chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shot site is hard; shot site about 2 inches long; shot site hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (shot site is hard), VACCINATION SITE SWELLING (shot site about 2 inches long) and VACCINATION SITE PAIN (shot site hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (shot site is hard), VACCINATION SITE SWELLING (shot site about 2 inches long) and VACCINATION SITE PAIN (shot site hurts). At the time of the report, VACCINATION SITE INDURATION (shot site is hard), VACCINATION SITE SWELLING (shot site about 2 inches long) and VACCINATION SITE PAIN (shot site hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up received on 26-May-2021 No new information.
Dizziness, burning sensation (whole body), nausea, sweating -> symptoms lasted 45 min-1 hour.
Received vax on 30OCT90 awoke from nap screaming, no fever; crying & screaming for 6-8 hrs, high pitched, squealing, according to mom. Also had redness & swelling of thigh, resolved w/compresses. Child fine next day 31COT90.
I received 3 vaccinations: (4/29/99; 6/8/99 and 5/9/00). Shortly after the 1st vaccination, I started with joint pain and stiffness and it is still getting worse. I tried physical therapy, Celebrex and Vioxx without results. I have been in excellent health before. Information received on 10/10/02 in a 60 days follow up report states, "Severe joint pain and inflam, arthritis."  Annual follow up on 08/05/03 reports : "Patient did not recover from adverse events.  Severe arthritis-like pain like I'm paralyzed."
VACCINE ADMINISTERED THAT WAS AT ROOM TEMPERATURE FOR MORE THEN 6 HOURS; VACCINE WAS STORED AT  ROOM TEMPERATURE FOR MORE THAN 6 HOURS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered that was at room temperature for more then 6 hours, and vaccine was stored at room temperature for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered that was at room temperature for more then 6 hours and vaccine was stored at room temperature for more than 6 hours was not reported. This report was non-serious.
I developed a moderate headache approximately 01:00PM on 04/08/2022 that did not go away. It was not responsive to TYLENOL. After having it for about a month, I went to a neurologist and I had a full neurological work up. There was no resolution and no treatment. There was no pathology in my scan. The headache lasted a total of nine weeks and then it went away.
pt recvd vax & was found dead @ home 11:23 as on 21DEC92; 23DEC92 autopsy determined COD to be arteriosclerosis, gen, severe, w/moderately stenosing calcific coronary atherosclerosis;
patient was having severe all filed a for days, continues to worsen.  Pain and stiffness on elbows, wrists, knees, fingers, upper and lower back.  No swelling.  Has developed fever to 100.  Has been taking ibuprofen 800 mg 4 times a day with minimal relief.
became unresponsive; hemorrhagic shock; syncope; abdominal pain; wasn't feeling good; nausea; vomiting; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope), ABDOMINAL PAIN (abdominal pain), FEELING ABNORMAL (wasn't feeling good), NAUSEA (nausea) and VOMITING (vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Splenectomy (did get embolization but progressed to further bleeding) on 24-Apr-2021.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (became unresponsive) (seriousness criterion hospitalization), SHOCK HAEMORRHAGIC (hemorrhagic shock) (seriousness criterion hospitalization), SYNCOPE (syncope) (seriousness criterion hospitalization), ABDOMINAL PAIN (abdominal pain) (seriousness criterion hospitalization), FEELING ABNORMAL (wasn't feeling good) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). The patient was hospitalized on 21-Apr-2021 due to ABDOMINAL PAIN, FEELING ABNORMAL, LOSS OF CONSCIOUSNESS, NAUSEA, SHOCK HAEMORRHAGIC, SYNCOPE and VOMITING. At the time of the report, LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope), ABDOMINAL PAIN (abdominal pain), FEELING ABNORMAL (wasn't feeling good), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Imaging procedure: (abnormal) abd imaging showed a large splenic subcapsular hematoma of unclear etiology (no hx of trauma) with hemoperitoneum.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABDOMINAL PAIN (abdominal pain), NAUSEA (nausea) and VOMITING (vomiting) to have an unknown relationship. No further causality assessments were provided for LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope) and FEELING ABNORMAL (wasn't feeling good).    Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provide at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provide at this time. Further information has been requested.
Pt did not think that he had the pfizer bivalent booster yet- did not think he had his vaccine card with him. Said that his last vaccine was over 2 months ago and that it was Pfizer but the first 2 vaccine he got were Moderna. Vaccine given, then patient found documentation stating that he had the pfizer bivalent booster already exactly 2 months ago. Informed pt that he got an additional dose of the bivalent booster when it was not needed and gave him documentation to take home with him stating that he got that vaccine at my clinic given by me on todays date.
Patient is pregnant and received the first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history information was provided.  The patient's past medical history included Pregnancy (live full-term baby) on 18-Oct-2018. Concurrent medical conditions included Drug allergy (Amoxicillin) and Drug allergy (Dramamine). Concomitant products included QUETIAPINE for Insomnia, PRENATAL MULTIVITAMIN + DHA for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 16-Oct-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pregnancy test: positive (Positive) Pregnancy test was positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Began with pain, stiffness, swelling, warmth at injection site. Developed into redness, pain, swelling, warmth at injection site and fever.
Like usual after vax, jogged for 3 1/2 hours with 2-3lb weights. At 2p had lunch and became nauseous, dizzy and weak so went to sleep. Woke up at 6pm and only ate some dinner because felt physically exhausted and woke up by noon next day. Problems resolved, no recurrence since then. No pain at site of injection or scratchy throat.
PATIENT STATED SHE WAS EXPERIENCING SEVERE PAIN IN THE LEFT ARM MUSCLES, EXTENDING INTO HER NECK, AND DOWN HER LEFT SIDE. PAINFUL TO TOUCH AS WELL AS MOVEMENT. SHE TRIED IBUPROFEN AND ACETAMINOPHEN WITH NO RELIEF. WAS GOING TO TRY LIDOCAINE SPRAY. WILL BE CONTACTING PCP FOR FOLLOW-UP.
One of five pt (B/W JUL-AUG 1990) experienced an inject site rxn which included erythema & swelling. Tx included ice packs @ site of inject & Tylenol PRN. Pt was afebrile.
Local reaction left deltoid area approx 4 inches diameter, red, warm, swollen. Denies discomfort.
second COVID vaccine on 1/13/2021.  Had a vaccine reaction on 1/14/2021  facial numbness, nausea & vomit x 5 days, chills, fever, HA.
Fever to 102.5 despite tylenol myalgias spontaneous bleeding from gums and in stool easy bruising/spontaneous bruising red spots[2-4mm] rash on face/neck/torso/arms/legs
Aprox 12 hours after vaccination onset of symptoms began. They included: fever (>101F), extreme muscle weakness throughout the entire body (to the point that I could not walk fully upright), muscle and joint pain, extreme drowsiness, severe headache (8/10 for pain), mild confusion, resting HR >100bpm (my resting HR is normally 50s-60s), SOB with ambulation, moderate, intermittent nausea, SpO2 remained >96% throughout. Around 1400-1500 9/29 I was able to make it to an urgent care where on arrival, and after just a slow walk from the car, my HR was 153bpm. They performed an EKG and recommended I go to the hospital. I managed to drive myself to the hospital where I was seen in ER. 1L of lactated ringers was given along with doses of Toradol, Zofran and Tylenol. Repeat temp checks were taken and temp was continuing to go down and I began feeling much better after the LR infusion.
Information has been received from a registered nurse concerning a female patient with a history of splenectomy who on 15-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided, expiration date on 16-JAN-2011). It was reported that on 02-JUL-2010 the patient experienced shingles. The nurse reported that on 08-OCT-2010 the patient still had a rash (location unspecified), redness, and swelling of her ear. The patient was being treated with NEURONTIN. At the time of this report, the patient's outcome was unknown. The patient sought medical attention at the physician's office. Follow-up information has been received from a completed questionnaire from a registered nurse concerning a 79 year old female patient with a history of chickenpox and no allergies (medications, food, other), who on 15-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 664628/1018Y) into right upper arm. Concomitant medications included prednisone, methotrexate, and leucovorin calcium. On 02-JUL-2010 the patient developed shingles. The patient had a rash in right breast to back right ear. The rash did not occur at the site of injection. The lesions were diffuse and distribution was linear putting. The patient had not recent exposure to chickenpox. Physician conclusion: the right ear was swollen, red, and painful in the eye and ear. The patient saw the physician of mom and stated that the patient should not have gotten shingles vaccine since she had a splenectomy 7 years ago. The patient was recently diagnosed in July 2010 with relapsing polychondritis. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On an unspecified date the sample was obtained from vesicle/lesion. The patient recovered from chickenpox on an unspecified date. Additional information is not expected.
This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 that were exposed to a fridge excursion on 21-JUL-2017 (lot # L011846 expiration date 16-JUN-2017, lot# L040459 expiration date 08-MAY-2017, lot# 026602 expiration date 19-OCT-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Headache - started within 2 hours of vaccination (14 May 2021). Chills - started approximately 8 hours and last 4 hours (14 May 2021). Headache - started on the morning of 15 May 2021 & encompassed entire head, but more painful in the sinus area.  Lasted entire day and was reduced after taking 600 mg ibuprofen  x 2 times during the day. Fatigue - slept the entire day on 15 May 2021 and then slept through the night into 16 May 2021. Nausea - stomach was upset but was not able to vomit on 15 May 2021. Fever - no fever, but it is very seldom that I have a fever. Muscle/joint pain was minimal.  On 16 May 2021 the only side effect is weakness but this might be contributed to the lack of eating on 15 May 2021 due to the nausea.  In contrast to the first vaccine given on 16 April 2021 where I was just tired on the next day the side effects from the 2d vaccine were strong.
Delayed onset dizziness/ lightheadedness; Warm spot on arm; Swollen spot on arm; Red spot on arm; Knee pain when bending; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Delayed onset dizziness/ lightheadedness), VACCINATION SITE WARMTH (Warm spot on arm), VACCINATION SITE SWELLING (Swollen spot on arm), VACCINATION SITE ERYTHEMA (Red spot on arm) and ARTHRALGIA (Knee pain when bending) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020. Previously administered products included for COVID-19: Remdesivir in September 2020 and Monoclonal antibodies in September 2020. Concurrent medical conditions included Fibromyalgia (She has fibromyalgia mostly in her upper body (not related to the vaccine).).    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ARTHRALGIA (Knee pain when bending). On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm spot on arm), VACCINATION SITE SWELLING (Swollen spot on arm) and VACCINATION SITE ERYTHEMA (Red spot on arm). In February 2021, the patient experienced DIZZINESS (Delayed onset dizziness/ lightheadedness). At the time of the report, DIZZINESS (Delayed onset dizziness/ lightheadedness) had not resolved, VACCINATION SITE WARMTH (Warm spot on arm), VACCINATION SITE SWELLING (Swollen spot on arm) and VACCINATION SITE ERYTHEMA (Red spot on arm) had resolved and ARTHRALGIA (Knee pain when bending) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   The concomitant medication was not provided.  The patient was admitted to hospital for a short while  for COVID-19 in September 2020 and received monoclonal antibodies and remdesivir. It was over 90 days since she had COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Initial additional additional follow up received. no new information was added.
Pt died on 1/31/22 Early in the the morning of 1/31 she developed trach site bleeding and shock requiring a pressor. PRBC and FFP were ordered. MD saw her around 6AM and made numerous changes to her plan of care. She was seen by ENT and bleeding was felt to have stopped. A little later in the morning she suffered brady-PEA arrest, code called, ACLS/BVM, Vfib, defib x1, then persistent brady PEA. No pulse after 17 minutes resuscitation. Cause of death: Strokes Due to: COVID-19 infection Other contributing factors: Acute blood loss anemia, trach site bleeding, COVID-19 pneumonia, sepsis, UTI
1. Superior branch retinal vein occlusion diagnosed 6/24/2021 - initial symptoms of right eye blurriness/haziness started one week prior. No treatment required at this time, retinal specialist is following. 2. Hashimoto's Thyroiditis diagnosed 8/18/2021.  Palpitations severe enough for an ED visit on 8/8/2021, follow up labwork concluded diagnosis. No treatment at this time.  Endocrinology appointment is pending.
RotaTeq given on 9/30/22 and had expiration date of 9/20/22.  No adverse reaction
Admission Date: 4/28/2022 Discharge Date: 5/4/2022  Condition on discharge: Stable  Patient is a 87 y.o. male with PMH of HTN, Paroxysmal afib on Eliquis, complete heart block s/p AICD placement, recent admission on 3/20 for (type B aortic dissection with intramural hematoma and subsequently admitted to cardiothoracic surgery for continued management. Over course of hospital stay patient developed DVT and was started on Eliquis. Patient was subseqntly treated and realeased on 3/29.               He presented to the ED on 4/28 with worsening exertional dyspnea and productive cough. Patient arrived to the ED in respirtaroy distress satting to the 80s in nonrebreather. Patient was started on BIPAP and improved. A chest xray showed pulmonary edema. Patient was subsequently admitted to the hospitalist medicine team for further medical management. Patient also found to be positive for COVID-19 pneumonia. Patient treated with 5 days of IV remdesivir and 7 days of Decadron. He should finish 4 more days of po Decadron 6 mg daily. He was weaned to RA, and did not require any home O2 at discharge. He was evaluated by PT/OT and was discharged home with HHC.   Patient was also found to be hypertensive to systolic blood pressure to the 200s and placed on a nitroglycerin drip. Patient weaned off nitroglycerin drip as blood pressure improved with BiPAP and IV Lasix.  Cardiology consulted increased hydralazine for improved blood pressure control.    Of note spoke with outpatient vascular surgery team no need for inpatient CT angiogram thorax they have arranged outpatient follow-up for repeat imaging and follow-up visit with vascular surgery has been scheduled.
Skipped menstrual cycle. I am not pregnant, it would be impossible due to no intercourse and permanent birth control. As of this writing, I am 7 days late for my normal cycle.
Developed a hot, red rash on left side of neck that spread and go worse since vaccine and now has a lump on neck too and painful.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 10:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 10:44 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant products were not provided.  On 27-Feb-2021, Excursion time was 09 AM, temperature was 33, Excursion time was 11 AM, temperature was 35, Excursion time was 12 PM, temperature was 35, Excursion time was 01 PM, temperature was 35, Excursion time was 02 PM, temperature was 35, Excursion time was 03 PM, temperature was 34, Excursion time was 04 PM, temperature was 34, Excursion time was 05 PM, temperature was 35, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-FEB-2021, vial was moved to clinic on 27-FEB-2021. 20 vials were sent to clinic. Vaccine BUD date was 23-Mar-2021. On 27-Feb-2021, vials were stored in cooler   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Marked swelling & redness - entire (L) arm shoulder to elbow within hours of shot some pain. No fever, no SOB, no wheezing.
Redness, pain and warm to touch at injection site.  Pt states size was around 3inches long.  No fever noted.
Hives and welts day after the vaccine. Took Benedryl and Pepcid
One day post vax the pt called the health department stating that when son woke up in the morning his upper lip was swollen. No difficulty breathing or swallowing. .