chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had a terrible flu; Initial information was received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via the social media.  This case involves a patient (unknown age and gender) who experienced terrible flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included influenza vaccine for prophylactic vaccination.  The patient's medical history, concomitant therapy, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious terrible flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There would be no information available on batch number for this case.
Patient noticed a golf ball size rash around the injection site. She did not feel "funny" or SOB. She did not describe feeling abnormal. Followed up with patient 48 hours later and rash has not resolved. She did not seek any additional medical attention.
This spontaneous report was received from a consumer concerning her 65 year old husband with no pertinent medical history or drug allergies. On an unknown date in July 2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number unspecified). Concomitant medications included metoprolol (reported as Netoprolol) and atorvastatin. Since July 2012 (since he received vaccination), the patient experienced rheumatoid arthritis and had major pain in all his joints. The patient sought medical attention (office visit). On an unknown date, unspecified blood test was performed and the result was unknown. No treatment was given for the adverse events. The outcome of rheumatoid arthritis and has major pain in all his joints was reported as not resolved. Additional information has been requested.
Initial report received from a healthcare professional on 5 November 2014. A female patient, whose age and concomitant medications was not reported, had received an intramuscular dose of FLUZONE QIV (Batch number UI159AA and expiry date 30 June 2015, dose number and site of vaccination were not reported), on 27 October 2014. The patient had hypertension in the past. On 27 October 2014, within few hours after receiving vaccination the patient had chest tightness, shortness of breath, redness and itching. Illness at the time of vaccination was none, Pre-existing physician diagnosed allergies and birth defects were unknown. The patient was treated with BENADRYL and steroids and laboratory data was unknown. The patient required ER visit. On an unspecified date, the patient was recovered. List of documents held by sender: none. Follow-up information received from healthcare professional on 20 March 2014. It was reported that, received no additional information to provide. List of documents held by sender: none.
This spontaneous report as received from a physician refers to a 50 year old female patient, as part of a marketing research program. No medical history and current conditions were reported. On an unknown date in 2008 the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number was unspecified). It was reported that the patient had received a PNEUMOVAX 23 vaccination one year prior in her physician's office. On an unknown date in 2008 the patient experienced large, local reaction on her arm. It was reported that the patient recovered without incident and physician reported the event at the time. The outcome of large, local reaction on her arm was reported as recovered on an unknown date in 2008. The reporter considered large, local reaction on her arm to be related to PNEUMOVAX 23. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Pfizer / BioNTech; vaccine administration date=04Oct2022 / vaccine brand other=moderna; vaccine administration date=20Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 73 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 011a21a), in left arm, on 28Oct2021 as dose 2, single (Lot number: 076c21a), in left arm and on 20Apr2022 as dose 3 (booster), single (Lot number: 028k21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2022, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; vaccine administration date=04Oct2022 / vaccine brand other=moderna; vaccine administration date=20Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 09Aug2023 to 14Aug2023.
2-3 wks p/injection in lt deltoid pt exp'd stiffness in left & left shoulder; discomfort left elbow persists;
Patient experienced skin reaction consisting of raised, itchy bumps starting about a day after injection.  The number of bumps increased continuously over the next few days.  Initially OTC Benadryl cream was applied which didn't alleviate the symptoms.  Oral doses of OTC Benadryl were also ineffective and reducing the number of bumps and severity of the itch.   No other fever or other side effects were observed other than significant fatigue.  A Dr. prescribed a 6 day regimen of oral prednosolone which substantially reduced the symptoms. However, now 19 days later, some bumps and itching still persist.  See attached picture. Should she get 2nd shot? Dr. Advised no,
Just the flu vaccine via offsite provider- vaccine was given too high per employee in right deltoid and now she cannot lift her arm above shoulder level without pain. Employee states that she felt air compress in her arm at the time of vaccine   I DO NOT KNOW WHICH VACCINE AS I DID NOT ADMINISTER IT. NO LOT NUMBER ETC
RECVD 1ST VAX ON 3-8-90. ONSET BEGAN IN AM OF 3-9-90: DIARRHEA,NAUSEA,VOMITING,TEMP OF 102 F,SNEEZING,RUNNY NOSE AND CHILLS. NOT SEEN BY PHYS AND NO TREATMENT GIVEN.RECOVERED 3-10-90. FOLLOW UPRECVD ENGERIX-B 1cc ON 3-5-90 EVENTS START ON 6
Within 24 hours I became dizzy, lightheaded, and I had nauseas. After 24 hours my chest felt extremely tight to where I could not take deep breaths. That went away after 6 hours. I was so nausea I couldn't eat for 48 hours. When I resumed eating food again the diarrhea and nauseas occurred. During this time, I noticed a mental fog. I couldn't think through detailed projects or thoughts. I had a hard time coming up with words to say when someone asked me a question that involved thinking. Most of my symptoms stopped by September 28th, but the nausea continued until Tuesday, September28th. On September 20th I went to work and passed out. I was carried to the ER Hospital. The doctors did test on me and my blood sugar was 327, my anion gap was high, and my EOS test for white blood cell count was also high. The doctors were able to get my blood sugar lower to where it was safe for me to go home. I don't have high blood sugar normally. I purchased a blood sugar meter and without any sugar consumption for 3 days my blood sugar is averaging 222 which is twice of what's recommended. My doctor prescribed diabetes medication, and my blood sugar has returned to normal levels. I wasn't a diabetic before receiving the vaccine. I am still taking the diabetes medication to combat the high blood sugar, and I am still getting occasional dizziness.
Patient reported she had a transient urticarial rash on her back 4 hours after receiving immunization.  The rash resolved after 24 hours with treatment with antihistamines.
Severe  body and join pain  . I was diagnosed with Fibromyalgia after my spinal fusion 2017, but I never experienced a ? flared  ?  like this before. The 2 nd  Moderna  shot triggered the Fibromyalgia soft points.    I I had no energy to the point the was extremely difficult to walk.  I was very depressed. My stomach was upset and I had headaches  on and off.  The night when the symptoms  stared  I vomited a few times , then always nauseous  . The symptoms lasted for almost exactly two weeks since the day I received the second shot.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; DIZZINESS; This spontaneous report received from a patient concerned a 30-year-old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with ibuprofen. The patient was not pregnant at the time of reporting or not breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, 1 in total administered at left arm on 03-APR-2021 for prophylactic vaccination. The patient was taking iron supplements. On 07-MAY-2021, the patient went to an (indoor) family dinner (total of 6 adult guests, all vaccinated). On 10-MAY-2021, one of the participants tested positive to SARS-CoV2. Over that week, 4 of the 6 participants ended up testing positive. On 11-MAY-2021, the patient started feeling symptoms and described as fever, loss of taste and smell, nasal congestion, headache, body aches, chills, diarrhea, dizziness and fatigue. Patient tested positive for SARS-CoV2 on 12-MAY-2021. Most symptoms lasted for about 5 days and patient reported that the only symptoms left were a tiny bit of nasal congestion and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 15-MAY-2021, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210554428-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a unknown number of lesions and was diagnosed with a mild case of varicella.
She is a member of my team. I have her her first dose. She told me she was due for her second dose. When I went to document after giving her shot, she was only 14d out from Dose 1. My error entirely; I?ll return to trusting no one and validating everything before giving the vaccine.
a repeat dose in this scenario should be administered 4 weeks after the improperly reconstituted dose; Only adjuvant portion given; Only adjuvant portion given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   On 21st February 2023, the patient received the 2nd dose of Shingrix. On 20th February 2023, the patient received the 2nd dose of Shingrix. On 20th February 2023, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 21st February 2023, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The reporter reported that CMA administered only the adjuvant portion of the Shingrix and received the repeat dose on next day with batch number 7KG39 and   As per the Disease Control recommendations, a repeat dose in this scenario should be administer 4 weeks after the improperly reconstituted dose (dose of adjuvant only).  That was coded for a vaccine as well for 21st February 2023. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received the repeat dose of Shingrix next day instead of 4 weeks, which led to inappropriate schedule of vaccine administered.
Tested positive for covid19; Hotness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills). In May 2021, SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had no allergies and no medical history reported. The patient did not receive other vaccines within one month prior to Moderna. No concomitant medications were provided.No treatment medications were provided.  Company comment: This case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive on the same day after receiving first dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-475434, MOD-2022-475425 (Patient Link).; Sender's Comments: This case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive on the same day after receiving first dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a nurse referring to a patient of unknown gender, between the age of 30 years and 49 years old, who was enrolled in the patient support program. There was no medical history or concurrent condition reported. On 07-JUL-2015, a vial of (Oka/Merck) VARIVAX underwent temperature excursions, which was at 8.9 degrees Celsius for 1 hour and 28 minutes, and then 0.4 degrees Celsius for 1 hour and 25 minutes on 28-JUL-2015. On 04-AUG-2015 the patient was vaccinated with a dose of the improperly stored vaccine (lot # K026386, expired date 15-DEC-2016, dose and route were unknown). The nurse reported the patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. As of 05-AUG-2015, it was unknown if the patient continued on (Oka/Merck) VARIVAX. This is one of several reported received from the same reporter. Additional information has been requested.
received improperly stored VARlVAX; Subcutaneous injection formulation administered by other route; This spontaneous report was received from a nurse referring to a 4 years old male patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 29-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 that has been verified to be valid, expiration date 23-JAN-2022, intramuscular in the left thigh for prophylaxis (dose and strength were not reported) (product storage error and incorrect route of product administration). Temperature exposure detected. Data logger was involved. Vaccine was removed immediately. No further vaccine was administered. Parents were being noticed and this dose of vaccine will  be repeated with new vaccine stock.     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006311:
This spontaneous report as received from a certified medical assistant refers to a 19 years old patient. The patient was vaccinated with a pediatric 0.5 ml dose of VAQTA (Lot # not reported) on 13-SEP-2012. No adverse effects were reported. Additional information has been requested.
PHARMACIST WHO PERFORMS CLINIC IN STORE, ADMINISTER JANSSEN SHOT TO 16 YEARS OLD.  NO ADVERSE REACTION HAS BEEN REPORTED YET.
I felt tired at 3:00 that day and then fatigued/exhausted.  After laying down to a few hours I began to feel feverish and achy.  By 8:00 that evening I was cycling between consciousness and sleep having delusional pre apocolyptic daydreams about people being removed from their homes.  Fever, chills and achiness built through the night, but symptoms gradually diminished through the second day.  On Wednesday morning, 48 hours after being given the TDAP shot, I was back at the doctor.  I still had a 101.2 F fever, and I also had a chest infection.  Now, at just more than 96 hours since I was given the TDAP shot, I still feel tired as well as a bit achy and feverish.
When I got my first dose of the Pfizer vaccine, I experienced some swelling in the area where I received my shot. The upper arm area where I got the vaccine was still swollen when I got my second dose. It has been six months now and my arm is still swollen (looks puffy) where I got the shots. There is no pain, but at times I do experience throbbing.
Dry itchy rash; Looked like Eczema; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included poison ivy rash (almost recovered).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and Boostrix (intramuscular). On an unknown date, immediately after receiving Shingrix and Boostrix, the patient experienced itchy rash and eczema. On an unknown date, the outcome of the itchy rash and eczema were unknown.   It was unknown if the reporter considered the itchy rash and eczema to be related to Shingrix and Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she had poison ivy prior to receiving vaccines, but it had almost disappeared. The patient developed rash after receiving the 2nd Shingrix vaccine and Boostrix vaccine on the same day.  This occurred approximately two months ago from the date of report. She reported that shortly after receiving vaccines, she developed a dry itchy rash on her lower legs, hands, and feet.  Her doctor stated that it looked like Eczema. The reporter did not consent to follow up.
Mild fever, aches, chills, light-headedness, weakness. I have taken an acetaminophen-based OTC medicine for the fever.
After first dose - no major side effects.   Date of second vaccine: 2021Jan27.  Side effects began 430a on 2021Jan28 started with body migraine.  715a, fever appx 101* and severe body aches/migraine.  Fever broke at 430p.  Body aches, migraine, and excessive tiredness ended 2021Jan29 appx 430p.  Tiredness completed to normal = 2021Jan30 noon. Since then, migraines appx every 3-4 days lasting 2 days (relieved with APAP 500 when needed in the day or Xanax 0.25mg in the evening) and daily tiredness lasting 3 hours after waking.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: severe pain in shoulder area, clavicle, back. Hx of tendonitis.
Hyperstesia in my left before arm, followed 24 hours later by blisters and rash, very painful. I was told by my Dr. that I had Herpes Zoster. I recieved treatment for my pain w.th pain killers. Soreness, induration and severe pain during the 3-5 days. Two weeks later, I started feeling tingling and burning in my left arm, followed by itching rash and small blisters. In addition I had hypersensibility in my left wrist.
Woke up with 102.5 degF fever, chills, sweating, body aches, headache, treated with Motrin. By 6/4/13 evening untreated fever was around 99 degF, still with mild body aches and headache. No additional sypmtoms appeared. Constant headache lasted a couple days. Headache was intermittent for a couple of weeks.
Pt recvd vax & 24 hrs later exp fever, achiness, lethargy, & a rash on hands & arms; These sx lasted 2 wks;
pt states fever, h/a, pain in arm & neck, joints sore;APAP & ice to area;
pt initially c/o throat burning & then immed c/o SOB & diff breathing;onset of initial sx began approx 5hr p/vax;pt immed taken to ER & given DPH, amoxicillin, & pred
This report was received from the investigator in a trial on 20 May 2010. A 28 year-old male subject with no relevant medical history received the following vaccines: ACAM2000 (lot number not reported) on 06 January 2010; and TYPHIM VI (lot number not reported), anthrax vaccine (other manufacturer and lot number not reported), and hepatitis B vaccine (other manufacturer and lot number not reported) on 05 January 2010. Sixteen days after receipt of ACAM2000, subject was diagnosed with unspecified disease of the pericardium. On Day 12 (18 January 2010), the subject had a normal Troponin I level. On Day 13 (19 January 2010), the subject had an abnormal electrocardiogram and a normal echocardiogram. On Day 19 (25 January 2010), the subject had an MRI of the heart which was normal. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.
Headache Body/joint ache Chills 101.5  F fever Above symptoms lasted about twelve hours.   Symptoms abated after administering ibuprofen
Injection site: tenderness and swelling of the lymph nodes in the same arms as the injection. General side effects: fatigue, muscle pain, fever (100.2)
EXTRE.ME IRRITATION AT SITE OF INJECTION SWOLLEN LYMPH NODES UNDER INJECTED ARM FEVER BODY ACHES
Patient is a 17 y.o. year old female patient who presents for Arm Pain (Acc by dad) received Men B 10/30/23 Right upper arm, started that night complains of soreness, red, swollen, burning, hot to touch, itchy.)