chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired and I have been really weak; Feeling bad; had tiredness/Tired; Headache; I don't know if my heart has been fast but I could feel it; Dizziness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Apr2021 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Feeling unwell" (unspecified if ongoing), notes: before he took the shot; "Solid Masses on Lung" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Apr2021, outcome "unknown", described as "Feeling bad"; FATIGUE (non-serious) with onset 17Apr2021, outcome "unknown", described as "had tiredness/Tired"; HEADACHE (non-serious) with onset 17Apr2021, outcome "unknown", described as "Headache"; HEART RATE INCREASED (non-serious) with onset 17Apr2021, outcome "unknown", described as "I don't know if my heart has been fast but I could feel it"; DIZZINESS (non-serious) with onset 17Apr2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "Tired and I have been really weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Consumer had the vaccine, the first one yesterday at noon. He felt fine all day. Today at around lunch time, he ate some pizza and had a beer. He has been feeling bad. He was querying if I he had the virus, could he be having symptoms because he had checked all the ones that were on the list. He had tiredness, a little bit of the headache, feeling unwell (Further not clarified if consumer was experiencing these symptoms, hence captured as event) and then it was fast heart, he doesn't know if his heart has been fast, but he felt it, dizziness, tired and have been really weak. He also stated he has been been trying to get a test for a long time to before he took the shot see if he has COVID because he has been feeling unwell. He did get a lung scan a couple weeks ago and they found some solid masses (History) in there since he used to work in a very bad environment. He got another lung scan scheduled in July.  No follow-up attempts are possible. No further information is expected.
Headache, body aches, and low grade fever  2-3 days Fatigue still on-going, but most severe 1-3 weeks Heart palpitations/fluttering, chest pain, shortness of breath, elevated blood pressure, worse when laying down still on-going, but improving Memory issues, forgetfulness, repeating things still on-going
I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon after, I started getting a mild headache toward the front of my head which intensified towards my temple area. My eyes felt strained ( the back of my eyes ). The  feeling was similar to a migraine/sinus pressure. I started getting cold and then my extremities were freezing. I got chills and was shivering ( it was cold in the building, but I wasn?t that cold upon entering ).  This was all in the first 15 minutes. I was told to stay for 30 minutes in the waiting area because of my allergy to erythromycin, just as a precaution. Around 20 minutes my mouth became very dry. I also had a metallic taste in my mouth. It became hard for me to swallow and I had to think to swallow because it wasn?t happening naturally. At that time I alerted someone  and asked if these reactions were normal. I was given a 25mg Benadryl and had people continuously check on me. It took some time before I was able to not feel the choking closed feeling from swallowing. Once I was able to swallow it felt as if I had something lodged in the back of my throat. Similar to the feeling of phlegm. I kept having to clear my throat because that phlegm feeling wouldn?t ?wash down?. I felt light headed, but not dizzy. More of a foggy feeling. Once they felt it was safe for me to leave I came home and rested. The headache lessened, I was still cold, but not chilled. Into the evening I was very tired and foggy in thinking.
Supper fatigued; chills; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 28-year-old female patient  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at Left arm on 25Jan2021 18:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergies: Seafood. Concomitant medication included spironolactone. The patient's historic vaccine included first dose of BNT162B2 received on an unknown date for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient experienced supper fatigued and chills on 26Jan2021 10:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on Jan2021. Information on lot number/batch number requested.
Sore arm, tingling on both legs, tingling resolved within 24 hours-MOTRIN for pain.
The patient presents to the clinic with c/o left upper arm pain and swelling after receiving a Tenivac TD vaccine Lot # U6669AA exp dtd 15 MAY 2022.  The patient reports pain in the arm on 24 JUN 2021 upon awakening, but did not think anything of it until she woke up on  25 JUN 2021 with increased pain and swelling to the arm and left upper flank pain.  Patient states that she did exercise the arm after receiving the vaccine, and denies any recent injury to the arm or previous reaction to a vaccine, She also reports nothing seems to make the pain better or worse, and admits to taking 200 mg of Ibuprofen by mouth at 0600 this morning to help with the pain, but it did not help. VAERS form submitted and a copy provided to the employee.
GLASSY EYES; CHILLS; STOMACH DISCOMFORT; FATIGUE; SWELLING AT INJECTION SITE; LUMP; PAINFUL; REDNESS; WARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced lump. On 12-APR-2021, the subject experienced painful. On 12-APR-2021, the subject experienced redness. On 12-APR-2021, the subject experienced warm. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced swelling at injection site. On 21-APR-2021, the subject experienced stomach discomfort. On 22-APR-2021, the subject experienced glassy eyes. On 22-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm, and swelling at injection site on 21-APR-2021, and chills on 23-APR-2021, was recovering from stomach discomfort, fatigue, and glassy eyes, and had not recovered from lump, painful, and redness. This report was non-serious.
COVID vaccine 1st dose received by patient on 3/31/21; shingles onset began around 4/14/21
:  Patient reports that about 48 hours after the Zostivax injection, he started having pain and swelling.  He reports the upper and lower arm were both swollen and painful.  No fever or chills.  No bodyaches.  Appetite was fine.  He was still able to use the arm.  No numbness or tingling in that arm that was unusual.  He reports that despite waiting for the last 5 days, it seems to be getting worse.  Yesterday was the worst day for him.  It was more painful for him yesterday than even the first 48 hours.  No oozing or drainage.  No other vaccines at the time.  He did have chicken pox as a child.  This report was submitted due to amount of swelling at 5 days following vaccination - no evidence of infection/cellulitis.  Seems most consistent with large local but it still extends to lower arm and is 7X30 CM in size.
Patient presented to the ER with complaints of dry cough and SOB for 1-2 days. On arrival in the ER, patient was noted to be afebrile, pulse rate of 136, respiratory 32, blood pressure 147/113.  Laboratory investigations revealed white count of 6.7, hemoglobin 18, platelet count of 128, serum electrolytes showed sodium of 141, potassium 5, BUN and creatinine of 30/1.3.  Patient was transferred to another hospital with COVID-19 pneumonia, rapid AFib and for further care. Patient received Remdesivir, Decadron IV, Baricitinib, antibiotics. Patient was discharged to SNU.
Itching and bumps at site.   C/O SOB.  Sxs occurred ~40 min after receiving the vaccine.  For ~30 min. pt seen by provider.  Sxs resolved.  VS T 97.8 F, BP 110/80, P 98, POXRA 98%.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot number not reported) on 16-APR-2012 and on 09-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. Additional information has been requested.
Immediately after receiving the Pfizer COVID19 vaccine, patient began feeling sick, dizzy, lightheaded. Patient was shaking and went unconscious for a few seconds. Patient regained consciousness but was able to sit and drink water until paramedics arrived. Administering pharmacist suspects it was a seizure but that was not verified. Patient left with paramedics.
on about the 8th day after vaccine I got nauseous had horrible diarreah some slight throwing up had chills and fever of 102 the next day temperature was almost normal but my nose was swollen and red had bad headache.  I went to a walk in clinic that is part of my doctors office. They said I had gasteritis and an upper respiritory infection.   That night I had horrible tinnitus and the sound of symbols in my head fever back up to 101  the next couple days my temperature would go in and out of having a fever the headache would come and go.  I couldn't eat much because even little amount of food would bring back nauseousness. Then on the 14 day the area of the shot turned red my lower legs near my ankles turned red but that had been there also on the 12 and 13 days.  Now on the 15 day my face feels hot my lips feel like the are swollen and buzzy and burning my face goes in and out of feeling sunburned when it isn't.  Not sure what is going to happen
Pt given DTaP in L deltoid swelled up to size of tennis ball. Warm and redden at injection site.
Hearing loss; Seizures; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) and SEIZURE (Seizures) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK. On 20-Mar-2022, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant) and SEIZURE (Seizures) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing loss) and SEIZURE (Seizures) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. On 20-Mar-2022 and 21-Mar-2022 patient experienced seizures and hearing loss. Patient stated that it was possible hearing loss could have came from covid shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of Humira as per reporter for event seizures and hearing loss was not reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 67 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Deafness and Seizure (AESI), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on detailed clinical course, relevant investigations, treatment, exact date and dose of vaccination was available in the report. Co suspect adalimumab could be a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Deafness and Seizure (AESI), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on detailed clinical course, relevant investigations, treatment, exact date and dose of vaccination was available in the report. Co suspect adalimumab could be a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Metallic taste in mouth, progressing to numbness and weakness in right side of face with noticeable droop in smile and right side facial muscles, numb tongue.
Patient presented to the pharmacy with a swollen arm that was warm and tender to touch. Also complained of a rash all over body. Also had pain.
broke out in several pox on trunk, neck, groin areas several days s/p inj;devel low grade temp, somewhat irritable;
Information has been received from a medical assistant concerning a 63 year old patient who on 04-JUN-2008 was vaccinated with a dose of VARIVAX (Merck) (route and administrating site not reported) instead of ZOSTAVAX (Merck). This was not due to product confusion. No adverse event was reported. The patient did not seek medical attention. Additional information has been requested.
Three children received a dose of the VARIVAX that was stored out of recommended temperature range.; Information has been received from the office manager and refers to a child patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R035226 and expiration date of 04-DEC-2020 (route of administration and anatomical location were not reported), for prophylaxis, which were stored in the range of 57.9 Fahrenheit degrees for 49 hours. No previous temperature excursion was reported. Unable to retreive the vial as it was disposed of after administration of vaccine.  Digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2009USA001660: US-009507513-2009USA002056: US-009507513-2009USA002057:
lightheadedness; shaking; This is a spontaneous report from non-contactable other healthcare professional. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot number: EN6205) via unspecified route of administration on 22Mar2021 (at the age of 35-years-old) as second dose, single for COVID-19 immunisation. Medical history included hypoglycemia from and unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot number: unknown) via unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. On 22Mar2021, during her fifteen minutes waiting period of injection, the patient began to experience light-headedness and shaking. The patient denied rash, difficulty breathing, difficulty swallowing, wheezing, itching and facial swelling. The patient complained of dizziness. Treatment included: water. The patient's follow up response towards treatment was good. The patient was escorted out of the facility and denied symptoms while ambulating out. The patient discharged and was stable to go home and follow up with primary care physician. Treatment was taken for the event which included with water. The clinical outcome of the light-headedness and shaking was resolved on 22Mar2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: VAERS Block was updated from Block 17 to Block 13 and also Block 10 ticked for SD BNT162B2. Treatment included: water added in the narrative.
On August 22 (2 days after vaccine) started bright red spotting vaginally noted on TP and underwear. This lasted about about 12 hours. I   am in menopause for almost 3 years.  I also fainted during this time period of spotting. I also had a brain fog that lasted for a couple of weeks. I also had issues with a feeling of lightheadedness for several days.. All of these issues have resolved.
Information has been received from a physician's assistant concerning a 26 year old female with no past history of seizure and no drug allergies, who on 26-JUN-2009 was vaccinated with her 1st dose of GARDASIL, 0.5ml. There was no concomitant medication. Subsequently, two weeks post vaccination the patient had seizure at home on approximately 10-JUL-2009. There were no labs and diagnostic tests performed. The patient was seen at a follow up visit. At the time of the report, the patient's status was recovered. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Vaccine 1/29/07 -1/31/07 felt soreness at lips - later that day developed fever blister on lip - over the next week lips (upper and lower) were covered with fever blisters. Cleared up by 2/12/07.
REFERRAL RECEIVED THAT PATIENT WAS ADMITTED WITH BILATERAL FOOT DROP AND PATIENT RECENTLY RECEIVED COVID-19 VACCINE. LUMBAR PUNCTURE SHOWED HIGH PROTEIN SUGGESTING GUILLAIN-BARRE SYDROME. FOOT DROP DID NOT PROGRESS AND THERE WAS NO WEAKNESS OR NUMBNESS IN THE LIMBS (PER MEDICAL RECORDS RECEIVED). PATIENT WAS TRASNFERRED TO HOSPITAL. PER ICP AND MEDICAL RECORDS RECEIVED, NO DIAGNOSIS OF GUILLAN-BARRE SYNDROME AND GBS/AIDP WAS NOT SUSPECTED. PATIENT LIKELY HAD CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, PERONEAL NEUROPATHY AND L5 RADICULOPATHIES WITH REMOTE LUMBAR LAMINECTOMIES PER MEDICAL RECORDS RECEIVED. AS OF 06/07/21 PATIENT REPORTED IMPROVEMENT IN HER SYMPTOMS SINCE HER BACK SURGERY. SHE IS CURRENTLY UTILIZING A WALKER AND RECEIVING PT/OT.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
TORN ROTATOR CUFF; JOINT PAIN; HEADACHE; CONDITION AGGRAVATED; This spontaneous report received from a consumer concerned a 59 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis, and moderate to severe adult crohn's disease. No concomitant medications were reported. On MAR-2021, the subject experienced condition aggravated. Laboratory data included: Flexible sigmoidoscopy (NR: not provided) not reported. On an unspecified date, the subject experienced torn rotator cuff, joint pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was increased. The patient recovered from condition aggravated on MAR-2021, and headache, and had not recovered from joint pain, and torn rotator cuff. This report was non-serious.
Patient received both influenza (left deltoid) and pneumococcal (right deltoid) vaccinations on 10/23/10 at approximately 3:00 PM. Patient indicated no problems with previous influenza or pneumococcal vaccinations on the VAR during consultation with the pharmacist. There was no immediate reaction following vaccination, but the patient returned to the pharmacy on 10/24/10 around 10:15 AM with visible redness and swelling in a circular pattern around the injection sites on both arms. She stated that she first noticed the reaction around 8:00 AM on 10/24/10 and indicated that she thought the reaction developed sometime overnight. Ice, compression, and diphenhydramine were recommended and the patient was encouraged to seek medical attention at a local Emergency Room. Patient called back to the pharmacy around 4:00 PM on 10/24/10 and complained of worsening swelling, pain, and redness at both sites. The patient was urged once again to seek medical attention at a local emergency room, which she seemed reluctant to do. Additional calls to the patient on 10/25/10, 10/26/10, and 10/27/10 were not returned. The patient's current status is unknown as on 3:30 PM 10/27/10.
Chills and body aches at 8pm evening of shot. Temperature 99.6. Hot sweats during the night. Upon waking up temperature was 102. Body aches persist.
Caller stated that she knows 2 patients who have died and 2 patients who had stroke.; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Caller stated that she knows 2 patients who have died and 2 patients who had stroke.". The following death information was reported, despite no fatal outcome. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event cerebrovascular accident and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.