chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Body loose; Chills; Fever; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches), HEADACHE (Headache) and LOOSE BODY IN JOINT (Body loose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MAGNESIUM, VITAMIN E NOS (VITAMIN E + MAGNESIUM) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches) and LOOSE BODY IN JOINT (Body loose). On an unknown date, the patient experienced HEADACHE (Headache). On 06-Feb-2021, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches) and LOOSE BODY IN JOINT (Body loose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Tylenol of 500 mg.   Reporter did not allow further contact
I was a little tired (second one was a little bit worse); I had a slight fever (second one was a little bit worse); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN, METFORMIN, Fibric acid and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)). At the time of the report, FATIGUE (I was a little tired (second one was a little bit worse)) and PYREXIA (I had a slight fever (second one was a little bit worse)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to MOD-2021-301864 (Patient Link).
the dose has expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Bexsero that had expired on 30th January 2022, which led to expired vaccine used. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
This spontaneous report has been received from a female consumer of unknown age reporting on herself. None patient's medical history, drug reactions or allergies were reported. Concomitant therapies included calcium (unspecified) and vitamin d (unspecified). On 10-JAN-2017, the patient was vaccinated during an unspecified meeting with ZOSTAVAX, subcutaneously  (dose, frequency, lot# and expiration date were unknown by the reporter) for prevent shingles. On 12-JAN-2017, the patient experienced "a big red spot that was the circumference of a golf ball and felt hot", around the injection site. Product quality was not involved. The patient reported that she did not received treatment for the adverse event and also none laboratory diagnostic studies were performed. Additionally, she did not sought medical attention. At the time of reporting the outcome of "a big red spot that was the circumference of a golf ball and felt hot" was reported as not recovered.  The relatedness between the event and ZOSTAVAX, was not reported    Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 21-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Acute onset of fever (101 1 hr after 2 tabs Tylenol),  high BP; 168/80 (prior BP=120/70), HR: 92 (typically 74) acute chills w/ profound, uncontrolled shaking , muscle rigidity, clenched jaw, nausea and vomiting, severe headache.  Symptoms lasted 12-16 hrs.   Note: no redness or swelling at injection site.   R arm sore/ tender to touch.   Headache and muscle aches persisted through day 10/30.
On Saturday July 3rd I noticed tightness in my chest, lightheadedness, and ringing in my ears. On Sunday, July 4th, I still had the lightheadedness, tightness in my chest, rapid heartbeat, and it was more difficult to breath unless I was sitting a certain way.  On Monday, July 5th I had severe chest pain, difficulty breathing, fluttering and pounding heart, when I took a deep breath I would feel my heart pounding but at a much slower rate and then it would go back to normal beats, severe ringing in the ears, extreme tiredness. This lasted for about 1.5 hours and I went back to bed and when I awoke 4 hours later my heart seemed to beat fine. Chest pain lightened up a bit, but breathing is still difficult. I?m very healthy and have not had any health issues. The heart issue this morning was so bad that I?m not sure if I should get the second dose. If things worsen, I will contact my doctor. I?m hoping that it goes away soon and this will be alleviated on its own, but I?m really worried about getting the second dose even though I want it.
Pt had prolonged fever of 104F, & prolong irritability, unconsolable x 6hr, w/altered cry; PE-normal; 12 hrs later inject site was only mild tender;
Report received from a physician via telephone on 12/19/00, regarding a possible adverse event associated with Fluvirin. A 68 year old male pt received Fluvirin on 12/4/00 and that same day, developed redness around the injection site. On 12/7/00, the rash became generalized all over the pt's body. The pt required hospitalization from 12/10/00 through 12/14/00. On the same day that the pt developed the skin rash, the pt also had started Clindamycin 600mg for an unknown reason. No other information was provided and attempts to obtain further information regarding these events, have been initiated.
The pt experienced hives, redness, bumps, swelling, tiredness, headaches, 50% loss of feeling in toes. All of these symptoms began 14 hours post vax. The pt is still being treated for symptoms. The pt had same reaction with previous shot.
Day 2 low grade fever, sore hot arm. Day 3 and present day  5 aching, swollen, hot arm above the elbow. It is painful trying ante histamine Benadryl and topical cortisone. Took day 4 and 5 Benadryl and icing Still painful, swollen, and hot. Moderna booster
Post vax, complained of itchy hands, red and raised areas appeared in a couple of minutes. At 13:00, arrived at ER with some respiratory difficulty, throat swelling and treatment was given. At 14:00, discharged home with improvement. On 12/15/00, returned to work.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history and drug reactions or allergies was reported. In November 2015 (reported as "around November 9, 2015"), the patients were vaccinated with the first dose of GARDASIL 9 (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown dates, the patient received the third dose of GARDASIL 9 sooner then recommended six month interval. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
passed out; fainted; migraine; feel body aches; fatigue; felt incredibly ill; nauseous; hitting head; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in Right Arm on 10Apr2021 11:30 (at age of 22 years old) at single dose for COVID-19 immunisation. Medical history included Seasonal allergies, asthma, Known allergies: peanuts (mildly). Concomitant drug was Yes. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8727) on 20Mar2021 11:30AM (at 22 years old) at Left arm at single dose for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. A few hours after second dose, on 10Apr2021 02:00PM, patient developed a migraine and began to feel body aches and fatigue. The next morning, patient felt incredibly ill. Shortly after rising, patient became severely nauseous and fainted, hitting head; patient became conscious and passed out again before being taken to the ER (Emergency room). All AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (IV and anti-nausea med. administered) received for all events. The outcome of the events was Recovering.  Information on the lot/batch number has been requested.
Gtven Pfizer Booster was putting the information  .had checked the expiration and thougtht it said 2/2/23 . Gave vaccine and didn't relized it had expired on 1/20/23..
pain/itching at site, redness/flushed feeling, body aches, fatigue
I received my third dose of my Pfizer COVID-19 vaccine in September of 2021. In December of 2021 I contracted a mild case of COVID-19 and I recovered pretty quickly. However, my shortness of breath never went away. I saw a few doctors and I was referred to pulmonology. I was told that my lungs look fine but was referred to a cardiologist. They did and echo cardiogram along with other tests and determined that I have aortic insufficiency which I did not have before. I was hospitalized in March of 2022 for concerns about my heart. I still can't breathe very well to this day. I was unable to work for 8 months. I have now returned to work, but it is difficult and I struggle.
My heart started racing. My chest felt tight and my legs felt heavy. Heart rate was in the 100's to 110's and at one point it spiked to 135. My throat was burning. I felt extremely tired.
Six patients vaccinated with expired Jynneos vaccine; Case reference number US-BN-2023-001033 is a spontaneous case report initially received from other health professional via Communications (reference number: USBAV23-0776) on 19-Jun-2023 and concerns six patients of unknown demographics.  The patients' medical history and concomitant medication details were not provided.  On unspecified dates, reported as since January 25th, Jynneos vaccine (batch number unknown) was in the refrigerator.  On an unspecified date, the Jynneos (batch number unknown) vaccine was past the beyond use date (BUD) and six patients were vaccinated with a dose of the expired Jynneos vaccine (batch number unknown), at unknown dose, subcutaneously, at unknown anatomical site of administration, for indication reported as smallpox/monkeypox prophylaxis (explicitly coded as 'expired vaccine used').  At the time of initial report, it was unknown if the patients experienced any adverse event due to Jynneos vaccination.  Additional information received on 20-Jun-2023 included the local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with a dose of the expired Jynneos vaccine, at unknown dose, subcutaneously, at unknown anatomical site of administration, for indication reported as smallpox/monkeypox prophylaxis, which is considered as expired vaccine used. It was unknown if the patients experienced any adverse event due to Jynneos vaccination. Expired product administered is considered as listed per company convention. The patients' relevant medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with a dose of the expired Jynneos vaccine, at unknown dose, subcutaneously, at unknown anatomical site of administration, for indication reported as smallpox/monkeypox prophylaxis, which is considered as expired vaccine used. It was unknown if the patients experienced any adverse event due to Jynneos vaccination. Expired product administered is considered as listed per company convention. The patients' relevant medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Knot at the site of injection (about 4 knots down her arm); Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot at the site of injection (about 4 knots down her arm)) and PYREXIA (Low grade fever) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Gout and Osteoarthritis.On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Knot at the site of injection (about 4 knots down her arm)) and PYREXIA (Low grade fever). At the time of the report, VACCINATION SITE MASS (Knot at the site of injection (about 4 knots down her arm)) and PYREXIA (Low grade fever) outcome was unknown. No treatment medications reported specifically for the particular event.The patient had no side effects with first vaccination. It was reported that She has taken her prescribed medication Indomethacin; she has gout and osteoarthritis.This case was linked to MOD-2021-386111 (Patient Link).
Information has been received from a registered nurse (R.N.), concerning an unspecified patient (unknown age and gender). The patient's pertinent medical history and concurrent conditions were not provided. ON 15-AUG-2016 the patient was vaccinated with improperly stored dose of (wistar ra 27-3) M-M-R II lot # L036851, expiration date 03-SEP-2017, (concentration, dosage and therapy route were unknown). Concomitant therapies were not provided. No adverse effects were reported. The vaccine was exposed to 55.6 F for 2 hours and 24 minutes and the call was made because of digital data logger. No product quality complain (PQC) was involved. This is one of two reports from the same source (MARRS # WAES1608USA008369). Additional information has been requested.
Moderate body pain; Fatigue; Mild headache; Low fever; Upset stomach; This is a spontaneous report from a contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 20Apr2021 at 14:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy, depression, anxiety and pre-diabetes. The patient had unspecified allergies to medications, food, or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN), duloxetine hydrochloride (DULOXETINE DR), lisdexamfetamine mesilate (VYVANSE) and buspirone (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. 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 21Apr2021 at 06:30, the patient experienced moderate body pain, fatigue, mild headache, low fever and upset stomach. Therapeutic measures were taken as a result of the events and included treatment with Over-The-Counter (OTC) medication Aleve. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events moderate body pain, fatigue, mild headache, low fever and upset stomach were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
I started to feel lower back pain and took Ibuprofen 200mg. I have never experienced a reaction to Ibuprofen. About 30 minutes later I started to feel excruciating pain in my stomach that would vary in intensity in waves and lasted for about 4 hours. I couldn't stand and had to sit down and put pressure on my stomach. It was felt mostly center and top left areas. My stomach felt hard and reminded me of pregnancy contractions (I am not pregnant). I was not nauseous and I had not consumed any alcohol. I tried eating something but it didn't help. I called the after-hours nurse since it was a Saturday night. She recommended watching it and getting checked in 4 hours or going to ER if no better. It improved around midnight and I went to sleep. I woke up feeling extremely exhausted but with no stomach pain.
Approximately 10 minutes after administration our staff was notified that the PT ( 13y/o male) was having an adverse reaction. Upon arrival the PT was found sitting upright appearing pale and weak. I immediately took the first set of vitals as follows ; BP 110/76, HR 67 , O2 SAT 97%. A second set of vitals were taken 15 minutes later as follows ; BP 119/84, HR 78, O2 SAT 96%. PT was stable and his pale appearance improved. PTs guardian was informed to continue observation of PT throughout the day and if PT appears to decline to report to an urgent care facility. PTs care was transferred to legal guardians.
This spontaneous report as received from a healthcare worker refers to a 25 year old female patient. On 27-OCT-2014, the patient was vaccinated with a first dose of GARDASIL (lot # K009811 exp 19-JUN-2016) (dose and route not reported). The healthcare worker reported that on 27-OCT-2014 in the evening, the patient experienced her finger became swollen in the same arm that she received the injection in. Later that day the patient's hand and the rest of the arm became swollen. The patient decided to go to an ER facility. While in the ER the patient began to break out in hives and was diagnosed with an allergic reaction to the vaccine. The patient was treated with prednisone. The outcome of allergic reaction to the vaccine was unknown. Additional information has been requested.
Admitted for pneumonia on 1-14-13 and receive PPSV23. Discharged on 1-18-13. Represented to ER on 1-21-13 with c/o worsening weakness/fatigue.  Diagnosed with Guillain-Barre.  Rec'd IgG. Intubated on 1-24-13, trach, PEG, vent for progressive ascending weakness.  Still hospitalized at this time.
Patient states that about 20 minutes after receiving the vaccine, she noticed her neck becoming sore. Shortly after, she noticed that her lips felt "tingly" and that her heart was "racing." In office she states that her lips feel "tingly" off and on now. She describes a tingling sensation around her face and head. Denies itchiness. Denies thickness/fullness of throat or shortness of breath. Provider assessed patient at time of triage. After 30 min on-site wait time, patient states that she feels "the same." Denies shortness of breath. Denies thickness/fullness of throat. Reminded to follow RCC's instructions for medication, and to call 911 if she begins to have symptoms that affect her breathing. Advised to contact office with any non-emergency questions or concerns. Patient released from monitoring at 14:50.
Stated she received the flu shot on Wednesday and began to have symptoms on Thursday -sneezing, sore throat, body aches, and chills. Temp 98.4 today instructed to take TYLENOL, follow up with PCP.
The patient received the flu shot and approximately 5 minutes later almost passed out. The patient was seated in a chair and given water.  No signs or symptoms of anaphylaxis were observed.  I took blood pressure readings every 5 minutes for the first fifteen minutes, then every 10 minutes for the next 20 minutes. After 30 minutes the patient was ok and his blood pressure was normal.
Back pain in right side rib area. Felt like a rib was out of place. Hurt to take deep breaths. Had a sharp pain in one particular area and then an entire backache. Started the night (Thursday) I got the vaccine and was completely gone by Saturday morning, like nothing had happened. I also experienced inability to get good sleep, fatigue, nausea, headache and head fog.  But, the back pain was the most significant.
This initial report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II, lot number L024265 with expiration date 01-JUL-2017 (dose, strength, route of administration and anatomical location were not reported. According to reporter, the vaccine experienced temperature excursion of up to 45.5 F for 362 hours and 12 minutes. No adverse effects were reported in any patients. This is one of several reports from the same source (1611USA007125 and 1611USA012963). Additional information is not expected since reporter did not give consent for follow up.
mother stated arm had small red area evening of 5/4/04 but by evening of 5/5/04 l arm was swollen & red from shoulder to elbow
COVID-19 Infection; COVID-19 Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 2, single (Batch/Lot number: FF2593) at the age of 77 years and on 09May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 78 years; all for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 007M20A) at the age of 76 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovered" in 2022 and all described as "COVID Infection". The patient underwent the following laboratory tests and procedures: COVID-19 rapid test (nasal swab) on 16May2022, which was positive. Therapeutic measures were not taken as a result of drug ineffective or COVID-19.