chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo; dizziness; nausea; vomiting; Headache; Vaccination site erythema; Vaccination site swelling; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm ), VERTIGO (vertigo), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo (doctor told her that it´s on her mid ear). Concomitant products included VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm ). On 15-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). On 16-Mar-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm ), VERTIGO (vertigo), DIZZINESS (dizziness), VACCINATION SITE SWELLING (Vaccination site swelling), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (Headache) outcome was unknown and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were discontinued last week. The patient's second dose was scheduled on 10-Apr-2021.  The patient's redness disappeared. Reportedly, the vertigo is 50% more intense.  No treatment information was provided by the reporter.
coughs; running a temperature; This is a spontaneous report from a non-contactable consumer (patient's daughter). An 83-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced coughs and was running a temperature (unspecified) in Jan2021.  The clinical of events coughs and running a temperature was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Patient was talking, speech became slow, began sweating and pale. RN came into room- I went to get water. Upon return his pupils were very dilated and large and he was not verbally responsive though he could follow verbal command. He took drink of water and in a few seconds was able to speak again- stating he could hear us the whole time but could not see or respond. No difficulty breathing, NO loss of consciousness. Eyes went back to normal- he was able to see, ate cookie and drank more water. Monitored in clinic 15-20 minutes after episode occured. BP during episode 78/43 before left clinic it was back to 118/72.
Bivalent was to be administered to 17 year old.  Monovalent Pfizer was delivered to us in the Bivalent bag.  Monovalent Pfizer was administered as booster dose
no adverse event; they accidentally administered 3 doses to children after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they accidentally administered 3 doses to children after the expiration date) and NO ADVERSE EVENT (no adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Patient relevant medical history,conditions, allergy, concomitant diseases and risk factor reported as unknown.     On 13-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (they accidentally administered 3 doses to children after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they accidentally administered 3 doses to children after the expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they accidentally administered 3 doses to children after the expiration date).    No concomitant medications was provided. The patient did not experienced any adverse events . No treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716538, US-MODERNATX, INC.-MOD-2023-716441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716441:same reporter US-MODERNATX, INC.-MOD-2023-716538:same reporter
He got pinkeye with the first vaccine and the second vaccine in an eczema flare.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 65-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Reporter states that because their facility has not been able to download the digital data logger, they have been put on hold by the Regulatory Authority at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the Regulatory Authority is made. There have been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility is unable to download the digital data logger, they will need to treat this issue as a temperature excursion. The data logger that caller is unable to download are for the months of DEC2021, JAN2022, and FEB2022. She says that they are filling out a temperature excursion assessment with the State at this time. Patients have been administered doses while the temperature excursion assessment has been ongoing.  No adverse reactions were reported by any patients.  No treatment medication information provided.
This spontaneous report was received from a pediatrician via company representative, regarding a girl patient of unknown age. The patient concurrent, historical conditions and concomitants medications were not reported. On unknown date, the pediatrician expressed that he had a patient who received a dose of GARDASIL 9 (strength, dosage, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On unspecified date, the patient experienced strong edema of the arm. During the company representative conversation with the pediatrician, the pediatrician was called by another physician, so the company representative was not able to obtain more information about the adverse event. The action taken with GARDASIL 9 was not applicable. The outcome of the event was unknown. The causality assessment between GARDASIL 9 and the events was not provided.
throat closing, shortness of breath, difficulty breathing. Given epinephrine and Benadryl with improvement
Patient had appointment to receive Moderna Booster #2 (Dose #4).  On the prevaccination Checklist patient listed 3 for the number of covid vaccines he has received.  His Covid vaccine card also had 3 doses of Moderna listed. to double check,  I went through the questions on the prevaccination checklist verbaly with the patient and he confirmed he wasn't sick, no history of adverse reactions, has received 3 doses of Moderna and was requesting to receive his Moderna Booster #2 ( 4th dose).  Moderna Booster administered without incident and no problems noted during 15 min post vaccine wait time.  When I was entering the vaccine in the system I noticed the patient had already received 4 doses of Moderna.  The Moderna 4th dose/Booster #2 was administered 5-3-22. Today 7-11-22 patient was contacted and he states he feels fine and not even a sore arm.
Vaccine was administered during a drive through event.  During the waiting period, she began to have facial flushing.  She was given benadryl 50mg po.  Symptoms resolved and she was monitored for an extra period of time at the site.  She was then dismissed to home with instructions to monitor carefully for additional symptoms and to seek medical attention immediately should these occur.
Patient complained of dull chest pain with pain score 3 of 10.  No radiation.  BP 124/80, SpO2 98h, HR 74 and respirations 18, awake and oriented x3.  Evaluated by Internist, EKG ordered with results meeting criteria.  Likely underlying panic attack.  EMS activated and taken to the ED. Called 4/15 but no answer.  Mailbox full and unable to leave message
I got shingles for the first time.   I felt a tingle on my face  just below my lip the day of the vaccine on Wednesday May 12th, it continued to the next day and on the third day, May 14th I got a painful rash where the tingling was.  I went to the doctor on Saturday the 15th and was diagnosed with shingles and prescribed the antiviral Valacyclivir
Death caused by probable cardiac arrhythmia on May 10, 2021. No previous heart symptoms. Had the normal reaction to the second dose (body aches, chills, low grade fever), but was recovering as of April 19.  First dose was administered 3/21/21. Second dose was administered 4/18/2021.
about 4PM on 30MAR93 about 1/2 hr p/vax pt began screaming unconsollably for 3 hrs; pt ceased crying when mom returned to pick up;
A few days after my second Covid vaccination I started experiencing fatigue, dizziness and shortness of breath.  I also noticed the calf muscle in my lower right leg began to swell.  The swelling continued to get worse and about a week later I noticed a significant amount of petechial hemorrhaging in my lower right leg.  I started using an ice-pack in an attempt to reduce the swelling.  I also sat/lay with my leg up (horizontal) as much as possible.  On 6/28 I visited with my primary care doctor to seek help in addressing the swelling.  My doctor sent me for an ultrasound which discovered a deep-vein thrombosis (DVT) and a CT scan which highlighted pulmonary embolisms in my lungs.  I was admitted to hospital where I was treated with blood thinners; Note: I had my first shot on 4/13/21 and also experienced fatigue, dizziness and shortness of breath, but did not experience any swelling. As a result of feeling unwell I delayed getting my second shot.
04/11/2021 I had a fever and on 04/12/2021. My wife saw my back and there was a blister of the size of a quarter, I touched it and it burst all over my back and it was fairly deep because I had a big hole on my back, It took about 10 days to to get everything out. It's about an inch diameter big. It is also indented, I don't have pain with it associated but I cannot put my arm right on the spot it is so tender. I'm still having issues with this. I had a doctor virtual appointment and she didn't think it was anything major but to keep an eye on it. I also had the booster vaccination 11/23/2021 Moderna and I did not have any issues with that. I still have the mark in my back and the skin reaction is still present.
small blister-like areas around site of inject; none found elsewhere on body-burning sensation in area of blisters;
Hives/Urticaria that started approximately 2 weeks after his third Moderna injections. No prior symptoms. He was initially treated with antihistamines but did nor respond well, instead got worse. Was given course of oral steroids but still did not have completed resolution. He was finally referred to allergist who initiated Xolair hots. He has has 2 shots and all his symptoms have resolved.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/07/21 2nd dose01/28/21 Diagnosed covid positive:09/05/21 Symptom onset:09/02/21 Exposure:community Symptoms:Fever, cough,muscle aches HA
NO ADVERSE REACTION. VACCINE HAD BEEN LEFT OUT FOR MORE THAN 24 HOURS. HAD BEEN TAKEN OUT OF REFRIGERATOR AT 10AM THE DAY BEFORE
Itchy rash on thigh and arm; rash feels scaly and hardens; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens) outcome was unknown. Not Provided          No concomitant medication was reported.Treatment medication included Benadryl lotion.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-066515 (Patient Link).
Patient head Gardasil immunization yesterday along with meningitis immunization. The next day his shoulder was swollen and red and painful with some itching. It was so swollen he cannot use the arm and twice the size of normal. We gave Motrin Tylenol and Zyrtec. We also put ice on it to bring the swelling down. I am reporting that the patient did not recover because we are still treating it. I have all confidence that he will recover.
Extreme pain, redness and swelling of arm down almost to the wrist. Called Doctor who recommended ice and pain reliever. Said if a temperature developed to go to urgent care. Still some swelling and discomfort 3 days later.
This spontaneous report has been received from a medical assistant referring to a 46 year old female patient. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions was not reported. Concomitant therapies included sterile diluent (DILUENT MRK) injection, lamotrigine(LAMICTAL), omeprazole(PRILOSEC), acetaminophen, butalbital, caffein(FIORICET), metaxalone, gabapentin, venlafaxine hydrochloride(EFFEXOR) and aripiprazole(ABILIFY). In approximately 2007, reported as "about 10 years ago", the patient was vaccinated with a dose of M-M-R II (dose, strength, indication, route, lot number and expiration date were not provided); however, despite of this, on an unknown date, the patient's titers for mumps came back negative. On 29-AUG-2017, the patient recived an expired booster dose of M-M-R II, lot # L020189 and expiration date 03-JUN-2017 (dose, strength and route were not provided) for prophylaxis. The patient did not received  treatment for the events but sought medical attention at the physician's office. The outcome of the patient and the causality assessment were not reported.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 30-APR-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot number N011651, expiration date 02-DEC-2018), 1 tube once, orally for prophylaxis. The vaccine underwent an excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 min and range at or above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 12 minutes. There was no previous temperature excursion. The digital data logger was involved.
Information has been received from a health professional concerning a 13 month old female who on 02/01/01 was vaccinated with the first dose of MMRII (lot #636659/0997K) in the left arm.  On 02/12/01, the patient developed a red rash on her abdomen, chest, back, neck and face.  On the following day, 02/13/01, she was seen by a physician and the rash was over the entire body and face.  The patient was ordered diphenhydramine (Benadryl) for itching as needed.  The diagnosis was measles rash related to therapy with MMRII.   It was reported that the patient recovered.  No additional information is expected.
Pain down (L) arm for several hrs after shot Fever 102-103 by touch 4 diffuse ache and headache 12 hrs after immunization
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: ff2590), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 037kz0A), in left arm and as dose 2, single (Lot number: 042l20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: DOSE 1 and DOSE 2,, Moderna Vaccine. Concomitant medication(s) included: LOSARTAN, start date: 16Feb2021. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
pt stated that after taking the covid vax she had a severe headache.  Later that day she started having fatigue, muscular body aches and left arm had fever around the injection site.  That night around 9:00 PM she had diarrhea.  Pt states she has a very sore left arm that is itchy and has a 2x3" red spot running down from injection site. Pt has not contacted them contacted at this time.
fracturing skull; collapses on stage, hits floor; This case was reported by a consumer via other manufacturer and described the occurrence of skull fracture in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced skull fracture (serious criteria GSK medically significant) and syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the skull fracture and syncope were unknown.   It was unknown if the reporter considered the skull fracture and syncope to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: The patient self-reported this case, was a comedian. The patient mocked about having the 3 experimental jabs, plus a shingles and flu vaccine, then instantly collapsed on stage fracturing her skull as she hit the floor. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Information has been received concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient "broke out with an unspecified rash". The patient sought unspecified medical attention. Additional information has been requested.
Headache, Myalgia, Arthralgia & Fever Narrative:  Pt received 2nd dose of COVID vaccine shot at 0945 on1/26/21. Onset of serious headache at 1315 that day. At 0200 the following day developed myalgias, arthralgias and low grade fever. Had mild soreness at injection site. Missed work x 2 days due to severity of symptoms. No known prior covid infection.  Other Relevant History:
A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, ringing in ears/tinnitus, dull discomfort upon movement/discomfort, lethargy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) headache, ringing in ears, dull discomfort upon movement, lethargy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, ringing in ears, dull discomfort upon movement, lethargy was unknown.
Severe pain to entire L arm; no local reaction, a single dot where needle entered; spasms to entire shoulder 7 hrs after injection given.
Patient described having pain in his left arm 3 days after getting the flu vaccine. Pain is in the shoulder down to the elbow. He has limited range of motion and cannot lift his arm above his shoulder. He says that he had a little bit of improve with the pain, but still has a lot of pain and still cannot lift his arm above his shoulder. He has seen his doctor on September 30th who says the pain and limitation of the shoulder could be due to the flu vaccine. He was prescribed cyclobenzaprine and is recommended to get physical therapy. He continues to be in pain the cyclobenzaprine is not helping.