chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via patient support programs and described the occurrence of fever in a elderly male patient who received Influenza vaccine Quadrivalent. Co-suspect products included fluticasone propionate, ADVAIR inhalation powder for asthma. In October 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ADVAIR 250/50 ug 250 mg at an unknown frequency. In November 2017, less than a year after receiving Influenza vaccine Quadrivalent and unknown after starting ADVAIR, the patient experienced fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge. The action taken with ADVAIR was unknown (Dechallenge was unknown). Rechallenge with ADVAIR was unknown. On an unknown date, the outcome of the fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge were unknown. It was unknown if the reporter considered the fever, feeling hot and cold, cough, sneezing, nasal congestion and nasal discharge to be related to Influenza vaccine Quadrivalent and ADVAIR. Additional information was reported as follows: This case was received from the consumer (spouse) via the patient assistance program. The age at vaccination was not reported. The patient was taking ADVAIR from 20 years for asthma. The patient and his wife went outside for dinner. That evening the patient started feeling feverish, hot and cold at the same time, developed cough, sneezing, congestion and drainage. The patient has not seen doctor yet. The patient was taking over the counter remedies for the symptoms. This case was not associated with product complaint.
VERY ITCHY; RASH ALL OVER BODY (RAISED AT SOME POINTS); FOUR QUARTER-SIZE RAISED MARKING ON HER ARMS (TWO ON EACH SIDE) WHERE SHE HAD THE BUG BITES; SORENESS IN LEGS, HIPS AND SHOULDERS; TIRED; SHARP PAIN IN HER ANKLE AND WRISTS/JOINT PAIN IN KNEES WHEN SHE WALKS; CONVULSING (SPASMING) STARTED FROM TOE AND SPREAD TO HER HEAD (TOE TO HEAD) THAT WOULD BE OFF AND ON; FREEZING; FEVER BETWEEN 100 TO 102 DEGREES F; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: mosquito bite, and concurrent conditions included: seasonal allergies, seasonal bronchitis, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced stomach issues (stomach ache) when treated with ciprofloxacin, and azithromycin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 14-AUG-2021, the patient experienced sharp pain in her ankle and wrists/joint pain in knees when she walks. On 14-AUG-2021, the patient experienced convulsing (spasming) started from toe and spread to her head (toe to head) that would be off and on. On 14-AUG-2021, the patient experienced freezing. On 14-AUG-2021, the patient experienced fever between 100 to 102 degrees f. Laboratory data included: Body temperature (NR: not provided) 100 to 102 degrees F. On 16-AUG-2021, the patient experienced soreness in legs, hips and shoulders. On 16-AUG-2021, the patient experienced tired. On 25-AUG-2021, the patient experienced four quarter-size raised marking on her arms (two on each side) where she had the bug bites. On 02-SEP-2021, the patient experienced rash all over body (raised at some points). On 02-SEP-2021, the patient experienced very itchy. The action taken with covid-19  was not applicable. The patient recovered from convulsing (spasming) started from toe and spread to her head (toe to head) that would be off and on, freezing, and fever between 100 to 102 degrees f on 17-AUG-2021, was recovering from soreness in legs, hips and shoulders, and tired, and had not recovered from sharp pain in her ankle and wrists/joint pain in knees when she walks, rash all over body (raised at some points), very itchy, and four quarter-size raised marking on her arms (two on each side) where she had the bug bites. This report was non-serious.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 6:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 6:26 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Ethnicity was reported. No concomitant medications were reported. The patient received Moderna vaccine past it's 30 day of expiry date. Vaccine went into 2 to 8 degree celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until it's manufacturing expiry date of 04-Apr-2022. No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Hemorrhage in genitourinary tract with undiagnosed hypertension and use of blood thinners as probable contributing cause. Symptom: blood in semen and traces in urine. Two events over the course of a week. Alleviated by ceasing daily aspiring intake and treatment of hypertension with medication. Patient previously had somewhat elevated blood pressure that went astronomical at the time of this incident.
Moderna COVID-19 Vaccine EUA:  immediately upon receiving injection, heart began racing, and what had been a relatively quite ringing in my ears for the past year or two, also immediately became 2-3x louder (maybe even more?), where it has remained ever since (nearly 2 months).  The heart rate settled down within a few second, but the ringing persisted, and has continued.  Before the vaccine, the ringing was a very high pitched, constant tone, like the high pitched tone I used to hear on an airplane sometimes, but it was so quiet that I only noticed when I would wake up in the morning or at other random times when everything around me was very quiet.  Since the vaccine, however, it has become loud enough that it's impossible not to notice it constantly; not so loud that I can't hear other things around me or people talking, but definitely loud enough that it's unmistakably there and can at times be a real distraction to focus and even conversation.
Initial unsolicited report received from nurse on 11 Nov 2018. This case involves patient (age and gender not reported) who was vaccinated with a dose of IPOL and TUBERSOL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as patient received doses of open product exposed to 1.4C. No adverse event reported. 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 Directive and Module of the Practices. 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. List of documents held by sender: none.
Throat started swelling on one side (side of injection); Face turned red; This is a spontaneous report received from a non-healthcare professional, contactable patient. A 63-year-old non-pregnant female patient received the single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6119), via an unspecified route of administrated in the right arm on 11Mar2021 at 1:00 PM (at the age of 63- years old) for COVID-19 Immunisation. The patients medical history included breast cancer, asthma and past drug history included allergic to codeine and morphine. The concomitant medications included fenofibrate (MANUFACTURER UNKNOWN) dose of 145 mg, pravastatin (MANUFACTURER UNKNOWN) dose of 20 mg and vitamin-D (MANUFACTURER UNKNOWN) of an unspecified dose used within 2 weeks of vaccination for an unknown indication. The patient did not receive any other vaccine with in four weeks prior to the vaccine. Prior and since the vaccination the patient was not diagnosed with COVID-19. On 11Mar2021 the patient experienced throat started swelling on one side (side of injection as reported) and face turned red. The clinical outcome of throat swelling and face red was recovered at the time of this reporting (Mar2021). No follow-up attempts are needed. No further information is expected.
pt recvd vax & at 8:30pm devel t 102 then inc t 104; called MD; tepid bath; 12am vomiting through noc; 4:15pm called hlth dept, conts to vomit; sl swelling at inject site;
About 5 x 10 cm region of Td warmth, erythema and induration in left tricep area; also reports dull, attacker pain through entire left arm, denies tingling or weakness in left upper arm.  No F/C/N/V.
In the patient's medical chart, the immunization information is incomplete. All I am able to report on is that the patient received the first Pfizer vaccine on 1/26/2021 and the second dose on 2/16/2021. This information was pulled from the an Immunization Registry. Lot numbers are not available. On 8/4/2021, the patient presented the ED with worsening symptoms following a previous ED visit the day before (8/3/2021) where he was diagnosed with community pneumonia and advised to monitor symptoms. During the ED visit on 8/4/2021, the patient was diagnosed with a NSTEMI, fever of unknown origin, SOB, and confusion. The patient was admitted for observation. Patient was tested for COVID upon admission to the hospital and the test returned positive. At the time of this note, the patient's condition is stable.
Shortness of breath; Wheezing on exertion; Cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), WHEEZING (Wheezing on exertion) and COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concurrent medical conditions included ivig.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), WHEEZING (Wheezing on exertion) and COUGH (Cough). At the time of the report, DYSPNOEA (Shortness of breath), WHEEZING (Wheezing on exertion) and COUGH (Cough) outcome was unknown.            No concomitant information provided. No treatment information provided.
LARGE RED, RAISED, WARM TO TOUCH 2 INCHES BY 2 INCHES.  TEMP OF 100. ORAL NOTED.  PAIN WITH WT BEARING.
constant headache Saturday, Sunday, Monday and today Tuesday.  Treatment is acetominphen extra strength and ice packs, tried excedrin migraine, no relief
pt recv vax & devel an inj site rxn characterized by redness, swelling & warmth;This is 1 of 7 pt of this facility to have an adverse exp p/vax lot#
10th day after MMR (1st dose) and swelling thigh. Febrile seizure 11am-focal generalized prolonged atypical-required intubation and ventilation. Rash dy 13.
Fever after first shot; Fatigue after first shot; Pain in the left arm after first shot; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever after first shot), FATIGUE (Fatigue after first shot) and VACCINATION SITE PAIN (Pain in the left arm after first shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2020, the patient experienced PYREXIA (Fever after first shot), FATIGUE (Fatigue after first shot) and VACCINATION SITE PAIN (Pain in the left arm after first shot). At the time of the report, PYREXIA (Fever after first shot), FATIGUE (Fatigue after first shot) and VACCINATION SITE PAIN (Pain in the left arm after first shot) outcome was unknown.            Concomitant medications were not reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-661804 (Patient Link).   Reporter did not allow further contact
Menstruation cycle stated two weeks early; Menstruation is painful; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation cycle stated two weeks early) and DYSMENORRHOEA (Menstruation is painful) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 04L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MENSTRUAL DISORDER (Menstruation cycle stated two weeks early) and DYSMENORRHOEA (Menstruation is painful). At the time of the report, MENSTRUAL DISORDER (Menstruation cycle stated two weeks early) and DYSMENORRHOEA (Menstruation is painful) had resolved.            Concomitant products were not provided. Treatment products were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: contact info provided: email address
Fatigue, intense bruising on and around the injection site in my upper arm.  Bruising is very dark, purple, red and black. Pain also spread down to my forearm starting the next day.  Diahrrea.
Patient was administered Flu (right arm) and Covid (left arm) vaccine together on Sunday, 11/06/22. Patient returned today (11/07/22) and presented with rash on her right arm (Flu). I advised her to take a Benadryl and consult with her doctor if not resolved within 24 hours.
did not receive second dose of moderna covid 19 vaccine within 42 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive second dose of moderna covid 19 vaccine within 42 days) in a patient of an unknown age and gender 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 PRODUCT DOSE OMISSION ISSUE (did not receive second dose of moderna covid 19 vaccine within 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive second dose of moderna covid 19 vaccine within 42 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   Reporter did not allow further contact
Muscle aches, diffuse, duration of 12 hours, improved with ibuprofen. Headache, diffuse, duration of 10 hours, improved with ibuprofen. Chills, duration of 8 hours, improved with ibuprofen. Pain at injection site, duration of 48 hours.
the uncommon symptoms experienced after vaccine was severe swelling of the gut with tenderness of the whole intestinal areas side and back pain to the touch.   unable to move due to significant swelling and pain.    onset started one day after the vaccine shot and lasted for more than 1 week.   patient saw the GI physician and was prescribed IBS medication.    patient still has some residual swelling and pain.  Patient does not want to get the second dose of the vaccine due to this event.
Right deltoid muscle-pain at injection site extending down arm to wrist-painful nodule 3x3cm at site with warmth-pt developed symptoms later that day after injection.
Approximately 7 days post vaccine administration, a welt the size of a palm (like a giant singular hive) with a 1-inch red circle around it appeared at the site of vaccination. Localized numbness, swelling, redness, heat, soreness present. I drew a circle around the redness & the welt. Within 12 hours, the welt had dissipated, but the redness had grown outside the outline. Swelling decreased, but site was firm, hot, red, and more sore.
Submitted to Docket No. 1980N-0208; 69 FR78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. My son was in the guard. He was told he had to take the anthrax vaccine. He had real doubts to the safety of the vaccine, and expressed that he did not want to take the shots. He was threatened with a court martial. So he took it. He became very ill for over a month. Achy bones, flu-like symptoms, and in general, miserable. When it came time to take the next of the series, he again declined. However the pressure was very great. So he took it again. This time he became very ill. Bones aching, his teeth feeling as though they were falling out. It took him quite a while to get better. When the time came up again to take the vaccine, he refused. They threatened him with a court martial and 10 years in prison. He refused. He believed it would kill him if he took the vaccine again. We all knew it was wrong. They continued to threaten him with a court martial. Then all of a sudden they quit threatening him and he was deployed. When deployed, they began to put pressure on him again. He continued to refuse. He never took the vaccine again.
This spontaneous report as received from a 79 year old female consumer diagnosed sometime in 2011 with breast cancer and heart fibrillation referring to herself. On 12-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous, (dose, dose number, lot number and expiration date were unspecified). Other concomitant therapies included BACTRIM, DILANTIN, PRADAXA, simvastatin (manufacturer unknown), METRAZOL (also reported as METRAZOLE), letrozole, a generic multivitamin (unspecified), Vitamin D3, biotin and Vitamin B12. On an unknown date, the patient was two or three day at the hospital for special surgery (unspecified). The patient also experienced, on an unspecified date, rash after using DILANTIN and an unspecified reaction while using BACTRIM so patient's physician thought she may be allergic to sulfa products. The patient also stated that, at the time of this report, she was currently undergoing treatment for scleroderma but could not specify if this occurred prior to or post receiving ZOSTAVAX. A mammogram and a sonogram were performed to the patient on unspecified dates (results were not reported). The patient sought medical attention, reported as "I went to the hospital". The outcome of surgery, rash and unspecified reaction was reported as unknown. The outcome of scleroderma was reported as not recovered/not resolved. Upon internal review, special surgery (unspecified) was determined to be medically significant. Additional information is not expected because the reporter refused additional contact.
Sore arm; Dose received 3/ dose number=3; This is a spontaneous report received from a non-contactable reporter (consumer or other non HCP).   A 59-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration site is unknown, administration date on an unknown date in 2021 (Lot number: unknown) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: Unknown, Anatomical site: Unknown) for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot Number: Unknown, Anatomical site: Unknown) for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received 3/ dose number=3"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021, outcome "unknown", described as "Sore arm".   Additional Information: The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Limping, not walking on left leg since receiving 2 vaccines in LVL. 3 days no fever, seen in clinic for dysuria and urinary incontinence x 2 days.
My husband described his left arm as being mildly sore after receiving his vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 13:45 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE. The following information was reported: MYALGIA (non-serious) with onset 05Mar2021, outcome "recovered", described as "My husband described his left arm as being mildly sore after receiving his vaccination". Therapeutic measures were not taken as a result of myalgia.  Additional information: Patient did not have other vaccine in four weeks. Patient did not received treatment for event. Patient did not covid prior vaccination and not teste post vaccination. Patient had no known allergies. My husband received his vaccination on Thursday, 04Mar not 03Mar. He mentioned to me that his arm was a bit sore on Friday evening 05Mar.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5 days after receiving the vaccination the patient developed generalized malaise progressing to encephalopathy.  He was admitted to the hospital with presumed septic shock, and work-up revealed hemophagocytic lymphohistiocytosis.  He died from the disease process 9 days after vaccination.
Patient was to receive his second dose of Monovalent Pfizer vaccine but instead received the bivalent vaccine.
Became "zombie-like", limp and decreased responsiveness. Decreased eating. Gone by the next day.
I tested positive for COVID-19 on 02/28/2023 I woke up with a hard cough. I had a fever the first 2 days 101. I did sleep and cough for 5 days. My provider prescribed PAXLOVID for 5 day treatment.
approx MAR92 pt recvd Engerix-B & pt exp arm pain & fever greater than 100 degrees;
chills, diaphoresis, fatigue, fever, abdominal pain, diarrhea, nausea, vomiting