chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid test: Result: positive; Unit: Not Provided; Covid test: Result: positive; Unit: Not Provided; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EK9231), on 28Jan2021 as dose 2, single (Lot number: EL8982), on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 27May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Kidney cancer" (unspecified if ongoing), notes: Kidney cancer had almost 20 years. The patient's concomitant medications were not reported. Past drug history included: Opdivo, start date: Nov2017, stop date: 2018, for Kidney cancer, reaction(s): "Had severe side effects and stopped it.", notes: Had severe side effects and stopped it. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 03Aug2022, outcome "not recovered" and all described as "Covid test: Result: positive; Unit: Not Provided". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown, notes: Took 2 COVID tests; (03Aug2022) Positive. Therapeutic measures were taken as a result of covid-19. Additional information: the patient tested positive for COVID and is all vaccinated and boosted. On Tuesday evening (as reported), the patient started feeling sick and that is why she took the COVID test. The patient started feeling the kind of typical symptoms, her body hurt, was so fatigued, had that scratchy, itchy throat and cough. Her cough has been kind of the worst and has that runny, mucousy nose. She does not have a voice either. On Wednesday, she woke up and felt more sick, with what she assumed were COVID symptoms or flu symptoms. The patient took 2 COVID tests. Wednesday night, she didn't sleep real well. The patient had to sleep in another room on a futon and didn't sleep very well. She thought it was because of that and was just not resting well and not able to get real comfortable. They were like flu symptoms, COVID symptoms and probably the worst she had was the cough. She had kind of a scratchy throat and achy body. Those symptoms seem to be better. It was just this vibrating and not being able to sleep. She had trouble sleeping even though she went in a different room. She had not been able to sleep at all last night. She started feeling sick Tuesday, 02Aug2022 and had positive COVID test 03Aug2022.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-MAR-2012 at 11:30am, ZOSTAVAX lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 03-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
body aches; severe fatigue; slight nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (body aches), FATIGUE (severe fatigue) and NAUSEA (slight nausea) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), FATIGUE (severe fatigue) and NAUSEA (slight nausea). At the time of the report, MYALGIA (body aches), FATIGUE (severe fatigue) and NAUSEA (slight nausea) outcome was unknown.        No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745580:Wife case
Sore soles of feet. Difficulty walking. Veins on arms and hands bulging, dark in color, painful.
Oro-labial-nasal rash characterized by clustering of vesicles and painful ulceration, bilateral/crossing midline of face affecting also hard palate and mucosal membrane of nasal passages. onset 3 days after vaccine dose #2.  reported fevers malaise and R sided body pain, strongly itching eyes prior to onset of facial rash. also reported some facial swelling and yellowing of skin, which had resolved by the time she reported symptoms on 5/4 Symptoms most suggestive of primary HSV outbreak, pt denied any hx of cold sores or similar episodes prior to this. resolving lesions still present on upper lip on 5/17, but no mucosal lesions present.
After the second dose I had headache and body aches. More concerning was a build up of fluid around my left armpit and left chest.
she did not get the second dose of SHINGRIX yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she did not get the second dose of SHINGRIX yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-MAY-2023 The pharmacist reported that a patient reported that she did not get the second dose of Shingrix yet. Education provided per content. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
I noticed my son was non responsive to me a few hours after the shot was administered. He would not look at me or respond to any verbal or physical communication. He played with his toys like a robot and had no sign of emotion or awareness of anything around him. I called his pediatrician right away and she told me to go to the hospital if he didn't improve. He remained like this for two days and the entire time I kept trying to communicate to him and there was no response. It was very scary!!!! On the third day he slowly made eye contact with me and by day five he started responding to me more. I did take him in to be checked out and there was nothing they could do for him. He now has attention problems and I believe it has something to do with what happened. I am currently having him evaluated.
"Hot to touch, feels like lump, can't sleep on that side, feels sore up into neck and throughout left shoulder blade" "no temp".
She is fully vaccinated. She started with a mild fever and coughing but then she had severe body aches and a sore throat that got worse so she went to the hospital.
several hr of dec responsiveness, dec tone on day vax given;pt brought back to office, found to be alert, interactive & in no distress
Diagnosed with brain tumors/ Oligodendroglioma; This spontaneous case was reported by a nurse and describes the occurrence of OLIGODENDROGLIOMA (Diagnosed with brain tumors/ Oligodendroglioma) in a 44-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OLIGODENDROGLIOMA (Diagnosed with brain tumors/ Oligodendroglioma) (seriousness criterion medically significant). At the time of the report, OLIGODENDROGLIOMA (Diagnosed with brain tumors/ Oligodendroglioma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  Reporter was enquiring whether it was noted increase of Brain tumors after receiving two shots plus booster vaccine. Reporter was wondering if doctors were reporting this and how would they determine if vaccine was cause or not. Reporter mentioned it was either a rare coincidence or suspicious.  Company Comment: This spontaneous case concerns a 44-year-old female patient with no medical history reported who experienced the unexpected serious (medically significant) event of Oligodendroglioma which occurred unspecified number of days after receiving a dose of mRNA-1273. There is no available information regarding clinical course and treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report   This case was linked to MOD-2021-032010, MOD-2022-532773 (Patient Link).; Sender's Comments: This spontaneous case concerns a 44-year-old female patient with no medical history reported who experienced the unexpected serious (medically significant) event of Oligodendroglioma which occurred unspecified number of days after receiving a dose of mRNA-1273. There is no available information regarding clinical course and treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
This spontaneous report as received from a nurse refers to a 49 year old female patient. Patient had no pertinent medical history apart from allergy to tetracycline and Penicillin. On 09-SEP-2016, the patient was vaccinated with the first dose of VARIVAX (lot # K021484, expiry date: 03-NOV-2016) to prevent chickenpox. Dosing details and route of administration were not reported. The vaccine was reconstituted with sterile diluent (STERILE DILUENT). Concomitant therapies included simvastatin (ZOCOR). On approximately 23-SEP-2016, 2 weeks after administration of the vaccine, the patient experienced a red, bumpy skin rash around the injection site (injection site rash). It was reported that in December (unspecified date), the nurse noticed the rash when the patient appeared for the second administration of the vaccine. A serologic screen of antibody titers was performed which revealed 16.2 (units unspecified) (antibody test abnormal). At the time of this report, the second dose was not yet administered. The event of injection site rash was reported to have resolved on an unknown date. The outcome of antibody test abnormal was unknown. No causality assessment was provided by the reporter. No product quality complaint (PQC) was involved. Additional information has been requested.
Extreme chills, shaking, shivering x 1 day, loss of appetite, diarrhea x 2 days, weakness, lightheaded x 3 days, shortness of breath x 4 days
Heart arrhythmia within days after vaccination. I thought it would eventually go away but it has not so I finally went to the doctor. Dr gave me an EKG and has changed my blood pressure med to Metoprolol. I need to have a Holtor monitor placed for 48 hours and then need to see a cardiologist.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (received 1st dose 8 months ago, refer case US2019GSK055998). On 18th March 2019, the patient received the 2nd dose of SHINGRIX. On 18th March 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 19th March 2019, the patient experienced fatigue and upset stomach. On an unknown date, the outcome of the fatigue and upset stomach were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the fatigue and upset stomach to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the husband who reported for her wife. The patient received SHINGRIX and the day of reporting she felt very fatigued, and had an upset stomach. The reporter did not consent to follow up.
24 hours after receiving  vaccine, small rash at injection site, slightly itchy. Bruising on opposite arm (left).   Day 3 following vaccine, I woke up with a vaginal yeast infection.
On the night of the 17th, I couldn't open my jaw very well. The next morning, it had worsened and I could only open my mouth about a half an inch. It only hurt on the left side, under my ear. I called and talked to the advise nurse. The doctor told her I could wait until the next day to be seen. The next morning, I could open my jaw and it was getting better, so I canceled my appt. By Tuesday, it was gone. I've never had this to happen before.
Patient developed symptoms and tested positive for COVID-19 on 1/10/2022. Patient had 2 doses of Pfizer, no booster dose.
UTI symptoms including dysuria and urgency within 12 hours. Treated for UTI the next day. Had identical issue on 3/1/2021 where she had the pfizer shot and had a UTI the next day on 3/2/2021
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 30-year-old, adult, male patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804687 was linked to the source case 201804657 due to the same reporter.
Itchy, red, warm, very slightly raised rash on the site of the Covid injection. Came on pretty quickly. It's been there 3 hours now, so I don't know how long this will last yet. I understand they are calling this "Covid Arm"?
This spontaneous report was received from a medical assistant, concerning a 23 years old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of PROQUAD (dose, frequency, route, lot # and expiration date were not reported). No adverse symptoms were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Missed period  Period was due around the time of the 2nd vaccine, April 1st.  It is now April 16th and my period has not come.  I do have symptoms such as tender breasts and cramping. I am not pregnant.  My cycle is usually like clockwork. (Every 22/24 days)
Redness with edema at injection site x 1 week. Dr. prescribed Cephalexin.
No additional AE details or PQC.; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/ allergies was not provided.  On 12-APR-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe, lot number: U022819, expiration date: 14-JAN-2023 (dose, dose number, route of administration and anatomical location was not reported) for prophylaxis (product storage error). No additional adverse event (AE) details or product quality complaint (PQC) was reported (no adverse event).  The administered dose of the vaccine experienced a non-supported temperature excursion of 70 degrees Fahrenheit for 96 hours. There were no previous reported temperature excursions. It was unknown, whether a digital data logger was involved.
aching more than with the second dose; specifically in her joints including hips, arm, back, and thumb/Joint tenderness; headache; was tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching more than with the second dose), ARTHRALGIA (specifically in her joints including hips, arm, back, and thumb/Joint tenderness), HEADACHE (headache) and FATIGUE (was tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (low IgM an autoimmune thing. .).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced PAIN (aching more than with the second dose), ARTHRALGIA (specifically in her joints including hips, arm, back, and thumb/Joint tenderness), HEADACHE (headache) and FATIGUE (was tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 28-Oct-2021 for Arthritis, at an unspecified dose and frequency. At the time of the report, PAIN (aching more than with the second dose), ARTHRALGIA (specifically in her joints including hips, arm, back, and thumb/Joint tenderness), HEADACHE (headache) and FATIGUE (was tired) outcome was unknown.            No Concomitant medication information was reported.  Around 3:30 or 4:00 last night she took an long acting arthritis. Tylenol which made her symptoms go away.The Tylenol is started to wear off and her joint soreness was coming back. She doesn't build a lot of antibodies.   This case was linked to MOD-2021-367770 (Patient Link).
Had Tetanus shot due to hand injury (couldn't remember when I had a shot ever, so yes I ok'd the shot) Had symptoms that accompany the vaccine normally, was told to take advil and cold compress, but the painfulness and tenderness was extreme. Then 7/20 when I woke up my arm was tense, and  a hot rash was there, and sort of numb feeling around the red area. I know that needed attending to, so called the facility and they had me come in. 07/20/14
1 WEEK AFTER DOSE NOTED SWELLING AND REDNESS AT INJECTION SITE
Within 2-3 days,  i noticed  a very small, slightly reddened raised  area, apprx  1-1/2   to 2 In. distal to the injection site, with itching.  1-23-21, my left arm  now had an oval  shaped  "splotchy"  area of pinkish  discoloration, apprx. 2 inches. with a few very small, red  'veiny' looking marks. 1-24-21,  The "oval"  shaped  pattern was no longer "splotchy"  but one  continuous pinkish discoloration, slightly larger  now  feeling  very slightly indurated at the site where I originally noticed the slightly raised area, that was itching.   1-25-21. The discoloration  extended  a little more distally but  the color was fading 1-26-21 The discoloration continues to fade, appearing "splotchy" again but now in some spots, appears "yellowing"  like a fading bruise and  it is  spreading ever so slighty, distally, less  itching
Patient presented to the ED with worsening dyspnea and lower extremity edema. Patient was found to have an elevated BNP with chest x-ray showing pulmonary edema. Patient has been treated with IV diuretics. Nephrology was also consulted due to worsening BUN/creatinine. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
extreme fatigue, nausea, pain at injection site. about a week after my first dose I developed extreme joint pain and shortness of breath and am still experiencing the pain and shortness of breath (just very winded easily going up stairs, doing laundry)
0n 10/27 client called stating she received a flu shot on 10/11/10. Has been having nausea, dry heaves & severe diarrhea about 8 hrs after shot. No temp. Symptoms lasted approximately 4 days. Saw her PP Dr. on 10/22/10 who did a stool culture negative results for Parasites. Started feeling better on 10/23/10 now feels better as of 10/27/10. Dr also prescribed FLAGYL x 10 days PO.
Friday morning my smell and taste went away for 3 hours. I had two COVID tests and both were negative. That was my only side effect besides a minor soreness that lasted for 24 hrs. All is good now.
This spontaneous report as received from a physician via a company representative refers to a 15 year old male patient. The patient's medical history and concurrent conditions were not reported. On 26-OCT-2015, the patient was vaccinated with one shot of GARDASIL in the arm, lot # K010215, expiration date May 2017 (frequency and route were not reported). Concomitant therapies included one shot of influenza virus vaccine (Manufacturer unknown) in the other arm at the same time. On the same date, on 26-OCT-2015, the patient passed out after getting the GARDASIL shot. The outcome of syncope was reported as recovered on 26-OCT-2015. The relatedness between syncope and GARDASIL was not provided. Additional information is not expected as the reporter did not allow to be contacted.
POD5 from laparoscopic gastric bypass who presents with concerns for ongoing GI bleed. Has been having consistent maroon colored stools along with dizziness and light headedness. Hemoglobin on admission was a two gram drop from her likely baseline. Currently, she is hemodynamically stable and hemoglobin does not warrant transfusion at this time. Will plan for observation and serial hemoglobin. If continued maroon stools and hemoglobin drop will likely need GI consult.   She was COVID positive on admission, with consistent CT findings on lungs. She is currently stable from this standpoint without fevers, chills, difficulty breathing. Could consider monoclonal antibodies if worsening symptoms.
MeningococcalB vaccine given instead of intended MeningococcalACYW at age 12
Patient says the vaccine was administered in the middle of the upper arm (too low). Received vaccine ~2pm, by same day had redness, by next day a raised welt (goose egg). Pt happened to have MD appointment. MD concerned but didn't have pt take any meds. Pt had been icing, and continued icing. Resolved after 2-3 weeks. (NO MD visit as a direct result of adverse event, pt already had one scheduled and brought up incident at that appt)
Patient received shot on 5/20 5:20 pm, pt came back on 5/21 AM had a 3" long 1" wide a red area, she saw that day the initial area was no longer red but felt bumpy and has a 2" red border around it. 5/22 saw pt initial area was blistered, and red border swollen. Sent to urgent care for prednisone and triamcinolone. Pt also had nausea and fatigue and flu like symptoms.
Pt reported itchiness to legs, hands and chin area. No redness, edema seen. Pt was speaking in full sentences, in no distress. Pt was given 25mg of Benadryl PO x 1.  At 1145am vital signs were O2 sat 99%, Heart rate 63 bpm, blood pressure 130/80, respiratory rate 14. P t was safely discharged at 1225pm. Pt was in no distress and all symptoms have resolved upon discharge.
Post vax, the pt developed rheumatoid arthritis which he believed was caused by Lymerix. He could not walk or get himself out of bed. He stated he was relegated to being inside places like malls and not moving around much. The vaccinee stated that it feels like if you try to bend it the skin is going to rip. It kind of feels like your bones are broken in the joint.
Pt received Hepatitis A vacc and HIV vaccine and has vasovagal syncope; injured - (L) maxilla joint.