chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented with dyspnea on exertion on 01/10/2022, 2 days after symptom onset. He was transported to the emergency room after a syncopal event as well. Found to have a hemodynamically unstable pulmonary embolism with extensive bilateral lower extremity deep venous thrombosis, left lower extremity worse than right. The patient was given systemic thrombolysis with alteplase on 01/10/2022, underwent mechanical thrombectomy with interventional radiology on 1/13/2022 as well as retrievable IVC filter placement on 1/16/2022. During his admission he was given heparin for anticoagulation, however even at extremely high doses he remained subtherapeutic and had worsening clot burden. Ultimately was started on treatment dose eliquis.
This spontaneous prospective pregnancy report was received from a consumer (patient's grandmother), concerning a baby patient of unknown gender. The consumer reported that on an unknown date the patient was exposed in utero to GARDASIL (Lot #, dose and transplacental route). Concomitant therapy was not reported. It was reported that now the patient's mother had 21 weeks pregnant and the baby had developed a heart problem known as "transposition of the great arteries". The reporter also stated that the baby had a high risk of being born with Down's syndrome. The baby's outcome was not known. This case was serious since transposition of the great arteries was considered a congenital anomaly. This case is linked to MARRS 1309USA010507 (patient's mother). Additional information is not expected.
At the time of vaccination, patient had a drop  that was visible.  Then, then next day, patient start seeing bruises. Then patient came in with the site of vaccination and around it  being black, blue and Yellowish. Patient says that it is not painful or bothersome. It looks as if he got burned.
Arm was very swollen and red the first day. That night I had chills and was extremely fatigued, joints (elbows, hips and knees) were extremely sore. I can't take Motrin and Tylenol did nothing to alleviate the pain.   The next morning I woke up and felt worse, chills and fatigue. I was unable to work for two days and spent that time in bed, mostly sleeping. By day 3, I started to feel a little better, but was still very fatigued. By day 4, I started to feel like my normal self again and by day 5, I was fine.
3-4 Month long symptoms of fatigue, body aches, nausea. Loss of appetite and energy. Notices previous inquiries come back after  they are healed. Spouse claims very large change in personality.
Parents noticed light rash day after vaccinations on Right thigh and Stomach area stated she had ran a fever for couple of days but was also teething Parent called 12-30-2020 stated the rash had come back and was red and raised on both thighs and stomach. Parents called pediatrician on 12-30-2020 Dr. stated unless rash had gotten worse by friday to call. Parent stated rash was not bothersome to child, and she was no longer running any fever and only had fever for couple days after vaccination. Spoke to parents on 12-31-2020. @ 2:00 Child had gotten worse over the night rash is from head to toes. took her to Dr they perscribed prednisone ointment and oral.
Severe herpes zoster along left arm immediately following 2nd HPV vaccine.  Now on Neurontin, Valtrex, pain meds.
Beginning about 4 weeks after vaccination, I developed severe joint pain that made it painful to walk or move generally. I had knee surgery to alleviate some of the symptoms in my knee. This then evolved over the next few months to be  extreme shoulder arm and hand pain. I could not go to work, and decided to take early retirement in December as I was unable to function effectively.
This may or may not have been related to the vaccine. I broke out in hives. In addition to the booster, had a flu vaccine  at a HCF on 11/18 and had multiple doses of no I and for a dental procedure on 11/18, and had Steroid injections in my knees through joint relief institute on Monday, 11-22-21.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was uknown. Additional information received: This product has been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range has not been established. This customer purchased one 10 pack of this product therefore it was administered to ten patients. The ages and genders of the patients are unknown at this time. This case is one of the 9 cases reported by the same reporter for the same vaccine.
Narrative:  COVID infection following COVID vaccine series 03/16, Pfizer, dose #1 04/07, dose #2 12/22 CXR impression: No acute cardiopulmonary process.  12/22 COVID swab, result: detected 12/22 pt admitted to ED cc: sore throat dx: COVID-19 LOS: 1 day 12/19 pt cc: cough, rhinorrhea, sore throat, fatigue, exposure: unknown 12/22 SARS-COV-2 Variant Sequencing: pending 12/28 clinically resolved
I had previously had above average soreness in the inject site, weakness in the arm with some swelling and redness, warm to the touch, but I awoke suddenly in the night around 2am in excruciating pain. The inject site felt as though someone had hit me with a sledgehammer and was significantly swollen, hot to the touch, and felt hard/stiff. I have broken bones before that hurt less than this event for comparison, this was solidly 9/10 on the pain scale. Ice was applied along with aspirin and acetaminophen. within 4-6hours the pain had slowly returned to a manageable level.
Information has been received from a physician concerning a female "around 20-21 years old" who was vaccinated with three doses of Gardasil (lot numbers not provided).  Subsequently the patient experienced pain at injection site and bruising at injection site.  No further information is available.
After receiving the Flu shot, I began to experience pain on both shoulders which travels down both arms, tingling on both legs and feet, Heart racing and irregular pace, fatigue and pain in my mouth (gums). Have been to the ER twice, seen a cardiologist, orthopedic Dr. My primary Dr. and now scheduled to see a neurologist with no one giving a straight answer as to why I'm in constant pain. Have s.
Light headed, vomit, passed out, convulsed all within 60 seconds. She woke up feeling fine, ate a popcicle, water and walked out fine.
marble-sized lump in clavicle/little lump is painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 32 years 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: BONE NEOPLASM (non-serious), outcome "unknown", described as "marble-sized lump in clavicle/little lump is painful".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax 1030AM 22JUN92 & @ 11AM same day was tired & weak, 330PM h/a started-lt side of head & eye @ time dec neck; 6PM nausea began & steadly inc; 1130PM vomited, dizziness, occ dry heaves;
Patient received 1 dose of Moderna COVID-19 vaccine 03/16/2021. Patient tested positive for COVID-19 03/19/2021. Patient subsequently admitted to the hospital for COVID-19 infection.
MOTHER REPORTS THAT PATIENT HAD A SLIGHT TICK BEFORE VACCINATIONS WERE ADMINISTERED.  HOWEVER, AFTER THESE SHOTS MOTHER CLAIMS THAT TEACHERS AT SCHOOL NOTICED PATIENT HAD MORE PROMINENT SEIZURE LIKE STARRING AND TICK MOVEMENT THAN NORMAL. STATES PATIENT DEVELOPED A 99.2 TEMP, HAD GENERAL WEAKNESS AND LEFT AREM THAT DTaP AND IPV WAS GIVEN IN TURNED RED FROM SHOULDER TO ELBOW. MOTHER WAS GOING TO F/U WITH FAMILY DOCTOR
Tiredness; did not have the usual energy level to do normal activities.; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 13.45, (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not have allergies to medications, food, or other products. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 24Feb2021 at 13.30, (at the age of 57-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 experienced tiredness and did not have the usual energy level to do her normal activities on 19Mar2021 at 10.00. The patient did not receive any treatment for the reported events. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness and did not have the usual energy level to do normal activities was resolved on an unknown date in Mar2021.   No follow up attempts are possible. No further information is expected.
Fatigue; muscle aches; fever again; I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic; hard to sleep; it was so awful; cough; stuffy nose; Patient recieved primary dose of Pfizer and then received moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough) and NASAL CONGESTION (stuffy nose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Anatomical site reported Left Arm.) on 14-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Anatomical site reported Left Arm.) on 05-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved primary dose of Pfizer and then received moderna vaccine). On 04-May-2022, the patient experienced DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough), NASAL CONGESTION (stuffy nose) and PYREXIA (fever again). On an unknown date, the patient experienced FATIGUE (Fatigue) and MYALGIA (muscle aches). At the time of the report, DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough), NASAL CONGESTION (stuffy nose) and PYREXIA (fever again) had not resolved and FATIGUE (Fatigue), MYALGIA (muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved primary dose of Pfizer and then received moderna vaccine) outcome was unknown.            No concomitant drug reported.  Patient received some unknown suspect medication with start date 4-MAY-2022 and end date 9-MAY-2022 for the treatment of COVID-19.  Also patient reported  never would have taken Paxlovid.
About 2 hours after the vaccine I developed hives on the back of my neck and all down my back.
Pt received immunizations, after standing and walking into hallway. Pt passed out (no injuries) Pt was also immediately following vital signs taken, pt seen by Dr. pediatric doctor.
Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. On 09-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K023534, expiration date 22-MAY-2016, and lot # L028645, expiration date 25-MAY-2017, dose and route not provided) (Incorrect product storage). No adverse effects were reported. ROTATEQ Lot: K023534 Expiration date: 22-MAY-2016; Lot: L028645 Expiration date: 25-MAY-2017. STERILE WATER DILUENT Lot: L051109 Expiration date: 25-JAN-2018. Temperature: 47F. Time frame: 144 hours. Previous excursion: No. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Feeling a cold tingly feeling in both of his legs; Feeling a cold tingly feeling in both of his legs; A spontaneous report was received from a consumer , other healthcare professional and the consumer  was also a 86-years-old male patient who received Moderna's COVID-19 vaccine and experienced a  cold tingly feeling in both of his legs.  Patient's medical history and concomitant medication list was not provided.  On 13-JAN-2021, patient received  Moderna's COVID-19 vaccine in his left arm .  On an unknown date ,about a week later the patient started feeling a cold tingly feeling in both of his legs. Symptoms are ongoing.  Treatment actions not provided.  Action taken with mRNA-1273 was not provided.  The outcome of events, started feeling a cold tingly feeling in both of his legs.was not recovered/resolved.
Caller stated she got vaccine on 2/11 and has been fine. She stated last night at injection site it was itchy and she noticed a black and blue mark. She denies fever, redness, SOB and chest pain. She denies she has any other reactions before this. RN reviewed with her to use a cool compress on the the site as it could help with itchy area. RN Advised to call her provider to ask what she could take for to help with itchy arm. RN stated will follow up with her tomorrow.
Gave an Expired Dose of Heplisav-B to a Patient; Initial Report Received on 16-Feb-2022  A registered nurse reported that a 22-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 15-Feb-2022, the patient received an expired dose of HEPLISAV-B (Lot # 933623, expiration date 22-Aug-2021, NDC # 4352800305) intramuscularly in the right deltoid. A clinician at the facility did not follow the 2-check validation process and gave an expired dose of HEPLISAV-B to the patient. The patient did not experience any side effects.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pt given immunization 2/20/12. Called office 3/9/12 stating she noticed the day before (3/8/12) pt's eye was cross-eyed & getting worse. Referred to ER. Sent pt to another ER.
Hospitalized on 9/11/21 - due to SOB, loss of taste, and difficulties breathing
Intussusception resulting in emesis and bloody stools, treated with an air enema by Surgery and requiring in-patient observation
In June or July while I was at the doctors for other reasons, I mentioned how poorly my legs are doing and it seems to be muscular but I get a sharp pain in my right hip but recently has migrated to the left side. With that, I got blood test done and had a slightly low platelet count. Was given an antibiotic at that time and it was 10 day course. Currently seeing an urologist because had bloody urine and had a biopsy sometime in Oct-Nov. It was just inflamed and was benign, so it was normal. I had breakthrough COVID in November right around the 25th. I was given Ivermectin for it with oversight by my physician, I recovered around mid Dec.  However I am still dealing with fatigue and pain in legs and headaches.
Felt a lot of chest pain/felt like she was going to have aheart attack; She was stressed about something but it felt really odd to experience that chest pain. felt really odd to experience that chest pain/she has never experienced anything like this before; Dizziness; I felt my heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (I felt my heart racing), CHEST PAIN (Felt a lot of chest pain/felt like she was going to have aheart attack), STRESS (She was stressed about something but it felt really odd to experience that chest pain.), FEELING ABNORMAL (felt really odd to experience that chest pain/she has never experienced anything like this before) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PALPITATIONS (I felt my heart racing) and DIZZINESS (Dizziness). On an unknown date, the patient experienced CHEST PAIN (Felt a lot of chest pain/felt like she was going to have aheart attack), STRESS (She was stressed about something but it felt really odd to experience that chest pain.) and FEELING ABNORMAL (felt really odd to experience that chest pain/she has never experienced anything like this before). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 25-Apr-2021, PALPITATIONS (I felt my heart racing) and DIZZINESS (Dizziness) had resolved. At the time of the report, CHEST PAIN (Felt a lot of chest pain/felt like she was going to have aheart attack), STRESS (She was stressed about something but it felt really odd to experience that chest pain.) and FEELING ABNORMAL (felt really odd to experience that chest pain/she has never experienced anything like this before) outcome was unknown.            No concomitant medications were reported   The patient stated that she had to go and talk to the healthcare provider on site and they asked her to be observed for an hour. They gave her water and kept checking in on her to make sure she was doing okay   This case was linked to MOD-2022-451533 (Patient Link).   Reporter did not allow further contact
Pt received vaccines then went home crying at received bath when noticed red all over skin and shaking. Came back to office and EMS called - pulse O2 decreased and shaking - went to ER - woke up with swelling the next day.
Reddened, raised, some induration 6.5x5 cm. Feel achy in arm and neck area.
pharmacist did not reconstitute the Aexvy vaccine/administration of vaccine adjuvant without active component; pharmacist did not reconstitute the Aexvy vaccine/administration of vaccine adjuvant without active component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9B2Y4, expiry date 20-OCT-2024) for prophylaxis.   On 19-AUG-2023, the patient received the 1st dose of Arexvy (intramuscular, right arm). On 19-AUG-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: pharmacist did not reconstitute the Aexvy vaccine/administration of vaccine adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: pharmacist did not reconstitute the Aexvy vaccine/administration of vaccine adjuvant without active component).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-AUG-2023 The reporter reported that a pharmacist did not reconstitute the Arexvy vaccine and the administration of vaccine adjuvant without active component was given in right arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They had not been able to reach the patient to inform her. The caller was also transferred back to VSC asking for replacement of adjuvant vial. The reporter did not consent to follow-up.
I had vertigo and it occurred when I looked down or laid down. My PCP referred me to and ENT Dr. I had to have therapy for the vertigo. I did therapy for awhile. They released me because I started to get better. The ENT I saw is actually doing a study due to seeing more people having vertigo after the COVID-19 vaccine.
Patient and her husband reported that patient had received the Moderna vaccine at her previous clinic.  The break in process occurred when staff failed to verify documentation of which vaccine patient had received. Patient had actually received Johnson & Johnson vaccine.  Once error was realized, NP in clinic was notified. Patient and her husband were informed and educated on signs and symptoms of possible adverse reaction or side effects.
On 2/25/2021 (morning of Day 8 post injection), I developed a red rash with a tender lump at the injection site.  Reading online that this is indicative of a non-serious reaction called "COVID Arm" (apparently found with some patients receiving the Moderna vaccine), I began self-treating by icing the injection site and applying OTC hydrocortisone cream with aloe 2 - 3 times per day.  Over the first two days of symptoms, the rash grew to about 1 inch in diameter.  As of this morning, 2/27/2021, the rash is fading and the swelling is going down.
Caller reports multiple doses of VAXELIS administered since temperature excursion; This spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded to Agency on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.
Information has been received from a licensed practical nurse concerning a 66 year old female who, on 29-AUG2006, was vaccinated with a second dose of Pneumovax 23 (Lot# not reported). On 30-AUG-2006, the patient returned to the office with a large left upper arm swelling, redness, inflammation and discomfort. It was noted that she had no problems with her first dose of Pneumovax 23 (date unknown, it was given at a clinic). The nurse also reported that the patient recovered (date not reported). Additional information is not expected.
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
Pt recvd vax & w/in 24 hrs of vax pt had either an onset of or an inc in apnea & required supplemental 02 & stimulation;