and purple / about ten small bruises) and ADMINISTRATION SITE BRUISE (about ten small bruises) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1-2/week prior to pregnancy) on 25-Jun-2020, Miscarriage (At 11 weeks gestational age Spontaneous abortion) on 18-May-2018 and Delivery (Live, full term birth) on 06-Nov-2019. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Dec-2020 to an unknown date for Pregnancy.   On 08-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 11:50 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 20-Dec-2020 and the estimated date of delivery was 29-Sep-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Pregnancy test: Positive. On 18-Feb-2021, Ultrasound foetal: normal normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported estimated date of conception as 06-JAN-2021. Patient had 2 prior pregnancies.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Pregnancy form received with additional information regarding LMP, previous pregtnancies, physician contact, medical history., and 2nd vaccine dosage.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Approximately 12 hours after injection - head ache, body ache, fever (highest was 102.8) body shakes, night sweats. Continuing as I write this.
Red erythematous rash around injection site. Fevers/chlls for 2 days. Rash spread to medial forearm. Rash not apparent anywhere else. No shortness of breath.
Employee was vaccinated on 1/12 prior to start of shift.  Called this am to report feeling extreme fatigue and arm soreness.  Stated she was not able to tie her hair or use arm without pain.  Denies fever, body aches at this time.
Patient was given a 3rd dose of Covid-19 vaccine.  It should have been Moderna that was given but Pfizer was given in error.  Patient was notified immediately.  No adverse effects reported.  Patient understands and was not worried about the dose of Pfizer that was given.
tingling, itching on the left arm, seen & cleared by EMS, B/P 153/103, P 86, O2 sat-99%
Large erythematous patch & swelling on leg; patch 24.5 cm x 16.5 cm.
Within a minute after receiving HPV patient felt faint and then had a syncopal episode. Dr. was called into room. We placed her on exam table with her legs elevated. Within 5-10 seconds she regained consciousness, was able to talk. Vitals taken-states she feels better.
The first day I had no arm pain as others suggested but later that day I began to be enervated. After going to sleep early in the afternoon I woke up light headed. I spent the weekend having trouble breathing. On Monday I used a sick day because of shallow breathing. Tuesday my light headedness went away but I was having trouble with my bowels.  That may have been due to snacking on cashews though. Tuesday night I ate some watermelon and drank two 32 ounce bottles of gatorade and I feel a lot better today. Breathing is still shallow but nowhere near what it was. It is back to being indicative of my morbid obesity
This is a spontaneous report from a contactable Physician through a Pfizer Sales Representative. This patient (age, gender and race unknown) received PREVNAR 13 (lot G73024, exp.date Oct2014) on an unknown date, single dose. Relevant medical history and relevant concomitant medications were unknown. It was reported that on 06Sep2013, patient experienced soreness and swelling at the site of vaccination. Relevant laboratory data was unknown. Therapeutic measures taken in response to the reported event were unknown. The clinical outcome of the reported event was unkown, at the time of report. Follow-up (11Oct2013): Follow-up attempts completed. No further information expected.
Received vaccine and initially had no symptoms. Woke up on 1/5 with sore arm and erythema 3"x4", area warm to the touch
His anus was activated,Nerves in his anus are not working properly; Anal problems, Went to nursing home temporarily because he fell, He always has to potty all the time; Kept feeling like he had to have a bowel movement,He went to bathroom about 14 times day,First he was going every hour now it's every 3 hours; Went to nursing home temporarily because he fell; Itching really bad; This spontaneous case was reported by a consumer and describes the occurrence of ANORECTAL DISORDER (His anus was activated,Nerves in his anus are not working properly), ANORECTAL DISCOMFORT (Anal problems, Went to nursing home temporarily because he fell, He always has to potty all the time), FREQUENT BOWEL MOVEMENTS (Kept feeling like he had to have a bowel movement,He went to bathroom about 14 times day,First he was going every hour now it's every 3 hours), FALL (Went to nursing home temporarily because he fell) and PRURITUS (Itching really bad) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) (Had a pacemaker) in 2020. Concurrent medical conditions included Heart disease, unspecified (Heart patient).    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANORECTAL DISORDER (His anus was activated,Nerves in his anus are not working properly), ANORECTAL DISCOMFORT (Anal problems, Went to nursing home temporarily because he fell, He always has to potty all the time), FREQUENT BOWEL MOVEMENTS (Kept feeling like he had to have a bowel movement,He went to bathroom about 14 times day,First he was going every hour now it's every 3 hours), FALL (Went to nursing home temporarily because he fell) and PRURITUS (Itching really bad). At the time of the report, ANORECTAL DISORDER (His anus was activated,Nerves in his anus are not working properly), ANORECTAL DISCOMFORT (Anal problems, Went to nursing home temporarily because he fell, He always has to potty all the time), FREQUENT BOWEL MOVEMENTS (Kept feeling like he had to have a bowel movement,He went to bathroom about 14 times day,First he was going every hour now it's every 3 hours), FALL (Went to nursing home temporarily because he fell) and PRURITUS (Itching really bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. The patient had to go to nursing home temporarily because he fell and it was reported that came back at the time of reporting. No treatment medication were provided.
pt. complains of headache on her right side of the head and seems anxious.   pt. out of her car waiting her dogs states that she feels better.  H/R 102
Redness, warmth + swelling beyond injection site. Pain + fever not responsive to Tylenol and Ibuprofen. Required an antibiotic
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-JUL-2016, the patient was inadvertently administered an expired dose of M-M-R II lot # J014872, expiry date 21-NOV-215 (dose and route of administration were not reported). No adverse effect reported. Additional information is not expected as the reporter refused further contact.
Heart function normal in March at Doctor office.  Afib detected at doctor office in June and referred to cardiology.  Dr. confirmed Afib.  Cardioversion performed October 26th.  Patient reverted back to Afib within a week.  Next, cardiologist recommends a cardioversion procedure to attempt to remedy the Afib.  Note that spouse also got vaccinated with both doses of Moderna on the same dates and times.  She too developed Afib.