chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 mL dose of Rotateq (lot number not provided). The physician reported that the patient subsequently developed severe diarrhea. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.
Previous 3 shots of Covishield    1/6/2023 6:15 PM Covid shot Bivalent  1/11/2023 5:30 PM Unexplained sudden shortness of breath, drop in Sp02 to 84, heartbeat irregular XRAY and contrast showed a significant fluid buildup in the lungs Diagnosed as heart failure, pneumonia was ruled out on 1/12/2023  treated with IV Lasix to drain fluids out 1/14/2023 5:00 PM sudden increase in heart rate while in toilet >184 after medication heart rate came down to 100 bpm 1/14/2023 11:30 PM, Heart rate increased again to 137 IV treatment brought the heart rate down 1/19/2023 Discharged from Hospital
Information has been received from a pharmacist referring to a patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. The pharmacist reported the patient received a dose of VAQTA (strength: 50/1.0 U/ml, dose, frequency, route, lot number and expiration date unspecified) approximately in 2016 (reported as two years ago). The pharmacist reported the patient received a second dose of VAQTA (strength: 50/1.0 U/ml, lot #: R006342, expiration date: 21-APR-2019, dose, frequency, and route were not reported) on 10-DEC-2018 (inappropriate schedule of product administration). No adverse effects reported.
Day 1 bleach scent  Day 2  left arm pain - could not use arm, extreme fatigue, hot flashes, fever of 99 , muscle and joint pain all night. Day 3 continuous bleach smell followed by hot flashes all throughout the day ( no fever or arm pain) Day 4. Blurred vision, could not focus on anything  irritable ,  when I would try to read and finally see a word it took me a while to comprehend it. No more bleach scent all day  Day 5. Woke up confused with blurred vision and complete confusion. I stop in mid sentence to try to remember what I was talking about. Constant day dream feeling, extreme brain fog.  Went to urgent care, they advised me to go straight to ER and I was not allowed to drive my car.   I have 2 small kids in school so I am having to make arrangements for babysitting and transportation before I can go soon.
Dizziness the morning after vaccination (lasted 1 hour), chills the morning after vaccination ( lasted 3 hours), sore shoulder around vaccination injection (lasted 2-3 days)
Discomfort; This case was reported by a other health professional via call center representative and described the occurrence of discomfort in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reported asked about needle size recommendations as Bexsero was administered to patient who expressed discomfort.  The reported stated that they were using 25 gauge needles but since the solution was thicker she was enquiring if there were any recommendations for a larger bore needle. The reported stated that this was not really a safety issue and that most people feel discomfort with vaccines, therefore she was opting out of providing additional information or follow up. The reporter did not consent to follow up. Additional supportive information: This was 1 of the 6 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR032491:Same reporter - Bexsero US-GSK-US2023AMR032492:Same reporter - Bexsero US-GSK-US2023AMR032493:Same reporter - Bexsero US-GSK-US2023AMR032489:Same reporter - Invalid case US-GSK-US2023031935:Same reporter - Flu Vaccine
1230PM elbow to shoulder pain, red splotches shoulder to fingers w/o itching, tingling & numbness of hands, fingers; pc to MD recommended anti-inflam med; breathing problems; rash-itches; allergic
This spontaneous report was received from a register nurse concerning a 36 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # J006954, expiration date 07-JUN-2015. Patient was schedule for revaccination (reported as next week, date unspecified). Co-suspect and concomitant therapies were not reported. The nurse reported that M-M-R II went through a unsupported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients, this case pertain to one of them. It was noted that the patient was scheduled for revaccination with M-M-R II nest week (date unspecified). This case is linked to 1404USA001099, 1404USA001100, 1404USA001102, 1403USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014297; 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
Within 5 mins of receiving immunizations, left warm + nauseous. Stood up + opened door at which point fainted. I saw her + helped her to floor so no injury. After 1 minute recovered. Kept her here for another 10mins. Ok in whole day.
Shortly after receiving the vaccine I noticed it was very painful to move my arm...when I got up the next morning to shower the pain was so severe to take clothes off and wash my hair that I was in tears....I have received the flu shot for many years before without any pain and thought it was just sore...but, the pain continued and I went to orthopedic clinic on December 4, 2015. I was seen by Dr's assistant. She did an x-ray of my shoulder and said the findings were normal, and gave me a cortisone injection in my shoulder, prescribed Piroxicam 20 mg, and sent me to clinic for therapy. I was diagnosed with a frozen shoulder from acute trauma. I have more movement now in my arm, but I still cannot take off or put on clothes over my head without pain...and I have limited arm movement, going from left to right and it can only be done with pain. I am trying to exercise my arm more...but, the nights I go to exercise class, the next morning I have more pain in my shoulder than normal. I am an avid golfer....and I am wondering now, if I will event be able to play again.
Within 10 days of dose one, severe outbreak rosacea or rash-like effect on face: hot, red and bumpy. Had to see MD for treatment. Also after #2 dose, lot EW0161 given 05/24/2021, same symptoms developed after 7 days from shot date.  Again saw doctor this time for treatment.
Red, itchy, swollen arm at injection site for 4-5 days  Did not do anything other than some regular lotion to help with itching  and the swollenness went away on its own
Pt was give high dose (vial not diluted with enough saline) and reported no adverse reaction 2 days after injection was given
Redness and warmth in 10 cm diameter around anthrax injection site on L deltoid.
Approximately 9-10 days following receipt of the first Moderna vaccine, my father stated he observed a large rash appear at the injection site the covered a large area of his arm.  The tissue was warm to the touch and he described feeling an occasional itchy / pulsating feeling in the surrounding tissue.
This non-serious medically confirmed report (initial receipt 10-OCT-2014) concerns a larger female patient. On the 10-OCT-2014, the patient received AFLURIA (batch number T57706) .5 ml annually via a one inch needed intramuscularly. After administering the vaccine, some of the AFLURIA did not go in completely and discharged down the patient's arm. The reporter stated this was not due to a defect of the syringe. The patient was fine. Outcome was not reported. Batch record review for lot T57706 noted: All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product lot T57706 were received and all results were satisfactory with no out-of specification results reported. Trend analysis of the product attributes were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch related issues identified that may have  caused the adverse events reported.
?Moderna arm? red rash on arm showed up  8 days post vaccine unresolved as of report.   Mild arm pain for 48 hours post vaccine resolved with no treatment.   Headache 2 hours post vaccine resolved by next morning with no treatment.
Rubber wire found in vial for injection. (Uncertainty as to whether this patient also got the affected bottles.
On March 18th I had a sudden onset of diarrhea/incontinence. I had no other symptoms.  I put myself on clear liquids. symptoms improved, then resumed with hematochezia and mucous. I took Loperamide with intermittent relief. This continued throughout March and into June. I lost weight. I contacted my PCP. I took Lomotil; this was effective. I was on a limited diet. I had a colonoscopy in August, 2021 which showed some mild inflammation in the lower colon. Diet changes do not resolve the situation. There was n o bleeding noted.  The symptoms continue.  am now on Budesimide.  Symptoms improved but not normal bowel function as yet.
Nausea, migraine, joint pain, dizziness, chills and lethargic
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 12-JUL-2016, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017, (Concentration and dose were not reported), via intramuscular. The patient's concomitant therapy was not provided. No adverse effects were noted. A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected because the nurse does not want to be contacted.
Employee reports itching and tingling to right arm that traveled to elbow, employee reported sensation was 'easing up' 5 minutes after it started. She also reported itching to flank area, no rash was noted. Employee was taken to ED for evaluation and treatment.
Patient tested positive for Covid-19 on 05/24/2022 and expired at home on 05/31/2022.
Received H1N1 injection on 10/31/09. Got "stomach virus" on 11/10/09. Had hives for 1-2 days on or about 11/16. Had complaint of numbness in back of legs on 11/18/09. Sister had "stomach virus" on 11/3. Sister had nasal H1N1 on 10/28/09 - has appointment with doctor.
Anaphylactic Chock N/V Erythema of body Decreased blood pressure Chills LOC loss of consciousness TX Solu-medrol 125mg IV Morphine 5mg Diphenhydramine 50mg IV
This initial spontaneous report was received from the mother of a currently 26 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. In 2003 or 2004, at the age of 12, the patient was vaccinated with GARDASIL 9 (dose, route, lot and number in series not provided). However, the mother also could not confirm whether the product was GARDASIL 9 or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine GARDASIL (note that GARDASIL was approved for marketing in June 2006 and GARDASIL 9 was approved for marketing in December 2014). The mother reported that GARDASIL 9 did not work the way it claimed. On an unspecified date (but reported as "recently"), the patient was diagnosed with cervical cancer and high grade HPV types 18 and 16.  Due to the diagnosis, the patient "has to have some, if not all, of her cervix removed." The patient has many medical bills due to the issues that resulted in the vaccination failure and the mother was trying to get her daughter's past, current, and possibly future medical bills covered by Merck. The mother stated if she needs to, she will get a lawyer. It was not specified whether the vaccination series was completed. The outcome of the events was unknown. Causality assessment was not provided. Upon internal review, cervical cancer was considered medically significant. The reporter did not provide consent to be contacted for follow up.
ABOUT 10 MIN POST INJECTION A HALF DOLLAR SIZE RASH APPEARED OVER INJECTION SITE. WAS ITCHY SO EMPLOYEE APPLIED BENADRYL CREAM AND RETURNED TO EMPLOYEE HEALTH OFFICE. I HAD HER SIT FOR ANOTHER 10 MIN. NO FURTHER ENLARGING OF RASH OR COMPLAINTS OF OTHER SYMPTOMS. EMPLOYEE RETURNED TO HER JOB. SUDDENLY FELT "VERY ODD" AND BEGAN HAVING SOME BREATHING DIFFICULTY. COWORKER TOOK HER TO EMERGENCY ROOM WHERE EMPLOYEE RECEIVED A BREATHING TREATMENT AND STEROID MEDICATIONS AND A NEBULIZER. EMPLOYE RETURNED TO WORK.
Raised, Red, itchy bump (larger than quarter size) under the site of injection. Painful/sore when pressed on. Last for 5 days.
For the past three weeks, since 11/22, I have had an enlarged lymph node on the left side of my upper neck. At first it was painful; once pain subsided after 1-2 days, the lump remains. My Dr. thinks it's from H1N1 spray that I received on 11/20. However, I've not been sick so this should not happen. I still have the enlarged lymph node. At one point I thought I had cancer, so this is not good.
Woke up at 02:00 with a pulling sensation through my face, neck and shoulders which slowly turned into numbness and tingling to my hands. Now I have numbness and tingling to my arms and feet, right leg weakness, as well as what looks like reynauds. This happened with the first two vaccines but it seemed like a coincidence and so I hadn't reported it.
Redness/swelling about the size of baseball x5-7 days; arm/armpit pain on a scale of 7 out of 10 for 5-7 days; Fatigue/stomach cramping/muscle aches x1 day.
Information has been received from a pharmacist concerning an adult female who a long time ago was vaccinated with PNEUMOVAX (lot # not reported) and had an allergic reaction. No additional information was provided. Additional information is not expected.
Awoken the very next day by body aches and headache. Weakness. Over the next day or so, started to experience light pain in scrotum area (first two weeks strong pain), and unable to empty bladder completely (always an urge to urinate even right after urinating). This bladder issue is ongoing, joint pain at times.
About 5 minutes after shot, pt felt extremely unwell, really hot, pale, blurry vision, confusion,  and feeling of fainting. After an ice pack , and Gatorade pt felt well enough to go home approx. 30 minutes after shot
Within ~1 minutes of receiving this IM Influenza injection (into the R deltoid), patient (employee) became diaphoretic, nauseated and dizzy/light-headed (vasovagal response; near syncope - did not lose consciousness).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
A few days after the vaccine I started to feel burning on my head much like a sunburn.  it would come and go over the next week or so. On July 4th I started getting headaches.  On July 6th I broke out with a rash and little pimples on my scalp.  I was diagnosed on July 8th with Shingles.  I was treated with Valacyclovir Tablets.  I am still taking them but my symptoms have almost completely healed.
About 15 hours after the shot I experienced chills all over my body even though I was under a sheet and two wool blankets.  The outside temperature was 72F.  I also could not fall a sleep all night after it started.
Patient began to experience back pain, coughing and itching throat. No rash,  swelling, or significant difficulty breathing occurred.  The paramedics were called and epi-pen and benadryl were administered IM by the paramedics.  The patient was monitored at had recovered by 3pm the same day.
Blurry vision, can?t focus. Tingling on my left cheek and left side of my nose. Chest tightness and pain. Can?t take a deep breath. Abdominal pain and bloating. Feel full after eating very little.  Small rash on both sides of my stomach.
Dizziness after the first dose; bad reaction for 2 hours after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness after the first dose) and ADVERSE DRUG REACTION (bad reaction for 2 hours after the first dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 025C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM for Dental treatment NOS, IBUPROFEN for Headache, OXCARBAZEPINE (OXTELLAR XR), TOPIRAMATE, LISINOPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (Dizziness after the first dose) and ADVERSE DRUG REACTION (bad reaction for 2 hours after the first dose). At the time of the report, DIZZINESS (Dizziness after the first dose) and ADVERSE DRUG REACTION (bad reaction for 2 hours after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114547 (E2B Linked Report). This case was linked to MOD-2021-116427 (Patient Link).; Sender's Comments:  MOD-2021-114547:Son's Case
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: It was reported as vaccine received as yes. The patient had no other medication in 2 weeks. The patient was treated for COVID-19 with antiviral Paxlovid orally from 26May2022 to 01Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Dizziness; Headache; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included LISINOPRIL for Blood pressure management.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-187041 (Patient Link).
>24 hours post DTaP 5 given, pt developed erythema, induration to entire anterior upper arm. No fluctuance, no fever. Tx with Duricef, Benadryl, cool compresses.
The cases were received on 22 March 2014 at GPV. Initial misuse report received from a health care professional on 16 October 2013. A 67-year-old patient had received FLUZONE Intradermal. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
pt describes flushed face & sweating 1min p/vax;tingling to rt side of jaw;35min to 1hr p/vax syncope episode @ home;2hr p/vax had diff breathing, mental confusion & diff in muscle coordination;had sz;sit staring & not responsive;ear ache;
Broke out with a shingles like rash on chin. Saw dermatologist who cultured the area and placed her on anti-viral medication.
Patient received shot Friday afternoon and called Monday morning stating she has a rash about 2.5" by 6" long going down her arm starting at the injection site. She said it doesn't itch or burn or hurt upon moving, but it does hurt if she touches it.