chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLIGHT PAIN NEXT DAY IN ARM.  FOLLOWING DAY A BIT BETTER.  THEREAFTER IT REMAINED ACHY.  THE FOLLOWING MONDAY THE PAIN SEEMED TO BE SPREADING UP ARM TOWARDS SHOULDER.  NEXT DAY SHOULDER & NECK.  TOLD DOCTOR, THEY SAID IT COULD BE RELATED TO VACCINE SINCE ITS SAME ARM.  MID WEEK CALLED PHARMACIST IF HE EVER HEARD OF ANYONE'S SHOULDER HURTING.  HIS RESPONSE WAS NO BUT IF IT WERE DUE TO SHOT IT SHOULD DIMINISH. THIS IS THE 3RD WEEK & I HEARD ON NEWS LAST NIGHT SOME ADVERSE REACTIONS WERE PAIN IN UPPER ARM &  SHOULDER. I WAS ADVISED TO FILL OUT REPORT.
vaccine was given incorrectly (Pentacel) Nurse only gave DTPA-IPV, but didn't mix the ActHIb powder/No AE; Initial information was received on 22-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4-month-old female patient who was given only DTPA-IPV from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing ActHIb powder (Product preparation issue).  Medical history, medical treatment(s), vaccination(s), family history were not provided.  No other vaccines were given.  On 22-Jul-2020, the patient received a second 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ344AA, expiry date- 04-Apr-2021) via intramuscular route in the right vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique. It was reported that nurse was supposed to give pentacel and only grabbed liquid and did not mix with the powder part and wanted to know if ActHIb can be given alone.  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 and Module VI of the 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.
Fever as high as 103.6, chills, muscle aches, sore throat, diuresis, fatigue, shooting pains, general decent flu symptoms. as of yet... its only been 6 hours.
Had redness at injection site the next morning - by noon Rt arm edematous from shoulder to elbow. Mom gave her TYLENOL & ice pks to arm- edema went down from below deltoid to elbow. Still has redness and some edema from shoulder to bottom of deltoid muscle. Has full ROM of arms & fingers. Mom reported it last pm.
This spontaneous report as received from a nurse refers to an unspecified patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot # J006236 and expiry date: 25-FEB-2015) which was improperly stored. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Approximately 24 hours after vaccines mother reports rash started on chest and progressed to back and then all over torso. Rash is a fine macula rash no itching when seen by doctor in clinic the am of 4/29. Child had no fever.  No treatment given.
Patient begin an involuntary and uncontrollable eye blinking / twitch within 12 hours of the vaccine.  Also developed an uncontrollable throat clearing tic, interrupting continuing speech to clear throat. Will also occasionally involuntarily nod head in a jerky way with eye blinking. Has not resolved nine months after vaccine.  Severity waxes and wanes, but has not resolved.
Patient received Janssen vaccine and did not notify vaccinator that he had all ready received first dose of Pfizer vaccine on 2/24/2021.
Myalgia, Arthralgia, Fever, FATIGUE, CHILLS Narrative:
CHIEF COMPLAINT:   pt dx covid on 12/7/21, pt having sob, cough, headaches difficulty breathing.  Pt having labored breathing at triage.  pt having a hard time completing full sentences.  Pt covid vaccinated.  -fevers.   HISTORY OF PRESENT ILLNESS:     Presents with: _covid, cough,  Duration: _cosntnat  Onset: _acute  Course: _same  Location Pain Onset: _generla aches  Location Pain at Present: _same  Pain Radiation: _denies  Pain Quality: _achey
rash all over his back and it itched like crazy and then started bleeding; rash all over his back and it itched like crazy; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EK4176, via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation.  Medical history included heart disorder from an unknown date. Concomitant medications included a lot of medications for his heart and stuff. In Jan2021 the patient experienced rash all over his back and it itched like crazy and then started bleeding when he scratched. He received Benadryl tablets lotion on it as treatment. The outcome of the events was unknown.
pt recv vax & awoke w/hives;next day exp shoulder pain, neck stiffness & achiness;tx advil;hives resolved;shoulder pain, neck stiffness, & achiness cont;
Arm pain/arm is hurting; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain/arm is hurting) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced VACCINATION SITE PAIN (Arm pain/arm is hurting) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm pain/arm is hurting) had not resolved and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.
severe headache and fatigue from 3 days after the shot continuing;  the illness has not stopped and is now 8 days after the shot
102 fever, Vasoconstriction severe enough to flare Reynauds syndrome in hands, feet and tongue.
No adverse event; expired doses of Moderna Covid-19 vaccine was given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna Covid-19 vaccine was given) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna Covid-19 vaccine was given). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna Covid-19 vaccine was given) 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 EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna Covid-19 vaccine was given).    No concomitant medications were reported.  It was unknown if patient experienced any allergies to (medications, food and other products). It was unknown if patient had COVID positive test or diagnosis. History relating to mentioned AE and both acute and chronic illnesses at the time of vaccination was unknown. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose) was unknown. It was unknown if AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was unknown if patient experienced a similar event in the past. It was reported that the vial had not undergone any temperature excursions.   No treatment medications were reported.
error resulting in administration of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No  treatment details were provided.
no other issues; ROTATEQ was improperly stored and administered; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.   On 08-FEB-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1742464, expiration date 20-SEP-2022; strength, dose schedule, route and anatomical location were not provided) for prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion in 47 Fahrenheit degrees (F) for 15 minutes. It was not reported whether there was previous temperature excursion or not. No other issues or concerns noted (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003395: US-009507513-2202USA003391:
Pt developed sneezing minutes after immunization. 1/2 hour later eyelids and mouth swollen, erythematous, and nose became runny, stuffy, red, had some urticaria trunk.
Extremely itching on both calfs/Extremely itching on upper thigh/Extremely itching on back/Extremely itching on arms sometimes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extremely itching on both calfs/Extremely itching on upper thigh/Extremely itching on back/Extremely itching on arms sometimes) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Extremely itching on both calfs/Extremely itching on upper thigh/Extremely itching on back/Extremely itching on arms sometimes). At the time of the report, PRURITUS (Extremely itching on both calfs/Extremely itching on upper thigh/Extremely itching on back/Extremely itching on arms sometimes) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Patient had initial fatigue/ somnolence in AM day after vaccine, in PM developing fever, HA, sore throat, myalgias stomach ache and chest pain. Chest pain every 20-30 minutes, worse when supine, pain with breathing when laying down that resolved when sitting up, presented to ED for workup.  Found to be tachycardia to 100s, hemodynamically stable otherwise.  Pro-BNP 193, CRP 1.57, Total bilirubin 1.1, d-dimer 274, troponin initially normal then elevated to peak 3.45, CK normal, ESR normal, CBC normal, BMP normal. Chest x-ray normal. ECG normal sinus rhythm, diffuse ST changes and J-point elevation in inferolateral leads.  Echo obtained read as normal, with EF 60% without pericardial effusion.  Working Diagnosis pericarditis/myocarditis. Cardiology and infectious disease consulted, and started on ibuprofen, tylenol, IVIG, methylprednisolone. Labs for COVID antibodies, lyme, echovirus, HSV 6, EBV, CMV, Parvovirus B19, coxsackie, adenovirus pending. Cardiac MRI planned to be completed.
pt recvd vax & beginning 2 days p/vax pt began to exp severe ringing in both ears;pt still has constant ringing in rt ear;pt states that MD thinks the problem is viral, & that pt will have to live w/it;
Information has been received from a consumer concerning her daughter, a 15 year old female with a sulfa allergy and no pertinent medical history, who on 02-JUN-2008 was vaccinated with a dose of GARDASIL.  There was no concomitant therapy.  The patient developed fever, cramps, nausea and flu-like symptoms the day of vaccination or the day after.  She had difficulty sleeping that night.  The consumer called the physician.  No lab diagnostic studies were performed.  The patient took TYLENOL and ADVIL.  The symptoms resolved the next day.  Additional information has been requested.
Recipient described feeling dizzy with blurry vision.  Vitals taken.  All WNL, except blood pressure elevated to 142/90.  He was escorted to wheel chair and remained with us for 15 minutes.  He was still reporting blurry vision and some dizziness. Vital signs remained stable with approximately same elevated BP.   He was taken to Emergency Department for observation.
First shot in fall of 2019, no 2nd dose yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (the patient received 1st dose of Shingrix in fall of 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt Date: 12-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know If he/she got another shingles shot now and would be considered second in the series. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
pt presents to clinic w/lt upper arm reddened et edematous, no apparent hives are noted;pt denies exp dyspnea or breathing problems;pt relays that swelling has gone down et is feeling less stiff et sore today;
Patient stated that he feels like his heart is racing. We took vitals at 12:17 pm heart rate 78, o2 96, Blood pressure is 141/78, 12:22 pm Blood pressure 137/91, and 12:27 pm heart rate 87, o2 98, and blood pressure 133/90. I asked the patient how he is feeling and he stated that he is feeling better. Patient was released home by himself at 12:29 pm
Patient was administered the Moderna vaccine despite being only 17 years old and the CDC not recommending the vaccine for people under 18 years old.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 12 October 2011 and 23 April 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown) On 5 June 2012, 43 days after vaccination with 2nd dose of HAVRIX, 8 months after vaccination with 1st dose of HAVRIX, the subject experienced not responding to therapy. The subject had a titer performed on 05 June 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994236A, A0994238A- A0994241A, A0994243A - A0994246A,
Fever, onset 08/30/2005, vomiting, headache, stiff neck onset 08/30/2005.  Hives the size of mosquito bites behind each knee, onset 09/01/2005.
Whole body hurt, felt pain in all joints, headache, nausea, exhausted, huge hives all over body which led to throat closing and swelling lips. Had to go to ER for treatment.
Fatigue [after second dose]; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue [after second dose]) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 032L20VT) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue [after second dose]). At the time of the report, FATIGUE (Fatigue [after second dose]) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-311231 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional document received with no new information.
Fever, Tachycardia, fatigue, injection site pain, hot flash Narrative:
This spontaneous report was received from a physician refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 12-OCT-2015, the patient was vaccinated with an unspecified dose of VARIVAX (Merck) lot # L013063 and expiration date 14-APR-2017 and he was also vaccinated with an unspecified dose of PROQUAD (Merck) lot# L030588 and expiration date 10-FEB-2017 as reported (route of administration and anatomical location were not provided for both vaccines). The reporter stated that the patient should had been vaccinated with M-M-R II and VARIVAX (Merck), the reporter referred that it was staff error only. No adverse events were reported. There was no product quality issue involved. This is one of two cases from the same reporter. Additional information has been requested.
herpes zoster; Information has been received from an attorney regarding a case in litigation. This case refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In or around 20-OCT-2017, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX), (dosage, route, anatomical location, lot number and expiration date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered a severe rash on her lateral chest wall and extended around the vertebrae of the back. The patient was diagnosed with herpes zoster. As a direct and proximate result of patient's vaccination, the symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. At the time of the report, the patient's outcome was unknown. The reporter considered the event to be related to suspect therapy.  The reporter considered the event of herpes zoster as disabling since resulted on severe and permanent personal injuries.
w/in 48hrs p/vax pt devel sl fever, pain, swelling, erythema @ inj site, which started to abate the 3rd day
On 4 May 2021, Dose 2 of the COVID Vaccine was administered to patient.  The first dose was on 3/24/21 and was Moderna.  The second dose was Pfizer.  No immediate reaction was reported.  This is for documentation purposes.
12-18-2008 Follow up from ER visit for ear infection- vaccines given. 12-19-08 fever-very fussy-diagnosis of otitis media, pharyngitis, pneumonia. ROCEPHIN given 12-20-08 + urine culture done 12-19-08, 12-22-08 doing good.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 15th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
Crying 3 hours non-stop. After receiving DTaP, IPV, Prevnar, HIB 8/30/02 (within first 72 hours) by history from parents.