chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days after the 2nd dose, I developed a severe right knee pain sudden onset. I took Motrin and went to sleep. When I woke up the pain went from 9/10 to 2/10. It resolved on its own. A couple days after, I developed vaginal bleeding which lasted about 4 weeks. About 3 weeks later, my generalized pain became more severe than it had initially been. It was a dark blood but has since resolved. In June, I had a primary care appointment, I had tests done for inflammatory markers etc. I went to rheumatology and the levels were still elevated. My ANA was also positive. I've been on prednisone for 3 months. That is for the inflammation. I am also on Plaquenil due to the psoriatic arthritis diagnosis. I had really bad ankle swelling as well. I was taken on amlodipine but that did not help. I am now on another blood pressure medication called spironolactone. I am still in a lot of pain and on a lot of medication. The pain is mostly joint pain. I also started taking turmeric as a supplement to help with the inflammation.
Redness at injection sore and swelling; still have redness 7 days after injection.  Extreme fatigue; flu like symptoms.  Had to go to bed for the day, the day after injection.
Patient is deceased (12.3.21);  hospitalized (11.23.21);  COVID-19 positive (11.26.21); fully vaccinated  Discharge Provider: Primary Care Physician at Discharge: Admission Date: 11/23/2021 Date of Death: 12/3/21 Time of Death:  6:46 AM Preliminary Cause of Death: Congestive heart failure (CHF) (HCC) DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Debility [R53.81] Weakness [R53.1] Noninfected skin tear of leg, right, initial encounter [S81.811A] Skin tear of left forearm without complication, initial encounter [S51.812A] Acute respiratory failure (HCC) [J96.00] HOSPITAL COURSE:  The patient is 97 y.o. female who presented with a mechanical fall. She lives independently and has a care aide who sees her three times weekly. She fell and her daughter found her on the floor (unknown down time). She was then brought to the E.D. with a LUE laceration requiring sutures. Imaging of the right femur, pelvis, and chest was unremarkable. She was able to ambulate in the E.D. with a walker but couldn't get on and off the toilet without assistance. Her family stated they can't care for her at home and the patient was admitted to the hospital. The patient was evaluated by PT/OT and they recommended SAR. Patient declined and the plan was to discharge her to assisted living facility. However, she developed a mild cough. Her care aide reported she had tested positive for COVID. COVID testing was done and patient was positive for COVID-19, not hypoxic so was not started on decadron. On 11/30/21, the patient developed respiratory failure and tachycardia. Chest x-ray showed cardiomegaly with bilateral pulmonary congestion and bilateral lung haziness in addition to left-sided lower lobe atelectatic changes, findings were worrisome for pulmonary edema versus an infectious/inflammatory process. The patient was given 20 mg of IV Lasix. Telemetry showed sinus tachycardia with frequent PACs versus atrial fibrillation.  The patient was started on Cardizem. The patient developed hypotension and RAP was called. The patient was lethargic, tachypneic and tachycardic. She was in respiratory distress. EKG was done and showed tachycardia. EKG findings were discussed with Cardiology and they felt that EKG shows Sinus tachycardia vs SVT vs atrial fibrillation. This was discussed with her daughter over the phone and daughter decided to progress with comfort care. The patient was transitioned to comfort care. Palliative care and hospice were consulted to assist with comfort care. The patient passed away on 12/3/21 at 06:46 am.
pt recv vax 17AUG98 & w/in 2 days post vax pt exp arthralgia & presented to MD office;arthralgia has persisted;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-SEP-2013 the patient was vaccinated with M-M-R II (lot# H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes. No know adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Felt hot all over and flushed right away with nausea. Within an hour I was fatigued, throwing up, and had a headache starting. After getting home from hospital I went to lat down and didn?t wake up for 17 hours. My body ached, my ribs hurt, and I had trouble saying awake for periods of time. This lasted for 3 days.
Itching/Rash and itching moved up legs, onto stomach and back.; Rash/Rash and itching moved up legs, onto stomach and back.; feet and hands red and swollen; feet and hands red; Throat tightness; Swallowing felt tight; This is a spontaneous report from a contactable other healthcare professional reporting for himself. A 46-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 12May2021 (Batch/Lot Number: EW0168) as single dose (at age of 46-years old) for covid-19 immunization. The patient concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot Number EW0153) via an unspecified route of administration, administered in Arm Right on 21Apr2021 as single dose for covid immunization. No other vaccine in four weeks, and no other Medications in two weeks. Patient was not diagnosed COVID prior to vaccination. No covid tested post vaccination. Known allergies reported none known. Other medical History was none. On 13May2021, the patient experienced less than 24 hours post 2nd shot, feet and hands red and swollen and itching. Rash and itching moved up legs, onto stomach and back. Throat tightness and swallowing felt tight. Continued for several days and had to seek medical treatment with steroids and hydroxyzine. Therapeutic measures were taken as a result of all events. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Pain in (R) shoulder that started after getting flu shot. Initially felt this was usual soreness but now unable to lift (R) arm above shoulder height or across upper body without experiencing increased pain. No obvious redness or swelling noted and arm cool to touch.
pt recv vax; cried for more than 3 hr inconsolably & would not nurse for more than 1 hr;would fall asleep briefly and wake up crying; feet warm to touch; T not taken;
I just received my first injection last night, I have a welt about 1in tall x 2in wide it is hot to the touch and it is raised above the skin. Other than that my arm hurts as I was warned it was. My chest feels heavy but I do not know id that is anxiety or the injection.
Pt vaccinated with DTP/OPV developed prolonged crying & irritability 8 hrs after lst DTP/OPV; Sibling of SIDS victim.
This spontaneous report as received from a Registered Nurse regarding a 5 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 09-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error).  Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, 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 dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING). At the time of the report, CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING) outcome was unknown. No concomitant medication were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of Humira was not working and flare up with Humira for co suspect Humira was not provided. No treatment details were provided. Company Comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, with reported Co-suspect product included non-company product ADALIMUMAB (Humira), who experienced non-serious, unexpected events of CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING) with vaccination with the dose 1 and dose 2 of mRNA-1273 vaccine. No other details regarding the events were reported. Event of Condition aggravated was reported as related by the reporter.  Outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, with reported Co-suspect product included non-company product ADALIMUMAB (Humira), who experienced non-serious, unexpected events of CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING) with vaccination with the dose 1 and dose 2 of mRNA-1273 vaccine. No other details regarding the events were reported. Event of Condition aggravated was reported as related by the reporter. Outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report.
superficial phlebitis; venous insufficiency; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. Medical history included blood clot. The patient stated that about 20-25 years ago she had a blood clot. She saw online that after 3-4 weeks some people had DVT, but it did not mention which vaccine (Pfizer or other). The patient's concomitant medications were not reported. The patient experienced superficial phlebitis and venous insufficiency on an unspecified date. The patient was asking if it is safe to receive the second dose. She said her doctor did not seem concerned with her getting the vaccine. She was due next Wednesday to have the 2nd dose. The patient was also asking if it is typical to have more side effects after the 2nd dose vs 1st dose; how long before getting symptoms, after getting the 2 dose; if people got blood clots after getting the vaccine; and how much immunity do they have after 1st dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Patient given first dose of COVID-19 vaccine at 11:04am.  Vial being stored in refrigerator had DO NOT USE BEYOND date of 10/14/21 at 0700 am.  Manufacturer (Pfizer) contacted and stated that they have off-label studies showing physical properties of vaccine are unchanged for 32 days.  Medical director consulted and does not advise re-administering vaccine.
hurting a lot; my arm was slightly hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm was slightly hurting) and PAIN (hurting a lot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (my arm was slightly hurting). On 25-Mar-2021, the patient experienced PAIN (hurting a lot). At the time of the report, PAIN IN EXTREMITY (my arm was slightly hurting) and PAIN (hurting a lot) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment products information was provided.
A non-serious, spontaneous report of eye blinking was received from a nurse, concerning a three year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 04-Nov-2008. Twenty four hours after administration the patient's eye started blinking and has not stopped. The outcome for the event was not resolved.
Miscarriage - MMR & varicella given 7/27/11 & 8/29/11. Positive pregnancy 9-13-11 (5-6 wks pregnant).
Pain in arm; Tenderness; Swollen arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), TENDERNESS (Tenderness) and PERIPHERAL SWELLING (Swollen arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included BIOTIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), TENDERNESS (Tenderness) and PERIPHERAL SWELLING (Swollen arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm), TENDERNESS (Tenderness) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown. Not Provided      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.   No Treatment information was provided.
Fever 101 degrees Friday night (11-17-06) and Saturday.  Severe pain left arm X4 days.  Redness at site.  Went to PMD today and is on antibiotic x 7 days.
Rash with intense itching for 21 days, general malaise and achyness for 10 days after shot.  This rash appeared in small red dots about 1/8th inch in diameter, showing in circles about an inch in diameter.  Extreme itch and soreness underneath the rash for sever days after which the rash would fade.  The worst on was under my left arm, went on for 5 days.
After getting vaccine and during the 15 minute wait, he became light-headed and started sweating profusely. He became pale and lips were white. Helped to lie down on matt, with feet in chair, and cool cloth applied to neck. Blood pressure was 100/64 and pulse was 64. After about 2 minutes, he said he felt better than when he first came in. I asked him if he had ever had this happen before and he said yes when he had blood drawn a few years ago. He was helped to sit up in a chair. He no longer had any light-headedness and his color was returning to normal. His lips were now pink. He was given a granola bar and water to drink. After staying for 20 minutes longer he left. He was called the next day by me and he said he had not had any light-headedness after he left.
5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms  5/26-5/27 trouble breathing, fatigue, light headed  5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots
Heart palpitations, pain at site of injection, fatigue that evening.  Next day  tired, tried to eat in evening but had to stop, felt like it would come back up,, cold but no fever, diarrhea , and pain at injection site. Wednesday=feel better pain at injection site now minimal, kept down oatmeal and more alert today.
this week my neck rings from time to time; neck pain\my left side woke up sore; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (neck pain\my left side woke up sore) and MUSCULOSKELETAL DISCOMFORT (this week my neck rings from time to time) in a female patient of an unknown age 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) at an unspecified dose. On 07-Sep-2021, the patient experienced NECK PAIN (neck pain\my left side woke up sore). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (this week my neck rings from time to time). At the time of the report, NECK PAIN (neck pain\my left side woke up sore) and MUSCULOSKELETAL DISCOMFORT (this week my neck rings from time to time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
itchy sensation in abdomen and head, headache, nausea, and facial flushing
had an expiration date of 7Nov2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 07-NOV-2022) for prophylaxis.   On 05-JUN-2023, the patient received Shingrix. On 05-JUN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: had an expiration date of 7Nov2022). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility was the same as primary reporter. Consented to follow up.  This case is linked with case US2023080474 and US2023080475, reported by same reporter.; Sender's Comments:  US-GSK-US2023080474:Same reporter US-GSK-US2023080475:Same reporter
15 minutes after injection, my lips were slightly numb. That reaction disappeared within 10 minutes. Four hours after injection, I became tired, with slight muscle aches. Eleven hours after vaccination, I woke with chills, fever, muscle aches, headache, and slightly sore arm. This lasted throughout the next day, with fatigue and an intensified headache, and a loss of taste (perhaps at 40% capacity). Two days after vaccination, I woke up with other side effects gone, but have a lingering headache and the loss of taste is still present. I do not see this adverse effect officially listed, but do see that others have experienced it. I will create another report to update on this adverse effect.
Motion sickness started 2 hrs post vaccination; nausea; Vomiting started 1 hr post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (Motion sickness started 2 hrs post vaccination), NAUSEA (nausea) and VOMITING (Vomiting started 1 hr post vaccination) in a 42-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 19-Nov-2023, the patient experienced MOTION SICKNESS (Motion sickness started 2 hrs post vaccination). 19-Nov-2023, the patient experienced NAUSEA (nausea) and VOMITING (Vomiting started 1 hr post vaccination). At the time of the report, MOTION SICKNESS (Motion sickness started 2 hrs post vaccination), NAUSEA (nausea) and VOMITING (Vomiting started 1 hr post vaccination) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
This spontaneous report was received from a healthcare worker refers to ten patients of an unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, ten patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L001327, expiration date 13-JAN-2017). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
I had sore throat, body aches, and I was very drowsy. After that I developed a cough and it was kind of difficult to breathe. I had a fever a few days later and I also had chilis. I felt very sore. I tested positive for Covid.
Pt rec'd 1st dose of Engerix-B on 31JUL90; Rec'd 2nd dose on 31AUG90; on 30SEP90 tested positive for Hepatitis B Surface Antigen; Hepatic profile was negative; Test repeated 2X at original lab w/ controversial results.  Another lab, was neg
Lump at injection site. Characteristics of lump: 2 inches in circumference, red, raised, hard, painful, itchy, warm to the touch.
Around noon on day after rash developed bright red, hot to the touch, about the size of palm of hand, noted to decrease in size as of 08/24/19 however severe flu like symptoms present and patient wanted to report event
Unreconstituted vaccine administered - patient experienced headaches, lightheadedness, and fatigue
Involuntary jerking / shaking of the head in a back and forth direction and sometimes only to the left.  I went to the Emergency Room, where I was diagnosed with "Bedtime Struggles" and they prescribed Keppra and Ativan.  From this point on Sunday night, the symptoms were not improving so my wife decided this was not right and very bizarre. She decided to rush me to hospital.  There was no treatment given but multiple tests were conducted.  I was released on Tuesday evening after the symptoms began to dissipate.  However, symptoms / shaking episodes continued until Monday, July 26th.