chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOCAL FOLD PARALYSIS; This spontaneous report was received from literature. This report concerned a patient of unspecified age, sex, race and ethnicity. The objective of this study is to determine the correlation of COVID-19 post vaccination recurrent laryngeal neuropathy resulting in VFP (Vocal fold paresis or paralysis). 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 not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vocal fold paralysis. Laboratory data (dates unspecified) included: Laryngoscopy (NR: not provided) confirmed VFP (Vocal fold paralysis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vocal fold paralysis was not reported. Results of the study includes: On preliminary search of the database (Vaccine Adverse Event Reporting System), 19 patients found to had experienced vocal fold paresis or paralysis. Among the 19 patient 1 received Janssen vaccine and the mean lag time between vaccination and symptom onset was 12 days. Patient reported symptoms prompting evaluation includes (The total 19 patient %): Dysphagia 1 (5.3%), weak voice 3 (15.8%), hoarse voice 6 (31.6%), sore throat 1 (5.3%), laryngitis 1 (5.3%), voice change 1 (5.3%), ear pain 1 (5.3%) and 5 (26.3%) not reported any symptoms. And patient demographics and clinical information includes: Past medical history of diabetes 3 (15.8%), hypertension (HTN) 4 (21.1%), hypothyroidism 3 (15.8%), depression & anxiety 3 (15.8%), chron's Disease 1 (5.3%), chronic kidney disease (CKD on) dialysis 2 (10.5%), and 6 (31.6%) were not reported any past medical history. The author emphasized that, for patients presenting with voice or swallowing complaints after receiving the COVID-19 vaccine, require prompt evaluation by an otolaryngologist, as the potential VFP side effect of vaccination is very rarely cited in the literature, and no causation has been established. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220308297- covid-19 vaccine ad26.cov2.s- vocal fold paralysis. 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.
Patient had an episode of BRVO in 2020.  She was closely followed by Retinal Specialists.  She was treated with injections.  Her symptoms went in to remission by the time she received her COVID booster.    In the weeks after receiving her booster, she started having symptoms again.  she went back to Retinal Specialist, where a retinal exam confirmed the recurrence of her BRVO.
one week after vaccine patient developed pruritic rash. only minor discomfort at injection site. It went away but now is back again after receiving the second vaccine yesteray
Local reaction to DTaP inj given on 5/19/14 red, warm area to (L) thigh, pain with walking.
Pt recvd vax & was cranky, crying, couldn't sleep, thigh swollen & hot; no temp taken; unable to take BP; had breathing difficulties, red rash on all parts of thigh; red, splotchy, 1" diameter around site & toward knee; rash;
10/1/14-~received flu shot in left deltoid area ~1:40pm. 10/4-cx presents with redness & swelling on the left bicep area, (~3" x 5") & states that area "hurts"& a reaction was from the flu shot. States that her arm hurt her upon receiving the injection on 10/1 but the redness & swelling did not appear in the bicep area until the evening of 10/1. She states that 10/3 evening thru 10/4 am, she was in the hospital for chest pain, unrelated to the reaction, & notified the nurse of the area but no treatment was given. I advised her to follow up with primary doctor.
A few hours after first shot my arm began to feel sore and that evening I woke with fever. The next day was a Wednesday and I had a headache and felt dizzy getting up out of bed. I also felt swollen and sore close to my right ear on my low cheek bone for two days.  The following morning, upon opening my eyes the room began to spin. I could not get out of bed for a good 10 minutes. Was throughout the day with vertigo. If I turned my head to the left or right even to brush my hair the room would spin and I had to hold onto the counter to keep form falling. Frid was the same. I started some meclizine, just 1/4 of a pill as I am sensitive to meds. Sat. I had to ask my husband to drive me. When I layed down at night my head started spinning and when I turned in bed at night especially to my right (same side where I felt swollen), I felt more dizzy.  On Saturday Oct 9th, I was still unsteady on my feet. I notice today and every day, I feel very tired around 3pm and until the evening. I don't feel good in my head....like something is moving around. I was less dizzy a week after the shot, but I have continued to have dizzy sensations when I lie down and get up. And if I bend over.  I read on line that people who had vestibular issues in the past, had dizziness. I never read anything about that symptom before tkaing the shot. I only read about flu like symptoms and or headache. I wish someone had used the word dizzy or I wouldn't have gotten this shot. I am not planning to get the next one.
This non-serious spontaneous case, initially received on 24-Sep-2018 and follow up on 02-Oct-2018 (combinedly processed), from other non-health professional (consumer), concerns a female pregnant patient of unspecified age. The patient had 2 previous pregnancies. On 09-Dec-2017, at approximately 10 weeks, the patient had a miscarriage or still birth due to blighted ovum, the embryo or fetus stopped growing at very early stage. The patient's current condition included mild polycystic ovarian syndrome (PCOS) (since an unspecified date). The last menstrual period (LMP) was 18-Apr-2018. The estimated delivery date (EDD) was 23-Jan-2019. The patient did not use birth control pills but had natural family planning method. On 21-Sep-2018, at approximately 22 weeks gestation (second trimester), the pregnant patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252661, expiry date: 31-May-2019]. The patient did not experience unspecified adverse events after vaccination. Update received on 24-Sep-2018: Significant case correction (IRD: 24-Sep-2018): The classification 'special case with no AE' was removed from the general tab. The event 'adverse event NOS' was added in the event tab. No changes were made in the narrative. Follow-up reported received from reporter on 20-Nov-2018: The patient's previous pregnancy history, historical condition (miscarriage or stillbirth), current condition (polycystic ovarian syndrome), estimated delivery date (23-Jan-2019) and last menstrual period (18-Apr-2018) were added. The reporter confirmed that the patient had a natural family planning method and no use of birth control pill and no unspecified adverse reactions were experienced after vaccination. The event (adverse event NOS) was deleted and the classification 'special case with no AE' was added in the general tab. The narrative was amended accordingly. Non-significant case amendment (20-Nov-2018): The sentences 'the company assessed the causality of the event: adverse event NOS an unassessable due lack of information regarding onset latency and the kind of reaction occurred' and 'experienced unspecified adverse event' were removed from the case comment.
Within 10-15 minutes: Shaking, red face/chest, ice cold hands and feet, feeling woozy. Was under observation for two hours, and then released to my husband?s care. Ongoing symptoms: Waves of severe nausea, fatigue, rapid pulse, nerve and muscle pain in legs, chills and sweats, stomach upset. Waves would last 3-4 hours and subside for a while, then come back. Contacted family physician at day 7, and was told to stick it out until day 90. Developed small rash on chest, and then began spontaneously breaking out in hives on my back, every few days. Most symptoms lasted 85 days.  Spontaneous hives continued for about 5 months, and then suddenly subsided.  Allergic asthma however, comp,steely cleared up during this time. Immune system seemed hyper sensitive for many months.
The dose was administered toward the posterior side of the right arm. It appears to be more in the SQ tissue and not in the recommended site of deltoid IM.
reconstituted with 0.7mL sterile diluent provided by Merck and meant for Merck live virus reconstitution, rather than 0.6mL Sodium Chloride solution with no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 45 years old male patient who received yellow fever vaccine - [YF-VAX] reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Feb-2023, the patient received an unknown dose of suspect yellow fever vaccine - , solution for injection (lot: UJ782AA; expiry date: 17-Feb-2024) via subcutaneous route in the left arm for prophylactic vaccination (immunization) reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution with no reported adverse 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.
PATIENTS ENTIRE FAMILY HAD COVID-19/ Exposure to COVID-19; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (PATIENTS ENTIRE FAMILY HAD COVID-19/ Exposure to COVID-19) and COVID-19 (COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (PATIENTS ENTIRE FAMILY HAD COVID-19/ Exposure to COVID-19) and COVID-19 (COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (PATIENTS ENTIRE FAMILY HAD COVID-19/ Exposure to COVID-19) outcome was unknown and COVID-19 (COVID-19) was resolving.            Relevant concomitant medications were not reported.  On 14-Apr-2021, patient received first dose COVID-19 vaccine manufactured by Moderna. On 17-May-2021, patient received second dose COVID-19 vaccine manufactured by Moderna. On unknown date, patient's entire family had COVID-19 and patient experienced COVID-19.  Treatment information was not provided.  The reporter's causality for the event of patient's entire family had COVID-19 was not provided. The reporter's causality for the event of COVID-19 with HUMIRA(ADALIMUMAB) was a reasonable possibility.  It was unknown if patient was enrolled in a covid-19 vaccine Trial.  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.
Warmth and swelling left upper extremity, traveling into axillary area, including left trapezius area.
Patient complained of dizziness post-vaccine admin. Vital signs checked and electrolytes given for rehydration. BP 96/66, P-64, O2 Sat 99% on room air. Patient observed further for 30 minutes, verbalized feeling better. Patient was released in medically stable condition to the care of her husband.
Pt received  vaccine at 1600 today, pt returned home with mother without incident. At approx 2330 later that night pt mother removed bandage from vaccination site, pt then reported to mother that "he had blurred vision and so I had him sit down. Once he was sitting down he got really pale and his eyes closed. He stopped responding for a few seconds and then he came to."
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CTEPH" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. Concomitant medication(s) included: OPSUMIT, start date: 14Apr2021; ORENITRAM, start date: 06Sep2015; ADEMPAS, start date: 16Jan2014; JANTOVEN, start date: 04May2008; SYMBICORT; SPIRONOLACTONE, start date: 10Jan2016. Past drug history included: Platelets, reaction(s): "known allergies Platelets", notes: known allergies Penicillin, Platelets. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical information: The patient had other medication in 2 weeks.
patient apparently had taken Johnson Johnson COVID-19 vaccination that the was about 4 days ago.  And since the that time patient had been having increasing shortness of breath patient denies any history of any fever chills denies any chest pain in.  Of of the by the time patient had presented to the ER patient was hypoxic and was having respiratory of difficulty patient was initially put on a non-rebreather observe mask
Following vaccination patient got up from table and started to feel lightheaded w/ tunnel vision and blackening. Patient then fell to floor, w/o loss of consciousness. Resulted in child abrasion, contusion on left side of face and mild concussion. Patient released from clinic w/ f/u appointment in 2 days.
Restless, chills, body ache, neck pain- (possible fever- did not take temp)
No additional AE; Patient that did not disclose pregnancy prior to receiving GARDASIL 9.; This spontaneous report was received from a nurse and refers to a 34-year-old pregnant female. The patient's medical history included blood thyroid stimulating hormone decreased, alpha-thalassemia silent carrier, pyelectasis of fetus, and vitamin D deficiency. Her drug reactions/allergies, concurrent conditions, and concomitant therapies were not reported. The patient was in the 25h pregnancy week. The patient's last menstrual period was estimated to be on as 02-FEB-2023, date of conception was estimated to be on 16-FEB-2023 and the due date on 09-NOV-2023.  On an unspecified date, the patient was vaccinated with human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered intramuscularly as human papilloma virus (HPV) vaccination (strength, frequency, lot #, expiry date, and anatomical location were not provided).  It was reported that the patient did not disclose pregnancy prior to receiving human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exposure during pregnancy) (onset date reported as 21-JUL-2023). No symptoms or additional adverse events were reported (no adverse event). On 24-JUL-2023, the patient recovered from the event and no treatment was given. At the time of reporting, pregnancy outcome was pending and fetal outcome was unknown.
Hives on my shoulders and upper back.  Took 2 Benadryl and it cleared up.  Hives came back the next day.  Took 2 more Benadryl and they cleared up.  Third day now, and I have a little itching and discomfort.  Will take more Benadryl when I am at home and can handle the drowsiness from the meds.
Pt said he felt like his heart was racing. He looked pale, just after receiving the flu shot. He was asked to lay down. his pulse  and BP were checked  P62 - BP 136/70. He was alert and oriented. Rested awhile, sat up, sipped some water, sat and stood for awhile while been observed. Felt okay to go home.
continue to grow and grow to my neck feet my leg, and my hand and my hand sort of turned, my left hand, turned kind of bluish color; Rash; Allergy; my neck is start swelling in the back. It hurt to do back my head.; my neck is start swelling in the back. It hurt to do back my head.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8732) administered in left arm via an unspecified route of administration on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced continue to grow and grow to my neck feet my leg, and my hand and my hand sort of turned, my left hand, turned kind of bluish color, rash, allergy, my neck is start swelling in the back. it hurt to do back my head. It was reported that the patient had a hive at first at home, my husband notice but I didn't think much about but then they continue to grow and grow to neck, feet, leg and hand and left hand turned kind of bluish color, it was weird, but patient was not sure it just you know being very protruding hives. Patient neck was start swelling in the back. It hurt to back of head. That was the next day. The patient stated that she should have take some Benadryl but didn't. Patient body was getting a lot of hives but just, patient do have allergies but not hives like that. The outcome of the events was reported was unknown. No follow-up attempts are needed. No further information is expected.
had very very positive side effects from each vaccine / increase effective extreme concentration, decreased anxiety, increased productivity/Increased energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 2, single and administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Sulfa allergy. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had very very positive side effects from each vaccine / increase effective extreme concentration, decreased anxiety, increased productivity/Increased energy". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination was not tested for COVID-19.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Low grade fever, chills, headache, nausea, extreme body ache, extreme fatigue (24 his), pain, swelling, redness, itchy rash at injection site (started within a few hours after and has not gone away). Foggy feeling, slight vision disruptions.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 90-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 89 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CELECOXIB, start date: 01Jun2018, stop date: 28May2023; CARBIDOPA AND LEVODOPA, start date: 01Sep2020, stop date: 28May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. 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: Linked Report(s) : US-PFIZER INC-202300204139 same patient/reporter, different drug/AE;