chrisvoncsefalvay/vaers-outcomes huggingface dataset:
achiness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achiness) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (achiness) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Ache, at an unspecified dose and frequency. At the time of the report, MYALGIA (achiness) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.
Following this first and a second dose 4 weeks later, I began to notice that my inflammatory arthritis was beginning to flare. I was experiencing increased joint pain in multiple joints that had been under control for over ten years on my current medication regiment.
Dizzyness, muddled thinking, somewhat confused.  Began when I woke up the day after around 6AM Wed,Dec 3th.  Called doctor, told me to wait it out, called the next day and went in to see him.  He did an EKG, my blood pressure was elevated (about 145 over 90), did a blood test, sent me downstairs for a chest X-Ray and a head CT. Each day after it got a bit better and I felt like my old self by Sunday, Dec. 7th.
Hives covering most of the trunks, arms, legs, neck, face. Returning 2 hours after Benadryl. Hives have been returning off and on for 48 hours now Vomiting (one instance) just shy of 6 days from first dose.
Rec'd Engerix-B on 8FEB90 lot no ENG 585A4, 8MAR90 ENG 586A4, & 9AUG90 lot no ENG 618A4. Pt had no antibody response (10SEP90). Given a booster on 17SEP90.
Discoloration like a bruise at the injection site; Raised rash on arm (red itchy lump)/Raised rash at injection site; Injection site redness; Injection site itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Discoloration like a bruise at the injection site), VACCINATION SITE RASH (Raised rash on arm (red itchy lump)/Raised rash at injection site), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, High cholesterol and Anxiety. Concomitant products included SERTRALINE HCL for Anxiety, PRAVASTATIN for Cholesterol, VITAMIN D [VITAMIN D NOS], VITAMIN D3, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]) and ASCORBIC ACID (ESTER C [ASCORBIC ACID]) for an unknown indication.    On 19-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE RASH (Raised rash on arm (red itchy lump)/Raised rash at injection site), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchiness). On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOLOURATION (Discoloration like a bruise at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. On 09-Apr-2021, VACCINATION SITE RASH (Raised rash on arm (red itchy lump)/Raised rash at injection site), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchiness) had resolved. On 23-Apr-2021, VACCINATION SITE DISCOLOURATION (Discoloration like a bruise at the injection site) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to MOD-2021-080431 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Added information of second dose and new event Discoloration like a bruise at the injection site. On 23-Apr-2021: Reporter's phone number and email address, concomitant drugs , 2nd dose lot number and  stop date of Discoloration like a bruise at the injection site event. On 18-May-2021: Patient's demographic details, Patient's medical history, concomitant medication details, and outcome of events, Causality were updated.
After the injection my arm started to burn.  I even said to nurse that my arm is burning.  I also have swelling, redness and my arm is tender with numb fingers (pinky and ring finger).
Last May 6, 2021, I recieved my 1st dose of MODERNA vaccine. For the last 5 days I don't feel any side effects on my body. But on the 6th day after my vaccination, I started to feel anxiety, insomnia, brain fog followed by  depression, panic attack and rapid heart palpitation and it lasted for 3 weeks. Until now, there are times that I can still feel the rapid heart palpitation.
intestine had twisted; experienced stomach pain; it is unclear if some of the colon had to be removed; This spontaneous case was reported by an other health care professional and describes the occurrence of VOLVULUS (intestine had twisted) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VOLVULUS (intestine had twisted) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (experienced stomach pain) and COLON INJURY (it is unclear if some of the colon had to be removed). The patient was treated with Surgery (Exploratory surgery) for Volvulus. At the time of the report, VOLVULUS (intestine had twisted), ABDOMINAL PAIN UPPER (experienced stomach pain) and COLON INJURY (it is unclear if some of the colon had to be removed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter No treatment medication details was provided.  Company comment include This is a spontaneous case concerning a male of unknown gender patient with no reported medical history, who experienced the serious (medically significant) unexpected event intestinal volvulus, on an unknown date after receiving  the third  dose of mRNA-1273. Patient experienced abdominal pain, went to ER, and was told "their intestine had twisted". Surgery was performed and it is unknown if a piece of colon had to be removed. The benefit-risk relationship of mRNA-1273 is not affected by this report. No concomitant medication details was provided.  It was reported that sometime following receiving the booster dose, the patient experienced stomach pain and went to the ER where he was told that his intestine had twisted. Exploratory surgery and it is unclear if some of the colon had to be removed. The contents of the stomach were aspirated on 26-Nov-2021.; Sender's Comments: This is a spontaneous case concerning a male of unknown gender patient with no reported medical history, who experienced the serious (medically significant) unexpected event intestinal volvulus, on an unknown date after receiving  the third  dose of mRNA-1273. Patient experienced abdominal pain, went to ER, and was told "their intestine had twisted". Surgery was performed and it is unknown if a piece of colon had to be removed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 7-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 11-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004251 with expiry date 22-SEP-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Headaches, 101 fever, missing school,positive mono, high titers with Epstein Barr, fatigue.
covid positive test date was on 22Dec2022; covid positive test date was on 22Dec2022; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (16Feb2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL8982) intramuscular, in right arm, on 18Feb2021 as dose 2, single (Lot number: EM9809) intramuscular, in right arm, on 19Oct2021 as dose 3 (booster), single (Lot number: FE3590) intramuscular, in right arm and on 23May2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthroscopic surgery" (unspecified if ongoing), notes: Arthroscopic surgery in left arm, previously. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Vaccine name: Flu shot, Anatomical Site of Injection: Right Arm, Number of Previous Doses: (One per year)), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2022, outcome "unknown" and all described as "covid positive test date was on 22Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive, notes: covid positive test.  Clinical course: The patient had received 5 vaccines in total. The patient had all of her COVID Boosters in right arm because of arthroscopic surgery in left arm, previously. Her right arm felt great until the 15Nov2022 booster given. Reporter stated the covid positive test date was on 22Dec2022.
brain fog is still present; short term memory loss ( 4days long); fatigue that lasted for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog is still present), AMNESIA (short term memory loss ( 4days long)) and FATIGUE (fatigue that lasted for 3 days) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (brain fog is still present), AMNESIA (short term memory loss ( 4days long)) and FATIGUE (fatigue that lasted for 3 days). At the time of the report, FEELING ABNORMAL (brain fog is still present) had not resolved and AMNESIA (short term memory loss ( 4days long)) and FATIGUE (fatigue that lasted for 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25JUN2021, updated Reporter information and patient stated that she didn't get her 2nd shot and Action taken was updated.
Right arm pain began when 1 mms were given and patient also is experiencing fatigue. 8 days since 1 mms were given in right arm. Pain has moved down the right arm and feels deeper and is increasing instead of decreasing. She is tired by 10 am each day.
Around 1:00am on 1/30, I woke from sleep with rigors, chills and nausea much like my first dose.  I took Tylenol as a tx, but this kept me awake until about 5:00am.  From 5:00am to 10:30am I was able to fall back asleep and woke up feeling back to normal.  Around 11:30am I showered and noticed a hard lump on my supraclavicular the size of a golf ball that was never observed before. This lump is still present on 2/1 and is planned to be checked as a precautionary measure by my PCP on 2/3.
After feeling sick for 24 hours, I started urinating bright red blood. It went away about 48 hours after it started.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Current conditions and medical history was not reported. On an unknown date approximately in 2013 (reported as last year) the patient was vaccinated with PNEUMOVAX 23 1 shot of injection. Concomitant medications were not reported. On an unknown date, after PNEUMOVAX 23 administration patient complained of swelling, redness and feeling hot at the injection site, and the pharmacist saw that there was a muscle indentation at the injection site. The patient was treated with BENADRYL and compresses. The outcome of the events was reported as recovered on an unknown date. Causality assessment was not reported. Patient sought unspecified medical attention. Product quality complaint was not reported. Additional information has been requested.
VACCINE VIAL WAS WARMED AT ROOM TEMPERATURE BUT DOES NOT KNOW HOW MUCH TIME HAD PASSED AND WAS ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine vial was warmed at room temperature but does not know how much time had passed and was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine vial was warmed at room temperature but does not know how much time had passed and was administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211015012.
Patient had severe blisters develop a couple days after receiving vaccine, they eventually popped and scabbed over.
migraines; blood glucose dropped below 80; severe shakes; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 14:30 at single dose at left arm for covid-19 immunization. Medical history included fibromyalgia, chronic migraines, degeneraive disc disease, spinal spinosis, celiac, arthritis, and type 2 diabetic, known allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks included prescribed medications. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient was a type 2 diabetic and the next day after the injection, on 05Jan2021 08:00 patient blood glucose dropped below 80 and patient usually run 128 and above. It was hard getting BG level up over 100 for over two weeks and patient had severe shakes, nausea, and migraines as an adverse effect from very low BG levels. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. Patient lowered insulin units as treatment.
No adverse event; One dose of improperly stored PROQUAD was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 23-SEP-2020, the patient was vaccinated with one dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # T005400, expiration date 12-AUG-2021, for prophylaxis (route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of -9 degree Celsius (°C) to 8°C (-2.5 C) for 3 hours and 45 minutes as recorded by a data logger. There was a previous temperature excursion of -9°C to 8°C (0.1 C) for 2 hours and 7 minutes. There was no additional adverse event reported.
Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    This case was linked to MOD-2021-066642 (Patient Link).
This spontaneous report as received from a consumer via Clinic refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M008589, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
High Fever, Chills, Shortness of Breath, Extreme Sweating, Dizziness, Headache, Severe Muscle Aches.
This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients of unknown age and gender. In an approximately November 2014 (also reported as between 17-NOV-2014 and 26-NOV-2014) the patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX (route, dose, frequency and lot # not reported) that was supported with in-house stability data. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
PATIENT CALLED ON 03/12/15 TO LET US KNOW THAT HE EXPERIENCED ABNORMAL SORENESS/REDNESS AT SITE OF INJECTION.  HE EXPERIENCE CHILLS AND GOT A SMALL RASH THAT LASTED NEARLY A WEEK.
Injection site itchy after 1st dose; Injection site red after 1st dose; Injection site warm to the touch after 1st dose; Bumps around injection site area after 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy after 1st dose), VACCINATION SITE WARMTH (Injection site warm to the touch after 1st dose), INJECTION SITE SWELLING (Bumps around injection site area after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch after 1st dose) and INJECTION SITE SWELLING (Bumps around injection site area after 1st dose). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red after 1st dose). On 13-Apr-2021, VACCINATION SITE WARMTH (Injection site warm to the touch after 1st dose) and INJECTION SITE SWELLING (Bumps around injection site area after 1st dose) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information  received on  19 May 2021 contains demographics, first event start date, outcome and second dose details updated.
I felt like I just had the worst flu of my life. Migranes, fever, chills, and massive fatigue. I also had a panic attack.
Patient reports feeling dizzy and lightheaded. (Patient had a similar reaction to the first dose.) Assisted patient in to wheelchair and wheeled her to the private observation area and assisted her to the gurney. Patient is 27 weeks pregnant. Vital signs at 1434 were BP 126/81, P 106, 96% on RA, no pain. Pulse at 1441 was 96. Gave patient water and apple juice. Patient reports feeling back to baseline at 1450. Patient driven home by husband.
Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative.  Teleconference call with my doctor on Thursday at 3pm.  Nose bleed Friday morning 11:00am.
This is a spontaneous report from a contactable Nurse, reporting for herself. This 65-year-old female patient received PREVNAR 13 Lot Number: T85621 Expiry date: 31Mar2020, intramuscular in right deltoid on 02Feb2018 14:30 PM at single dose for immunisation. Medical history included breast cancer from Jun2016 to an unknown date, diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced itch at the injection site. There is no redness or swelling, but it itches every day from 16Feb2018 and worsened. The outcome was not recovered.
approx 15 mins post inject, onset itching legs bilateral w/bumps all over legs; face red & warm to touch; no fever; completely recovered by next day;