chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness on his right arm which progressed to his shoulder and collar bone; something in his blood; A spontaneous report was received from a healthcare professional concerning a 72-years-old Male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events something in his blood, soreness on his right arm which progressed to his shoulder and collar bone.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021,patient received first of two planned doses of mRNA-1273 (lot/batch: 037K20A) via unknown route in the right arm. On 19-fe-2021 prior to the onset patient received second of two planned of mRNA-1273(Batch:037K20A) via unknown route in the right arm for prophylaxis of covid-19 infection.  On 22 Feb 2021, the patient experienced the events something in his blood. On 24 Feb 2021, the patient experienced the event soreness on his right arm which progressed to his shoulder and collar bone.  Treatment details included Metronidazole, Oxacillin, Famotidine.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, something in his blood, soreness on his right arm which progressed to his shoulder and collar bone was unknown.
Rash at injection site is erythematous and mildly raised and bilobed with a "figure8" appearance. Rash began showing 8 days after injection given
Influenza vaccine given in error.  MD order was for Hepatitis B vaccine.  Infant was 4wks of age at time, well under the age limit for receiving the Influenza vaccine.   The infant received 0.5mL dose.  No adverse reactions noted.
Pt  was given flublok instead of regular flu.  Health dept was called and said it wasnt a health issue.  I called parent to let them know.  No known issues.
Local pain; Been sick; Diarrhea; No sense of taste or smell; No sense of taste or smell; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell) and AGEUSIA (No sense of taste or smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell), AGEUSIA (No sense of taste or smell), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell), AGEUSIA (No sense of taste or smell), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications or treatment details reported.
Pt received MENACTRA in (R) deltoid IM. Pt stated he got headache the next morning and felt really tired/fatigued. Pt Reported he felt fine the next day while in our office for another procedure. Advised to take MOTRIN/TYLENOL for HA. No local reaction.
Patient became unconscious momentarily after the shot and had difficulty breathing. Immediately called 911. The EMT checked him and found all vitals normal. Patient OK & did not want to go to ER.
pt recv vax 23MAR98 815AM & BP 148/80, pulse reg no SOB/air hanger, n/v present mid chest pain radiating to lt arm;?diaphoresis;no prev rxn, no hives, no itching;advised to take to ER;
swelling & redness initially around inj site, then extended down & enveloped circumference of lt upper arm;looks like a cellulitis;
Nurse (LPN) administered 0.2 of the orange top Pfizer BioNTech of the Covid-19 vaccine to patient who is 12 yrs old on 12/2/2021. Patient received first dose of Pfizer 0.3  on 11/11/2021 which at the time patient was 12 yrs old as well. No adverse event was noted, patient feeling fine per mom.
Narrative: Patient was a 84yr male. Patient was previously seen by palliative care services. Per death note the death was caused by cardiopulmonary arrest from septic shock. Vaccines do not appear to be related to event.
"Hives" began day after shots given, worse by 2nd day. Eyes puffy. Areas affected included arms, legs, face, ears. Blotchy reddened, raised patches. NO circular, resp. easy, alert. Child very fussy PTA here but smiling, quick-not scratching.
The injection site became hot, red and swollen  7 days after the injection which was given Jan. 29 th.  and  It is still red and itchy 6 days after it appeared Feb. 4th.
This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), VACCINATION SITE URTICARIA (Vaccination site urticaria), VACCINATION SITE REACTION (Covid arm), CHILLS (Chills) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (allergic to sulfa), Drug allergy (Allergic to clindomycin), Allergy (Allergic to some skin product.), Sunscreen sensitivity and Insect bite allergy. Concomitant products included CALCIUM and VITAMIN D NOS for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced LETHARGY (Lethargy), VACCINATION SITE URTICARIA (Vaccination site urticaria), VACCINATION SITE REACTION (Covid arm), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, LETHARGY (Lethargy), VACCINATION SITE URTICARIA (Vaccination site urticaria), VACCINATION SITE REACTION (Covid arm), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment for the event was not reported.  The patient reported experiencing same event with 1st dose.   This case was linked to MOD-2021-016680 (Patient Link).
Lightheadedness and dizziness for 2 days after the injection. Difficulty standing, walking, and operating a motor vehicle. Rested and drank fluids for the 2 days of the symptoms
Covid arm, A rash around the injection site, started about 9 days after the shot.
Child was given pediatric dosing orange cap ages 5-11 when he should have recieved the 12 and older formulation
Started having swelling to left axillary lymph nodes and pain to left collar bone and left axillary area (pain and lymph nodes are still swollen) Fever, chills, body aches, fatigue, headache x 4 days
Timing error.  First dose given 08/12/2022, second dose given 09/07/2022, two days prior to eligibility.   Child will have to be vaccinated again.
This spontaneous report as received from a Nurse refers to a patients of unknown demography. On an unknown date the patients were vaccinated a dose of GARDASIL 9 via an injection into the gluteal muscle (Incorrect route of drug administration). No known adverse effects.
2-3hr p/vax pt began to feel dizzy, nauseated & then proceeded to have emesis & diarrhea x 6hr (emesis x 4);lower face became swollen & had ear pressure bilat;chest became tight w/o wheezing;restless sleep;next day flu like sx & malaise;
Facial and throat swelling , headache, tiredness Rapid heartbeat, weakness, Wheezing  Chills Sweated through 2 outfits Joint and muscle pains
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: In 2018, about 6 months before the reporting date, the patient had sore arm after the dose of SHINGRIX she had no other symptoms. The patient provided details of the physician. For tolerance after 2nd dose refer case US2018189458.
At 5:30 this morning my lip was swelled. I applied ice and went back to sleep. About 6:30 this morning  it was swelled bigger. At about 2:00 I went to the walk in clinic. Got a shot, took Benadryl, and starting predisdone in the morning.
Patient states he has multiple painless ecchymotic areas on body for 3(three)days. Areas include axilla, groin, abdomen. Ares measure 1 cm x 1 cm. Large eccymotic area on left arm below immunization site. Denies vesicles or drainage from areas. Afebrile. Systemic pruritis present for past 48 hours, relieved by Benadryl.
no adverse effect; The patient was administered an improperly stored dose of Proquad; This spontaneous report was received from an office manager refers to a patient of unknown age and gender.  Patient's pertinent medical history, concurrent conditions, past drugs and allergies were not reported. Concomitant therapies included sterile diluent.   On 26-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency and route were unknown) (lot number S003868 and expiration date 08-AUG-2020) for prophylaxis. It was reported that the diluent used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored. The temperature excursion was noted with a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.2 Fahrenheit) for 2 hours. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint reported.
I had a 16 year old with his mother come in for a covid shot.  Got all the info then headed over the shot room where he was waiting.  Looked as nervous as any other kid.  His mother was close by watching.  I usually carry a conversation with the kids asking them questions as I get ready and give them the shot.  I was successful in giving him a shot.  Told them to wait 15 minutes before they leave.  Got a knock on the door from the mother only to find the kid sprawled out on the floor which alarmed me.  The mother said he was light headed.  I talked to him he said he felt  dizzy and his head was spinning.  I asked if he needed some water which he said yes.  I went back after fetching the water and suggested he stay there and that I would check on him in 5 minutes.  Went back and he was sitting on the chair with his mother next to him.  Mother said he has a phobia of needles.  Mother was thankful I was checking up on him.  He and his mother walked away 5 minutes later.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
Pt recvd vax 21NOV93 & devel hyperglycemia, fever 100 & convuls; upon request for addtl into, reporter stated that pt could not be identified;
16 Y/O PATIENT RECEIVED THE COVID19 (JANSSEN) VACCINE AT OUR WALK-IN CLINIC ON 4/8/21
patient aged 16 years of age received a first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 16 years of age received a first dose) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 16 years of age received a first dose). On 02-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 16 years of age received a first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stayed in the pharmacy for 15 minutes after receiving the vaccine and left afterwards.  No adverse events were reported. No concomitant medications were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-225670 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: The follow up document contains NO NEW INFORMATION. On 17-Jun-2021: Follow-up information received on 17-Jun-2021: Second dose added. Updated race and ethnic.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number-021B21A) with no associated AEs reported.
Patient called and said arm is swollen says the size of baseball and red and hot. Told patient to put ice on it and take IBU watch and worsens to seek medical attention patient says arm was sore last night, also called patient told to take BENADRYL.
Patient with J+J COVID vaccine 03/23/21 who admitted with hypoglycemia, significant urinary tract issues, and bowel obstruction who incidentally tested detected during admission testing.  No s/s of COVID during stay, no hypoxia.  Discharged home.
All symptoms started within 1-3 hours of receiving vaccine. Nausea, body aches/sore, tired, chills, loss of appetite, skin flushed appearance, sinus issues (ears draining, nasal congestion). Fever and more intense body aches (all past injuries and even my bones hurt. It hurt to move, sit, and laydown) started that evening.  Next day: Fever, chills, intense body aches (painful to move), nausea (on and off throughout the day), skin flushed appearance, headaches. Day 3 (Sunday/day of form submission): Body aches and nausea (on/off) continue. Treating symptoms with ibprophen 600mg, soup, electrolytes, and rest.
1st dose on 5/18/2022, 2nd dose on 4/11/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received HAB (Twinrix) (batch number H3SG9, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix (received first dose on 18th May 2022 of lot number: lot number: 4F3YY and expiration date: 1st January 2023).   On 11-APR-2023, the patient received the 2nd dose of Twinrix. On 11-APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 5/18/2022, 2nd dose on 4/11/2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Apr-2023 The pharmacist wants to know how to proceed with Twinrix third dose. The reporter consented to follow-up by email. The patient received second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
COVID + 10/15/22 - Vaccination status - moderna x4 BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 10/15/2022 Discharge Date: Oct 17, 2022  Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic congestive heart failure, unspecified heart failure type [I50.9] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 92-year-old man with past medical history significant for  diastolic HF, CAD s/p CABG, atrial flutter s/p ablation, HTN, HLD and BPH who presented to the ED with cough and shortness of breath.  Was saturating 76% o on room air in the emergency department and placed on 2 L which subsequently improved to 90%.  COVID-19 PCR was positive. CXR showing mediastinal widening likely due to goiter, no airspace consolidation or effusions.  Admitted with acute respiratory insufficiency with hypoxia, treatment for COVID-19 pneumonia.  CT angiogram thorax demonstrated no pulmonary embolism, without any pulmonary consolidation or pleural effusions, worsening thyromegaly with left lower retrosternal extension, tracheal deviation, , known due to mass effect from above (tracheal diameter 1 cm previously 1.3 cm in 2019). Possible tracheal bronchomalacia.  Findings were shared with ENT who recommended outpatient follow-up only.  Patient was started on Decadron, remdesivir for COVID 19 PCR and continue with IV diuresis.  Patient's hypoxia quickly resolved and he was no longer supplemental oxygen.  IV Lasix was transitioned back to his home dose furosemide at discharge.  Patient was discharged on oral Decadron.  Id patient was evaluated by SLP who showed no significant dysphagia and recommended no further SLP intervention.  Patient was evaluated by PT and OT recommended home with assist.  Patient was subsequent discharged home in medically stable condition.
needle stuck in patient's arm/ the needle came off remaining in the patients arm; Syringe broke during administrat ion of dose of Pneumovax, with vaccine contents splashing backwards; Syringe broke during administrat ion of dose of Pneumovax, with vaccine contents splashing backwards; the needle came off of the syringe; the needle came off remaining in the patients arm; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 09-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dose; strength, route, lot # and expiration date were not reported) for prophylaxis. During administration, syringe leaked where Luer Lok and the needle was attached and broke with vaccine contents splashing backwards, then the needle came off of the syringe while was stuck in patient's arm (remaining in the patients arm) (syringe issue, poor quality device used, injury associated with device, needle issue and incorrect dose administered). Product quality compliant involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  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
c/o arm became red, swollen & warm to touch in deltoid area; mom brought pt to clinic, t98.8 ear probe; entire deltoid area edematous & tender to touch inc redness & warmth; ref to PMD;
Vaccine given 10/16/06. Today she awakened at 3 AM with a painful red streak extending up her shoulder onto her torso (from her smallpox vaccine site). The streak is red, hot, indurated and painful. Treated with oral antibiotics.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). Concurrent medical conditions included multiple allergies. On 30th September 2015, the patient received FLUARIX QUADRIVALENT. On 30th September 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability), injection site erythema (serious criteria disability) and injection site itching (serious criteria disability). On 2nd October 2015, the patient experienced sore throat (serious criteria disability) and viral syndrome. On 3rd October 2015, the patient experienced generalized rash (serious criteria disability), fever (serious criteria disability), chills (serious criteria disability), sinus headache (serious criteria disability) and fatigue (serious criteria disability). The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site itching, sore throat, generalized rash, fever, chills, sinus headache, fatigue and viral syndrome were unknown. The reporter considered the injection site pain, injection site erythema, injection site itching, sore throat, generalized rash, fever, chills, sinus headache and fatigue to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the viral syndrome to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient developed injection site pain, redness and itching within 24 hours of receiving the FLUARIX QUADRIVALENT vaccine. Two days later she developed a sore throat. Three days after the vaccine, the patient developed a rash on her arms (antecubital fossa areas), fever, chills, sinus headache and profound fatigue. At the time of this report, the rash had spread to the patient's trunk, back and abdomen, neck and upper chest, buttocks, thighs and arms. It had also spread to her face (forehead and cheeks). The patient was seen by the reporter (physician) and the patient was slated to see an allergist as well. The patient had been off from work because of the fever, chills and fatigue and was not to return to work until afebrile. The reporter stated she felt the symptoms may still be evolving and possibly caused by the FLUARIX vaccine, but she had no ruled out viral syndrome. The patient was treated with antihistamines and a script was provided for Azithromycin in case patient developed sinus infection. The reported batch number for this case was 95251 which does not exist, so as per our sales database it was changed to 9525T.
Severe abdominal pain, vomiting. Will take her to clinic if symptoms don't improve in 3 hours.
Vaccines given on 6/23/01. Pt states left buttock turned red with itching at site and generalized body itching 2 days post vax. Pt states that cleared up in 2 days, at which time right buttock turned red around injection site which remains pink and raised rash today on 6/29/01. Afebrile.
4/17/08 temperature to 104.2 and had febrile seizure. Seen  E.D.
significant increase in tremors warranting ER evaluation within approx. 12 hrs of vaccine administration
onset of shingles in lt T5 dermatome: over lt upper arm, lt chest, & lt back on 22NOV95; treated w/Zovirax;
swelling & itching increasing in size lt deltoid & down back of arm tx w/atarax & cold compress;
17 y/o female patient received extra Men B vaccine. No adverse reactions were reported or noted.
On 19 February 2021 patient received second Moderna mRNA vaccine dose and on 26 February 2021 patient noted onset of urticarial lesions affecting her arms which subsequently spread to affect her face and lower extremities. Lesions waxed and waned over the next seven days despite use of oral antihistamines and course of oral glucocorticosteroid. No laryngeal, pulmonary, GI/GU, neurologic, or cardiovascular symptoms.
Patient stated that she had a sore arm from the flu shot lasting 2 months after administration. She stated that about 2 days after receiving the shot, that she noticed her arm hurt when trying to lift plates over her head. About 2 days after that, a rash started to develop that extended from the administration site, and eventually grew down the length of her arm to her elbow. She stated that the rash was raised, red, and hot, and that it took about 3 weeks for the rash to go away.
I had general sides effects.  Chills nausea vomiting muscle joint pain.  With in 6 hours after the vaccine lasting approx 6 hours or so.