chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt given vaccine on Thurs l0/29  on l0/30 warm didn't want to nap in am then during diaper change on floor pt head fell back eyes  rolled back and generalized twitching of arms, legs, pale lips turned blue duration 3 min  called 9ll   no temp taken  Pt transported to ER via ambulance vomited x 4 during transport lethargic in ER  No fever  On Thurs pt also fell off bed while playing with brother, hit carpet no LOC, no vomiting or behavior chg CT scan of head ordered in ER neg  left leg at site of vaccine red and warm on Sat l0/31 self resolved on ll/1/2020
I experienced dizziness when laying down and turning my head to the left.  Dr.  diagnosed Benign Paroxysmal Positional Vertigo.  Doctor related this is usually due to a calcium crystal that comes loose in the left inner ear.  (This may or may not have been related to a trip & fall I had about 3 days prior to the first instance of the dizziness.)
had a testing, came up positive; had a testing, came up positive/sporadic coughing and a little short of breath. Maybe a little sore throat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Pfizer COVID Vaccine (further clarified) on 20Dec2020. And maybe two days after that, the patient kind of developed a little like very sporadic coughing, it was very mild and a little short of breath. Maybe a little sore throat so that's why the patient was concerned. The patient had a testing in Dec2020, they did swab the patient's throat, it came up positive. The outcome of events was unknown.
Information has been received from a consumer, concerning her 13 year old daughter, who in December 1998, was vaccinated with the first dose of VARIVAX (Merck) (Lot # unknown). The patient's mother reported that her daughter "was not immune to chickenpox" after receiving one dose of VARIVAX (Merck) based on an "recent" titer. The mother stated that pediatrician informed that children were getting chickenpox despite having two doses of VARIVAX (Merck) (Waes # 1008USA00530). No immune to chickenpox was considered to be disabling. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Patient first stated that he felt dizzy around 11:40AM and was moved to the floor to lay down. Vital signs were initiated. Patient stated feeling "tightening" in his chest and both upper extremities and was experiencing contractions and unable to move his fingers.  The patient stated feeling numbness and tingling in his left fingers and feet. Patient stated feeling hot when experiencing numbness and tingling. Patient stated tasting metal on his tongue.  Patient stated feeling sharp pain in his left flank area. Patient turned to his side and started shivering and stated feeling cold and having chills. Patient reported improvement in mobility in lower extremities and left hand.  EMS was called at 11:47AM and arrived onsite 25 minutes later. Assessment was initiated and patient was taken to the nearest hospital. Patient left the vaccine site at 12:18PM via EMS.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-542606, MOD-2022-542616 (Patient Link).
Nausea, fever, malaise, then fainted and lost consciousness, fell, and split open lip, tongue, cheek, nose and disrupted normal dental bite
Arm was swollen; Arm was very sore; Red from her shoulder to elbow/ arm was so red; Hands were ice cold and she wore gloves, had two down blankets; Put sweats on; Did nothing but sleep; Nauseous; Fever; Chills were unbearable; Felt very tired; Shaking was unbearable; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), PAIN IN EXTREMITY (Arm was very sore), ERYTHEMA (Red from her shoulder to elbow/ arm was so red), PERIPHERAL COLDNESS (Hands were ice cold and she wore gloves, had two down blankets) and TREMOR (Shaking was unbearable) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PYREXIA (Fever), CHILLS (Chills were unbearable) and FATIGUE (Felt very tired). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm was swollen), PAIN IN EXTREMITY (Arm was very sore), ERYTHEMA (Red from her shoulder to elbow/ arm was so red), PERIPHERAL COLDNESS (Hands were ice cold and she wore gloves, had two down blankets), TREMOR (Shaking was unbearable), HYPERHIDROSIS (Put sweats on), SOMNOLENCE (Did nothing but sleep) and NAUSEA (Nauseous). At the time of the report, PERIPHERAL SWELLING (Arm was swollen), PAIN IN EXTREMITY (Arm was very sore), ERYTHEMA (Red from her shoulder to elbow/ arm was so red), PERIPHERAL COLDNESS (Hands were ice cold and she wore gloves, had two down blankets), TREMOR (Shaking was unbearable), HYPERHIDROSIS (Put sweats on), SOMNOLENCE (Did nothing but sleep), PYREXIA (Fever), CHILLS (Chills were unbearable), FATIGUE (Felt very tired) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pain at injection site that moved into shoulder and neck area 4/10. Pain described as intermittent, sharp.
Sepsis with hypotension, improved. Source likely aspiration pneumonia cant rule out cellulitis from stasis dermatitis. Received 10 days of antibiotics. I stopped atenolol and decreased lasix because of lowish blood pressure. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
sore arm for approx. 2 weeks; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: This case was reported by the patient's parent. The patient received dose of Bexsero vaccine and experienced a sore arm for approximately 2 weeks. The reporter did not consent to follow-up.
24hr post vax pt devel severe pain in rt arm;next day pain spread to the hips, back & shoulder & c/o fever, noc sweats & loss of mobility in rt arm;tx w/Ibuprofen w/o relief;1mo later erythrocyte sedimentation rate 125;joint pain
After Dose #2 of Moderna COVID-19 on 03/04/21, I developed a red rash on my left arm, in the fleshy part of my arm, down two thirds of the way to my elbow. As the days progressed, that rash moved around on my upper arm, was warm to touch and a little itchy. I also had tender points in my upper arm for a few days.  After a few days I started getting red bumps on my upper left arm and I assumed it was because I had been scratching the area. The rash and red bump area on my arm became larger and soon covered the whole of the fleshy part of my upper arm. Hydrocortisone 1% or other medicating lotions were of no help.   See separate Continuation Page, not part of this form.
called at 1:25 pm stating that a couple hours after receiving the vaccine he had sharp pains on the left side of his chest.  He states he had about 4 episodes where he had 2-3 sharp pains each.  At 2:15 pm when I spoke to him he hadn't had any further episodes but stated if he needed to he would go to urgent care or seek medical treatment as I had advised since this is not an expected side effect.
My first shot was on 8/21 in the am. Within 20 min all my nerves were on fire. It felt like an electric current running through my body. This lasted as intermittent jolts for a few hours. I did get the typical fever up to 103?s, chills, feel like crap, arm red and swollen at the injection site reactions but also much more. By the evening my tongue became swollen and all my joints hurt. I walked around with my epipen and didn?t sleep for more than 20 min in fear of not waking up. I was puffy everywhere. My chest hurt to breath. No coughing or congestion. Just a heavy feeling/horrible feeling when taking a breath. Walking became an issue because I would lose strength and collapse. This lasted for a few days. I was nauseated and had diarrhea for almost 2 weeks. I lost my taste and smell. Not to mention eating was difficult due to my swollen tongue. About day 2-3 all past injuries felt like new injuries. The pain was almost unbearable for 2-3 days and then was better. My hair started falling out at about day 5 and I am still losing more than I should. I itch everywhere but when I itch it burns/hurts. I still have this. By day 6 my skin became dry and peeling with white raised bumps that itched really bad. The dryness is still here and lotion doesn?t help. By day 6 I also smelt different. It?s hard to describe but it was kind of a sour smell. I still smell different. The headaches that started almost immediately and are still lingering are horrible. Still taking ibuprofen at least once a day if not more to function.   Care was self treatment. I am a nurse. I had my epi pen and my phone. Did not want to go to the ER for worry of exposure to covid and other viruses.
Woke up 3:30am with severe fatigue and chills.  Fainted while trying to get medication.  Mother woke up from sleep when she heard patient hit a wall while fainting.  Called 24hr nurse hotline.  They recommended being seen by a doctor.  We were able to get water, ibuprofen and Tylenol in her by 4:00am and waited 30-40 minutes.  The medication lessened symptoms so we chose not to seek further treatment.  Staying on both Tylenol and ibuprofen kept symptoms at bay for the next 36 hours.
4/4/21 - ITCH HANDS - NIGHT - CLARITIN 4/5/21 - WORSE - Hands & Feet - continued with CLARITIN 4/6/21 - Called PCP office - use Benadryl - (ALL BODY) 4/9/21 - ER - Dx. Pruritus -    Test - Estimated Glomerular Filtration Rate          - Basic Metabolic Panel - BMP          -CBC WITH DIFF  D/C with FAMOTIDINE 20MG, Prednisone 20MG, Omeprazole 4/10/21 ER DX. FLANK PAIN, BACK PAIN  Tests - Urinalysis with Reflex CULTURE  D/C with MEDS Famotidine 20MG, Omeprazole 20mg, Prednisone 20MG x2 4/14/21 - PCP visit - Finish Prednisone, start Medrol 4/15/21, continue Zyrtec, add Benadryl if needed, Platelets - X-ray. 4/19/21 - ECCHYMOSIS, SKIN PROBLEM - ER (Bruise)              - Estimated Glomerular, Filtration Rate              - Basix Metabolic Panel - BMP              - CBC WITH Diff.              - Hepatic Function Panel              - PT-INR) Prothrombin Time)     D/C with meds - Omeprazole 20mg  Last Zyrtec was on May 4, 2021 - Had some itch every-so-often after that. Itch gone by the middle of May 2021. AMEN!
c/o dizziness, lethargy, chills, body aches, h/a; no acute distress when seen in ER: also employee was seen in ER 15APR95 w/no acute distress;
Initial information received on 19-Nov-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 24 years old male patient who experienced seizure, while he received vaccine FLUZONE. The patient's concomitant medical condition included Bipolar disorder and Anxiety (patient stated that he has a history of being bipolar and having anxiety for which he takes Lamotrigine). Concomitant therapy included LAMOTRIGINE (details not reported). The patient is not complaint with his lamotrigine. The patient's past vaccination(s) and family history were not provided. Concomitant medication was none. Reported other vaccine none. On 12-Nov-2018, the patient received a First dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AC via unknown route. On 15-Nov-2018, the patient developed a serious seizure 3 days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. It was also reported that seizure to be due to his non-compliance with this therapy. (Other relevant tests included No lab data.) Final diagnosis was seizure. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for seizure. List of documents held by sender: none. Sender's Comments: 24 years old male Patient experienced seizure 3 days after vaccination. Time to onset is compatible with the role of vaccine. Patient had medical history of being bipolar and having anxiety for which he takes lamotrigine.  However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Mother presented to the clinic accompanied by her two children. Only one child was scheduled for immunizations. I mention this because the Mother reports that approximately one month later both of her kids developed " approximately 20 to 30  red dots to the arm pits, collar area buttocks, abdomen, back of ears & back of knee. Mother states that her children c/o lesions being "painful to the touch but did not blister" Mother reports they did not develop fever or other symptoms and the rash has resolved. Mother states she did not use any new lotions or detergents or introduce any new foods to her children. She also reports they were not exposed to potential environmental allergen. Mother feels that the vaccine could have been responsible for the reaction her children had. The mother did not take her children in to see their PCP for evaluation of rash. The child had recieved both of these vaccines in the past without any adverse reactions. The mother is highly anxious about immunizations. The mother did show me a picture of the rash. The rash looked like flat red spots.
PATIENT PRESENTED WITH HIVES ON TRUNK AND EXTREMITIES. STATED THAT YESTERDAY FACE AND NECK WERE COVERED WITH HIVES.  PATIENT TOOK TYLENOL PM LATER THAT EVENING.
Flu like symptoms starting around 2AM, aches, which continued until mid day 3/3.  Rash on my arm, shoulder growing down to my elbow, itchy, hot.  All subsided about a week later.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to a patient of unkown age and gender. Information about the patient's relevant medical history and concomitant medications was not reported. On 17-AUG-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K020181, expiration date 24-JUN-2016, exact dose was not reported) route of administration defaulted to oral. No adverse effects reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been information.
She has no energy; She has little fatigue; 2 days after receiving 1st dose, she started retaining a lot of water.; Her whole body was swollen; Her hands are swollen; Ankle swollen; feet swollen; arms swollen; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), ASTHENIA (She has no energy), SWELLING (Her hands are swollen) and JOINT SWELLING (Ankle swollen) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), SWELLING (Her hands are swollen), JOINT SWELLING (Ankle swollen), PERIPHERAL SWELLING (feet swollen) and PERIPHERAL SWELLING (arms swollen). On an unknown date, the patient experienced ASTHENIA (She has no energy) and FATIGUE (She has little fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FLUID RETENTION (2 days after receiving 1st dose, she started retaining a lot of water.), OEDEMA (Her whole body was swollen), ASTHENIA (She has no energy), SWELLING (Her hands are swollen), JOINT SWELLING (Ankle swollen), PERIPHERAL SWELLING (feet swollen), PERIPHERAL SWELLING (arms swollen) and FATIGUE (She has little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was not reported. Vial was place in refrigerator on 18-Nov-2021 and vial did not undergo any temperature excursion. It was reported that patient did not experience any adverse event.
Severe pain in right shoulder enough to wake me and keep me awake. Lethargy, low grade fever, aching muscles. Swelling of injection site and slight bruise.
Within 11 hours, was cold and could not warm up for another 7 hours.  Morning after injection, patient had light headedness, nausea and a sore arm at the injection site.
itchy measle like bumps on both arms, neck, shoulder & back.  Hoping for it to go away in a few days.  Taking benadryl at night.
Pt presented to our facility on 5/11/21 with altered mental status and tachypnea, ultimately diagnosed with Bickerstaff Brainstem Encephalitis (Guillain-Barre variant) by neurology.  Currently intubated and receiving IVIG.
Injection site soreness - mild; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the right arm on 24Mar2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included mild high blood pressure and heartburn. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), vitamin A (MANUFACTURER UNKNOWN), vitamin B12 (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) for unknown indications and unspecified medication for heartburn, all from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 at 08:00, the patient experienced injection site soreness-mild. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event injection site soreness-mild. The clinical outcome of the event injection site soreness-mild was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Injection MENACTRA given on 5/5/10. Lot# 42928AA Exp 5/14/10 site swollen with fever.
Pt reported large, red, swollen skin on entire upper right arm starting day after influenza imz administration, but has cleared up as of day 9 post imz. No additional reaction or irritation reported. Pt has had no history of this type of reaction from any imz in the past, and this was not the first time she'd received HD version of influenza vaccine. Pt also received RSV imz in opposite arm but reported no reaction on that side.
Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored VAQTA (lot # L022259, expiration date 06-APR-2017, lot # L023936, expiration date 15-MAR-2017). The vaccines had been exposed under temperature 1.05 degree Centigrade for 49 hours, but did not undergo previous excursion. Data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received FLUVIRIN vaccine and was fine after administration post 10 min. Pt went home and approx 1 hr later called pharmacy stating she passed out. Pt contacted primary care shortly after.
Woke up shivering, whole body felt tight, muscle pain and weakness, fever 100.5, headache not relieved with Tylenol,loss of appetite,  exhaustion.  No energy to do anything. Slept 11 hours straight last night.  Felt better when awoke at 6:30. a.m.  All symptoms gone.
genital herpes for the first time, severe fatigue, hot flashes, dizziness, nausea, no appetite, memory loss, poor brain function
Varicella positive symptoms include vesicles, fever, itching, rhinorrhea-onset first lesions 2 days ago 4/18/18.