chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness; Mental changes; Mood changes; continuous side effects; Fatigue; Pressure on hips; Ringing in the ears; Uncontrollable muscle twitches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Pressure on hips), TINNITUS (Ringing in the ears), MUSCLE TWITCHING (Uncontrollable muscle twitches), ASTHENIA (Weakness) and MENTAL STATUS CHANGES (Mental changes) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 03A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Pressure on hips), TINNITUS (Ringing in the ears) and MUSCLE TWITCHING (Uncontrollable muscle twitches). On an unknown date, the patient experienced ASTHENIA (Weakness), MENTAL STATUS CHANGES (Mental changes), MOOD ALTERED (Mood changes), VACCINATION COMPLICATION (continuous side effects) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Pressure on hips), TINNITUS (Ringing in the ears), MUSCLE TWITCHING (Uncontrollable muscle twitches), ASTHENIA (Weakness), MENTAL STATUS CHANGES (Mental changes), MOOD ALTERED (Mood changes), VACCINATION COMPLICATION (continuous side effects) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Followup received : events were added and patient demographics were updated.Fatigue,Weakness,Mental changes,Mood changes, Continous side effects were the events and the outcome is unknown. Date of birth is updated in demographics.
Headache, Myalgia, Fever, NauseaVomiting, chills, fatigue Narrative:
approx 2yrs p/vax pt maculopapular rash. rpt MD noted that some vesicles were fluid filled.
Patient received 0.2mls of the adult Pfizer diluted with 1.3mls sodium chloride instead of the peds pfizer.
Felt flu like about 4-5 hours post shot. About 6 hours post shot started to lose muscle function in legs and arms, which got progressively worse over the course of the evening, and lasted for about 12 hours overnight day of the second dose shot. Could not roll over in bed, had to get assistance to go to bathroom and to change. Very scary. Could not lift arms up.
PATIENT HAD SEIZURE IN LESS THAN ONE MINUTE AFTER RECEIVING THIRD IMMUNIZATION.  IMMUNIZATIONS GIVEN IN THIS ORDER - MENACTRA, TRUEMBA, GARDASIL
FELT COLD AT NIGHT TIME; LOW GRADE FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 11-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced felt cold at night time. On 11-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, muscle aches, and felt cold at night time. This report was non-serious.
Freezing/chills, temp between  102 and 100 degrees, sweating,  really bad headache,  dizziness,  nausea, wheezing,  pain at the injection  sight, couldn't stay awake. No treatment  was unable to  get out of bed for almost  12 hours.  Temp at 100 now
Hyperthyroidism Iodine uptake decreased; Thyroiditis subacute; Blood thyroid stimulating hormone increased; Hyperthyroidism Iodine uptake decreased; Neck pain; Thyroxine free decreased; This is a spontaneous report from a non-contactable consumer or other non hcp. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 42-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hyperthyroidism iodine uptake decreased, thyroiditis subacute, blood thyroid stimulating hormone increased, neck pain and thyroxine free decreased. On an unspecified date, the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: increased, iodine uptake: decreased and thyroxine free: decreased. The time to onset was 3 days. The side effects lasted 3 days. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient reported a shell fish allergy that produces similar reactions. Patient has not taken Benadryl before and dose not own an Epi-pen.
No additional AE; administered IM instead of SC; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 11-DEC-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) intramuscular route (Incorrect route of product administration) lot number U024221 expiration date 04-AUG-2023 (dosage regimen was not provided) as prophylaxis.  No additional adverse event was reported.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa drugs, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other Medication in 2 weeks. Patient had known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
21 hours post vaccines was playing then collapsed seizing. Lasted 1 min. Stopped on own. EMS took to ER. Post ictal 20-30 min. U/A, CXR, CBC done in ER. All neg. Gave dose ROCEPHIN.
Information has been received from a pharmacist referring to a 60 year old female patient. Concurrent condition included pain. Past drug history was unknown. Medical history included no conditions weakening her immune system and no vaccines within the last week. On 28-AUG-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot # was L020482, expiration date 02-SEP-2016, strength unknown) and FLUVIRIN (Novartis), 0.5ml once intramuscularly (lot # 1514601, expiration date 01-MAY-2016, strength unknown). Her concomitant medication included possibly an unknown pain medication. On 29-AUG-2015, the patient experienced redness, swelling and hot to touch at the injection site, nausea, weakness and round welts. On 30-AUG-2015, she felt worse. On an unknown date, the pharmacist advised her to use a cold compress to alleviate the swelling, but it did not work. There was no lab performed. As of 30-AUG-2015, it was unknown if she would have the ZOSTAVAX or the FLUVIRIN again and the patient continued to experience worsened redness, swelling, and hot to touch at the injection site as well as nausea, weakness, and round welts. Causality between events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient had bruise on left arm. Slightly red and larger than the size of a quarter. Patient states no longer feeling any pain for the vaccine.
Twelve hours after the second dose I had severe body aches and joint pain all over my body. I had a fever of 102. Those symptoms lasted for 24 hours. I missed two days of work. One month after the shot my shoulder became painful and I was having trouble with the range of motion. I went to Urgent Care and it was diagnosed with Bursitis. One month after that I started to have tingling and pain in my feet. I returned to the Urgent Care and they told me I had a Morton's Neuroma. I was given Steroids but when the course ran out the pain returned. I then started to have pain in my left wrist in the mornings which would improve over the course of the day. My doctor checked my blood work for Rheumatology markers. I started to have joint pain and swelling in my hands and fingers. It was painful and then my ankles started to have problems. I currently have pain and swelling in my wrists, ankles, shoulders, hands and fingers. I have been prescribed Plaquenil but it is not working. My Rheumatologist has indicated some kind of inflammatory arthritis. She has indicated that it is very aggressive and I am still developing new joint problems.
Pt received another initial peds dose instead of the pfizer bivalent vaccine. No adverse reactions reported. Pt mother notified.
COVID ARM. Huge red area below the injection site of the Deltoid muscle darkening all the way down to the elbow and pooling there as a huge red arc. Painless with no itching.
1. Day of injection-pain at site.  2.  2nd day after injection-general body aches (flu-like), no URI sx x2 wks.  3. Noted numbness from injection site to finger tips, persists now. This is in follow-up to report(s) previously submitted on 2/14/2008; 4/7/2008. Initial and follow up information has been received from a licensed practical nurse concerning a 24 year old patient with a history of whiplash from a motor vehicle accident (resolved) and carpal tunnel) (resolved) and allergies to PENICILLIN, SULFONAMIDE and AZITHROMYCIN who on 18-OCT-2007 was vaccinated IM with a first of GARDASIL (Lot#658561/1063U). On 18-OCT-2007 at 10:00 am, the patient was vaccinated into upper left arm with a second dose of GARDASIL (Lot#658282/1263U). Concomitant therapy included YAZ and ALLEGRA. On 18-DEC-2007, the day of the vaccination, the patient experienced soreness and numbness in her arm (also reported as pain at the injection site) where the vaccine was given. On 19-DEC-2007, the second day after the injection, the patient reported that she felt very achy, as if she was coming down with something (general body aches, flu-Like symptoms, but no urinary symptoms) and felt very ill. Then the patient noted numbness from the injection site to her fingers. Unspecified medical attention was sought. Then the patient noted numbness from the injectionsite to her fingers. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. Follow up information stated that the patient had full range of motion in the arm she received the injection in. On 11-FEB-2008, it was reported that the patient still had pain and numbness and that nothing had changed. The patient declined her third dose of GARDASIL. On 18-MAR-2008, the patient stated that her condition was worse. She had discomfort extending the length of her arm to her shoulder and back. It was reported that she saw her primary care physician in January 2008 and has another appointment in April 2008. No product quality complaint was involved. Additional information has been requested.
Fever was the main thing. I developed a rash on the arm  - on the left arm - on the 19th of January with a fever. Doctor's visit on 21st. Treatment was ice. The fever went away. The rash was all the way down to my elbow and it lasted  four days- through the weekend. It itchy and hot.
My period has been regular for years and light for my entire life. I was due to start my menstrual cycle on April 1 but I had a severe reaction to dose 2 of the COVID vaccine and was sick for several days so I didn't think much of it when I missed that cycle completely. Then on May 1st bleeding started and was extremely heavy. After 6 weeks I went to my women's health clinic and they ruled out other serious causes with an ultrasound scan and a biopsy. Via ultrasound they confirmed that my uterine lining was very thick, which makes sense with the inflammatory nature of this vaccine (activating immune system, etc.). I have been able to stop the bleeding by taking LoLoestrin, though it comes back quickly, even mid-month if I miss one day of the pill. I am finishing the second pill pack and after the third I will return to the women's health clinic for a follow up.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Lump left arm), DIARRHOEA (Diarrhea) and INJECTION SITE ERYTHEMA (Redness(left)) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hernia and Indigestion. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness(left)). On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (Lump left arm). On 11-Mar-2021, the patient experienced DIARRHEA (Diarrhea). On 12-Feb-2021, INJECTION SITE ERYTHEMA (Redness(left)) had resolved. On 17-Feb-2021, PERIPHERAL SWELLING (Lump left arm) had resolved. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.
got sick; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious social media case from a patient.  This case involves a patient of unknown demographics who was sick (sickness), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient was sick (sickness), (unknown latency) following the administration of INFLUENZA VACCINE.   On an unknown date, reported in the consecutive year, the patient again had received another dose of suspect INFLUENZA VACCINE (other dosing details same as previous) and again on an unknown date (latency unknown) was sick (sickness) following the administration. At present, the patient reported of not administering the suspect vaccine anymore.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
An erythemic, non-pruritic area to right arm measuring 5cm X 5cm.
My mother collapsed in the dr office about 10 seconds after the flu shot and went into cardiac arrest. She is currently in ICU. 01/22/07-records received and reviewed. DC DX for DOS 12/02-12/16/06- Acute witnessed cardiopulmonary arrest with resuscitation Ventricular fibrillation Acute respiratory failure Anoxic encephalopathy Prior history of intracerebral hemorrhage, status post aneurismal surgery Methicillin resistant Staphylococcus aureus pneumonia Hypokalemia Cardiomyopathy. HX: Became syncopal and collapsed in physician's office after receipt of flu vaccine. She immediately came to and was aware of her surrounding. Ambulated to car, as son was driving out of parking lot, patient had a sudden cardiac arrest.. Found to be in ventricular fibrillation and after 4 cardioversions procedures converted into a slow sinus rhythm. Seen in ER required intubation and dopamine drip and dobutamine.  PMH: MVA in 1998 in which she experienced a myocardial infarction. CVA followed with a balance disorder. Cerebral aneurysm which was repaired. CHF with an ejection fraction of 35% in 2003. After CVA and aneurysm repair the patient had decrease in peripheral vision and peripheral neuropathy, dysphagia and hyperlipidemia. PE: Did not respond to verbal or painful commands, eye movement was random, at times seemed to have purposeful eye movement but would not move her extremities or reposition her body.  Remained obtunded. Ventilator and life support withdrawn. Hospice management. Comfort measures. Transferred to hospice unit. Spoke with hospice unit, patient expired on 12/17/06.  1/25/07 Received Death Certificate which reveals COD as anoxic encephalopathy, cardiopulmonary arrest & CAD.
I have noticed my right leg swe; got "covid arm"; felt like I got hit by a bus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I got hit by a bus), PERIPHERAL SWELLING (I have noticed my right leg swe) and MYALGIA (got "covid arm") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like I got hit by a bus), PERIPHERAL SWELLING (I have noticed my right leg swe) and MYALGIA (got "covid arm"). At the time of the report, FEELING ABNORMAL (felt like I got hit by a bus) had resolved and PERIPHERAL SWELLING (I have noticed my right leg swe) and MYALGIA (got "covid arm") outcome was unknown.            No treatment medication provided. No concomitant medication provided. The report stated that the patient had COVID arm  after the fist dose. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable, reporter didn't provide any causality assessment.
Friday the 26th     Headache, fever of 100, and extremely runny nose all day Monday the 29th  extreme tiredness all day, late afternoon spike in blood pressure (169/90)
Patient is unable to be discharged from hospital since sub-acutre rehab facilities won't accept COVID+ patients
Arm and shoulder pain mucular in nature radiating from injection site to shoulder joint and elbow. Range of motion in arm has diminished and pain is severe enough to cause sleeping issues and does not subside enough with pain killers to feel comfortable.
05/11/2022 - runny nose cough 05/12/2022 - runny nose and cough, cough got worse, in the late afternoon I had chills and late afternoon I had a slight fever 99.7 ( I do not ever get a high fever - my normal is 97) I went right to bed. I did a home test which came back positive in 2 minutes, My doctor called in Paxlovid and I took my first dose that evening, 05/13/2022 - I woke up feeling what seemed to be better, but later I started feeling worse again, but I never go super sick. I was able to function. I am feeling better than before, but I am doing better, I cough less and doing better. Plus I am a real active person, I am not a normal 79 year old.
nasal polyps; This case was reported by a consumer and described the occurrence of nasal polyp in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Nucala, the patient experienced nasal polyp. The patient was treated with mepolizumab (Nucala). On an unknown date, the outcome of the nasal polyp was unknown.   It was unknown if the reporter considered the nasal polyp to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. Age at vaccination was not reported. The patient received a dose of Shingrix and experienced nasal polyps. The patient stated that she was prescribed Nucala for nasal polyps. She reported that she was supposed to start her first dose of Nucala on 7th September 2021 but she did not start it until 21st September 2021 because she got the Shingles vaccine and her dose had to be pushed back. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021191013:same reporter US-GLAXOSMITHKLINE-US2021AMR203624:same reporter, same patient
Immed headache & lightheaded.  Chills later in day. Sore arm, pain at injection site, fatigue, feeling ?off.? Heavy sweating during night, pain felt in muscles & joints.  Next Morn: achey, mild headache, fatigue, chills/sweats, no appetite. Later in afternoon became tingly , lightheaded, nausea, started blacking out, laid down.  Injection site hot, red, swollen, itchy. Chills/sweats throughout night. Next day: felt better as day went on.  Slight chills/sweats.  Still feeling of ?off? and injection site warm, itchy.
Developed red papules multiple on B/L thighs with induration, no streaking, no warmth.
Patient presented to the office for well child visit. Kinrix, Proquad and Influenza vaccines were administered with permission of patient's father. Patient's mother, who was not present at the visit, called the office to confirm vaccines received at the visit. Mother was given information about vaccines given, and she reports that patient received Kinrix and Proquad on 10/02/2023 with Health Department. Patient received duplicate vaccines. No known adverse event due to this duplication.
This medically confirmed spontaneous report (initial receipt 07-FEB-2011) concerns a 79 year old male patient. On 22-SEP-2010, the patient received AFLURIA. On 06-FEB-2011, the patient was diagnosed with H1N1 influenza and bacterial pneumonia. The patient went to the hospital emergency room twice and was released (not hospitalised). The patient received oseltamivir for treatment. The event outcome was unknown. The reporter considered events serious due to intervention required to prevent serious criteria (two trips to ER), significant disability or incapacity and events being life threatening (very weak).
VACCINE GIVEN ON MONDAY.  TUESDAY DEVELOPED FEVER AND WEDNESDAY HE HAD DIARRHEA.  OVER THE NEXT FEW DAYS THE DIARRHEA BECAME PROGRESSIVELY WORSE AND ON fRIDAY THERE WAS BLOOD NOTED. SEEN AT MEDICAL CENTER ED.
sore mouth, myalgia, low grade fever, photophobia, perifollicular palpable lesions of arms, legs, chest,itching;eventually required Pred, Periactin;