chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling faint and dizzy off and on; Prolonged hormone disruption (symptoms similar to PCOS& thyroid disorders); probable link to cystgrowth; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Mar2021 (at the age of 20-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included multivitamin (vitamins C, D, B, E, etc.) (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient felt faint and dizzy off and on and had prolonged hormone disruption, the symptoms were similar to polycystic ovary syndrome (PCOS) and thyroid disorders; and a probable link to cyst growth. The events resulted in doctor/other health care professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling faint and dizzy off and on and prolonged hormone disruption were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, fever, body aches, headache. Chills started around 8:30 PM that night. About an hour and a half later, fever set in. My body felt very hot but I was still cold. Went to bed without taking any pain relief. I woke up at 2 AM, took Tylenol and went back to sleep. I woke up again at 3 AM, felt very hot and turned on my fan. When I woke up in the morning at 7:30 AM, my body still aches and I still had a headache. I took more Tylenol. Headache went away but for the rest of the day I felt very lethargic, a little foggy in my brain, slightly achy. I took Tylenol again when I went to bed at 9 PM and when I woke up at 4 AM the next morning I felt better. All symptoms are gone.
patient received 2 doses of the product fluzone HD QIV with no reported adverse event; Initial information received  on 20-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old male patient who received 2 doses of the product influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Dec-2022, the patient received a second dose of suspect influenza quadrival A-B high dose HV vaccine  at a dose of 0.7 ml once  (lot UJ918AD and expiry date: 30-JUN-2023)(form and strength: unknown) via intramuscular route in the left deltoid for Immunization  On 12-DEC-2022 the patient received 2 doses of the product fluzone hd qiv with no reported adverse event (extra dose administered) same day following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, patient received 2 doses of the product fluzone HD QIV and is calling to get guidance moving forward. Patient did not experience any adverse reactions. Patient received a dose o f FLUZONE HD QIV in their office last week on 12-DEC-2022. However, they did not realize that the patient had received a previous dose in Oct-2022.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Had razor sharp freezing pain throughout my body the entire day and night. Put gloves on flannel pjs, heated blanket could not stop the pain or get warm the entire day and night.
No adverse event Bivalent given instead of monovalent Covid 6m-4yr Pfizer as dose 1 of Primary Series.
Initial unsolicited report received from a non-health care professional (office staff) on 27-Oct-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of  FLUZONE HIGH DOSE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced redness below the injection site that traveled towards the inner bicep area and both had swallowing issues but no real respiratory issues. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Patient presented for his second covid-19 vaccine dose. Pt believed he had received Moderna for first dose. Pt did not have vaccine card on his person. DOB given by patient and DOB in EMR did not match which led to initial confusion and failed to reveal that patient's first dose had been Pfizer. Once date of birth was corrected and it was determined first dose was Pfizer, patient had already received the Moderna dose.
After 20 min of receiving FluMist, returned to the room.  Two hours later, person brought patient to the office with c/o vomiting.  Person came to pick up patient from facility.
Localized swelling in lt thigh, reported to be 2 x rt side, same area; Reported 24 hrs p/inject by mom; Reported by tele call not observed by RN; mom invited to return to clinic but refused; No MD visit; mom denies fever, induration;
Father describes immediate hives. Child developed pruritic rash, which had persisted since immunization.
Neuropathic pain in back and bilateral arms Narrative: Received 1st dose of COVID vaccine 1/4/2021. On 1/20/2021, he started to experience neuropathic, burning sensation over his back and bilateral arms. This is persistent and he is about to get an MRI under the care of his primary care physician.
This spontaneous report as received from a nurse practitioner refers to a 50 year old female patient with no pertinent medical history or drug reactions/allergies. On 20-NOV-2014 the patient was vaccinated with ZOSTAVAX lot # K007986, expiration date 03-SEP-2015 (dose, frequency and route of administration were not reported). Concomitant medication included COUMADIN. On 21-NOV-2014, the patient experienced red, swollen and sore localized reaction at the injection site. There was no treatment given for the adverse event. No lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of red, swollen and sore localized reaction at the injection site was reported as recovering. The relatedness between red, swollen and sore localized reaction at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
19DEC95 pt recv vax&that evening pt devel t103&was inconsolable for more than 3hr;by the 3rd day pt was improved;
Symptoms began 4/18/16 in the evening. Pt. reports fever (38.3 degrees Celsius), ear ache, head ache, itchy throat, and shortness of breath. On 4/19/16 the pt. reports redness and purities on the left arm where vaccines where applied lasting a week. Fever lasted 7 days. Pt. did not take analgesics or antipyretics.  Symptoms lasted 9 days. Joint pain began 3 days after vaccines. Stomachache and neck stiffness began 4 days after vaccination. Pt. states she was bed bound for two weeks. Pt. went to see PCP 7/12/16, PCP suggested pt. no longer receive vaccines due to possible adverse reactions.
Presented with increasing SOB, productive cough, fever; Covid + PTA (8/25) and received monoclonal antibodies PTA; ; admitted With Covid PNA; treated with Merrem, Vanc, Zithromax, No O2 required  Patient is a 34 y.o. female who was admitted with cavitary pna after covid.  Cultures obtained and she was started on Vanc and merrem.  She immediately felt better.  Was adamant about going home. Will go home on levaquin/doxycycline pending cultures.  Leave midline in    Disposition: She will be discharged today to home
Narrative:  Pt is an 83 YO male with PMH of schizophrenia, UTI, AKI, and HTN whose death was reported to the agency by another agency. No evidence that death was caused by COVID-19 vaccine.
No adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    Concomitant product use was not provided by the reporter.  Dosage text was reported as Initial Booster.  Treatment information was not provided.  This case contains information for the 10th patient out of 16 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687: case
"Pt presents to COVID Vacc Clinic on 7/21/21 for an unknown reason and informed staff that after one of her Pfizer doses (unclear which one or both), she had wheezing, SOB, chest congestion.  Pt has a hx of exercise induced asthma. Prior to vaccination, pt had a chest cold.  She had 2x negative COVID tests at that time. Medications at the time of vaccination: Albuterol, multivitamin 1/4/21 Pfizer EJ686; 1/27/21 Pfizer EL8982"
Noticed rashes/redness/itchiness on left arm, entire neck area, and upper chest. Pain radiating from injection site up to neck area. Neck area is tender to touch and swollen.
Lost interaction and communication with others, quit demonstrating pleasure or pretend play, fixated on TV, flapped hands, blank stare. Evaluated for deafness-negative. ABA, GF/CF diet treatments. Per 60 day followup: Recipient has residual symptoms of restricted interests, repetitive behaviors, delayed communication and delayed social skills.
PATIENT CAMEBACK TWO DAYS AFTER VACCINE ADMINISTERED AND HIS BICEP AND PART OF ARM WAS RED
Developed a firm and moveable "cyst", 2 inches below antecubital crease on anterior forearm, same arm (left) as Anthrax immunization given. Cyst is currently 1 cm in size.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On 10-MAR-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # K010628, expiration date: 30-OCT-2015) 0.65 ml, subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had a sore arm for about a day after receiving the Moderna Dose 4 vaccine. Since receiving the first COVID-19 within two weeks, I have had both upper and lower gastrointestinal issues. I have had multiply procedure to diagnose and treat to my health issues. I have a history of gastrointestinal issues. As of yesterday, my doctor says I have irritable bowel syndrome and inflammatory disease.
pt says 45 minutes after getting the vax her blood pressure spiked to 220/119.  She BP is normally 137 or 124 over 76 or 74.  She was monitored for over 3 hours.  Her balance was off the entire day.  She had weakness in her left arm.  She went home with headache, runny nose, and coughing.  She took her migraine medicine Ubrelby for her headache.  This did not help just made her sick to her stomach.  Pt says the all of the symptoms are better but she has a constant migraine. Pt has contacted her doctors.  They sent her a package of steroids medication to take which she has not started taking yet.  She has reached out to her doctors before starting meds due to her health conditions.
Throat tightness, dizziness. Diagnosed in ER with anaphylaxis. given epinephrine and steroid burst. Seen in clinic by me (how I got involved in case) and felt patient was stable. Continued steroids, advised family to pick up epi-pen prescribed by ER, and got them an allergist appt.
Hospital onset Covid-19 infection.  ED note states patient had been vaccinated.  Patient's current health status incongruent with accurate history retrieval.  No family to request information from.  Possible extenuation of patient's hospital course from infection acquisition.  Patient's Covid-19 status negative on admission 12/18/21, retest 12/27/21 also negative.  Patient extubated 1/7/22, related symptoms reported 1/8/22 = chills, SOA, increasing cough.  Fever reported 1/9/22.
Patient developed a raised, reddened, and painful rash to top of left thigh near injection site - this rash presented on 10/25/21. She also developed a intermittent post vaccine fever as high as 101F that began the day of the vaccine and is still present today. Patient developed diarrhea.
Upon waking on 3/17/21 at 6:00 a.m. (the day after my second dose of the Moderna Covid-19 vaccine).   I experienced floaters and blurred vision in my left eye.  There was one larger black spot in my field of vision larger than the floaters.  The large black spot has gone away in my left eye on the same day it occurred.  The blurred vision and floaters continue (over a week later) in my left eye.
Potential of extra dose of varicella vaccine may include rash or prolonged fever. There are reports of slight increased risk of febrile seizures with MMRV given as first dose. But if pt does not have fever, then this is a small in risk.
tiredness; body pain; allergy; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, body pain and allergy that was removed on the second day. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
10/11/11 vaccine administered high in deltoid. Alot of pain during injection. Increasing pain for the next two weeks and loss of use of arm. Diagnosis by neurologist after EMG of chemical neuritis due to flue vaccine. 3 days treatment with I.V. SOLUMEDROL. Still taking gabapentin and piroxicam. Am go two times per week for occupational therapy. On leave from work through January 25, 2013.
Lip swelling and shortness of breath that began about 10 hours after injection. Other common post vaccine symptoms were observed.
Received YFV at 4pm. Developed high fever and profound weakness about 9 pm. Went to ER. Fully conscious in ER - went home and within 2 days was much better,fully recovered in 4 days.
Patient developed total body erythematous papular rash, somewhat pruritc within 8 hours of administration of the vaccine
I am a postmenopausal woman (10 years) but in the evening after I received my Covid shot that morning I experienced vaginal bleeding. Not a lot, just several drops, but I have had no vaginal bleeding for many years and it was very unusual. It didn?t persist. I just had it enough to observe and didn?t see it again after changing undergarments.
The injection site appeared to be of normal appearance for over a week. No skin reaction. The local tissues tingled off and on like a mild burning sensation, which resolved initially.  But then after it appeared I was on the mend, the injection site suddenly opened up into a small open sore about 9 days post injection. It does not appear infected. It?s a small opening in the skin that has a mild burning sensation that still has not closed and healed. It?s very strange.  I?m scheduled to get #2 this Saturday (1/30) and not sure if I should get the second dose.
Fever of 104 and higher for seven days straight.  Within 48 hours after vaccine
I had sore throat, headache, slight fever, weakness. It felt like a cold. Saturday / Sun I tested negative with COVID-19 home test. Monday I tested positive. Severity was mild to moderate like a bad cold.
Delayed menses 3wks. Dizziness x 1wk. Rash on arm and numbness at injection site x 4days (red pin-dot) Arm felt heavy x 1wk Reported to office 12/04/08.
Her tongue began swelling; There were ulcers on the side of her tongue; She had blurriness.; She had a film over her; Discharge coming out of her eyes; Her eye appeared red 5 days later.; Rash at injection site; Acheness; Stiff neck; Really exhausted; Soreness; She also had nausea.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had blurriness.), SWOLLEN TONGUE (Her tongue began swelling) and MOUTH ULCERATION (There were ulcers on the side of her tongue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease. Previously administered products included for an unreported indication: TETANUS VACCINE (14 days before covid-19 vaccine.) on 23-Feb-2021.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), FATIGUE (Really exhausted), PAIN (Soreness), NAUSEA (She also had nausea.) and MYALGIA (Acheness). On 14-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had a film over her), EYE DISCHARGE (Discharge coming out of her eyes) and VACCINATION SITE RASH (Rash at injection site). On 17-Mar-2021, the patient experienced VISION BLURRED (She had blurriness.). On 18-Mar-2021, the patient experienced SWOLLEN TONGUE (Her tongue began swelling) and MOUTH ULCERATION (There were ulcers on the side of her tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had blurriness.), SWOLLEN TONGUE (Her tongue began swelling), MOUTH ULCERATION (There were ulcers on the side of her tongue), VISION BLURRED (She had a film over her), EYE DISCHARGE (Discharge coming out of her eyes), FATIGUE (Really exhausted), PAIN (Soreness), NAUSEA (She also had nausea.), VACCINATION SITE RASH (Rash at injection site) and MYALGIA (Acheness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not provided.  The patient was scheduled with 2nd dose on 06-APR-2021.
Chills, nausea, dizzy. I felt ill for two full days. Loss of appetite, nausea, chills, dry mouth.
HISTORY OF HEMIPLEGIA MIGRAINES. LEFT SIDED WEAKNESS, LEFT FACIAL DROOP. ELEVATED BP. Narrative:  EMPLOYEE WITH HISTORY OF HEMIPLEGIC MIGRAINES, SHE BEGAN HAVING LEFT SIDED UPPER & LOWER EXTREMITY WEAKNESS LEADING TO NUMBNESS WITH LEFT SIDED FACIAL DROOP. BP ELEVATED WHICH RETURNED TO NORMAL WITHIN 30 MINUTES OF REACTION. SHE STATES THIS IS NORMAL, NO TREATMENT NEEDED. ER DR ON SITE CONCURS TO LET EMPLOYEE GO HOME TO REST. SHE IS AWARE TO SEEK IMMEDIATE ATTENTION IF SYMPTOMS DO NOT RESOLVE OR IF THEY WORSEN.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose, route were not reported). On an unknown date unspecified number of patients experienced soreness at injection site. The outcome of soreness at injection site was not reported. The relatedness between the event and GARDASIL was not reported. Additional information is not expected due to no consent for follow up.
itchy, red spots on face. chin, forehead,above my lip, cheek. Using calamine lotion for itching and bacitracin  ointment. 15 days since 2nd dose , and still having new spots that itch.I spoke with a pharmacist and she had not heard of this reaction on the face. It could be a reaction to something else but do not know what???
PATIENT DEVELOPED REDNESS AT INJECTION SITE. THE RED AREA BECAME INCREASINGLY  WORSE AND STARTED TO ENLARGE.  IT WAS NOT GOING AWAY AFTER SEVERAL DAYS AND THE PATIENT FELT LIKE IT WAS GETTING WORSE AND NOT BETTER.  THE PATIENT VISITED URGENT CARE ON  5-6-19 WHERE SHE WAS DIAGNOSED WITH CELULLITIS AND GIVEN A COURSE OF ANTIBIOTICS.   SHE REPORTS THAT THE SITE IS MUCH IMPROVED AT THIS TIME.
severe hair loss/getting handfuls coming out; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced severe hair loss/getting handfuls coming out on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up (11Oct2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported information included. Follow-up attempts are completed. No further information is expected.