chrisvoncsefalvay/vaers-outcomes huggingface dataset:
concerns about some effects that I believe it is having on me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (concerns about some effects that I believe it is having on me) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (concerns about some effects that I believe it is having on me). At the time of the report, VACCINATION COMPLICATION (concerns about some effects that I believe it is having on me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Apr-2021 at 3:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.74  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 9 AM temperature was 35 total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
a few days after receiving my second dose of the covid 19 vaccination, i started having difficulty seeing the words on my computer and reading fine print on items. i changed into a new pair of contact lens and that didnt help any, nor did wearing my glasses.  it was getting difficult to do my job because it was taking me longer to try to read .  i called my eye doctor on 1/6/2022 to make an appointment for an eye exam thinking i was needing a stronger prescription.  my exam was set for 1/21/2022.  on 1/21/2022 as i was getting ready for work, i closed my right eye to put on my eye makeup and could not see myself in the mirror,it wasnt blurry, it was just a grey area. that scared me so i covered each eye in comparison and there was definately a  distinct difference in what i could see out of my left eye vs my right eye.  1/21/2022, my eye doctor confirmed i had a blockage in my left eye and called an opthamologist to get me in to their office the same day.  1/21/2022 i went to (Privacy) and was tested and have been diagnosed with a central retinal occlusion which is causing severe hemorraging in the back of my eye, and causing the retina to swell which is causing my vision loss. i had to go back to the clinic on 1/24/2022 to receive the first injection into my eye to help reduce the swelling so that i do not lose any more vision. these injections  are now scheduled every 4 weeks to control this.  i have no contributing factors or medical history that would cause me to produce blood clots. i have had 2 blood panels done in 2021, the first one in may, and the last one in sept 2021, and all metrics came back in the normal range on both occasions.  the only thing different in my life to question is receiving the 2 doses of the moderna covid vaccine  .  1st dose dec 5, 2021 and the second dose 1/2/2022
Onset of itchy rash on 6/8/21.  Diagnosed as Herpes zoster with complications on 6/10/21.  Treated with valacyclovir, and rash resolved in 7 days.  Immediately after completion of anti-viral, onset of severe and persistent fatigue, paresthesias primarily on left side of body, discomfort encircling torso/abdominal tightness, sleep disturbance, worsening of full-body fasciculations.  Treated with supplements of vitamin B12, and Flexeril as needed for sleep.  Symptoms have improved, but not resolved as of reporting.
pt recvd vax & devel rash @ inj site;no further details were provided;
A 27 year old female received pre-exposure RabAvert, first dose on 2/7/02. She tolerated the first injection with no ill effect. The second injection was given on 2/14/02. She experienced hot and cold flashes, severe muscle ache (especially around the injection site), headache, difficulty sleeping, and very mild overall flu-like symptoms. The flu-like symptoms began approximately 4 hours after the second injection and lasted for 25 hours. All symptoms had spontaneously resolved by 2/15/02. She subsequently received a third injection, to which she had no reaction. She did not seek medical attention. Patient was not on any other medication.
PATIENT REPORTED TO ER FOR SHORTNESS OF BREATH. LABS REVEALED SLIGHT D-DIMER ELEVATEION. PE, MI, PERICARDITIS RULED OUT THROUGH CT, CXR, EKG AND SUPPORTING LABS. PATIENT IS PHYSICIAN AND CURRENT I, RESIDENT REQQUESTING VAERS SUBMISSION DUE TO HIS CONCERN OF MYOCARDITIS.
caller reports 4 weeks before getting the first dose, she had filler injected by her eyes and now one of her eyes looks all messed up and she will need surgery to correct that problem.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Pfizer (159558). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "she got the filler injections", start date: 02Mar2021 (unspecified if ongoing), notes: Caller states she waited from the time she got the filler injections on 02Mar2021, 6 weeks. There were no concomitant medications. The following information was reported: OCULAR DISCOMFORT (medically significant), outcome "unknown", described as "caller reports 4 weeks before getting the first dose, she had filler injected by her eyes and now one of her eyes looks all messed up and she will need surgery to correct that problem.". 4 weeks before getting the first dose, she had filler injected by her eyes and now one of her eyes looks all messed up and she will need surgery to correct that problem. It was reported that filler had to be completely removed. It was reported that she wanted to see out of courtesy what they were wiling to do for her. Caller states now she is stuck having to correct her eye, it is  completely sunk in on the left side.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Arm weakness  Soreness Aches  Bruise  Red lesion/bump  Warm to touch    No treatment yet . Waiting on doctors response .
flu for 2 1/2 weeks; very ill; extreme muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu for 2 1/2 weeks), ILLNESS (very ill) and MYALGIA (extreme muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu for 2 1/2 weeks), ILLNESS (very ill) and MYALGIA (extreme muscle ache). At the time of the report, INFLUENZA (flu for 2 1/2 weeks), ILLNESS (very ill) and MYALGIA (extreme muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SICK; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.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 02-MAY-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case.No concomitant medications were reported. On 02-MAY-2021, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick on 08-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210527035.
This spontaneous report as received from a other health professional refers to 2 patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On unspecified dates (reported as "between 09-SEP-2016 and 06-OCT-2016), the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (dose and route were not reported) lot # L016598 and expiry date: 26-JUN-2017. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the 4 reports from the same reporter. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of PAIN (it gave them pain, and they don't recall been sore until later on the day of the vaccination/how long does the soreness last), INSOMNIA (did not sleep at all/went to bed at 9 o'clock/slept for two hours/couldn't sleep at all, because their arm hurt/they haven't gone to sleep at 9 o'clock since been a boy and woke up at 12 o'clock), PAIN IN EXTREMITY (arm hurt) and FATIGUE (has been very tired since/felt tired/very tired/felt fatigue and felt like doing nothing) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     The patient never had COVID positive test or COVID diagnosis. The patient did not have any acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (first booster) and COVID-19 Vaccine Johnson and Johnson (primary series). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine Johnson and Johnson and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy and Blood pressure high.    On 31-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, the patient experienced PAIN (it gave them pain, and they don't recall been sore until later on the day of the vaccination/how long does the soreness last). On 01-Jun-2022, the patient experienced INSOMNIA (did not sleep at all/went to bed at 9 o'clock/slept for two hours/couldn't sleep at all, because their arm hurt/they haven't gone to sleep at 9 o'clock since been a boy and woke up at 12 o'clock), PAIN IN EXTREMITY (arm hurt) and FATIGUE (has been very tired since/felt tired/very tired/felt fatigue and felt like doing nothing). At the time of the report, PAIN (it gave them pain, and they don't recall been sore until later on the day of the vaccination/how long does the soreness last) and PAIN IN EXTREMITY (arm hurt) had not resolved and INSOMNIA (did not sleep at all/went to bed at 9 o'clock/slept for two hours/couldn't sleep at all, because their arm hurt/they haven't gone to sleep at 9 o'clock since been a boy and woke up at 12 o'clock) and FATIGUE (has been very tired since/felt tired/very tired/felt fatigue and felt like doing nothing) was resolving.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.   Concomitant medications of the patient included unknown high blood pressure medicine and an unknown sleeping pill nightly.  The adverse events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized). The symptoms of the patient were bit better. The patient wanted to how long the soreness last because it had been three days.  No treatment information was provided by the reporter.
ON 12/31/20 IN THE MORNING, DEVELOPED CONGESTION AND MILD SORE THROAT. ALSO, JOINT PAIN IN THE HANDS. LOW GRADE FEVER WITH ONSET ON 1/2/21 WHICH RESOLVED 1/3/21. STATES JOINT PAIN CONTINUES
Hypertensive Crisis  OCT 2nd 2022 - 195/138 BP OCT 27th 2022- 209/143 BP OCT 29th 2022 - 167/101 Normal BP for me 110/70
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 16Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 20Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 28Mar2022 as dose 4 (booster), single (Lot number: FK989S), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polymyalgia rheumatica" (unspecified if ongoing); "known allergies to Quinolone family of drugs" (unspecified if ongoing). Concomitant medications included: METHYLPREDNISOLONE, start date: 26May2021; METOPROLOL, start date: Jan2016; ATORVASTATIN, start date: Jan1999, stop date: 11Nov2022; OXYBUTYNIN, start date: Jan2019, stop date: 11Nov2022; PRILOSEC [OMEPRAZOLE], start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Nov2022) Rebound of COVID, notes: Rebound of COVID both symptoms and test on 20Nov2022. Therapeutic measures were taken as a result of covid-19, which included Paxlovid from 11Nov2022 to 15Nov2022. Clinical course: The patient had rebound of COVID, both symptoms and test on 20Nov2022 at 09:00. Symptoms were mild as of this reporting date, but worse than the first round of COVID on 11Nov2022. The rebound of COVID was treated with cough medicine and had not recovered at the time of the report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325693 same reporter, patient, and product; different dose and event;
Both times headaches, anger and agitation for up to 2 weeks after the vaccine. DUE FOR DOSE 3 ON 9/21/2022
patient called on 8/14/23 and stated he was having problems with his left arm since the vaccine in 1/2023. states that his shoulder has hurt him off and on since the vaccine administered on 1/27/23. This was the first call of complaint.
From initial information received on 11/07/03, from a physician regarding an adverse event occurring in the USA, it was reported that a 77 year old male patient received a dose of Fluzone SV '200-'2004, lot number U1089AA, administered intra muscularly (site not reported) on 10/27/03. Three days late, on 10/30/03, the patient developed a headache, fever and fatigue. A purpuric rash was noted on his lower legs below his knees. The physician ordered blood tests, which showed a normal white blood cell count, decreased platelets and an increased sed rate. The patient contiues with the purpuric rash and complaints of headache, fatigue and low grade fever. Reportedly, the events have not resolved.
24 hours after shot given developed hives to L leg, L back, and a few hives to R leg.  Hives resolved around 36 hours after injection then reappeared on B/L legs about 54 hours after injection with erythema to B/L legs an B/L arms, all of which resolved within 8 hours.  pt has never had hives or rash before.
On the above date and time, the above named received her 2nd dose of Pfizer Vaccine, 0.30 ml, I/M Left Arm.  After approximately 5 minutes, pT complained of nausea, stomach cramps, and had the feeling of being 'hot'.  Vitals were taking: HR: 53; SPO2: 99% RA; BP: 118/78; hot to the touch at her facial cheeks.  While speaking with pt's mother over the next few minutes, pt was feeling a lot better.     She left the Clinic with her mother without further issue or incident.  Prior to leaving, pt's mother was advised to seek medical attention should the symptoms return.  No further action was taken.
a patient was given an expired dose of Menactra vaccine, No AE; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (Office staffer)  This case involves an 18 years old male patient who was given an expired 0.5mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6208AB, expiry date: 08-Jul-2020) via intramuscular route in the right deltoid for prophylactic vaccination on an unknown date (mentioned as today).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  They had standing orders so no physician specifically ordered the vaccine.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may have had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 07-OCT-2013 the patient had received a dose of VARIVAX (merck) (lot number #H011233, exp. date: 06-JUN-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences was reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA008561; #1312USA011520; #1312USA011521; #1312USA011522; #1312USA011523; #1312USA011524; #1312USA011526). Additional information has been requested.
Headache; Fatigue, didn't feel full strength back for 2 more days; Tongue felt thick; Throat felt like a slight sore throat; This spontaneous case was reported by a non-health professional and describes the occurrence of TONGUE DISORDER (Tongue felt thick), OROPHARYNGEAL PAIN (Throat felt like a slight sore throat), HEADACHE (Headache) and FATIGUE (Fatigue, didn't feel full strength back for 2 more days) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TONGUE DISORDER (Tongue felt thick) and OROPHARYNGEAL PAIN (Throat felt like a slight sore throat). On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue, didn't feel full strength back for 2 more days). At the time of the report, TONGUE DISORDER (Tongue felt thick), OROPHARYNGEAL PAIN (Throat felt like a slight sore throat), HEADACHE (Headache) and FATIGUE (Fatigue, didn't feel full strength back for 2 more days) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-023308 (Patient Link).
Narrative: Patient received Moderna COVID-19 vaccine from facility on 2/27/2021. He was identified by a pharmacy technician as overdue for his second dose. He was contacted via telephone and reported that he had a "stiff neck" after the first vaccine and that it is "livable". He declined the second COVID-19 vaccine.
Patient came in for second dose of vaccine. Patient and mother read and consented to the vaccination and read the prevaccination checklist. patient advised of potential side effects and recommendations of care for next few days (stay hydrated, possible soreness, take Advil or Tylenol for possible low grade fever or headache). Patient asked about hydration and meal prior to visit. Patient presented with nervousness/ anxiety and mother/ patient still consented to vaccination. vaccination was given, patient was taken to waiting area with crackers and juice given. while waiting the patient became diaphoretic. As patient walked to the back with mother to use restroom, patient showed signs of ataxia. patient was assisted into recovery position and never lost consciousness. Vital signs taken at 11:15 am BP: 99/45 (left leg), HR: 77, SPO2: 99%. Patient was fanned to cool off and decreased in diaphoresis. vital signs taken again at 5 min intervals. Patient monitored for 30 minutes, encouraged fluids with total intake of 700mL fluid. Last set of vitals taken while standing at 11:45 am were BP: 118/60, HR: 102, SPO2: 99%). Patient was given more fluids and monitored for 15 more minutes and then discharged from the clinic with parents.
Pt recvd HIB vax & 2 months following vax pt devel small nodule @ the inject site;