chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with sore sore arm and headache. Gradually throughout the day my entire began to ache more and more until my entire body was aching. Around the time I went to bed, I began to experience fever and uncontrollable chills and weakness. Headache still persistent through the next day and symptoms persistent all throughout night. Was given ibuprofen to help reduce fever and was effective fairly quickly. I had lasting effects through to the next morning.
took shingles shot, still got them again/ Suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with amitriptyline. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 3-AUG-2022 Reporter's Comments: The patient self-reported the case via  interactive digital media. The patient had the Shingles shot and still got shingles again. The patient took Amitriptyline every day to hold them back to that day. The patient still felt like the shot had helped. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 21 year old female patient with no  pertinent medical history or drug reactions/allergies. On oy-AUG-2014 the patient was accidentally vaccinated intramuscularly with a 0.5 ml dose of M-M-R II (lot number reported as J00020R). Concomitant therapy included iron (unspecified (+) minerals (unspecified ) (+) vitamins (unspecified) (prenatal vitamins). At the time of the report (13-AUG-2014), the patient was 31 weeks pregnant. The patient's Last Menstrual Period (LMP) was: 08-JAN-2014, Estimated Date of Conception 22-JAN-2014 and Estimated Delivery Date (EDD) 15-OCT-2014. Initial exposure to M-M-R II was at 30 week of pregnancy. The reporter stated that the patient needed to receive M-M-R II for an unspecified "paperwork" but should not had received with M-M-R II due to being pregnant. No adverse effect reported. No lab diagnostics studies performed. No treatment was given for the events. The patient did  not seek any medical attention. Lot number J00020R is an invalid lot number for M-M-R II. Additional information has been requested.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Delayed or missed monthly cycle (menstruation) by 7+ days.; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) as dose number unknown, single via an unspecified route of administration on an unknown date (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient had delayed or missed monthly cycle (menstruation) by 7+ days, no possibility of pregnancy. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken because of this event. The patient did not receive treatment. The clinical outcome of the event delayed or missed monthly cycle (menstruation) by 7+ days was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Country added in patient tab, vaccination Facility Country added, concomitant Therapy updated.  No follow-up attempts are needed. No further information is expected
pt recv 1st vax;2 wk later, exp lightheadedness, mild HA, some muscle ache & some muscle weakness; sx cont & recv 2nd vax;, muscle weakness;pt dx w/ a bacterial infect & tx w/ Cefaclor;
Child's left eye became swollen.  Pt assessed for resp distress and exp wheezing noted.  Pt also had a cough.  Parent notified sated that child "always swells up like that when he gets a shot."  Pt given 12.5 mg Benadryl and parent picked up.
The vaccine messed with my MS - made my bad left leg useless - couldn't lift leg, foot drop was very bad. That lasted overnight.  I also had a lot of pain in my right (good) leg. I can't bend the leg and put weight on it. Spent the next morning in the ER - they x-rayed right leg and found some bone-on-bone going on. Doc's hypothesis is that the vaccination triggered a subclinical case of arthritis in that knee/leg.
Patient described feeling numbness under the right eye.  The numbness radiated down the right side of the face.  Patient reported that the numbness subsided after 2 minutes
Total body itchiness beginning ~2 days after injection.  Excessive lethargy and tiredness on day 6. Hives, swelling, itchiness, rash around entire upper arm at day 7 that took an additional 3-4 days to resolve.
About 2pm 10/21/10 pt states (R) eye burning & felt like something in it. Later eyelid & skin near eye burning. On 10/22 stayed same. On 10/23 (Sat) red & whelps on eyelid, forehead, hairline. On 10/24 took BENADRYL & HC cream OTC. 10/25 eyeball ok, but hurts, still burning. Referred to PCP.
She reported her chest was feeling tight and heart was racing. Blood pressure and oxygen sats were in a normal range. Heart rate was elevated >100. She reports not feeling well. Gave her some water. Monitored vitals and symptoms. Ambulance was called. Started to feel better by the time the ambulance got there so did not seek medical attention after that. Lasted about 15 minutes. Today 5/6/2021 followed up with her and she reports she has chills, a headache, swollen, tired, body aches, etc.
during fir few days reports sore arm w/@ knot 3" in diameter, tired, weak, sore throat & mild h/a;by 6th day p/getting flu vax had fever (no over 100);chills, joint aches from neck to groin (not legs);exhausted & flat on back, vertigo;saw M
Patient states she began to have redness and tenderness at the site of injection. This redness spread down to her elbow, but not up to the shoulder. She went to her doctor's office for follow-up on Tuesday, Sept. 2nd, at which point the doctor gave some steroid medication for inflammation. Pt states that she has had some relief and that she has also been given steroid cream by her docor for use on the site. The patient states that there is a small knot in the area of the injection, but that the redness, swelling, and tenderness have decreased since the medications have been given by her doctor.
My mother got vaccinated for shingles, and still got it the same year/ Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: My mother got vaccinated for shingles, and still got it the same year/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 This case was reported by consumer via interactive digital media. The reporter reported that he's mother got vaccinated for shingles and still got shingles the same year. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory details were unknown at a time of reporting.
This non-serious spontaneous case, initially received on 09-Oct-2018, reported by other health care professional (nurse) concerning a 66-year-old, elderly, female patient. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 2 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252233 and expiry date: 31-May-2019). The nurse reported that, she had given the suspect vaccine 3 times over the amount that she was supposed to give the patient. The patient did not experience any adverse events after vaccination. Update received on 02-Nov-2018: Non-significant case correction (09-Oct-2018)- The sentence in the case comment 'company assessed the causality of the event as not related to the suspect vaccine considering the accidental nature of the event as medication error and the causal role of suspect vaccine was unlikely' was replaced with 'The company assessed the causality of the event as not related to the suspect vaccine considering the accidental nature of the event (medication error).' Non-significant follow up received from the reporter on 01-Nov-2018: The nurse confirmed that the patient had not experience any adverse events after vaccination. The narrative was amended accordingly.
Covid19 breakthrough.  1st Vaccine received on 07/28/2021.  91 y/o PMH CHF, Pacer, Nephrectomy, Non small cell Lung Cancer in remission presents to ED with c/o worsening SOB x24 hours, cough and congestions.  Pt using Home Oxygen at 2L NC.  Initially O2 2L NC-98%, but while in ED, pt with PEA cardiac arrest s/p 14 min CPR.  Vented and admitted to ICU.  Treating with IV steroids, IV abx, Remdesivir and pressors.
pt recv vax 14FEB96 & was found to be pregnant (positive home pregnancy test) LMP 3FEB96-estimated time of delivery was 10NOV96;during first trimester pt underwent an elective abortion d/t perceived risk from the vax
left shoulder warm to touch, tenderness, swelling about 2 inches, bruising.  Used ice compress to alleviate symptoms with no relief. Recommended to see primary provider if symptoms worsen.
Breakthrough case admission after two vaccines Pfizer 3/20/21 Lot# EP7534;  Pfizer 4/10/21 Lot# ER8734
The patient presents with fever, chills, Shortness of breath and Patient complains of cough increasing shortness of breath
Symptoms started around 11 hours after vaccination - chills, tremors, myalgias, restless legs, fatigue, dizziness, headache, arm pain at injection site no issues with my pregnancy - EDD 10/16/21
GARDASIL & VARICELLA vaccine given.  Pt alert, appropriate.  Escorted to hall.  Pt had syncopal episode, attended & examined by PA. VSS.
This is a spontaneous report from a non-contactable nurse who reported for herself. A female patient of an unspecified age and ethnicity received PREVNAR13, via an unspecified route of administration in DEC2014 at single dose. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness, swelling itchiness, pain and her arm hurt. The events were non-serious with outcome of unknown. No follow-up attempts possible. No further information expected.
L hand edema, hematoma which burst and caused bleeding sending pt to the ER for pressure dressing and 2 stitches.  L hand and arm progressively got more edematous and bruised looking (severely black/blue/purple) and the hand continued to bleed and swell on 2/6/21.  Severe arterial and venous issues and apparent blood clots.  On 2/7/21 there were also lumps noted on left inner thigh.  Pt. stopped eating or drinking on 2/8/21 and expired on 2/12/21.
I ended up being induced due to high BP & almost having preeclampsia. Due date was 9/11, born, 7lb even.   Previously gave birth & had a miscarriage  08/17.   Immediately (a couple days) after birth, I developed a severely itchy rash on my inner biceps. It remained stable until 03/2019 and then it spread across my entire body, targeting mostly my scars, stretch marks and tattoos (scars). I have seen multiple doctors and no one knows what is causing it or how to treat it, just that it?s some type of auto immune disorder. I?ve not been referred to Clinic. My appointment is next week.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 12-year-old female patient received BNT162b2 (BNT162B2), on 22Nov2021 at 15:00 as dose 2, single (Lot number: FH8020) at the age of 12 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "sleep support" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN oral taken for sleep disorder, start date: Mar2021 (ongoing). Vaccination history included: BNT162b2 (Dose:1, Vaccination time:14:00, Anatomical site of injection: Left arm, Batch/Lot number: FH8020), administration date: 27Oct2021, when the patient was 12-year-old, for COVID-19 Immunization, reaction(s): "she got her first period", "first period was heavy, with a lot of red blood (bright)". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 23Nov2021, outcome "unknown", described as "heavy flow in a bright red blood color"; MENARCHE (non-serious) with onset 23Nov2021, outcome "unknown", described as "her period was back, believe it is a side effect of the vaccine on the menstrual cycle. period would probably happen in spring 2022, After Arm pit hair and more breast dev.". Therapeutic measures were not taken as a result of menarche, heavy menstrual bleeding. Additional information: Prior Vaccinations were none. Concomitant medications included vitamins used for Health support via oral route, Start date:2018, Ongoing. The patient got her first dose of COVID vaccine on 27Oct2021 and on the very next day 28Oct2021, she got her first period my daughter first period was heavy, with a lot of red blood (bright) it lasted seven days approximately. One month later, withheld went for her second COVID shot 22Nov2021 and on the very next day her period was back. Again, heavy flow in a bright red blood color. She don't believe this was a coincidence. She believes it was a side effect of the vaccine on the menstrual cycle of girls and women, specially because withheld pediatrician asserted on Aug2021 that she was on tanner stage 2 heading to stage 3 and its growth spurt in height: period would probably happen in spring 2022, After Arm pit hair and more breast dev. Follow-up (08Jun2022): Follow-up attempts are completed. No further information is expected.
admitted local Medical Center on 1.16-1.22.2023, transitioned to comfort care 1.22-1.25.2023 expired 1.25.2023
Information has been received from a physician concerning a child who was vaccinated with varicella virus vaccine live (Oka/Merck). It was reported that the patient transmitted the varicella virus to the mother causing shingles. The mother sought unspecified medical treatment and her current status was not reported. No product quality complaint was reported. No further information was reported. Additional information has been requested.
86 year old vaccinated female with CKD 3b and COPD was admitted for Covid-19 pneumonia causing exacerbation of COPD. She was treated with Remdesivir and steroids. She also developed PE from Covid-19 infection. She has been on anticoagulation. can accept her today and will be transferred. She is on oral taper dose of Prednisone
Within two weeks of receiviing my first vaccine I had to go to the emergency room because I was having problems breathing. I had shortness of breath, heart palpatations, that changed my life drastically. Im still suffering from those symptoms and more. I am lightheaded, dizzy, fatigued . Ive been to a cartio, pulmin, endro, gastro, hemoto, had all the tests recomended and the doctors say all test results came back nornal.
Hot, swollen, red splotchy arm that spread over the next to days to involve the entire upper arm.  Resolution with Benadryl within 72 hours.
No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 6th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up information received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up information received includes suspect vaccine batch number was added. On 28-Feb-2023: Follow-up information received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Depression/anxiety; "Anxiety" (unspecified if ongoing). Known allergies: No. Concomitant medication(s) included: ZOLOFT, start date: 15Jan2009; LAMICTAL, start date: 15Feb2021. Vaccination history included: Covid-19 vaccine (DOSE: 1, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG IN-EFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: anti viral details: product: COVID 19 Treatment brand: Paxlovid treatment start date: 06Apr2022 treatment stop date: 11Apr2022 indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. It was reported that, extremely bitter and metallic taste in mouth. The intensity was almost unbelievable. It made it difficult to eat, sleep, or drink liquids. Nothing made it better. It only went away about 10 hours after patient had taken a dose. Also patient had akathisia after the evening dose. Patient felt like just had to get up and walk around. Patient limbs were just ready to go- could not lay still. Adverse event start date: 06Apr2022 at 08:00 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
postherpetic neuralgia; shingles; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 28-NOV-2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster) and routine health maintenance.   On an unknown date, the patient experienced painful cluster of sores on his right lateral buttock that burned and was diagnosed with shingles. The patient continued to suffer recurrent shingles outbreaks and has been diagnosed with postherpetic neuralgia. The patient did not recover from the events. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The event was disabling.   The reporter considered the events was related to Zoster Vaccine Live (ZOSTAVAX).
Moderate redness at injection site, low-grade fever within hours of injection. Approximately 8 hours later noted small amount of facial and peripheral edema. C/o malaise.
1 week after 2nd vaccine my vision started getting weird, lines through it, fuzzy vision, , felt the world was spinning around me, head fog, made me feel weir dand out of it. So far its been 7 days of it. I had an eye exam and they said everything looked good and normal and my glasses prescription had not changed. But they have seen about 5 other patients with similar symptoms after they had got their vaccines too. They are wondering if its linked to the vaccine, I have not had eye issues or symptoms like this ever!  My eye Dr. had called another local eye doctor in our area asking if he had also seen this happening too and he said yes, and is taking 2-3 months to resolve.
GAVE 16YR OLD PATIENT MODERNA VACCINE ON 3/31/2021, PT DIDN'T HAVE ANY COMPLICATIONS OR SYMPTOMS. DEPARTMENT HAD TOLD US TO GIVE VACCINES TO PATIENTS 16 YRS OF AGE AND OLDER.