chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED by EMS on 11/25/22 with fever, body aches, chills, cough and associated shortness of breath. She took an at-home COVID test the day prior which resulted positive. In the ED, patient noted she has been feeling very weak and unable to care for herself in her current state. Repeat COVID test also positive in the ED. Ultimately, patient admitted 11/25/22 - 12/5/22 for acute respiratory failure with hypoxia, COPD exacerbation, and pneumonia due to COVID-19 virus, among other problems. Patient was treated for both COVID and COPD exacerbation.
Ischemic stroke on 5/27, with acute onset right sided weakness in upper and lower extremities, right sided facial droop, aphasia. Received TPA and thrombectomy with interventional neuroradiology. Deficits persisted. No significant other comorbidities.
swelling in her mouth, jaws; swelling in her mouth, jaws; blisters on her lips and blistering inside of her mouth; Swollen lips; Redness, blistering/bleeding of the lips; Redness, blistering/bleeding of the lips; Redness, blistering/bleeding of the lips; This is a spontaneous report from a contactable consumer or other non hcp. A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number ER8734; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in the left amr on 16Apr2021 8:45 (age at the time of vaccination was 20-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, there was no other medications the patient received within 2 weeks of vaccination. The medical history included hypersensitivity from an unknown date and unknown if ongoing Verbatim was Allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling in her mouth, jaws on 29Apr2021 swelling in her mouth, jaws, blisters on her lips and blistering inside of her mouth, swollen lips, redness, blistering/bleeding of the lips. the  patient not diagnosed with COVID- 19, and since the vaccination, the patient has not been tested for COVID-19. The patient was treated with A Dexamethasone shot and prescribed 2 medications Prior to vaccination. Therapeutic measures were taken as a result of swelling in her mouth, jaws (swelling face), blisters on her lips and blistering inside of her mouth (oral mucosal blistering), redness, blistering/bleeding of the lips (lip erythema), redness, blistering/bleeding of the lips (lip blister), redness, blistering/bleeding of the lips (lip haemorrhage). Doctor or other healthcare professional of-fice/clinicvisit. The outcome of event swelling in her mouth, jaws was unknown and all other events were not recovered.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at a single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue, vomiting, headache, and injection site reaction on an unspecified date and inquired if she will have a severe reaction if she gets another dose. The outcome of the events was unknown.
She had labored breathing in her chest and rib cage hurt for 36 hours post vaccination. She also had a urinary tract infection at the time and felt her heart flutter. In the past, she reported a history of reaction to any vaccine, including polio.
shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. In or around 2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a painful and burning rash across her body. The patient was diagnosed with shingles as a result of receiving zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered to be not recovered.    The lawyer considered the events shingles to be disability.
arm hurting a little bit.; 4 months after her 3rd shot, she got a 4th shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurting a little bit.) and EXTRA DOSE ADMINISTERED (4 months after her 3rd shot, she got a 4th shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909 and 026LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (4 months after her 3rd shot, she got a 4th shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm hurting a little bit.). On 21-Dec-2021, EXTRA DOSE ADMINISTERED (4 months after her 3rd shot, she got a 4th shot) had resolved. At the time of the report, VACCINATION SITE PAIN (arm hurting a little bit.) outcome was unknown.            No concomitant medication and treatment information was reported. She stated that she did not have any side effects aside from her arm hurting a little bit. She was also directly exposed to someone who had COVID-19 but she did not get COVID-19.
Patient was vaccinated on 8/13 with first dose of Moderna vaccine and presented to ED on 8/19 diagnosed with COVID infection and was hospitalized
Two days after having the vaccine broke out with the flu. Started experiencing numbness in my legs and toes. Felt like mercury was in the body. Did chiro and acupuncture therapy for nerve issues.
PT BECAME PALE SHORTLY AFTER IMMUNIZATION WAS ADMINISTERED. HE WAS OBSERVED TO BE UNSTABLE ON HIS FEET. PT DID NOT SPEAK THE LANGUAGE AND THERE WAS A INTERPRETER PRESENT AT TIME OF VACCINATION AND AT TIME OF EVENT. INTERPRETER REPEATEDLY ASKED THE PT TO DESCRIBE HIS SYMPTOMS WITH NO RESPONSE. PT'S MOTHER, TOOK HIM OUTSIDE WHERE HE WAS OBSERVED TO VOMIT. PT WAS BROUGHT IMMEDIATELY BACK INTO THE OFFICE WHERE HE WAS PLACED ON THE EXAM TABLE TO LAY DOWN. HE REPORTED FEELING DIZZY BUT HAVING NO OTHER SYMPTOMS. PALENESS WAS STILL NOTED BUT COLOR WAS RETURNING AND PT REPORTED THAT HE WAS BEGINNING TO FEEL BETTER. HE WAS GIVEN SOME WATER AND A SUCKER AND CONTINUED TO IMPROVE. PT WAS ASKED TO STAY ANOTHER 10 MINUTES AND REPORTED TO BE FEELING FINE BEFORE HE WAS ADMITTED TO LEAVE.
After receiving vaccine c/o extreme dizziness, weakness. BP 100/60, P 80 min. Given oxygen by EMS with no improvement. Taken to hospital for evaluation.
Vertigo was coming back when she was watching TV; Heart was racing; Felt terrible like I was going to die,She stated it felt severe and came out of nowhere, She could only lay on her right side; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo was coming back when she was watching TV), TACHYCARDIA (Heart was racing) and FEELING ABNORMAL (Felt terrible like I was going to die,She stated it felt severe and came out of nowhere, She could only lay on her right side) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VERTIGO (Vertigo was coming back when she was watching TV), TACHYCARDIA (Heart was racing) and FEELING ABNORMAL (Felt terrible like I was going to die,She stated it felt severe and came out of nowhere, She could only lay on her right side). The patient was treated with VITAMIN C [ASCORBIC ACID] at a dose of 500 milligram and IBUPROFEN at a dose of Two ibuprofens. At the time of the report, VERTIGO (Vertigo was coming back when she was watching TV), TACHYCARDIA (Heart was racing) and FEELING ABNORMAL (Felt terrible like I was going to die,She stated it felt severe and came out of nowhere, She could only lay on her right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.
Received 0.5ml H1N1 vaccine in Left deltoid at 11:27am.  I instructed her to stay for 15 min. after shot, as we do with all vaccine patients.  She informed us she felt a little "woozy" shortly after the shot but she felt it was because she did not eat much today.  She ate a snack bar from her purse and sat longer.  She then felt "like I might black out" so brought into clinic again and put on exam table.  Vitals stable (11:48am 130/80 Pulse 80)  11:55am 128/80  HR 110, 12:00  130/80  HR 84).  911 called as her symptom of feeling "like I might faint" continued.  She denied any respiratory symptoms, denies chest pains, denied throat tightness or constriction, denied abdominal pain or feeling like needing to move her bowels and no rashes noticed.  The site of the injection was evaluated before she left with EMS and there was no redness or swelling at the site.  She was able to speak clearly (no slurred speach) and without difficulties.  Her only complaint was that EMS arrived and took her to she felt like she might faint as well as some "woozy" feeling.  EMS arrived, evaluated her and took her to Hospital at 12:10pm.  I called her at 3:49pm to see how she did in the ER. She informed me that she started to feel better after about 45min.  She was at home when I spoke with her and feeling tired but better.  She states she took a Benadryl in the ER but no other medications were given.
Shingles and I have never had shingles before   Also, very ill for a month
Red, swollen firm area at injection site, low grade fever, body ache, lethargic. Treatment ADVIL and TYLENOL.
Heat blisters, arthritis on my low back, ache bones, joints and muscles sleeping disorders, appetite loss, right arm pain, mobility and hot to touch problems,high blood pressure, dizzy upon standing and falling down, high cholesterol, fever and others. 1/4/10 Still with high blood pressure, joint pain, sleep disturbance, muscle pain and depression.  03/26/2007 VAERS report submitted with vax. record and several pages of medical records attached, including a report of 4/29/2003 for a fall which resulted in injury to right shoulder and left knee.  DX:  Impingement Syndrome.  F/U 5/4/2003 for same shoulder injury DX: Strained muscle Right Shoulder. TC to Pt/reporter to verify AE onset date.  Pt. stated it was on/about May 1, 2004.  Updated in VAERS.  04/09/2007 MR received for multiple OVs beginning 5/27/2004 through 3/6/2007. Initial c/o R shoulder pain 2' past trauma. Multiple OVs with problem list including the following DXs: Hypercholesteremia, Joint Pain, HTN, Depressive Disorder Alcohol Abuse, Rotator Cuff tear, Neck Pain, DDD-cervical, Spinal Stenosis, LBP, Hip arthralgia.
This spontaneous report as received from a pharmacist (patient's father) via company field representative refers to a 12 years old female patient. The patient's medical history and concurrent conditions were none. On an unspecified date in July-2015 the patient had received her second dose of GARDASIL, lot # and expiry date was not reported. The patient had received unspecified concomitant medications. On an unspecified date in July-2015, the patient experienced visual disturbances (disability) and optic neuritis (disability). Therapy with GARDASIL was discontinued on an unspecified date in July-2015. Later in December-2015, she had chronic seizures (disability). Recently, on an unspecified date, she was diagnosed with inflammation of the left hemisphere of her brain (disability) and she could not speak (disability). The GARDASIL was not reintroduced. The outcome of the events were reported as not recovered. Upon internal review the events cannot speak, chronic seizures and inflammation of the left hemisphere of her brain were considered to be medically significant. Additional information has been requested.
Patient presented to the pharmacy on 1/24/2023. The injection site was red (size of an orange), warm to touch, and slightly swollen. I advised her to see her provider. She then returned and informed us she had an infection at the injection site.
My ankle through my toes just became horribly painful and my feet at the same time were very painful; I couldn't walk; I got a horrible headache that last throughout the night and took an Aspirin that didn't helped at all; Chills; Cough; Low grade temperature; My ankle through my toes just became horribly painful and my feet at the same time were very painful; This is a spontaneous report received from a contactable consumer (patient).  An 88-years-old patient of unspecified gender received first dose of BNT162B2 (formulation: Solution for injection, Lot number: EL0168 and expiry date: not reported) via an unspecified route of administration as DOSE 1, SINGLE on 17May2021 at 04: 30 in afternoon for covid-19 immunization. Medical history included: The patient had COVID in the last two weeks of Dec2020 and patient was told to wait at least 3 months before taking vaccination. The patient underwent an eye surgery on an unspecified date. Concomitant medications were not reported. On 17May2021 (about 4 hours later taking first shot of vaccine), the patients ankle through toes just became horribly painful and feet at the same time were very painful. The patient had terrible time, couldn't walk, and tried to rub and rub that lasted for a good hour and then dissipated slowly. The patient had a horrible headache that last throughout the night and took an Aspirin that didn't helped at all. The patient had chills, picked up cough and a very low-grade temperature, not a high temperature. Outcome of headache was not recovered, Events (ankle through toes just became horribly painful and feet at the same time were very painful and could not walk) were recovered on 17May2021 and outcome for all other events was unknown.  No follow-up attempts are needed. No further information is expected.
1 hr p/recvd flu vax pt devel swelling & redness @ inject site-lt deltoid; pt required ER/MD visit; recovery occurred w/in 24 hrs;
Patient had positive HCG on 12 Mar 03.  Had conducted home pregnancy test prior to receiving vaccination with negative results; LMP 25 Jan 03
13JAN97 stomachache, h/a;14JAN98 stomachache, h/a, nausea;15JAN97 stomachache, fever;16JAN97 stomachache, fever;
On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went down to normal. Later I realized that I had two swollen lymph nodes on the left side of my neck. Next morning  01/11/2021 at woke up noticed another swollen above the hollow of the clavicle.
75 plus papular & papulovesicular lesions started 23 days after receiving vaccines.
The patient's wife was with him while he was waiting the 15 minutes.  She stated that he was feeling nauseous and dizzy.  When I went to check on him, he was sloughed over to the right side of his chair with his eye closed.  The wife tried to talk to him, but he was unresponsive for a little while.  When he came back to responding, he was sweaty and said that he felt like he went to sleep.  I had one of my technicians call 911.  His wife believes that he had a seizure.  He was sweaty and pale.  The EMT ended up taking him to go to the hospital to get checked out.
Arm feels like its burning, hot; hard knot, seems like its getting bigger Spreading down to her elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm feels like its burning, hot) and INJECTION SITE CYST (hard knot, seems like its getting bigger Spreading down to her elbow) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FUROSEMIDE, AMLODIPINE, LISINOPRIL, FLUOXETINE HYDROCHLORIDE (PROZAC), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and PROPRANOLOL for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm feels like its burning, hot) and INJECTION SITE CYST (hard knot, seems like its getting bigger Spreading down to her elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm feels like its burning, hot) and INJECTION SITE CYST (hard knot, seems like its getting bigger Spreading down to her elbow) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included insulin xultroph.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Client received his first dose of Covid vaccine in the clinic on 4/1/2021 at approximately 10:25 a.m.  Client was walked to the courtroom for observation for 15 minutes post-vaccination.  This is standard procedure.  When his 15 minutes was up, Nurse informed him that his time was up and he was free to go, and signed him out.  As she was speaking with him, she noticed he was disoriented.  She asked if he was all right and fanned his face for a few seconds. 2nd nurse came by at that time, and the women helped pt. back to the clinic and onto a pad on the floor in a nurse?s office. Third person was called. Vitals were taken several successive times (BP ranged from 148/99 to 155/104), Temp was normal and in 97.5 to 98.4 range.  Resp 16-18. Pulse was between 78 and 93.  Client was disoriented, could not state his name and could not name anyone for us to call.  Ammonia salts were employed with no effect.  All emergency meds, oral airways, and AED were gathered in case they were needed. No other meds or equipment were used. By standard called for the clerk, and By standard, to call paramedics.  She called 911 x 2 and when put through to EMS, was given a disconnect notice.  She ran down the hall to the constable?s offices, who placed the call and had paramedics on their way.  Then two constables (male and an unknown female constable) came to the Health Dept.   Third person got the client to answer with whom to call. Third person called the client?s mother-in-law and employer.  Both arrived after the client was transferred via ambulance and left to join him immediately at the hospital.  As all this was happening, Nurse, 2nd Nurse, third person, and Bystander were attempting to ensure pt. airway and breathing were patent.  He never had difficulty breathing and never had wheezing.  There were no other visible signs of anaphylaxis. His color was pale, then improved, but became pallid again at about the time the paramedics arrived.  He was never alert or oriented throughout the event. Paramedics arrived at approximately 11:00 a.m. They did an initial assessment and received report on what had occurred and data gathered.  They then had to lift pt. onto the stretcher.  He was then transported to Hospital.
Patient should have been given the Hepatitis B vaccine instead of the flu vaccine. Manufacturer has no data as they have not done studies on anyone under the age of 6 months. Mom was informed by MD regarding the injection. F/U done 10/12/2018 and 10/15/2018 mom reports no adverse effects or side effects.
Patient called on the phone and told me that her injection site was red,  swollen slightly, painful and that  her jugular vein was throbbing when she pressed down on it and so she was worried.  i asked her if she was able to take tylenol and if she could apply ice pack to the site of injection. i also told her to call her primary care doctor or go to urgent care to asses the throbbing of  vein in her neck.
Variability of menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Variability of menstrual cycle) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced MENSTRUAL DISORDER (Variability of menstrual cycle). At the time of the report, MENSTRUAL DISORDER (Variability of menstrual cycle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experiencing ongoing variability in menstrual cycle to the point where it was unacceptable. Had followed up with OBGYN to do ultrasounds looking for cause. No attributable cause.She reported to V-safe. It had been stated that wanted to report to AE hotline feels "it needs to be taken more seriously by Moderna" States she was frustrated because she bled all of January said just started period again today after only 2 weeks.  No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-483763 (Patient Link).
Pt complained that she had arm pain radiating to her neck and splotches to left chest wall and neck at urgent care visit. Pt called office and reported that her arm was hot to touch, and swollen. Based on reported s/s of pain and warmth to area MD ordered cool compresses/ice pack and 2 aleves bid. Urgent care provider ordered steroids after assessment of site.
Patient was seated to receive vaccines: Varicella, Tdap (left arm) & Menactra (right arm), in that sequence.  Within seconds of the last injection, patient lost consciousness. Symptoms included: pale diaphoretic skin, gurgling sound, head extension, limp body, several jerking movements of head and arms, slump to the right, and slow fall to the floor in face down position. He continued breathing though was unresponsive to loud voice or touch. Duration of loss of consciousness was approx. 60 secs. He regained consciousness spontaneously and was immediately alert and oriented x3. Vitals during LOC: 134/78, P 60, R 14. Vitals at 2:55 pm 124/82, P 68, R 12.