chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included bug bite. On 7th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and chills. On 27th June 2018, the patient experienced rash, pruritus and hives. In June 2018, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the pruritus and hives were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, rash, pruritus and hives to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left arm and woke up in the middle of the night after receiving the vaccine with fever and chills and flu-like symptoms. The reaction lasted 12 hours and resolved. Twenty days after vaccination, the patient started to have itching and hives off and on ever since. The patient described the rash as hives or big mosquito bites on the trunk of her body. She claimed that the rash appeared where she gathered sweat and where there was friction. The rash had also presented on the top of her legs where the crease in her legs reach her buttocks and up to the shoulder on her back. The patient had a biopsy done by her dermatologist and it came back as an inconclusive bug or drug reaction. The patient was not certain if the rash was related to a bug bite. The patient had provided contact details of her physician.
joint pain; muscle pain; chest pain; muscle twitching; headaches; stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "muscle pain"; CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "chest pain"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "not recovered", described as "muscle twitching"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headaches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "not recovered", described as "stiffness".  Clinical course: The patient is having an adverse reaction to Pfizer COVID vaccine for months now.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient reports arm pain when lifting since influenza vaccine on 10/15/08.  No treatment. Advised patient to call MD and report sx.
At the time he passed out and had a seizure in the chair. He has had fairly significant pain at the injection site ever since.
was not fully vaccinated this morning; A spontaneous report was received from a consumer concerning a male patient, of unknown age, who was administered Moderna's COVID-19 vaccine, but he was not fully vaccinated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb2021, prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection.  The patient reported that he was not fully vaccinated. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event "not fully vaccinated", was considered as resolved on 03 Feb 2021.; Reporter's Comments: This case concerns a male patient of unknown age who received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection and reported that he was not fully vaccinated. There were no reported events in this case of incorrect dose administered
acute onset of a single supraclavicular lymphadenopathy. It is causing pain across the top of my shoulder on that same side.
Developed  herpes simplex infection in R eye within 12 days.Symptoms were scratchiness and irritation of Reye.  I had cataract surgery 7-29-21 and 7-22-21.
COVID-19; COVID-19; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: G53277) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), on 27Mar2021 as dose 2, single (Lot number: ER8732), on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "cutaneous lupus" (unspecified if ongoing); "Calcium pyrophosphate deposition disease" (unspecified if ongoing); "Mild intermittent asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Macular degeneration" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tmp/smx, reaction(s): "Drug Allergy". The following information was reported: IMMUNISATION (medically significant) with onset 28Sep2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 28Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 and BNT162B2, BNT162B2 OMI BA.4-5 to the events COVID-19 and drug ineffective cannot be ruled out.
symptoms after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (symptoms after second dose) 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 12-Feb-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 ADVERSE EVENT (symptoms after second dose). At the time of the report, ADVERSE EVENT (symptoms after second dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
no reaction or side effects at time of injection; then 5 days later on 1/4 developed red bump on right forearm that progressed to rash on both forearms, upper legs and torso; no itching pain, swelling of diff breathing
Feverish; Sore shoulder; I was just feeling dizzy like sleepy the whole time after getting the vaccinated; Little itchy; Shivering; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW017), via an unspecified route of administration, administered in Arm Left on 21Apr2021(at the age of 17-years) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Consumer stated, "So we, my family took vaccination Pfizer vaccine on like 2-3 days ago at (pharmacy name withheld), me, my father, my mom and my brother, we took it, we three were able to get the side effects immediately after getting the vaccine like 2-3 hours we started getting like feverish and all that was normal, my brother he was started numb his hands were numb and his one leg is numb, and yesterday night he was even feeling pain in his arm but he just took a sleep because we couldn't contact anyone it was closed so he slept and today morning the pain is gone but the numbness is still there, so it was kind of change because none of us had this reaction, so we were little scared to like you know hence contacting Pfizer to the website that we had the number so we were hoping that we can get any solution is it normal if it's not what can we do?" On 21Apr2021 the patient experienced feverish with outcome of unknown, sore shoulder, I was just feeling dizzy like sleepy the whole time after getting the vaccinated, little itchy and shivering. Therapeutic measures were taken as a result of sore shoulder. Patient recovered from feverish. Patient was recovering from events I was just feeling dizzy like sleepy the whole time after getting the vaccinated and little itchy. The outcome of the event shivering was unknown.   No follow-up attempts are possible. No further information is expected.
Developed swelling, pain, redness to L arm late afternoon. Had received TDAP injection that morning. States swelling and redness increased seen in emergency department; 9/1/07 v.s. 98.7-90-18 116/70, Given vicodin, keflex, atarax Rx; Dx. Cellulitis of L Arm, Local Reaction To Vaccine Reported 11/14/07 on visit to office.
BELLS PALSY TYPE SYMPTOMS RIGHT EYELID STILL SLIGHLTY VISSABEL AFTER 9 DAYS, CHILLS 3 DAY, FATIGUE 2 DAYS
joint pain and body aches; joint pain and body aches; she had body and joint pain and exhaustion after the first dose; her left arm hurt; exhausted; sick; This is a spontaneous report from a contactable consumer (patient).   This is one of two reports. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in left arm on 19Mar2021 09:48 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing Interstim Implant for Bladder from 2016, ongoing Inverted T waves all her life, clarifying she had issues since college, ongoing hypoglycaemia since high school, ongoing gluten intolerance (she stated in her 40s, she was told she had gluten intolerance, and another autoimmune issue referred to as leaky gut. She said she wasn't formally tested for leaky gut, but her leaky gut diagnosis was done by elimination), ongoing asthma diagnosed with moderate asthma as a child and Lobular Carcinoma-Right Breast from Dec2020 to an unknown date, she had a lumpectomy on her right breast in Dec2020. She said at that time, she was diagnosed with a lobular carcinoma that was not cancerous, but considered a high risk lesion, and was removed. The patient's concomitant medications were not reported. No any additional vaccine administered on same date of the Pfizer vaccine. No prior vaccination within four weeks. On an unspecified date in Mar2021, patient got sick. She said she had joint pain and body aches, and her arm, and all that stuff. She clarified the day she got her first COVID-19 Vaccine shot (on 19Mar2021), her (left) arm hurt, and she was exhausted. She said she went to bed at 7:00PM that night (19Mar2021), and the next morning (20Mar2021), she woke up with the joint pain and body aches, condition aggravated. She said the (left) arm pain, joint pain, and body aches hurt less the second day, and eventually went away. Patient stated she didn't go to her doctor because she kept thinking her joint pain would be gone soon, and it hasn't and took ginger (clarified as Nature's Way Brand Ginger Root 1.1g capsule), and turmeric (clarified as Solgar Curcumin) for her joint pain. Outcome of the event joint pain was not recovered and rest all events was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Patient presented at the pharmacy on 05/18/2022 (12 days after date of vaccination), reporting ongoing injection pain. The pain radiates to nerves up through neck and down to the forearm.  He stated that he couldn't lift his arm for more than 45 degrees. He has tried TENS stimulation, lidocaine cream rub and Tylenol, but none of them has helped. He suspected the pain was due to shot given too low at the deltoid insertion. He was advised by the pharmacist to try ibuprofen OTC and continue to monitor pain level.
No other AE reported; Employee on training used a 30gauge 1/2 needle instead of 25gauge 5/8 to given the injection. It may have been given subcutaneous instead of intramuscular; Employee on training used a 30gauge 1/2 needle instead of 25gauge 5/8 to given the injection. It may have been given subcutaneous instead of intramuscular; This spontaneous report was received from a nurse concerning a 4 month old patient, gender unknown by reporter. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 15-SEP-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB)  for prophylaxis (lot # T011167 has been determined to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and established as 27-MAY-2022) (strength and dose were not provided). The nurse reported that the employee on training used a 30gauge 1/2 needle instead of 25gauge 5/8 to given the injection and it may have been given subcutaneous instead of intramuscular (incorrect route of product administration and circumstance or information capable of leading to medication error).   No adverse event reported.
After the 15 minutes sitting after the shot the nurse asked me if i was okay because I was red, my arms, face and eyes.  I sat for 45 minutes longer and they provided me water and juice and I felt okay to go home.  That evening at about 11:50pm chills and temperature started at 99.1 and went to 103.1 during the night, 5:00am heart racing, sweating and headache/for the following days headache was bad, very tired, arm sore and body aches.  Sunday 1/17/21 fever down, headache dull but injection site red and itchy 2 inch circle
Extreme fatigue Moderate pain in the injection arm Moderate to severe headache.  Still there even after ibuprofen. Mild nausea only lasted about an hour about 6 hours post injection.  Body aches treated with ibuprofen  and rest
I felt the vaccination triggered some auto immune factor....all my POI symptoms are back in full force after the vaccination....my situation was in total control till then but I skipped period and I suddenly started having lot of mood swings/hot flashes and weird enough, started having knee pains may be after 2 weeks or so. Besides these, I had regular side effects like swelling the upper arm and lymph node swell for 3 weeks first time and second time I used lot of heat pad so, was only there for a week. I definitely felt this vaccine triggered my auto immune factor
She has a ball in her left arm at injected site/It never dissipated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (She has a ball in her left arm at injected site/It never dissipated) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-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 VACCINATION SITE SWELLING (She has a ball in her left arm at injected site/It never dissipated). At the time of the report, VACCINATION SITE SWELLING (She has a ball in her left arm at injected site/It never dissipated) outcome was unknown.            No concomitant medication was reported.  Treatment information was not provided.
On 4/3 I woke up with Sudden Sensorineural Hearing Loss (SSNHL)  in my left ear. I could not hear anything, and had tinnitus and dizziness. I was given prednisone 30mg for 5 days, zyrtec-D, and cefdinir for 10 days. This partially cleared up, but I still cannot hear in my left ear, and have tinnitus. I went to the ENT on 5/19 and was given a transtympanic steroid injection of 24mg/ml Decadron. After a week, I don't think it has gotten any better, and I might have permanent hearing loss.
Felt swelling and noticed redness and soreness.  Progressively increased in all of the above. Now area hot and pink and swollen 13 X 9 cm.
Patient received COVID-19 booster vaccine (Pfizer) on 9/25/21. On 9/27 she reported generalized weakness, not getting out of bed or eating for 2 days. On Wednesday 9/29 she went to Urgent Care for a COVID-19 test which was negative and a chest CT was ordered. There were findings of effusion so she was referred to the emergency department. Upon presentation to the emergency department, the patient was hypotensive, experiencing new onset atrial fibrillation, and requiring 2L oxygen. Cardiology was consulted and advised to monitor with telemetry. The following morning 9/30/21 the patient denied chest pain, shortness of breath, palpitations, and dizziness. A pericardiocentesis was completed on 9/30/21. Post-procedure the patient remained hypotensive and complained of mild chest tightness. The following day, the patient reported shortness of breath and a nonproductive cough. The patient was started on colchicine 0.6 mg BID. The patient's statin was continued. On 10/2/21, metoprolol was added for rate control for atrial fibrillation and patient reported cough and wheezing. On 10/3 the patient was started on Eliquis 5 mg twice daily for stroke prevention and did not complain of cardiac symptoms. The patient had no further cardiac complaints on 10/2 and 10/3/21 awaiting procedures for cardioversion. The patient tolerated the procedure and did not complain of chest pain, shortness of breath, palpitations, cough, or wheezing. On 10/6/2021 the patient was stable for discharge. She was discharged on home medications with the addition of metoprolol tartrate 25 mg twice daily, Eliquis 5 mg twice daily, colchicine 0.6 mg twice daily, and an albuterol inhaler. Her home amlodipine was discontinued.  She was instructed to follow up outpatient for further monitoring.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-AUG-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
pt recvd vax & screamed for 4-5 hrs w/ high pitch; inc t;could sleep only for brief time(10-15 mins) throught the night; apap did not help;
High Fever, headache , body aches, shivering, extreme arm pain , loss of appetite, general malaise. Two weeks after the vaccine, swollen lymph nodes above the clavicle lasting two months thus far.
Irregular menstrual cycle. Since the booster shot (I had J&J as my original vax), my periods have been arriving 7 to 10 days late, after 7 to 10 days of pre-period sever cramping. The periods themselves are heavier and more painful than before as well.
Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and chest pressure. EMS evaluated the patient on-site. The patient was hypertensive (223/180). EMS administered O2 2lpm via nasal cannula. In the ED, the patient reported they felt flushed with a headache. They remained hypertensive (167/89). ED physician admitted patient to inpatient telemetry unit for 1-day. Discharged with diagnosis of chest tightness with associated SOB and palpitations, reproducible on palpitation, troponin negative and EKG with no acute ST-T wave changes, no arrhythmia noted on telemetry, low likelihood of acute coronary syndrome. Patient was instructed to follow-up outpatient for PET stress test and 2D Echo.
Joint pain in his knees after his Moderna Covid-19 booster dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (Joint pain in his knees after his Moderna Covid-19 booster dose.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain in his knees after his Moderna Covid-19 booster dose.). At the time of the report, ARTHRALGIA (Joint pain in his knees after his Moderna Covid-19 booster dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter was calling regarding their son who was the patient. The patient received the booster dose in Dec-2021. The reporter stated that the patient reported joint pain in their knees after the Moderna Covid-19 booster dose.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow up received contains no new information.