chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 81 y.o. male with history of PVD,T2DM, CKD Stage III, hypertension, AAA rupture w/ open repair, iliac artery stenosis s/p R iliac artery stent (2006), and left popliteal artery psa s/p angiogram, who presented to Hospital 9/22/2023 for left foot pain found to have LLE popliteal artery occlusion. Vascular surgery and peripheral cardiology evaluated, s/p angiogram on 9/25/23 showed extensive chronic limb threatening ischemia in the L popliteal and proximal PT arteries, as well as left external iliac artery stenosis. Course was complicated by COVID PNA on 9/28 for which he completed a 3 day course of Remdesivir. Vascular surgery initially planned for left femoral to posterior tibial bypass with saphenous vein and iliac stenting but procedure was re-scheduled due to patient being in COVID isolation. Patient will be discharged on Eliquis, has follow up with Vascular surgery on 10/12/23.
Fatigue; Nausea; Arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 07-Feb-2021, the patient experienced FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm soreness), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved.        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.
Vaccine dose #1 given 4/3/2021 Lot # EW0151 Pfizer  Patient had a cardiac arrest at home at died in the ED. Not a covid related death.
Redness, swelling, and pain around site of injection.  Mother stated that started on 10/22/2013 and thought would improve.  Mother contacted clinic on 10/24/2013.  Pt had no noted fever.  Temperature was 97.6 in the clinic.
Patient received first dose of Astra-Zeneca COVID-19 vaccine prior to moving. Patient requested to complete the primary series now. Based on World Health Organization recommendations, the provider was advised that the series could be completed with either of the mRNA COVID-19 vaccines (Pfizer or Moderna). The patient was vaccinated with the Moderna COVID-19 vaccine. After administration of the vaccine, reporter was notified that the patient should have received the Pfizer-BioNTech COVID-19 vaccine to complete the series based on the CDC Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized. Patient has not reported any adverse effects since receiving the Moderna COVID-19 vaccine.
I had the vaccination on March 11 and got tested on March 15 for COVID. On March 16th. I was advised that I was positive. I did not initially have symptoms. I had severe nausea and ringing in my ears. Both ears were very annoying. It got bad enough that I began checking my side effects on other medications I was taking but was unable to find anything related. I tolerated it as best as I could. It started getting a little better but its not always as intense. Some days it is worse than others. Today is one of the days that I have the bad ringing in my ear. I have a hearing test scheduled but had to cancel because I ended up in the hospital for pneumonia. I rescheduled it for April 4.
Pfizer 5-11 dose given instead of Pfizer 11+ This was a booster dose
PATIENT EXPERIENCED SYNCOPE WHILE SITTING IN A WAITING AREA CHAIR, APPROXIMATELY 3-4 MINUTES AFTER RECEIVING VACCINE.  THE PHARMACY STAFF RUSHED TO HIS ASSISTANCE, 911 WAS CALLED, AND STORE MANAGEMENT ASSISTED.  HE WAS AWAKE A FEW SECONDS LATER AND DAZED.  WE MONITORED THE PATIENT UNTIL PARAMEDICS ARRIVED.  HE WAS IN GOOD SPIRITS AS HE LEFT WITH THE PARAMEDICS FOR FURTHER MEDICAL ASSISTANCE DUE TO A CUT ON HIS CHIN,ETC.
seizure; fever; her daughter may have known allergies to that could be present to the administered vaccine; This spontaneous report was received from a consumer who was also the patient's mother, concerning a currently 16-year-old female patient. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  In approximately 2005 reported as "when the patient was 12-months old", she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), prophylaxis. Ten days post-vaccination of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), the patient experienced multiple seizure. In addition, she developed a fever (pyrexia) that did not resolve immediately. The reporter further stated that her daughter might have a known allergy that could be present to the administered vaccine (allergy to vaccine).   At the time of the report, the patient had recovered from pyrexia. However, the outcome of seizure and allergy to vaccine was unknown.     The causal relationship between the event of allergy to vaccine and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was related. No causality assessment was provided regarding the other events and the suspect vaccine.    Upon internal review, the event of seizure was determined to be medically significant.
15 hours after I recieved the injection I took my evening medications. Topamax, mobic, black cohosh, dong quia, frankincense and turmetic. I delveloped a burning sensation all over my body and itched all over including my eyes and bottom of my feet. Nothing including cold water helped this feeling. I called the hospital which told me this was an allergic reaction to something. I have been taking these medications for over a  year. I couldn't go to the hospital because of being the crisis hotline person being on call with my job. I then took two of my morning medications zyrtec and singerlar and soaked in an oatmeal bath which relieved the symtoms. When I woke up this morning my eyes still burned and were feeling itchy as well as my arms. I put bendryl creme on them and took a ativan. I work as a mental health professional I seen a nurse at work this morning who checked me out stated to continue doing what I already am if the feeling continues I need to go back to health department in morning to report it to them and get checked out by the doctor and I should d/c the herbal medications in case it's causing the allegic reaction.
24 hrs of Flu like symtons. Sever joint pain that endures to this day  4/23/21. I can barely curl my fingers and pain in both elbows. wrists and shoulders I was given steroid  shots and knock down the pain last given on 4/18 but pain is back. I am nearly a cripple
she has tinnitus/felt like someone was blowing a leaf blower/There were sounds; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (she has tinnitus/felt like someone was blowing a leaf blower/There were sounds) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 016B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced TINNITUS (she has tinnitus/felt like someone was blowing a leaf blower/There were sounds). At the time of the report, TINNITUS (she has tinnitus/felt like someone was blowing a leaf blower/There were sounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
pt devel cellulitis @ site of Td immunization;6cm area of erythema & tenderness lt deltoid;
Red itchy bumps up and down left arm; White sores in mouth; Seems like an allergic reaction
Trouble sleeping; Felt it going through the left side of her body like a warm flow; Pain in her left hip; Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg; Pain under her arm, into her armpit; Pain spread in the left side of her back, described as nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Pain spread in the left side of her back, described as nerve pain), INSOMNIA (Trouble sleeping), FEELING HOT (Felt it going through the left side of her body like a warm flow), ARTHRALGIA (Pain in her left hip) and MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced NEURALGIA (Pain spread in the left side of her back, described as nerve pain). On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (Felt it going through the left side of her body like a warm flow), ARTHRALGIA (Pain in her left hip), MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) and AXILLARY PAIN (Pain under her arm, into her armpit). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping). The patient was treated with Physical therapy (Massage unit) for Neuralgia and Physical therapy (Massage unit) for Myalgia. On 17-May-2021, FEELING HOT (Felt it going through the left side of her body like a warm flow) had resolved. On 31-May-2021, AXILLARY PAIN (Pain under her arm, into her armpit) had resolved. At the time of the report, NEURALGIA (Pain spread in the left side of her back, described as nerve pain), INSOMNIA (Trouble sleeping), ARTHRALGIA (Pain in her left hip) and MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) had not resolved.            Concomitant medication was not reported.  Treatment medication was not reported.
Can I take second after 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient miscalculated time for his/her second Shingles shot. The patient asked could he/she take his/her second shot after 6 months. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.
pt recv vax 19MAY97 & 20MAY97 pt was irritable & devel 3 vesicles & fever of 101;
Information has been received from a physician concerning a 20-month-old white female with a history of respiratory distress syndrome (RDS) at birth and no allergies who on 20-OCT-2005, at approximately 1000, was vaccinated SC in the left leg with the first 0.5 mL dose of Varivax (Lot #651045/0324R). There was no concomitant therapy or illness at the time of vaccination. The physician reported that in June 2006 (also reported as approximately 01-JUL-2006), the patient developed a possible zoster-type rash on the back of her right leg and a blister on her right calf. The blister started to resolve and then became a "patch" of about 1.5-2 cm in diameter with vesicular lesions and some scabs. There was no recent exposure to chickenpox or shingles. On 01-AUG-2006, the patient was seen by the physician. At that time, the patient presented with a cluster of tiny red papulo-vesicular lesions with small central vesicles/scabs (not large enough to extract fluid). She had a maximum temperature of 99.5by ear, but no other systemic symptoms. A PCR swab of a lesion on her left leg/calf was sent for analysis. On 16-AUG-2006, the patient was noted to be recovered. Interpretation of the PCR swab indicated an inadequate specimen, negative for B-globin, no strain I.D. VZV DNA was not amplified. Additional information is not expected.
The patient became pale and light headed within minutes of his vaccination.  He also reported his vision dimmed.  He reported he has a history of this reaction with any injection.  We gave him water and took his blood pressure, it was initially 69/58 with a pulse of 46.  Five minutes later it was 164/93 with a pulse rate of 41.  Five minutes later it was back down to 82/50 with a pulse of 87. Five minutes later he was feeling better, his color and site normalized and his blood pressure was 117/70 with a pulse rate of 69.  We let him sit for a while longer and when he was comfortable he got up, walked around, and left.
Patient fully vaccinated with pfizer 2/22/21 and 3/15/21 and admitted to the hospital with COVID pneumonia. Patient was placed on Dex 6mg PO QD x10d remdesivir. She completed remdesivir treatment. Patient did well with treatment. Patient also with Acute Hypoxemic RF Secondary to Covid pneumonitis. Was placed on oxygen.  She is now weaned down to 1 L nasal cannula.
GVHD in leg muscles. Treated with prednisone, Sirolimus. Physical Therapy.
This initial spontaneous report was received from an office manager referring to three patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unspecified date in approximately 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # L024129 with expiration date 21-JAN-2017; dose and route were not provided). The reporter stated that since 28-SEP-2015, the patients experienced adverse reaction to receiving a dose of the vaccine and reported severe swelling, redness, and warmth in the hand of the arm that received the PNEUMOVAX 23. The patients sought medical attention (called the physician office). Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the events mentioned above was unknown. The relatedness between the events to PNEUMOVAX 23 was not reported. Additional information has been requested.
This spontaneous report was received from a medical student concerning a patient of unknown age and gender who on 25-JAN-2013 was vaccinated with a dose of ZOSTAVAX (lot number H011331, expiration date 08-SEP-2013) (route not provided) that was exposed to 20F for 552 hours. NO adverse event reported. This is one of several reports received from the same source (Other MAARS number 1302USA001215, 1302USA000400, 1302USA001214). Additional information has been requested.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 03-AUG-2017 the patient was vaccinated with PROQUAD lot # M033209 for prophylaxis. Other suspect therapies included sterile diluent and VARIVAX. On 03-AUG-2017, 1 day after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration to be not related to PROQUAD, VARIVAX and sterile diluent. The reporter considered no adverse event to be not related to sterile diluent, PROQUAD and VARIVAX.
pt recv vax 15 or 16AUG97 & in 1997 pt devel varicella w/approx 1 to 10 lesions;
Myalgia, Fever, injection site pain, fatigue Narrative: Employee reports injection site pain, fever (100 F), body aches, and fatigue. No medications taken. All symptoms have resolved.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 16-MAR-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # K010465 with expiration date of 23-MAR-2016; dosage and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache. Extreme muscular and joint pain in entire body. The pain was incredible.  Burning skin. Chronic tiredness. Difficulty breathing. Abdominal pain. It was very bad. Now 6 weeks post still joint pain and muscle pain. Have new thing that started on 10/02/2021
Inflammation Sciatic Nerve; Stabbing pain right hand, left knee, left arch; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL NERVE LESION (Inflammation Sciatic Nerve), PAIN (Stabbing pain right hand, left knee, left arch) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025C21A) for COVID-19 vaccination.     The patient's past medical history included Sacroiliitis (lasted for months.), Radiculopathy (Patient had 2 pinched nerves. he felt electric shocks every time he moved during sleep and upon walking which lasted for 2 months and in middle of August, the pain had resolved) and Accident automobile (The patient was injured in 2002, in a car accident) in 2002. Previously administered products included for an unreported indication: FLU (flu shot every year.).   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Stabbing pain right hand, left knee, left arch). On 06-Jun-2021, the patient experienced PERIPHERAL NERVE LESION (Inflammation Sciatic Nerve). In 2021, the patient experienced CHILLS (chills). At the time of the report, PERIPHERAL NERVE LESION (Inflammation Sciatic Nerve) was resolving, PAIN (Stabbing pain right hand, left knee, left arch) outcome was unknown and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information provided by the reporter includes that he had experienced electric shock on left side of body radiating from left buttock to foot. Symptoms were continuing every day upon walking. After treatment and chiropractic therapy the pain had shifted to right side but less severe. Patient had reported that he took Steroids for treating severe left side pain. He also stated that after 2nd dose of vaccine, he had experienced stabbing pain in left knee in middle of night and radiated towards left foot which continued for 30 minutes.  Additional information includes for lab data where patient had underwent Ultrasound test on an unknown date and results were inconclusive.  Treatment information was not provided by the reporter.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of unusual crying in a 9-week-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). The subject's medical history included prematurity. Concurrent medical conditions included cow's milk intolerance, rectal bleeding and reflux (nos). Concurrent vaccination included haemophilius influenza type b;manufacturer unspecified;unknown;unknown;unknown given on 26 March 2013; pneumococcal (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 26 March 2013; rotovirus (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 26 March 2013. Concurrent medications included PRILOSEC. On 26 March 2013 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, unknown thigh). On 26 March 2013, "within 1 hour" after vaccination with PEDIARIX, the subject experienced unusual crying. The "unusual crying" lasted for more than 3 hours and was "on and off for 2 to 3 days." At the time of reporting, the nurse practitioner reported that the adverse event "may lead to discontinuation of the pertussis-containing vaccines for this" subject. On 29 March 2013, the event was resolved. Follow up was received from reporter on 10 June 2013. The nurse practitioner reported that the adverse event resolved after 5 days on 31 March 2013. which was previously reported as resolved after 3 days on 29 March 2013. The reporter did not consider this case to be serious. The healthcare professional documented that the event was not associated to a congenital anomaly or birth defect and was did not jeopardize the subject or require intervention. The healthcare professional stated that the subject experienced "red area at vaccine site/ leg only. 'Normal per mom' not extreme ." The healthcare professional also documented that the subject was "not consolable with crying after vaccination. Then after that was fussy on and off [fussiness] and not herself [not well being] for at least 5 days." By 1 April 2013, the subject was normal. The healthcare professional documented that on 3 May 2013, 38 days after vaccination with PEDIARIX, the subject experienced "similar event" of unconsolable crying that lasted for 2 hours. The subject was seen on 4 May 2013 and had a viral rash or urticarial rash per the reporter. The reporter also stated that the "following day asymptomatic." On 20 May 2013, they subject received ROTATEQ and experienced fussiness for "20 min then okay." On 31 May 2013 the subject was given PREVNAR and had no reactions. The reporter stated that DTAP series has been interrupted and documented that they are "withholding DTAP vaccine until seen by neurologist per the mom request." The reporter also stated that they are "giving vaccines one at a time."