chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIENT REPORTED THAT HER ARM (AROUND THE SITE OF INJECTION) WAS SWOLLEN, RED AND WARM TO THE TOUCH. SHE RECEIVED HER MODERNA BIVALENT COVID VACCINE BOOSTER 2 DAYS AGO AND HER SYMPTOM BEGAN THE MORNING AFTER AND HAD INCREASED IN AREA ON THE SECOND DAY.  THE AREA APPEARED INFLAMMED ABOUT 2.5 INCHES X 2.5INCHES. PT WAS ADVISED TO CONTACT HER HEALTHCARE PROVIDER TO GET IT EVALUATED AND TO GO TO THE ER IF IT WORSENS. THE INFLAMMATION APPEARED LIKE A "COVID ARM"  AND SHE WAS ALSO ADVISED IN THE MEANTIME TO APPLY COLD COMPRESS AND TAKE SOME TYLENOL FOR PAIN RELIEF.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 06-DEC-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion with 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49.1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE WARMTH (With pink hot area surrounding the injection site) and VACCINATION SITE ERYTHEMA (With pink hot area surrounding the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Removal of kidney stone (unsucessful) on 03-Feb-2020, Lithotripsy renal on 04-Mar-2020, Stent removal on 23-Jun-2020 and Lithotripsy renal (kidney stone clear/lithotripsy) on 07-Jun-2021. Concurrent medical conditions included Kidney stone since 26-Jan-2020.    On 27-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE WARMTH (With pink hot area surrounding the injection site) and VACCINATION SITE ERYTHEMA (With pink hot area surrounding the injection site). At the time of the report, PAIN IN EXTREMITY (Very sore arm) had resolved and VACCINATION SITE WARMTH (With pink hot area surrounding the injection site) and VACCINATION SITE ERYTHEMA (With pink hot area surrounding the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.  Patient had  sore arm for about a week. Patient uses hair dye.   This case was linked to MOD-2021-406092, MOD-2021-406101 (Patient Link).
very disoriented; pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), CONFUSIONAL STATE (very disoriented) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C211A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Anticoagulant therapy, ALPRAZOLAM (XANAX) for Anxiety, SALBUTAMOL SULFATE (VENTOLIN [SALBUTAMOL SULFATE]) for Asthma.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), CONFUSIONAL STATE (very disoriented) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in arm), CONFUSIONAL STATE (very disoriented) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
one week (04/12/2021)  after 1st dosage injection 4/5/2021) in left arm, all of a sudden constant ringing/humming in right ear with occasional pings and has not gonna away,  It started about 8pm on 04/12/2021.
Information has been received from a physician concerning a 4 year old male with no known medical history or allergies who on 5/23/2006 was vaccinated with a SC dose of PROQUAD (lot 651815/0950R). There was no concomitant medication. On 5/24/2006 the patient developed swollen cervical lymph nodes and torticollis. Unspecified medical attention was sought. He was referred to an ENT specialist and physical therapy. No laboratory diagnostic tests were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Swollen cervical lymph nodes ant torticollis were considered to be disabling. Additional information has been requested.
As a physician for over 40 years I tend not to pay attention to my symptoms if I develop the flu or a virus. I just put up with it  I received a COVID-19 Moderna vaccination on January 7. Approximately 12 hours after I started to develop adverse reactions. These of Inc. severe myalgias, fever to 102, chills, headache, severe fatigue (to the point where it is difficult to get out of bed)  Not much reaction at the injection site. Hydrogen saturation  in the 90s and pulse in the 70s.  I did contract Covid in March 2020. I was alone for two weeks. However no respiratory problems or hospitalization.  I?m currently speculating that having had covered in March has resulted in a significant immune reaction from this vaccine.  I would appreciate your input on this.  Can I expect this again when I receive my second vaccine in one month?  Thank you
received vaccine, pain and arm burn all the way to fingers. pain started day later, numb, both arms, fingers hands, pain legs, bones shoulder cracking sound, snapping, hands and fingers freezing up in claw position, loss of strenght in arms , legs, hands, fingers, ankles pain, in joints and muscles, no sleep, headache, throbbing pain, sharp pain, not able to sleep, rapid heart beat, loss of strenght in hands and fingers, pain throbbing freezing hands, fingers unable to open hands, not go away, called docter, perscribed pain pills, still not go away, called docter subscribed sterioid, releived some but pain still there, pain now is back been till now 3/30/2021, progressively worse
woke w/swelling under lt jaw, w/accompanying malaise, arthralgia, felt like flu on 7/31-by 8/1/ swelling had extended to rt jaw w/arthralgia & malaise;recovering from sx by today 8/3/99;
Raised reddened area at site of injection within 20 minutes of vaccine. No vesicles appeared at this time. 12:05 pm vaccine given, 12:10pm c/o itch, 12:15 pm reddened area appeared.
PT SAID BEGINNING YESTERDAY (7/19/2018) MORNING SHE FELT ILL SYMPTOMS INCLUDE MILD FEVER, NAUSEA, DRY HEAVES. SHE ALSO REPORTED A VERY SORE ARM.
3rd dose subcutaneous; Inappropriate scheduled of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 001A21A and 201B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency. Concomitant products included LAMOTRIGINE (LAMICTAL), OXCARBAZEPINE, GABAPENTIN, QUETIAPINE, HYDROCHLOROTHIAZIDE, OMEPRAZOLE, NALTREXONE HYDROCHLORIDE (NALTREXONE [NALTREXONE HYDROCHLORIDE]), BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), LYSINE, COLECALCIFEROL (D3), MELATONIN, NATTOKINASE, RESVERATROL, GLYCERINE MONOLAURATE, INOSINE (MONOLAURIN [GLYCERINE MONOLAURATE;INOSINE]), FISH OIL, ASCORBIC ACID (VIT C), LEVETIRACETAM (LEVRA) and IMMUNOGLOBULIN G HUMAN (IGG) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous). 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered). On 25-Aug-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (3rd dose subcutaneous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) had resolved.            Caller states that Patient is immunodeficient. She also stated that she got a sore arm with the1st dose and with the 2nd she got fever. Concomitant medications also included Sertiamen along with above mentioned medications. No treatment details were reported.   This case was linked to MOD-2021-296521, MOD-2021-296516 (Patient Link).
Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 19-Nov-2021 an open vial was found in the refrigerator, Staff had been drawing doses from opened vials without taking in consideration the hours after the first punctured. Patients after 05-Nov-2021 were potentially getting their doses from vials punctured longer than 12 hours ago. Concomitant medication use was not reported. Treatment information was not reported..   This case was linked to MOD-2021-395851 (E2B Linked Report).; Sender's Comments:  MOD-2021-395851:Second patient case
Pain at injection site; Red area/redness almost gone but she feels it there; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE ERYTHEMA (Red area/redness almost gone but she feels it there) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, High cholesterol and Acid reflux (esophageal).   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE ERYTHEMA (Red area/redness almost gone but she feels it there). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Red area/redness almost gone but she feels it there) was resolving.            The concomitant medications included blood thinner pills, blood pressure pills, high cholesterol pills, medication for reflux. The patient did not take any treatment for adverse events.
I had vaccination on 10/01/2022. On 10/29/2022 I was having eye pain. This continued for a week and my vision started to become blurry. I went to my ophthalmologist on 11/07/2022 Optic Nerve was inflamed and had edema. I had a brain MRI on 11/10/2022 and was diagnosed with Optic Neuritis. I was hospitalized high dose IV steroid treatment and was in patient for 3 days and 2 days outpatient. I am currently on an oral taper. Mild antibody disease. I am waiting for plasm exchange for the myelin oligodendrocyte glycoprotein.
Fever of 100.8, headache, chills;  did not take any medication - just drank lots of liquids; fever broke at around 10:00pm and started feeling better before bed
No adverse effects reported by the Nurse.; pediatric dose of RECOMBIVAX HB vaccine instead of an Adult Dose of RECOMBIV AX HB; This spontaneous report was received from a nurse referring to a patient of unknown age.  Information about concurrent condition, concomitant medication and medical history was not reported.   On unknown dates, the patient was vaccinated with the first and second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. In 2003, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot# 641071/1069L, reported batch number was 1069L, expiration date 01-JUN-2004, strength and dose, route were not provided). The nurse reported that there was a possibility that the patient was administered a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) instead of an adult dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for the third dose of the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vaccination series (inappropriate dose of vaccine administered). No adverse effects reported by the Nurse.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis.  On 28th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The caller states that her husband (patient) received a dose of SHINGRIX and he had flu-like symptoms for about 3 days. The patient did not report this information to his healthcare professional. This case has been linked with case US2018GSK164957, patient's wife's case (reporter).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 22May2021 as dose 2 , single (Lot number: EN6199), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 14May2022 at 10:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies; Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 15Jun2017, stop date: 10Jun2022; PRAVASTATIN SODIUM, start date: 15Jun2017, stop date: 10Jun2022; ESTRADIOL, start date: 15Jun2017, stop date: 10Jun2022; NORTRIPTYLINE HCL, start date: 15Jun2017, stop date: 10Jun2022; ACTONEL, start date: 15Jun2017, stop date: 10Jun2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: home test still positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was reported a patient had rebound of symptoms (runny nose, congestion, cough).
Incorrect diluent dosage at 9am on 5/19/21. Instead of diluting the Pfizer vaccine with 1.9 ml of sterile water, I used 0.9 ml of sterile water to dilute the vaccine. A dose of 0.3 ml were give to the patient. Patient stayed for 15 mins and no reactions occurred.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients may have been vaccinated with a dose of ROTATEQ (Lot number, expiry date, route and dose were not reported) that was exposed to 53 Fahrenheit for 48 hours and then were exposed to 30 Fahrenheit for 72 hours. No adverse effects reported. Additional information has been requested.
A patient received the MMR vaccine on 07/09/20 at 16:19. Unit RN called  doctor at 18:38 reporting itching from the patient. Vitals were within normal limits. Patient was given 50 mg diphenhydramine, which patient noted was effective. Doctor followed up with patient on 07/10/20. Left ventral forearm had no visible rash, and patient noted rash on right forearm was gone. Abdomen was also free of rash. Patient noted rash on their forehead and chin/neck area. The chin/neck area was affected by wearing a face mask and sweating. Their forehead was erythematous and had acne present. Patient noted the rash arose after receiving the vaccine and was not present before the injection. Patient denied any shortness of breath with rash. Rash was presumed to be due to MMR vaccine. Hydroxyzine was increased to 50 mg TID and 50 mg hydroxyzine 50 mg q24h PRN itching was added to help with further itching. Patient was marked with MMR vaccine allergy. One dose PRN hydroxyzine given 07/11/20, symptoms improved. Per the product insert, M-M-R II vaccine has skin-related adverse effects listed as SJS, erythema multiforme, urticarial, rash, measles-like rash, pruritus, injection site reactions (pain, erythema, swelling and vesiculation). No percentages accompany these adverse effects. This was rated as possible.
Several episodes of vasculitis (one week after 2nd dose) that required prednisone by mouth and betamethasone cream off and on for over 5+ months.
Vomiting liquid, phlegm x 1 7FEB92 up @ 330AM c/o arm hurting-back to sleep; c/o stomach ache; t99.8 ax 7FEB92;
Information has been received from a physician concerning a 5 year old female patient with no relevant history or preexisting medical conditions and relevant past drug history unknown who on 05-APR-2010, was vaccinated IM with a 0.25 ml dose of PNEUMOVAX 23 for recurrent middle ear infections. An ENT (ear nose throat) specialist recommended PNEUMOVAX 23. The nurse who administered the PNEUMOVAX 23 decided to administer the vaccine as a split dose as follows: 0.25 ml on 05-APR-2010 followed by 0.25 ml on 09-APR-2010. There were no relevant concomitant medications. It was reported that on 05-APR-2010, within hours of receiving the PNEUMOVAX 23 in the mentioned manner, the patient's arm showed redness and tenderness at the site of injection. As of 08-APR-2010, the patient continued to experience redness and tenderness at the injection site. There were no relevant laboratory tests performed due to the events. The reporting physician was going to recommend the patient not to be administered with the second half of the remaining dose of PNEUMOVAX 23 vaccine on 09-APR-2010 and that they would wait until the events resolved and then revaccinate the patient. Additional information has been requested.
T 99.7 T 99.9 - 1/2 hr later 650 acetaminophen
Received Vaccine 1/15/21 and 2/5/21. Transitioned to Hospice care. Expired 4/13/2021.
Pt waited in clinic for 30 minutes.  Approximately 5 minutes after leaving she felt swelling in the lips.  She took Zyrtec and called the clinic about 20 minutes later to report incident.  She was having improvement of symptoms at that time and when called (30 min after using Zyrtec) and she states the swelling was almost completely resolved. Advised to use Zyrtec in the AM and Benadryl in the PM for the next 5 days.  Go to the ER if symptoms start worsening
Dizziness, Nausea, Vomiting, Positional Vertigo, Equilibrium Problems, Headaches
Erythema, warmth, swelling about 20cmx10cm around site of injection. No fever.
3 times Emergency Rooms. 6 days Hospital Stay. 6 days In House Rehab.  5/13/09 hospital records received DOS 12/4/08-12/9/08. FINAL DIAGNOSIS: Guillain Barre syndrome, hypertension, urinary retention, constipation, hyponatremia At time of vaccination c/o ear fullness and sinus pressure. Post vaccination tingling in hands feet back, facial numbness. Bells palsy. Diffuse pain and weakness right side of face. Nausea, vomiting. Lower extremity weakness. Dysphagia. Administration of IVIG. Discharge to rehab facility for PT, OT, speech therapy.  5/15/09 Received ER medical records of 11/26 & 11/30/2008. FINAL DX: Bell's Palsy 11/26/08 records reveal patient experienced sinus infection & tx w/oral antibiotic by PCP.  Developed weakness & numbness to left facial area & paresthesias of hands & feet.  Tx w/steroids, antivirals & patching.  Referred to PCP.  11/30/08  FINAL DX: neuropathies of UE & LEs Records reveal patient experienced increased & progressive stinging/burning pain & tingling of arms & legs & returned to ER twice this date.  His pain interferred w/sleep.  Tx w/pain meds w/good results & d/c to home on steroids & neurontin & referred to PCP.  7/1/09 Neurology consultant records received DOS 12/4/08 to 5/21/09. Assessment: Post infectious polyneuropathy/Guillain-Barre sundrome. Patient presents with bilateral facial weakness, tingling, and numbness of all 4 extremities, increasing weakness of lower extremities. Speech impaired. Reflexes absent. Diminished vibration sense. Difficulty walking. Cranial nerve 7 loss of function. Hyponatremia.