chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID positive; Missed second dose; Dry uncontrollable cough; Severe headache; Lethargic; Swelling at injection site; Fever; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID positive) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), POTASSIUM, RIFAMPIN, VITAMIN D NOS and PREDNISONE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced COUGH (Dry uncontrollable cough), HEADACHE (Severe headache), LETHARGY (Lethargic), VACCINATION SITE SWELLING (Swelling at injection site), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site). On 12-Mar-2021, the patient experienced COVID-19 (COVID positive) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, COVID-19 (COVID positive), COUGH (Dry uncontrollable cough), HEADACHE (Severe headache), LETHARGY (Lethargic), VACCINATION SITE SWELLING (Swelling at injection site), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient concomitantly used some heart medications and allergy medication. On 11-Mar-2021, the patient developed shortness of breath within 20 minutes, dry uncontrollable cough, body aches, fever, severe headache, lethargy, pain at injection site, swelling at injection site. The patient was injected with antibodies on 12-Mar-2021. The patient took Tylenol (acetaminophen) as treatment. The patient is waiting for 90 days post antibodies injection to receive her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Tested positive for COVID-19. Treatment information updated.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # 030A21A, with associated Adverse Events of  cough, headache, COVID-19 , lethargy, vaccination site swelling , vaccination site pain and pyrexia.. Based on the current available information and temporal association between the use of the product and the start date of all the events except COVID-19, a causal relationship cannot be excluded.Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.
SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report for the following literature source(s).  A 47-year-old female patient (unknown if pregnant) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the event  and suspect drug  cannot be excluded.The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
10/11/02 c/o edema and redness at below the injection site. Also fever at injection site. 10/21/02 states no problems at this time.
Patient has soreness in the joint area of the left shoulder, Patient states that the injection site was above the muscle of the arm. It felt higher then usual and patient assumed it was how it is done now.
Headache, off kilter, could not seem to wake up. Lasted all day about 24 hours after vaccine. Took Motrin and slept almost 24 hours. Body aches
I started feeling a little something. I was just feeling off, but I wanted to take a test because was going to see my grandkids. I got a prescription for PAXLOVID. I took the whole regimen for all 5 days and on the last day I was feeling fine but then I started to notice I was feeling dizzy. I ended up getting diagnosed with vertigo. It was really bad; I woke up screaming because my head felt like it was in a hurricane. I didn't have any other COVID-19 symptoms. I had fatigue after the vertigo. I don't know if it is related to the PAXLOVID or the COVID-19 but the vertigo was the worst part. The vertigo lasted for about 24 hours. It has not returned since then.
Fever and chills from 8:30 pm on 3/8 until 1:30 am 3/9
Breakthrough case admission after three vaccines Moderna 4/12/21 Lot# 025B21A;  Moderna 5/10/21 Lot# 018B21A;  Moderna 11/30/21 Lot# 033F21A
Information has been received from a consumer concerning her son (a "6 year old" male) with history of gastrointestinal dysbiosis and high yeast levels as well as drug reaction to Amoxicillin who in February 2004 was vaccinated with a dose of MMR II (644981/1235M). Concomitant therapy included a dose of VARIVAX (647265/1097N) in February 2004. It was reported that at first there was nothing immediately wrong with the patient but then around 12 months of age (approximately year 2004) the patient stopped eating well and had yellow loose stools, which turned into "gastrointestinal dysbiosis". Then around 18 months (approximately year 2005) the patient stopped learning new words and at 2 years of age the patient stopped saying old words and was totally spaced out, and was diagnosed with autism. The consumer reported that the patient had high levels of yeast and also had excessively high measles titers. Unspecified medical attention was sought and at the time of the report, the patient was going through ADA therapy and biomedical protocols and there was slow progression with his autism." The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. No additional information is expected.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in October 2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, expiry date in July 2016 (dose, route of administration, anatomical location and lot # were not specified). This is one of two reports received from the same reporter. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a elderly female patient who received SHINGRIX. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm and swelling arm. On 29th May 2-18, the outcome of the erythema of extremities, pain in arm and swelling arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting healthcare professional was the patient. She is a researcher or investigator and a retired registered nurse (RN) practitioner. After receiving SHINGRIX, the patient experienced arm redness, swelling and soreness that lasted for 4 to 5 days. The patient reported that the reaction was more significant than what she expected. The patient was in a rush and did not provide too much information. The patient did not want to provide her address.
I have been feeling extremely tired and fatigues in my feet and legs; my ALT, AST, and Alkaline Phosphate levels jumped very high; my ALT, AST, and Alkaline Phosphate levels jumped very high; my ALT, AST, and Alkaline Phosphate levels jumped very high; Some of my lymph nodes showed little growth; have no energy to do anything; I can not do any activity being always tired; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 21Feb2021 14:30 (Lot Number: EL9261) as single dose (at age of 75-year-old) for covid-19 immunisation. Medical history included hodgkin's lymphoma from 2014, Stent in heart. Patient had no allergies. Concomitant medications included isosorbide (ISOSORBIDE); losartan (LOSARTAN); metoprolol (METOPROLOL). First dose of bnt162b2 (BNT162B2) was administered on 27Jan2021 in Left arm (at age of 75-year-old) for covid-19 immunisation, lot number: EL9262. Patient stated that since he got his second dose of Pfizer COVID 19 vaccine, he had been feeling extremely tired and fatigues in his feet and legs. Few days after that his Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Alkaline Phosphate levels jumped very high, although with time they were coming down slowly in Mar2021. The tumor marker did not show any signs of liver cancer in Mar2021. Some of his lymph nodes showed little growth. Patient was maintaining his weight constant. His doctors had no explanation for his tiredness and fatigue. Patient had no energy to do anything. Before the vaccine he used to walk 3 miles a day and doing bike too. Now he could not do any activity being always tired. Onset date for the events Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. Patient was recovering from ALT, AST, and Alkaline Phosphate levels jumped very high, while he had not recovered from the other events, at the time of the report. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.
Itching spots that show up randomly on skin in diverse locations. No contact with anything on skin.
Patient received her 1st Anthrax vaccine morning of 22 August 07. Initially c/o feeling numb to left upper arm and shoulder area 30 minutes after vaccination. Numbness got worse during night spreading to other parts of body. Confused next morning was sent to hospital with escort. Stayed at ER x 3 hours then released back to ship.
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder; 1 booster dose was administered on 2FEB92 cont nonresponse;
Awakened Friday morning after injection on Wednesday and my Eyes and  face were swollen, eyes burning, watery, nose running an d two large nodules on side of face under skin and turned skin dark on top of nodule, no pus head.  Very lethargic.    Lasted all day.   Saturday symptoms subsided, but the nodules are vague but still can see.
Pt. states she received 2 vaccines in (R) arm (pneumonia & typhoid). Arm felt "itchy" for several hours, then became "red, swollen, hard". Lasted 2 days. Totally resolved.
Hemolytic Anemia  Positive D-dimer  Blood transfusion  Macrocystic anemia  Destruction of RBC hemoglobin 80  On home oxygen
This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician stated that she was recommending SHINGRIX to the patient, and that patient stated he knew someone who developed shingles after getting SHINGRIX. No other information was provided. This case was considered as suspected vaccination failure because the time to onset and schedule completion of SHINGRIX was unknown at the time of reporting.
Sores in mouth, nose and under the eye. Inflamation in gums. All occurring Monday after 2nd vaccine.
Right after the shot I felt a warm sensation down my body which resolved in a few minutes. That night my arm was very sore, warm and itched. The next morning my arm  also became very red. I also had extreme fatigue.
recv vax,exp dec appetite;16JUN devel rash on extremities,fever,anemia;12JUL9cough/pneumonia;hosp w/resp distress-intubated,dx w/GianottiCrostiSynd,immune system defect,pneumocystis carinii pneumonia,early EBV infect,expired 24AUG95,COD-Acu
This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. On an unknown date approximately in 2015 (during time frame of improper storage) the patient was vaccinated with 1 dose of (Merck) VARIVAX (lot# K010336 and expiration date 22-JUL-2016) which was improperly stored at 7C from 07-JAN-2015 to 11-MAY-2015 subcutaneous. There was no known adverse effects. This is one of the two reports from the same source. Additional information has been requested.
Initial information received on 15-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who received an expired dose of vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; FLUZONE QUADRIVALENT; MMR VACCINE; VARICELLA VACCINE; and IPOL. On 13-Feb-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5148AA (expiry date: 09-FEB-2019 ) in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was reported that no adverse event occurred. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
After receiving 4 immunizations the child fainted in the lobby, while waiting 15 minutes before leaving office.
4 months multiple infection, sickness, fatigue etc etc. Severe adverse reaction, almost fatal 1 xray, 3 panoramic X rays, 1 CAT scan, 1 CAT scan with dye, AVELOX, CLINDAMYCIN, PREDNISONE, ERYTHROMYCIN, DELODIN, etc etc.
Very itchy skin, extremely large and prominent hives, skin reacts to heat, touch, and hot water.
Received the Moderna Vaccine at 1549.  Presented to the ED at 1635 with c/o localized swelling, lip swelling with right facial swelling.
A lot of pain at injection site followed by restricted arm movement.  Headache later in the day followed by lethargy.  Next day extreme lethargy and nausea.
GOT COVID; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint.
VACCINATOR OVERLOOKED PATIENT AGE AND MISTAKENLY ADMINISTERED MODERNA TO 16YO PATIENT
pt received 1st COVID vaccine on 10/27/21, site was painful from administration from the beginning, on 11/3/21 noticed a rash on her trunk, 11/4/21 noticed redness and swelling to the injection site, warmth.
Headache, neck pain, arm pain, photophobia, blurry vision, subjective fever.
On the 8th day after shot (2/12/21) about 9: 30 pm my arm started itching.  The skin was a little rough and the itching area seemed about nickel-sized and located about an inch BELOW  the injection site.  The itch was constant through the night, and in the morning  on Saturday, the area was red and warm and firm to the touch, about 3" by 2."  The itching lasted about 24 hrs, the color and heat about 48 hours, and the firmness was mostly gone at 72 hours.  Other information:  I weigh about 122 lbs.  The  clinic did not offer a choice in  needle lengths.  It was a long  needle (1-1;2"?) used on everyone, whereas  the CDC standing orders suggest a needle length of 5/8" to 1" for weights less than 130 lbs.
Generalized rash started 8/29/16 - no treatment. Ulceration at vaccine site on (L) thigh 8/19/1-> AMOXIL.
Received shot 12/28/2020 Monday Monday evening started feeling normal side effects By Tuesday morning 12/29/2020 vomiting, severe arm pain, horrible migraine headache, horrible body aches, chills, exhaustion, and eyes burning. By Tuesday night very ill, vomiting uncontrollably, horrible headache, bad enough medication taken to sleep and stop vomiting (phenagren).  By Wednesday skin hurt so bad couldn't touch or be touched....shower was miserable.  Continued vomiting and lips started to swell.  Started taking benedryl.  Lips swollen.  So tired and body aches horrible.  Vomiting continued...no food eaten since Monday.  Call urgent care about lips and symptoms,  they said to take benedryl and continue to monitor if things worsen go to hospital.  Vomiting continued into late Thursday night.  Unable to eat normally now, stomach very very sensitive and nauseated.  Extremely tired and headaches continue.  Fearful to get booster.  Been sick for 7 days and still not well.
Injection site tenderness for 48 hours Myalgias for 72 hours Morning nausea for 4 days post-injection Chills for 48 hours Headache for 72 hours
Allergic reaction starting 30 minutes after 2nd dose of vaccine. Patient developed red rash all over face, chest, and upper arms, as well as facial swelling and rapid heart rate. Patient was sent by employee health to the ED for assessment. Was given diphenhydramine and famotidine in the ED. No epinephrine, steroids, or discharge prescriptions.
Within hours of second injection had pain, swelling, itching, redness below injection site hot to touch. 4 days post vaccine affected area has progressively expanded to area 5x 3 inch rectangle mid deltoid to just above elbow. Remains red, itchy, hot, sore despite oral/ topical antihistamine, cold compresses and topical steroid use. Bicep more tender than deltoid but both muscles sore and swollen.
12 days post vax the pt developed about 20 skin lesions described as very itchy and having a tiny red dot with a white center on the left side of her body and also 1 or 2 lesions on the right leg. It was noted that the pts lesions seem to be slower to develop than her siblings.
Today is the 8th day after 1st vaccination and I have swelling about the size of a quarter, heat and itching at the vaccine site on my left arm.  I also noticed earlier this morning around 6:45am that I had tenderness in the underneath [armpit] area of that same arm.
Red pimple like rash - first noticed on face - then also on back and legs. Approx #10. Afebrile not itchy. No other symptoms reported.
severe nausea and abdominal pain started 2 weeks after injection. Has not got any better. Still nauseated and having abdominal pain 6 months later. Have to take antiemetics three times a day and have had a 35 lb weight loss. Can not eat due to pain and nausea.
SYMPTOMS: BURNING, ITCHING, THROBING, "HURT LIKE HELL". RED AND SEVERELY BRUISED SIGNS: BLISTERING, DARKING SKIN - PIN POINT FROM INJECTION SITE DOWN ARM ROUGHLY 2  DAYS FOLLOWING INJECTION THE BURNING AND ITCHING STARTED AND REDNESS AND NOW IS KEEPS GETTING WORSE AND WORSE
I had at least 101 fever, chills, my left arm ached with pain and I could barely move it. At one point, it felt like all of the roots of my teeth were in pain at once. I had to miss two days of work and I slept  most of the time. I took Advil to reduce the fever
Pain and sight of injection, extreme itching underneath the skin, huge rash left almost a complete square
Severe pain and swelling in some joints of both my right and left hands: both thumb bases palm side, 1st joint pain in both thumbs, index and middle fingers on both hands. The pain and duration have increased after my 2nd Covid-19 Moderna vaccine on 4/27/21. Pain and swelling has become chronic at the date of reporting to VAERS
Breakthrough COVID case, asymptomatic, hospitalized for other reasons, incidental find on testing protocol.
1305 Fainted from Sitting position in observation room, no trauma noted.  Assisted to supine position with legs elevated on chair, regained consciousness.  BP 70/42. HR 106.  At 1315 Resting BP now 94/50, HR 86, O2 Sat 98%,  assisted to W/C and taken to EMS room to lie down on cot.  Snack given.  At 1330 Feeling better now.  BP 110/60, HR 61, O2 sat 98%.