chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 25 year old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated subcutaneously with dose 1 MMR II (lot # and dose not reported) as a child on 01-MAR-1989 and was vaccinated subcutaneously with dose 2 MMR II (lot # 1579AA; exp date 12-OCT-2013) (dose not reported) on 14-SEP-2012. No other co-suspects were reported. Concomitant medications included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and ENGERIX-B. The nurse practitioner reported that the patient performed a "home pregnancy test" on 21-SEP-2012 and a confirmatory home pregnancy test on either 22-SEP-2012 or 23-SEP-2012 and these tests noted she was pregnant. Her LMP was on 18-AUG-2012, the EDD was 25-MAY-2013. The patient went into the office of the reporting nurse and no treatment information was reported. Additional information has been requested.
Ok on 4/26/2021 at 10:00PM I was going to bed and I had some water and I dropped it and I had a bottle of medication and I dropped that as well. I went to pick it up and I could not pick it up, I fell onto the bed and I could not get up. My left leg and left arm were paralyzed and I could barely speak. I could tell I could was having a stroke and I called my wife in as best I could and they called 911. They determined yes it was a stroke and they took me to the ambulance. When I was in the ambulance it went away, it only lasted about 15 minutes. I was taken to the hospital and stayed there for three days.
3 days after vaccine administer, developed headache, sore throat, rhinitis, tinnitis.  Tinnitis persisted 2 weeks later; audiogram documents diminished hearing as compared to 2006 testing.
Patient received Pfizer bivalent booster dose for 5-11yr age group in error.
About 10 minutes after administration, patient said he had a scratchy throat. It was not that way prior to administration. No difficulty breathing. I gave him water and asked him to sit for an additional 15 minutes. I explained that typical allergic reactions occur within 15-30 minutes. Patient then said his heart started raising and he did not feel good. He also started sweating and got chills. At that time he agreed to have EMS called.
24 hours after vaccination, patient experienced left arm pain that has lasted for > 2 weeks (Constant throbbing and aching). No redness, swelling or deformity noted. Normal muscle strength. Somewhat diminished range of motion due to discomfort.
Mild ear infection on right ear. My PCP started me on Zpak. No pain, just some occasional clear discharge.
Revaccination with different COVID-19 vaccine; interchange of vaccine products; My third was moderna Needed one week to recover/Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and VACCINATION SITE PAIN (My third was moderna Needed one week to recover/Pain in arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    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 and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and VACCINATION SITE PAIN (My third was moderna Needed one week to recover/Pain in arm). At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown and VACCINATION SITE PAIN (My third was moderna Needed one week to recover/Pain in arm) had resolved.            The patient's first 2 shots were BioNTech had pain in the arm where it was injection and 1 day off at the second shot. The third dose was Moderna and needed nearly one week to get 100% recovered.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Paresthesia and questionable weakness bilateral lower extremity, as well as paresthesia of all fingers; weakness of respiratory muscles; plasmapheresis, on ventilator; monocytosis.
declined to take the 2nd dose; Body itching; Right foot became swollen, red and hot; Right foot became swollen, red and hot; Right foot became swollen, red and hot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body itching), PERIPHERAL SWELLING (Right foot became swollen, red and hot), ERYTHEMA (Right foot became swollen, red and hot), FEELING HOT (Right foot became swollen, red and hot) and PRODUCT DOSE OMISSION ISSUE (declined to take the 2nd dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient had allergies to everything in her blood and is highly sensitive).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Body itching). In March 2021, the patient experienced PERIPHERAL SWELLING (Right foot became swollen, red and hot), ERYTHEMA (Right foot became swollen, red and hot) and FEELING HOT (Right foot became swollen, red and hot). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (declined to take the 2nd dose). At the time of the report, PRURITUS (Body itching) had not resolved, PERIPHERAL SWELLING (Right foot became swollen, red and hot), ERYTHEMA (Right foot became swollen, red and hot) and FEELING HOT (Right foot became swollen, red and hot) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (declined to take the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient doctor gave her an antibiotic shot and other medication and the swelling got better. She also stated that she had allergies to everything in her blood and is highly sensitive, so she declined to take the 2nd dose.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received on 22-Jul-2021 and included new patient medical history was added, new events (peripheral swelling, erythema, feeling hot and missed dose) were added, treatment information for the patient was added.
Suddenly realized the site where I got the vaccine on my left arm is hard and swollen, very red and warm. Similar to a spider bite but much larger.
Narrative:  72 YO M with PMH of DM, COPD, GERD, HTN, OA, OSA reported myalgia of injection site and temperature 99.5 after first dose of COVID vaccine on 1/18/21, which resolved without intervention. Patient also reports alopecia which began around this time, which is ongoing as of 3/18/21. Patient did receive second dose of COVID vaccine on 2/18/21.
Pt developed projectile vomiting, found on ultrasound to have intussusception; in OR noted to have Meckel's diverticulum.
DEATH; STROKE; BLOOD CLOTS; This spontaneous report received from a consumer via a social media via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total , administered on an unspecified date of 2021 for covid-19 prophylaxis. 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 got blood clots and had a stroke, and passed away (death) from unknown cause of death on mother's day (Date unspecified). It was unknown if an autopsy was performed. It was reported that "My husband got that J J shot last year and he got blood clods and then had a stroke and passed away on mother's day". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause of death on an unspecified date, and the outcome of blood clots and stroke was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:20220919319- covid-19 vaccine ad26.cov2.s -Death, stroke. The event(s) has an unknown/unclear 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.  20220919319- covid-19 vaccine ad26.cov2.s -Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
presented to the ER on 10/3/21 with shortness of breath.  Patient started feeling COVID like symptoms on Sunday the 26th.  Patient when had a COVID swab done on 27th which was positive.  She began to feel slightly worse few days ago in regards to her respiratory status.  Her dyspnea has been getting progressively worse with activity.  When she felt even worse and decided come to the ER to be evaluated.  Patient denies any cough fever chills.  Her GI symptoms seem to be improving.  When she arrived to the ER she was found to be hypoxic an ABG done revealed a PO2 of 55. Patient's has been placed on 2 L of oxygen via nasal cannula.  She will be admitted overnight to see if we can wean her off oxygen. Being treated with Decadron and remdesivir. Respiratory support.  Over the course of hospitalization patient stopped requiring oxygen, her breathing discomfort improved and she was ambulating in the room going to washroom without any difficulty and without any oxygen requirement.   Patient is medically stable to be discharge Home on 10/5/21
Patient developed hives and itching all over body 30 minutes after HPV vaccine given.  Patient called our office and reported this 1-2 hours after hives developed.  Spoke with Dr., instructed to take Benadryl for hives and itching.
Feels weak; Stiff muscles; Headache for the past 10 days; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff muscles), HEADACHE (Headache for the past 10 days), CHILLS (Chills) and ASTHENIA (Feels weak) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031821A) 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) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff muscles), HEADACHE (Headache for the past 10 days), CHILLS (Chills) and ASTHENIA (Feels weak). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff muscles), HEADACHE (Headache for the past 10 days), CHILLS (Chills) and ASTHENIA (Feels weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she is afraid to receive the 2nd dose. No concomitant medications and treatment information were reported.
Right thigh with leg warm , red cellulitis. Amoxil , Zyrtec , Benadryl
After dose #1, patient had redness, rash and soreness at the vaccination site.  She also had flu like symptoms.  After dose #2, she started noticing some weakness, numbness and tingling in her arm that radiates down to her hand and fingers.  She also has an indention in her left deltoid muscle approximately the size of a quarter.  You can't see the indention, but it is very palpable.  She did not have as much soreness at the injection site and did not have a rash with the 2nd shot.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown date the patients were vaccinated with doses of improperly stored ROTATEQ (route oral, dose, dose number and lot # were not reported) or GARDASIL (dose, dose number, lot #, route and application site were not reported). Concomitant therapy was not reported. Concomitant therapy was not reported. Additional information has been requested.
Friday at 18:00, 48 hours, post vax, had backache, joints, equilibrium, diarrhea X 1 and periorbital edema on 5/12/01. Took Benadryl po on 5/12/01 PM and it helped with the flu-like symptoms. On 5/14/01, pt with swelling, redness at site with blisters-open/closed. Left arm edema from deltoid; left anticubital area warm to touch. Vital signs 97-64-18 BP 130/80.
Patient and MOP agreed to MENVEO, MenB wasn't offered at first. MenB given. Advised MOP and Patient that MenB was given instead of MENVEO. MOP and patient verbalized understanding and 2nd MENVEO shot was then given.
Gave patient flu shot yesterday. Patient said a little bit of swelling showed up last night. Patient came in to pharmacy today 10/18/17 around 1 pm, and showed her arm. Area of vaccination is red, swollen (size of a palm). She reports no pain, slight itchiness. Contacted DPM and referred patient to nearby walk in clinic today.
Noticed patient, at the age of 12 months, was sick/ill immediately after his battery of shots on 8/21/00. The shots received on 8/21/00 include the MMR, Comvax, Prevnar and Varivax, comprising 5 signatures or lot assignments on the vaccination records for that specific day.   The decline of overall development became even more obvious after the next round of Prevnar on 10/23/2000 (reduced eye contact, lack of response to name, lack of language,etc.) And continued into December (Prevnar 12/20/2000).
Four days after vaccine was given, patient experienced arm heaviness, gait instability, right hand numbness, and leg nubness from hip to feet. Patient presented to local hospital ER where provider evaluated and determined nothing was wrong. The condition got worse, legs began to shake, patient then presented to a larger hospital ER for a neurological evaluation. Patient was admitted to the hospital and worked up for stroke symptoms as well as trans-ischmic attack, which were negative. Numbness persisted and MRI with contrast of brain and cervical spine was done. It was noted that there were 3 lesions in the cervical spine area that were likely the cause of the patients symptoms. A spinal tap was deferred until wash out period of antiplatelet therapy was done. Patient received 3 x 1gm Methylprednisolone in the hosptial and was discharged on day 4 after presetation to hospital with diagnosis of acute transverse myelitis. Patient received spinal tap 7 days later with additonial blood testing. Significant findings from spinal tap included myelin binding protein and was negative for oligioclonal bands. No infection was noted. Patient followed up with neurologist on day 29 of symptom onset after discharge. Patient continues to have symptoms of numbness and burnign in legs and feet, numbness in torso region and right hand fingertips. She has bowel and bladder urgency but not incontinence. The neurologist determined this was an isolated case of acute transverse myelitis as all other potential neruological conditions were ruled out. Further MRI of brain and cervical spine recommended in 5 months to determine resolution of leisons or worsening of condition. Patient received a second course of oral prednisone taper for ongoing symptoms.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/25/2023 HYPERCHOLESTEROLEMIA
Fever 102+, nausea with vomiting 24 hrs, nausea 48 hrs
Pt received vaccines on 4/24/07 and subsequently developed 9x11cm indurated, warm, red area on (L) upper arm. Pt in NAD, afebrile
This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb lip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Numb lip). At the time of the report, HYPOAESTHESIA ORAL (Numb lip) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact.
started the sunday am after the vaccine. I started vomiting, chills, nausea, body ache, Diarrhea  , headache and dizziness, fatigue, my eye were sensitive to light and I had a cough and a runny nose and a cough for two weeks. I felt sick and couldn't sleep. My doctor could not see me because of covid, I did a covid test.
I had headaches and eye ball pain. My arm was hurting very badly and I had a dry cough. My eyes were bright red. My finger would go numb and useless.
Developed tinnitus in right ear within 24 hours of vaccination; developed tinnitus in left ear roughly 3 days later. The tinnitus has been constant since the beginning of symptoms, and persists over a week later.
Began with symptoms on 4/9/22- SOB with increasing weakness and hypoxia noted on admit to hospital.  Treatment includes: admission, O2, cardiac monitoring, dexamethasone.
This is a prospective pregnancy case. This 29-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX Quadrivalent, FLULAVAL Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcome sin women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX Quadrivalent or FLULAVAL or FLULAVAL Quadrivalent during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden on 5th November 2014.  On 5th November 2014, as unknown time after receiving Flu Seasonal QIV Dresden the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.  Additional details provided: Nurse reported that, she did not know EDD or gestational age. This was 1 of the 2 reports received from the same reporter.
loud tinnitus/The noise in both my ears is intrusive and annoying; difficult to concentrate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Lot number: 8028) at the age of 61 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid. Concomitant medication(s) included: SYNTHROID; VALSARTAN. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin", notes: Known allergies: azithromycin; Cipro, reaction(s): "Known allergies: Cipro", notes: Known aller-gies: Cipro; Protonix, reaction(s): "Known allergies: protonix", notes: Known allergies: protonix. Vac-cination history included: BNT162b2 (Pfizer second primary, Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Pfizer first primary dose, Dose Number: 1, Batch/Lot No: EL9266, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 04Nov2021, outcome "not recovered", described as "difficult to concentrate"; TINNITUS (non-serious) with onset 04Nov2021, outcome "not recovered", described as "loud tinnitus/The noise in both my ears is intrusive and annoying". Therapeutic measures were not taken as a result of tinnitus, disturb-ance in attention.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not had COVID prior vaccination and also not tested positive post the vaccination. It was reported that, patient had prolonged (lasting several weeks) episodes of loud tinnitus after each booster and she had recent omicron booster. The noise in both ears was intrusive and annoying, making it very difficult to concentrate. Patient did not received any treatment for AEs.  Follow-up attempts are completed. No further information is expected.
COVID-19 infection symptoms began on 02/26/2023. I had a runny nose, congestions, low grade fever, cough and headaches. On Tuesday 02/28/2023, I lost sense of taste and smell. At this point the congestions went down to my chest. On 03/01/2023 with a home COVID-19 test I tested positive. I called my doctor that morning he then called me back and prescribe Paxlovid for 5 days along with Prednisone. He also advised me to take Vitamin C, Vitamin D and Zinc. After 3 weeks of having COVID-19 infection I went to my garden doing my normal things and all of a sudden I was experiencing difficulty breathing. According to my doctor I have a solid nodule in one of my lungs. I will be going to my doctors office for more tests to rule out my problem. I tested negative on 03/09/2023.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX injection (lot # M002061, expiration date 12-JAN-2018, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
fatigue; aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (aches and pains) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and MYALGIA (aches and pains). At the time of the report, FATIGUE (fatigue) and MYALGIA (aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-082942, US-MODERNATX, INC.-MOD-2021-082955, US-MODERNATX, INC.-MOD-2021-082980, US-MODERNATX, INC.-MOD-2021-082989 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082955: US-MODERNATX, INC.-MOD-2021-082980: US-MODERNATX, INC.-MOD-2021-082942: US-MODERNATX, INC.-MOD-2021-082989:
Rash with mild severity and sudden onset since 1 day. - Use BENADRYL & hydrocortisone tx: will observe for now if worse to call & start ATB.