chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive Covid19 after Moderna vaccine; Off label : Doses administered 14 days apart; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid19 after Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Off label : Doses administered 14 days apart) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Off label : Doses administered 14 days apart). On 15-Nov-2021, the patient experienced COVID-19 (Positive Covid19 after Moderna vaccine). On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Off label : Doses administered 14 days apart) had resolved. At the time of the report, COVID-19 (Positive Covid19 after Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, SARS-CoV-2 test: positive covid-19 (Positive) Positive COVID-19.         No concomitant medication information was reported. No treatment medication information was reported.  On 11NOV2021 Thursday patient was having the sniffles, headache and cold like symptoms of COVID-19.  This is a spontaneous case of Inappropriate schedule of product administration for this 65-year-old female patient, with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID 19. The event occurred 7 months 15 days after the first dose of mRNA-1273 vaccine and 7 months after the second dose of mRNA-1273 vaccine. It was reported that patient experienced sniffles, headache and cold like symptoms and was confirmed Covid 19 positive. Vaccine doses were administered 14 days apart. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: No new information was received.; Sender's Comments: This is a spontaneous case of Inappropriate schedule of product administration for this 65-year-old female patient, with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID 19. The event occurred 7 months 15 days after the first dose of mRNA-1273 vaccine and 7 months after the second dose of mRNA-1273 vaccine. It was reported that patient experienced sniffles, headache and cold like symptoms and was confirmed Covid 19 positive. Vaccine doses were administered 14 days apart. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
patient over 45 years of age may have received Gardasil 9; patient over 45 years of age may have received Gardasil 9; no additional adverse events reported; This spontaneous report was received from a pharmacist, via companny representative, referring to a male patient whose age was reported as over 45 years-old. The patient's medical history, drug reactions/allergies, and concomitant therapies were not reported. His concurrent conditions included genital warts.  The pharmacist reported that the patient may have recieved hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, on an unknown date (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error) (strength, dose, frequency, route of administration, lot number and expiration date were not provided). No additional adverse events were reported.      The outcome of the events was unknown.
Pain on right arm; Tested covid-19 positive after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on right arm) and SARS-COV-2 TEST POSITIVE (Tested covid-19 positive after 1st dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones, Heart racing and Cancer. Concomitant products included METOPROLOL and WARFARIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Tested covid-19 positive after 1st dose). On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on right arm). At the time of the report, PAIN IN EXTREMITY (Pain on right arm) and SARS-COV-2 TEST POSITIVE (Tested covid-19 positive after 1st dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Extreme throbbing headache when laying down, less painful when sitting up. Extreme back pain up and down spine when sitting or laying. Took 500mg naproxen, seemed to dull the pain, pain came back strongly when medicine wore off. 20 hours after the pain started it had stopped completely.
After about 12 hours, I started getting body aches and a low grade fever (99.7 degrees).  Then about 3 hours later, a throbbing headache started.  When I woke up (about 6 hours after the headache started ~ roughly 24 hours after the vaccine), the headache was better and the fever had broken.  I still had mild body aches.  Also, the injection site was a lot more painful than my first shot.
A 9 yr old boy, received father's dose (adult dose) of Covid vaccination. The father was notified and advised to remain longer under supervision. The father also stated that son was of adult weight at 110lbs. The father informed to contact pharmacy with any concerns. The vaccine were properly labeled with peds sticker and placed in toe with correct var form, father's vaccine card was in the child's tote.
I experienced pain in the arm and some fatigue the next day after receiving the second shot. However, I went to the doctor on April 19th to get a mammogram and then it was discovered that I had enlarged lymph nodes. On May 27th, I took an ultrasound and I was told that the lymph nodes were no longer enlarged.
She had swelling and redness that covered almost all of the front part of her upper arm not just at the injection site on her left arm; She had swelling and redness that covered almost all of the front part of her upper arm not just at the injection site on her left arm; Swelling and redness covered front part of arm; Swelling and redness covered front part of arm; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0186; expiry date: unknown), via an unspecified route of administration, administered in the left arm on 11May2021 (at the age of 66 years old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0171), first dose via an unspecified route of administration, administered in left arm on 19Apr2021 as a single dose for COVID-19 immunization and experienced redness and swelling for a few days at the injection site. On 12May2021, the patient developed redness and swelling to the top/front part of her injection arm. She wanted to know if she was ever needed to get a booster dose of this vaccine, will it be ok for her to get it based off this side effect. She had swelling and redness that covered almost all the front part of her upper arm not just at the injection site on her left arm. It was everywhere. It looked like a bad sunburn on one arm. Yesterday, it finally started going down. The redness has gone away. The patient did not have a prescribing doctor. She went to saw the pharmacist after the swelling and redness lasted Wednesday, Thursday, Friday. She just popped in last Friday. She showed up, and the pharmacist's eyes got big like woah. He took a picture of it. She told him it had been there since Wednesday night. He said to call and report it, and to take Ibuprofen and Ice it. She did not take any other medication. She did take the ibuprofen for the swelling. The first shot did turn red at the injection site but not all over her whole arm like the second one. It was red and lasted a couple of days and went away. This one went days and days. It covered almost her whole upper arm. She stated that it finally resolved on 18May2021. The outcome of the events was recovered on 18May2021.  Information about lot/batch number is available. Further information has been requested.
All general symptoms attributed to flu - general malaise, nausea, fever and aches and pains beginning at 3 AM the night preceeding the vaccination. Lasted for 2 days with resolution on 3rd day.
pt recv vax 28JUN96 & that evening exp fever, h/a, heavy armpit pain, some rash on chest;pt stated that began to feel better p/1wk;
she was feeling unwell; She reported flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 02Jun2022, outcome "unknown", described as "She reported flu-like symptoms"; MALAISE (non-serious) with onset 02Jun2022, outcome "unknown", described as "she was feeling unwell".  Additional information: It was reported that the event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5m-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had six temperature excursions as follows: two for 64 hours each one with a lowest recorded temperature of 31 F (-0.555555556 Celsius) and a highest recorded temperature of 48 F (8.888888889 Celsius), one of 328 hours with a lowest recorded temperature of 29 F (-1.666666667 Celsius), one of 88 hours with a lowest recorded temperature 30 F (-1.111111111 Celsius), one for 64 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and the other one for 264 hours with a lowest recorded temperature of 33 F (0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Fever, chills, Migraine like headache, dizzy upon first arising from bed.,, Loud ringing in ear and extreme bright light, feeling of fainting, quick nauseous feeling.
Took Pfizer vaccine hours from being exposed/Tested positive; Took Pfizer vaccine hours from being exposed/Tested positive; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Took Pfizer vaccine hours from being exposed/Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive and took Paxlovid; Positive, notes: Ten days later still testing positive and experiencing mild symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
After getting the shot my lips became swollen and I had multiple ulcers in my mouth that came day 2, day 3, and day 4.
her arm was sore/sore arm; feeling a little queasy; it took her appetite away; the nausea she didn't eat; the nausea she didn't eat; feeling unwell (queasiness); This is a spontaneous report from a contactable consumer or other non HCP (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced her arm was sore/sore arm, feeling a little queasy, it took her appetite away, the nausea she didn't eat, feeling unwell (queasiness). Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday. On Thursday and Friday her arm was sore, then patient felt alright. On Sunday patient started feeling a little queasy, this sensation comes for 2 or 3 minutes and the goes away, in the middle of the night patient woke up and felt queasy, it took her appetite away, patient laid down and fall asleep (Patient stated that she didn't lose her appetite but because of the nausea she didn't eat). Patient felt the same way yesterday and today. Patient read in the paper the list of side-effects, patient describes her symptoms as nausea and feeling unwell (queasiness), patient would like to know if this could be related to the vaccine. Patient would like to know if someone can have side-effects from the vaccine after 3 or 4 days or if they come right after. Patient stated that she went and took the Pfizer vaccine shot on Wednesday and her arm was sore the next couple of days. Stated that she was alright. Stated that this is the third day. Stated that for the past couple of days that she was queasy. Stated that she that she decided to read the side effects and one was feeling unwell and nausea. Stated that it was like she was feeling unwell and a little queasy but patient did not put the two together with the shot. Stated that she still does not know if it is connected to shot. Stated that yesterday was the second day and she felt like that last night. Wanted to know if this is a side effect of the shot. Stated that she got shot on Wednesday and wanted to know if she can have side effects four days later. Is Pfizer Covid 19 vaccination shot. Stated that she was in the hospital prior to the shot. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
AFTER  GETTING THE COVID 19 MODERNA BOOSTER 0.25 ML DOSE PATIENT COMPLAINT UNUSUAL FEELINGS, DIZZINESS, FEELING WARM AND SWEATING, AND WAS FEELING TO USE BATHROOM,DISORIENTED AND CONFUSED AND DROOLING FOR A FEW MINUTES. ONE OF THE PHARMACY TECHNICIAL CALL EMERGENCY  AND WE WERE TAKING TO PATIENT AND GAVE HER COLD PACK TO  USE ON HER NECK AND SHOULDER. PATIENT WAS WAKE AND AWARE OF SURROUNDING AFTER FEW MINUTES. PARAMEDICS  CAME AND TOOK HER TO HOSPITAL.
Sneezed a few times over the weekend-typical sign of a cold coming).  Then got runny nose, nasal drainage, scratchy throat. Taking claritin already for allergies, and added a decongestent and flonase.  Started Monday, April 5 in the morning, noticed when I first got up.  It is clearing up and getting better. Also had a very sore arm the following day, but was fine after that.
1150:                                1200: HR: 68, Resp: 18, BP 118/73, O2 sats: 100% HR: 74                               1205: HR: 100, Resp: 20, BP: 122/77, O2 sats: 98% Resp: 20 BP: 112/73 O2 sats: 100%
After seven days of receiving the shot my arm had an itchy rash and a large swollen welt about 4 inches in diameter from the injection site.
Sore arm near area of injection; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 19:00, the patient experienced sore arm near area of injection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm near area of injection was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-MAY-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 single dose 0.5mLVls 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 2016 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning, female patient, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on an unknown date. Nurse reported that the patient was pregnant inadvertently received FLUMIST on 27-Feb-2014. No symptoms to reported. The outcome of the event of ADMINISTRATION TO A PREGNANT FEMALE is unkonwn. The report was considered to be non-serious.
Patient presented to the medical center on 6/8/2022 complaining of change in mental status, hematuria and SOB. Patient was a memory care resident who was initially brought to  the ED on 06/07 due to hematuria.  Patient had indwelling Foley catheter due to urinary retention. Foley catheter was exchanged and he was sent back to the memory care facility. Patient was brought back to ER again with recurrent hematuria and change in mental status. His vitals were stable. He was slightly tachypneic. Chest x-ray was suggestive of worsening congestive heart failure with increasing edema as well as increasing bilateral infiltrates suggestive of bilateral pneumonia. He was COVID positive. ED physician discussed patient with cardiologist, considering hematuria no anticoagulation/antiplatelets, continue beta-blockers. Hospitalist team was called to admit patient for further management. Patient with Bilateral COVID-19 pneumonia. This likely triggered his change in mental status and pulmonary congestion. Remdesivir not started as noted CKD with creatinine clearance less than 30.  Supportive care was provided. Suspected UTI due to indwelling Foley catheter with gross hematuria. Foley catheter was exchanged on 06/07 on the initial ED visit. Persistent hematuria. Patient had CBI started in the ED with some improvement. When CBI was stopped in the ED hematuria recurred. Patient was started on vancomycin cefepime. NSTEMI.  Known CAD.  Likely triggered by acute infectious process as discussed above. Metoprolol was started in the ED. No anticoagulation or antiplatelets agents due to gross hematuria. Patient was admitted to floor. Physician was called to patient room due to patient being found unresponsive. Patient died 6/9/2022 at 19:55
2/2/12 Noted with elevated temp and increased confusion & rash. 1/31/12 99.7 at 0425, 99.1 at 0730, 100.5 at 1400, 100.8 at 1915, 98.8 at 2140. 2/1/12 99.1 at 0530, 99.3 at 0815, 100.2 at 1145, 100.4 at 2130, 99.4 at 2230. 2/2/12 102.3 at 1245.
Thumping and ringing in ears Headaches? an excessive amount of headaches Weight loss - as much as 20 pounds right now Trouble sleeping Fatigue
11 INCH BLOOD CLOT IN LUNG; This spontaneous report received from a consumer via a company representative via social media concerned a male patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 an unspecified date, the patient experienced 11 inch blood clot in lung. The reporter stated that, "My good friend took the shot and a week later almost died with a 11 inch blood clot in his lung". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 11 inch blood clot in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220236850-covid-19 vaccine ad26.cov2.s- 11 inch blood clot in lung. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Tachycardia-Mild
- Extreme flu-like symptoms (extremely high fever, migraines, body aches, chills, muscle cramps, achiness, weakness for 48 hours following the shot starting at ~6hours after the shot) - More abnormal adverse event: irregular menstrual period for the first time ever (second period after the shot),  despite being on oral contraceptives (normally the timing is exactly consistent)