chrisvoncsefalvay/vaers-outcomes huggingface dataset:
double vision; drooping eyelid; left eye turns inwards; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision), EYELID PTOSIS (drooping eyelid) and STRABISMUS (left eye turns inwards) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history. ). Concomitant products included LEVOTHYROXINE and TAMSULOSIN for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIPLOPIA (double vision) (seriousness criterion hospitalization prolonged), EYELID PTOSIS (drooping eyelid) (seriousness criterion hospitalization prolonged) and STRABISMUS (left eye turns inwards) (seriousness criterion hospitalization prolonged). At the time of the report, DIPLOPIA (double vision), EYELID PTOSIS (drooping eyelid) and STRABISMUS (left eye turns inwards) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the events included initially 2 aspirins.  Based on the current available information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
Approximate 2 inch diameter red area to back of right upper arm. Complains of arm heaviness and discomfort to axillary area. Recommended to see physician.
Following 1st dose of vaccine: multi-joint stiffness and soreness that lasted 1-2 months following 1st dose Immediately following 2nd dose of vaccine: very mild sensation of throat swelling that resolved within a few hours. So mild that I wasn't sure if I was imagining it.  Within 3 days of 2nd dose of vaccine: red rash on L upper arm about the size of a softball with swelling and burning throughout Left arm. Continue to have intermittent swelling and occasionally burning sensation in the L arm. Most apparent with heat exposure and increased activity. No PMH of similar s/s.  Within 2 weeks of 2nd dose of vaccine: Severe chest tightness and intermittent heart palpitations and sensation of heart racing that gradually improved over 3-5 days. Heart data from activity tracking watch shows intermittent spikes in heart rate at periods of rest typically at night within first few weeks of 2nd dose of vaccine. Continue to experience intermittent chest pain/tightness during high intensity exercise which I had not previously encountered. No PMH of cardiac conditions or similar s/s.  Within a few months began experiencing significant bilateral medial knee joint pain during hikes. Symptoms continue to persist. MRI's recently confirmed cartilage fissuring in the trochlea and medial femoral condyle. No PMH of knee joint conditions or similar s/s.
Maculopapular exanthem - delayed hypersensitivity rash. T - 101.3
I was overly tired. Around 8:30 pm I started to feel very tired. I rested for the night and woke up at my normal time 6:00am. I was still very tired when I woke. I ended back in bed at 9:30am till 2:30pm. Once I was up again I was still tired. I did complete daily activates as normal. Went to bed at my normal time 10:00pm Saturday night and woke 6 am Sunday. Felt great and well rested.
Arm soreness, fever (100.6), muscle aches and pains, fatigue, chills, nausea.
positive COVID test occurred 7-10 after second vaccination injection; positive COVID test occurred 7-10 after second vaccination injection; This is a spontaneous report from a contactable consumer (Patient). An adult male patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, batch number/ Lot Number was unknown and expiry date was not provided), via an unspecified route of administration, in Mar2021 at as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. As reported, it was unknown whether other vaccine received in four weeks of vaccination, allergies. The patient previously received first dose of BNT162B2 in 2021. In Mar2021, patient had positive covid test occurred 7-10 after second vaccination injection. It was unknown whether treatment received or not. Patient does not have COVID, prior vaccination. Patient has tested for COVID, post vaccination (test type: unknown, in Mar2021, result was positive). The outcome of the event was not resolved.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
By 7:30 pm I had cold, or flu symptoms. Scratching throat, headache, body aches.
autoimmune hepatitis; idiosyncratic response; Initial unsolicited valid serious case report received from the literature abstract on 18-Oct-2019.    The following is verbatim from the a abstract:  The pathogenesis of autoimmune hepatitis entails complex interactions between triggering factors, autoantigens, genetic predisposition, and immunoregulatory networks. Implicated triggering factors are numerous and include toxins, medications, and infectious agents. In this article, we present a unique case of a 31-year-old woman with severe autoimmune hepatitis apparently abruptly triggered by vaccination. All evidence suggests this was an idiosyncratic response to either hepatitis A or yellow fever vaccination.   This case involves a 31 years old female patient who experienced autoimmune hepatitis (autoimmune hepatitis) and idiosyncratic response (idiosyncratic drug reaction), while she received vaccines HEPATITIS A VACCINE and YELLOW FEVER VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HEPATITIS A VACCINE and YELLOW FEVER VACCINE produced produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious autoimmune hepatitis (Unknown latency) following the administration of YELLOW FEVER VACCINE and HEPATITIS A VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a idiosyncratic response (idiosyncratic drug reaction) (Unknown latency) following the administration of YELLOW FEVER VACCINE and of HEPATITIS A VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was idiosyncratic response and autoimmune hepatitis.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for autoimmune hepatitis and idiosyncratic response.  Information on the batch number was requested.; Sender's Comments: This case involves a 31 years old female patient who experienced autoimmune hepatitis (autoimmune hepatitis) and idiosyncratic response (idiosyncratic drug reaction), while she received vaccines HEPATITIS A VACCINE and YELLOW FEVER VACCINE. Time to onset is unknown with the role of vaccine. However, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be individually assessed.
PAIN OF MY BACK AND NECK AND WHEN I BREATHE I FEEL WEIRD MY CHEST LIKE AND FEVER , THE SATURDAY I FEEL WORSE THEN I CALL TO NURSE LINE OF MY CLINIC AND THEY TELL ME THAT I NEED TO GO TO ER THE DR GIVE TYLENOL AND NAPROXEN AND BENADRYL
On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% on 3L oxygen, hands cold, pulse weak. Temp 92.5F MD notified. EMS activated. EMS arrival and HR 20. Family refused transport to ER. Resident expired at 2:40 am on 2/24/21 Meds continued: duloextine, VITd2,hydralazine, synthroid, lisinopril, mag ox, folplex, pantoprazole, potassium chloride, ellipta, ensure, hydrocortisone cream, boost, deprox, xanax, morphine, lorazepam, tylenol, albuterol inhlation, ventolin inh.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Could not see, eyes dilated, could not walk, fell, had to assist getting up and getting to bed.
UNILATERAL STIFF NECK STARTED ON DAY 5 AND PROGERESSED OVER 24 HOURS TO SEVERE BILATERAL NECK PAIN AND COULD NOT FLEX OR TURN HEAD. PAIN SEVERE REQUIRING NARCOTIC MEDS FOR 2 DAYS (PAIN 8 OUT OF 10) BEFORE STARTING A 3 DAY COURSE OF PREDNISONE AT 30 MG PER DAY. GOT RELIEF WITHIN 12 HOURS OF STARTING STEROIDS. HAD SOME CONTINUED NECK PAIN FOR 4-5 DAYS BEFORE BACK TO NORMAL AT THE MOST SEWVERE POINT I WAS CONSERNED ABOUT MENINGITIS BUT I HAD NO FEVER.   THIS IS MY 5TH COVID VACCINE INJECTION OVER THE LAST 2 YEARS AND THIS NEVER HAPPENED BEFORE
have rash on back and stomach started after first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (have rash on back and stomach started after first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (have rash on back and stomach started after first shot). At the time of the report, RASH (have rash on back and stomach started after first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided  Treatment medication was not provided   This case was linked to MOD-2021-193871 (Patient Link).
gynecomastia; This spontaneous report as received from a receptionist via a company representative refers to a currently 16-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates in 2015, the patient was vaccinated with three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On unknown dates in 2015, reported as at the same time, the patient was administered with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and meningococcal vaccine (unspecified) (manufacturer unknown) (doses, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, about 6 months after the series of vaccine administration, the patient experienced gynecomastia. No treatment was given for the event.   The outcome of the event was reported as recovering/resolving, as he was getting older. The relatedness between the event and suspect vaccines was not reported.
FLUBLOK was given accidentally to a 5 year old with no AE.; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a five years old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiration date not reported) via an unknown route and administration site for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day at the time of vaccination).  At the time of report, no adverse event was reported.  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 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.
left eye kept watering; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (left eye kept watering) and SNEEZING (sneezing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included LORATADINE for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LACRIMATION INCREASED (left eye kept watering) and SNEEZING (sneezing). At the time of the report, LACRIMATION INCREASED (left eye kept watering) and SNEEZING (sneezing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
7/23/21 10am shot. Allergic Recation with in 15 mins of shot, numbness of throat, tongue, neck and right jaw, rash on neck, lower face, taste of metal in mouth, tingling tongue Sent home from ER at 12:30. Gave me bendyrl and Pepcid  Felt sharp chest pain in center of chest, lightheaded, low blood pressure around 3pm. Keep dropping passed out 10pm. Went back to ER at 11pm. Waited in ER until 8am, fainted twice at 3am.  7/24/21 8 am They did ekg, blood work, urine and chest x-ray. 1 litter IV fuilds, Tylenol, ondansetron. Went home around 1 pm to follow up with pcp.   7/23/21-still have symptoms 7/30/21 on and off chest pains, light headedness, fainting at least once to twice a day.   Sore throat, on and off fever
Headache, intermittent muscle spasms and tingling to my arm down to my fingers, muscle soreness.
Patient returned to clinic on the day following flu shot with complaint of facial swelling (area around eyes & cheeks) which she noticed upon awakening on the day after the shot. No itching, rash or other swelling. No hx. of egg allergy. Takes no meds. Only known drug allergy is penicillin.  Exam revealed no significant swelling of face or elsewhere, no rash and no respiratory distress. B/P: 130/84, P 64. Lungs clear. No swelling of pharyngeal mucosa. Prescribed Benadryl 25-50 mg. q6h prn (#12)and patient advised to go to ED or return here prn return of swelling or other symptoms.
pt recv vax 9MAY97 & 19MAY97 pt devel swelling around the inj site that proceeded to become inflamed & sore;It was noted not well distinguished whole upper arm;pt hosp; sx persisted;
SHINGRIX vaccine given 8/10/2018, patient noticed arm rash/redness on 8/11/2018 with following small blister like eruptions on 8/12/2018. Area involved was from injection site down to elbow, continued for 5 to 7 days. Also patient had fever reported.
Cough; Nasal congestion; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 017E21A, 012M20A and 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Urticaria aquagenic. Concurrent medical conditions included Anxiety and Postural orthostatic tachycardia syndrome. Concomitant products included CYCLOSPORINE, AMITRIPTYLINE, TOPIRAMATE and CLONAZEPAM for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient experienced COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) had not resolved.            It was reported as patient had no allergy.  The co suspect drug was reported as unknown (manufacturer Pfizer), Batch/lot number: GA6765, Start date: 13-MAY-2022, stop date: 17-MAY-2022, Indication: Treatment of COVID-19.  No treatment medications were reported.
After the shot I had a red lump at the injection site and it was warm and tender to touch. It went away about 3-4 days later but has come back a week later. Now it?s very itchy, red, warm to touch
Transient maculopapular, pruritic eruption on chest, back neck, face both arms-12 days after SPV & 13d after Anthrax #2.  Also with large local prescription after Anthrax dose 1-2.  Also presisten tremulousness after Anthrax #2 & SPV #1.  Rash resolved.
Received vaccine on 3/3/2021 then was found dead in bed by her husband on 3/7/2021.
Recieved second dose 2/5/21. Woke up the morning of 2/6/21 with really bad body aches, fever started out 100.7, took Tylenol at 1:30PM took nap, woke up 3 hours later fever was up to 101.3. Fever lasted all day with really bad body aches, ended up with a headache, also felt very lethargic. Tylenol didn't seem to help with my fever.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 08-NOV-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
stored Shingrix vaccine in the freezer for a while / administered after being exposed to freezing temperatures / might be 18 patients related; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. GSK representative reported that an Office manager from a medical facility mentioned  that they had stored Shingrix vaccine in the freezer for a while. And that these vaccines were administered to around 18 patients after being exposed to freezing temperatures, which led to incorrect storage of drug. No further information was available. The reporter consented to follow up.
No additional AEs were reported; improperly stored vaccine; This spontaneous report was received from a healthcare worker and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 16-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #x010531, expiration date: 11-APR-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) which temperature showed -14 C for 47 minutes. There's no previous temperature excursion/ Previous temperature excursion showed -9.7 C for 40 minutes (product storage error). No additional adverse events (AEs) were reported.