chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the day I had the booster administered (September 06, 2022 5th booster), I had a little tiredness. Then on September 09, I was feeling stuff like I had a stuffy nose with a sore throat. My husband had already tested positive so I tested myself on the 10th and was positive. I called my primary care physician office and they prescribed Paxlovid. My symptoms were never bad but the Paxlovid helped with the drainage and stuffy nose. I have not completely recovered as I am experiencing a little sore throat and stuffiness. By the end of taking the Paxlovid I didn't have any symptoms. The day after I completed the medication, I tested negative using a home test. I completed another test on Monday September 19, 2022 and I tested positive again. A few days after that I had the sore throat and stuffiness. I plan to follow up with my healthcare provider regarding what I am experience.
Patient had an embolic stroke and then had carotid endarterectomy post vaccination  (He is comorbid, however)
VERY TIRED; HEADACHE; SLIGHT FEVER; This spontaneous report received from a consumer concerned a 7 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient had no known allergies, and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-OCT-2021, the patient experienced very tired. On 19-OCT-2021, the patient experienced headache. On 19-OCT-2021, the patient experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very tired, headache, and slight fever. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 26-SEP-2010, was vaccinated with the first dose of VAQTA and on 10-MAR-2011, 16 days prior to six month minimal interval from the first dose, was vaccinated with the second dose of VAQTA (doses, routes and lot numbers not reported). No adverse effects were reported. Additional information has been requested.
DIFFICULTY BREATHING BEGINNING THAT FRIDAY WORSENED OVER THE WEEKEND. WENT TO THE EMERGENCY ROOM,
Fever apprx. 12 hours after injection to 105. Pain 8 hours after injection. Erythema, warmth 24-48 hours after injection. Fever persisted. 8 x 10 cm induration.
Patient got shot around 4pm Monday.  The next day, she woke up feeling "hung over."  As the day progressed, she experienced bad headache (with sensitivity to light), bad arm pain (hard to move at all), hives, arm hot to the touch, fever of 102.2 at urgent care, dry heaving, stomachache.  Patient sought care at urgent care later that day.  Symptoms cleared up by Thursday around 4pm.
THE PATIENT CAME IN TO GET HER FIRST COVID VACCINE AND ABOUT 15 MINUTES AFTER THE VACCINE SHE STARTED FEELING HOT AND FLUSHED AND HER ARM STARTED FEELING NUMB.  SHE WAS GIVEN 2 CAPSULES OF BENADRYL 25 MG CAPS AND SOME WATER. AND AS I OBSEREVED HER  SHE STATED THAT HER SYMPTOMS WERE GETTING WORSE AND SHE STARTED HAVING CHEST TIGHTNESS AND DIFFICULTY BREATHING.  SO I THEN GAVE HER AN EPIPEN AND CALLED 911 AND WAITED FOR THE FIRE FIGHTER AND AMBULANCE TO COME
Erythema, swelling, induration, tenderness at injection site. High fever (> 102), myalgias.
BAD REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. On an unspecified date, following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient experienced bad reaction and had a bad flu and the patient had to go to the ER (emergency room) where the doctor recommend the patient to used Tylenol and that really helped the patient a lot (dose number in series 1). It was reported that the patient used Tylenol for years and it did not disappoint the patient (dose number in series 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with second dose of covid-19 vaccine ad26.cov2.s, the patient had bad reaction (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious. This case, involving the same patient is linked to 20220408757 (dose number in series 1).
After receiving Gardasil patient fainted and fell to floor.   Patient's vital signs were taken and monitored for about 30 mins after episode.
Unexpected pain returned at injection site 10 days after administration (01-25-2021), as well as mild swelling & redness (01/26/2021).
Fever, intractable nausea and vomiting, fatigue, headache, body aches and diarrhea
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Dec2020 as dose 1, single (Lot number: 025J20-2A), in left arm, on 17Jan2021 as dose 2, single (Lot number: 025J20-2A), in right arm and on 20Aug2021 as dose 3 (booster), single (Lot number: 088D21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "autoimmune cholangitis" (unspecified if ongoing); "Probable autoimmune disease of liver" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) negative, notes: On day 5 when Paxlovid finished patient felt good and tested negative; (07Jun2022) negative, notes: Retested negative on days 7 and 9; (09Jun2022) negative, notes: Retested negative on days 7 and 9; (01Jun2022) positive, notes: Patient began Paxlovid on first day of symptoms and positive home antigen test; (11Jun2022) positive, notes: on day 11 felt sick and home antigen test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Rebound Covid on day 11 of infection. Patient began Paxlovid on first day of symptoms and positive home antigen test. On day 5 when Paxlovid finished patient felt good and tested negative. Retested negative on days 7 and 9 but on day 11 felt sick and home antigen test positive. Was sick/symptomatic 4 days. Also developed and treated for sinus infection at this time with Augmentin.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective  (LOE) cannot be ruled out
pt recv vax 31OCT96 & exp diabetic coma on 5NOV96 & died that day;pt had no hx of diabetes;
On awakening-930AM had temp of 102ax was given tempra p/formula experienced vomiting; Fever kept elevating through day even w/tempra adm; also diarrhea; Taken to ER;
I experienced experienced extreme hands (started out in the middle and pointing finger knuckles which become very stiff) and joints. I made an appointment with my doctor and he took an X-ray of my hands (recommended taking an over-the-counter pain medication. I ended going to see him again and he conducted some additional tests (Rheumatoid factor, blood work, and check for Gout). I had to call again to complain about the swelling and he prescribed a diuretic (Lasix 10mg) to help with the swelling. The medication helps with the swelling but the pain is still there along with continual swell (right wrist is painful and my hands grip strength is reduced). I also went to Urgent Care because my hands were severely swollen and they asked me to double the dosage of the Lasix that I take along with using ice to help control the swellling.
Rash starting on back and spreading to extremities and right side of face; no fever or other reported symptoms; advised to call/see pediatrician to ensure related to immunizations.
5weeks post vax devel mild pain & yellow spots near area of inject; also c/o loose feeling of limbs (legs & arms); is nervous
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reproted. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported) and an unspecified Influenza virus vaccine (unspecified)(manufacturer unknown) (dose and route were not reported) concomitantly. On an unknown date the patient experienced pruritus that lasted between 2 and 3 months. Additional information has been requested.
period is also late; Severe joint pain in my thumbs; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0183), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 15:00 as dose 1, single for COVID-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. Severe joint pain in my thumbs a week after getting the first dose. My period is also late. I experienced both of these for five months after having Covid19. Things were just getting back to normal a month before I got the vaccine. The outcome of both the events was not recovered.
She notes arm soreness, mild malaise first 24-48hrs.  After day 3, started to note L sided neck soreness which progressively increased in size.  Remains tender and firm today
Patient received the flu vaccination and complained of being light headed. She said she gets nervous with shots. I offered to give her time to collect herself, but she stated she was fine and ready for the HPV vaccination. Just a few seconds after receiving the HPV vaccine, the patient fainted. She was seated so she slumped forward and did not sustain any injuries. She regained consciousness after approximately ten seconds and was answering questions within approximately a minute. The patient was not exhibiting any other signs or symptoms of distress. She was given a beverage, and was supervised for the next approximately 30 minutes. She did not have any problems the rest of the day.
This spontaneous report as received from a nurse refers to a 20 year old male patient with cardiac murmur. The patient has unknown drug reactions or allergies. There were no concomitant medications. On 16-JUN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot #K002923, date of expiration 26-FEB-2016 (dose and route unspecified) and dose of RECOMBIVAX HB (lot #, date of expiration, dose and route unspecified). On 07-JUL-2015 the patient developed shingles rash on an unspecified area of the body. The patient sought medical attention, he went to see a physician assistant. On 14-JUL-2015 the patient started VALTREX for the shingles. No laboratory diagnostic studies were performed. The outcome of the event was unknown. The relatedness between the event and (Oka/Merck) VARIVAX and RECOMBIVAX HB was not reported. Additional information has been requested.
Client is age 12 and received a 3rd (booster) dose of Pfizer vaccine at an offsite clinic (less than 6 months since her second dose). Multiple safeguards to prevent this type of error were in place, including color-coded wristbands, staff education prior to the clinic and just-in-time training at clinic, only one vaccine type per vaccinator station, and at least 2 points in clinic flow where age, vaccine type and dose number are verified. This error was discovered upon record review, and the client's guardian informed immediately upon discovery. Client's guardian reported that client experienced fatigue and congestion that started >6 days after receipt of this vaccine dose. He denied any noted symptoms or adverse effects <6 days after the vaccine dose was administered. Since booster doses are not authorized for less than age 16, there is not currently guidance on whether this specific dose should be repeated at the appropriate interval. This was discussed with the guardian. This error will be discussed with the vaccine team to identify any adjustments to off-site clinic processes to prevent this type of error in the future.
Received immunization on 03/14/05, the next night noticed swollen area on right arm. Red area measured 2.5 x 3, patient's mom given Elocon cream to put on area.
flu like symptoms for approximately 3-5 days; breathing issues; pain; foot issue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for hypersensitivity (ongoing); FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Extreme flu like symptoms". The following information was reported: RESPIRATORY DISORDER (disability) with onset Apr2021, outcome "not recovered", described as "breathing issues"; PAIN (disability) with onset Apr2021, outcome "recovered", described as "pain"; LIMB DISCOMFORT (disability) with onset Apr2021, outcome "recovered", described as "foot issue"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms for approximately 3-5 days". The patient underwent the following laboratory tests and procedures: pulmonary function test: (Apr2021) 3.6 L, notes: Test to get beselly. Specific Relevant Test for thromboembolic events with thrombocytopenia was reported as none. It was unknown if therapeutic measures were taken as a result of respiratory disorder. Therapeutic measures were not taken as a result of pain, limb discomfort.  After each shot extreme flu like symptoms for approximately 3-5 days. Patient had stomach issues with pain, constipation and nausea. Testing does not showed any causes. Paralyzed lower right diaphragm breathing test from 3.3 litres LFT (Apr2021) to 2.6 litres LFT (Dec2021) phrenic nerve not worked per EMG testing. Continuous testing at (withheld) for causes and corrective action. No previous similar problems prior to vaccinations. Patient took many other vaccinations over the life with no issues.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe allergy; my body felt cold; tightness in my chest/chest tightness got worse; not easy to take my breath; left and right foot started swollen/both left and right foot got more swollen(mostly the left one); Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot; I can't even step on my foot at all; can't sleep/hard time to sleep with; This case was received via  Medicines Agency (Reference number: US-irms-MOD21-125290   ) on 01-Aug-2021 and was forwarded to Moderna on 01-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergy), FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath) and PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Severe allergy), FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath), PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)), PAIN IN EXTREMITY (Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot), DYSSTASIA (I can't even step on my foot at all) and INSOMNIA (can't sleep/hard time to sleep with). At the time of the report, HYPERSENSITIVITY (Severe allergy) outcome was unknown and FEELING COLD (my body felt cold), CHEST DISCOMFORT (tightness in my chest/chest tightness got worse), DYSPNOEA (not easy to take my breath), PERIPHERAL SWELLING (left and right foot started swollen/both left and right foot got more swollen(mostly the left one)), PAIN IN EXTREMITY (Pulsing pain/pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot), DYSSTASIA (I can't even step on my foot at all) and INSOMNIA (can't sleep/hard time to sleep with) had not resolved.            No concomitant medications reported. No treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received contains  Reporter details, patient demographics, Events update - Feeling cold, Chest discomfort, Dyspnoea, Peripheral Swelling, Pain in extremity, Dysstasia, Insomnia, dose-1 and dose-2 details and same events after second vaccine
After HPV-9 approximately 10 min later pt. became lightheaded dizzy, hot and pale. Placed in chair tolerating apple juice and cookies, cool rags placed on pt.
Intense Headache, neck ache, body ache, fever. Missed work (01/14/21) neck ache, body ache, moderate headache (01/15/21).
Patient presented to the ED and was subsequently hospitalized for hypotension due to hypovolemia and toxic encephalopathy within 6 weeks of receiving COVID vaccination.
Started to feel whooshing in left ear/whooshing (tinnitus); started to feel tired/fatigue; started feeling nauseous, by 5hours after vaccine having serious nausea; By bedtime arm was hot; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 01Mar2021 at 07:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis, arthritis and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram hydrobromide (CELEXA), cyclobenzaprine hydrochloride (FLEXERIL), atorvastatin calcium (LIPITOR), hydrocodone (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC): all for unknown indication from unknown date and unknown if ongoing. The patient previously received povidone-iodine (BETADINE) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 at 08:15, the patient on way home started to feel whooshing in left ear, started to feel tired, started feeling nauseous, by 5 hours after vaccine, had serious nausea and by bedtime arm was hot. The patient reported on the day of reporting as 'today- had whooshing (tinnitus), nausea and fatigue'. Therapeutic measures were taken as a result of the events feel whooshing in left ear, feel tired, feeling nauseous/had serious nausea and included treatment herself with tums and diphenhydramine hydrochloride (BENADRYL) and for the event arm was hot included treatment herself with ice pack on for about an hour. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcomes of the event arm was hot was recovered on unknown date in Mar2021 and of the events whooshing in left ear, feel tired and feeling nauseous/serious nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
I was seven weeks pregnant at the time of vaccination. Two hours after vaccination I began to bleed vaginally which proceeded to miscarriage over the course of four days. As of date, the vaginal bleeding is unresolved.
Pt suffered swelling and redness of Right foot, swelling began PM of shot date, experienced pain in great toe, relieved, and washing on foot 01/26/05.
Severe heartburn started 3/31 at 6pm. It has persisted off and on with some relief with Tums.  Severe diarrhea started 4/1 12:30am, with multiple bouts through 4:30am.  Headache onset 4/1. Muscle aches- primarily back pain started 3/31.
Patient was possibly inadvertently given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State was notified
No additional AE/PQC; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report was received from a consumer and refers to a 69-year-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger recorded a 46.7F temp on 03-MAR-2023, and did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours. No additional adverse event was reported.  This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002667: US-009507513-2304USA002675: US-009507513-2304USA002694: US-009507513-2304USA002759:
03/29/21 - severe headaches started and continued 04/03/21 - balanced/dizziness/vertigo feeling started and continued 04/04/21 - admitted to ICU and diagnosed with Hemorrhagic Stroke