chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given VARIVAX and Hep B (ENGERIX-B) vaccines at office during wellness check. Waited in office 15 min after injection. No problems noted. Mom called office back shortly after leaving and stated that patient was itching and had hives. No SOB, etc. Advised to give BENADRYL and come back to office for monitoring. Monitored in office x30-45 min. No further symptoms. Home on BENADRYL.
Temperature of 100.5 occurred 5 days after vaccination was administered and lasted 36 hours.  Temperature of 102.8 occured 8 days after vaccination and lasted 12 hours.  Mild rash on face appeared 5 days after vaccination and lasted 3 days.
Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a non health care professional. This case involves a 26 years old female patient who received vaccine TYPHIM VI (lot NIK811M and expiry date 19-Oct-2019) via intramuscular route in the left deltoid on 14-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to occupational exposure to product as While vaccination it was observed that a moderate amount of vaccine was on the administrator's gloved hand. He did not observe where it was leaking from. I verified this fact twice with the caller. He did not keep the syringe. It was put in the sharps container. It was not reported if the patient had any adverse event. It was also a case of syringe issue. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Patient did state she had not eaten breakfast before coming to the office this morning but had done well with the 1st Gardasil vaccine.  She did drink 4 oz orange juice before the vaccine.  She was put in a semi-reclined position afterward.  After 5 minutes I checked on patient and she stated she felt dizzy and slightly nauseated.  She was given additional orange juice, cool compress was applied to her forehead, and placed in reclining position.  BP was  122/79 and HR was 97; about 20 minutes later BP 119/80 and HR 109.  Continued to monitor her, vital signs remained stable.  She remained in the office for 45 minutes total, during which time she was able to transition to sitting which was well-tolerated, she was seen by Dr. before being discharged from office, at time of discharge BP was 118/75 and HR 93.  Left office in good condition with both parents, parents aware to call back to office if symptoms worsening or additional concerns or questions.
Muscle aches, headache, chills, injection site hot, red and hard for one week, rash on upper body, blisters on face
Injection site swelling, redness, soreness. 2 Advil taken, ongoing pain.
On 2/26/02 at 15:00, the pt's left upper arm was red, swollen and painful. No fever. Ice was applied and Tylenol given. On 2/27/02 at 16:00, the pt's left upper arm was red and swollen. Contacted PCP and was told to continue Tylenol and to call if increased redness or swelling. On 2/28/02 at 11:00, left upper arm swelling and redness was decreased.
Immediate weakness  after shot. Numbness in arm. Approximately 1 hour later face has a few  Hives. Face and neck are itchy.
Information has been received from a pharmacist referring to an unspecified patient of unknown age and gender. There was no concurrent condition or medical history reported. No drug reactions/allergies was provided. On 16-NOV-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K005402, expiration date 07-NOV-2015) (dosage, strength and route were not reported). There was no concomitant medication reported. The vaccine was properly stored. No adverse effects was reported. Additional information has been requested.
Patient reports that shortly after he received vaccine his 49 year wife developed shingles dx 6-21-07 by her PCP after rash x 10 days.
Fever, excessive crying while awake, red painful swollen injection sight, vomiting, irritability, drowsiness, withdrew from parents, did not trust the doctor or nurse and began to scream when they entered the room which looks like signs of post traumatic stress.
Pt recvd Engerix-B, Recombivax or Heptavax 13MAY91; 13JUN91 & 12JUL91; pt donated blood on 15MAY91 & tested pos for Hep B antigen; 21NOV 91 labs showed pos Hep B surface antibody & neg Hep B surface antigen w/nl liver enzymes;
This spontaneous report was received from a pharmacist and refers to a 73 year old male patient. Pertinent medical history or drug allergies/drug reactions were not reported. On an unspecified date in June 2013, the patient was vaccinated with the first dose of ZOSTAVAX (lot number, dose, route of administration and strength were not reported) at the pharmacy. On an unspecified date in March 2015, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (lot number, dose, route of administration and strength were not reported) at the primary care physician office (extra dose administered). Additionally, it was reported that the patient sought medical attention calling to the pharmacist (date and details were not specified). No adverse effects were noted and there was no product quality complain involved. Additional information is not expected as the reporter did not consent for new follow up attempts.
Redness, swelling at injection site (adverse event reported by Pt. today 7/23/16. No record of ER treatment on file).
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates the patients received doses of improperly stored ROTATEQ orally, lot # L027076 with expiration date: 25-MAY-2017 and lot # L033543 with expiration date: 30-MAY-2017 (dose and vaccination site were not reported). Administered doses of ROTATEQ underwent temperature excursion at 28.6 Fahrenheit degrees, for 4 hours. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
transferred to medical facility from hospital 6/17/22, routine covid test collected as part of admission process- tested positive on binax rapid antigen test 6/17/22  had previous negative Abbott molecular test at hospital 6/16/22
Information has been received from a pharmacist concerning 4 adult patients who were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported to be product confusion. No adverse experiences were reported. A product quality was not involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Employee received flu vaccine approx 11:30 am on 9/23/08.  Went to lunch outside, ate sardines.  After returning to work felt warm and flushed. Before leaving for home at 3:30-3:45, came to Employee Health.  Face was flushed and swollen,hives on neck, no respiratory distress.  She was taken down the hall to ACU(ambulatory Care)and treated.  Seen by MD.  Treated with solumedrol and benadryl, observed and sent home on prednisone and benadryl. Spoke with her 9/30 and she reported facial symptoms improved by 9/24 but hospitalized on 9/26 and admitted until 9/28 for respiratory distress.  10/02/2008 Ambulatory Services MR received for 9/23/08 with DX:  Anaphylactoid reaction with unknown allergen. Pt presented 4 hours s/p Flu shot with c/o red face, watery eyes, dry tickle type cough and some difficulty breathing. PE (+) for erythema of face and neck and mild conjunctival edema and erythema.  TX with Solumedrol IV, Benadryl and O2. D/C with Epipen and Medrol dosepak./pc 10/10/2008 MR received for DOS 9/26-28/2008 with D/C DX:  Acute Allergic Reaction.  Asthmatic Bronchitis. Reactive hyperglycemia.  Insomnia.  Allergic Diathesis. Pt presented several day after above incident with increased wheezing, tachypnea, and non-productive cough with chest discomfort after. Admitted due to RR 28 and wheezing despite nebs and steroid tx. Feeling of chest constriction continued despite tx. D/C on steroids, Combivent, Benadryl and with Epi-pen PRN.
Date and time of vaccination: (list both if they received both shots): 1st: 1/18/2021, 2/8/2021 at 0900 Brand and lot of vaccine: Pfizer 1st#: el1283, 2nd#: el9263 Starting feeling chills in the afternoon, become worse in the evening. Fever of 101.5. C/o muscle weakness, fatigue. Feels like "covid symptoms". Taking Acetaminophen as needed. Site injection pain as well. Denies dizziness/neuro changes, SOB, chest pain or DIB.
Patient reported to check-out table approximately 13 minutes after receipt of vaccine complaining of feeling "hot and dizzy".  I was called to patient's side to evaluate.  A pulse ox was placed and gave a reading of SPO2 100% and HR 80.  Quick history was taken and patient was moved outside due to cooler temperatures.  Patient was able to ambulate under her own power and did not appear ill or have any signs of respiratory distress or AMS.  She did note a sensation of tingling/numbness in her lips after sitting down outside  There were no signs of labial edema or edema of the airway.  Patient was given cold water and 25mg po Benadryl with improvement in symptoms 25 minutes later.  After her extended observation period patient was released from the vaccine site with strict follow up precautions.
Hives on both legs after receiving PEDIARIX, Hib, PREVNAR, ROTATEQ & FLUZONE. BENADRYL 2.5 ML q 6h.
07/03/2021 chest pain for several days, got better after a few days, and then got worse. As of 07/10/2021 I have not had any more chest pains.
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/23/2021. Death 8/26/2021.
Localized redness to left upper arm where varicella vaccine administered measuring 5.5cm x 4.0cm. Area slightly raised, not hot but slightly tender. MD Dx: skin allergic reaction from varicella shot. Redness start 8/19 PM resolved 8/23 AM.
The patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies.  On 10-OCT-2020, the patient was vaccinated with and expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S025133, expiration date: 15-SEP-2020) dose reported as 1 shot (dosage regimen, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event details were provided combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
2 cm x 3 cm raised, warm red area. Rx TYLENOL/Ibuprofen & ice to area.
Evening of injection: confusion, weakness, Night developed more weakness and incontinence, Next day: severe weakness, unable to ambulate, follow directions, mumbling, sleepy, incontinent. Taken to ER - CT of head, EKG, Chest Xray, Labs, UA. Radiologist diagnosis start of Right lower lobe pneumonia. Given IV antibiotic and admitted to hospital. Admission MD thinks no pneumonia with profound weakness. Improved next day and discharged. Same evening as discharge had expressive aphasia. Next day speech normal again and weakness gone. Admitting physician said had another dementia patient with same symptoms and cleared in a couple of days.
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: recieved vaccine after 10 min she became unresponsive. She was laid on the ground and given an epi dose by the nurse awhile the pharmacist called 911. She started to come back after 3 min she opened her eyes. The rescue came and asked anyone whoe was not family to leave. They gave her the ok to go. We contacted the pateint today. Her father says she is doing well and only complained of a mild HA and mild nausea last night. Will be seeing her doctor for further recommendations.
received a covid positive diagnosis; received a covid positive diagnosis; This is a spontaneous report from a contactable nurse (patient). A 35-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 21Dec2020 09:45 at a single dose for COVID-19 immunization at the hospital. The patient has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and did not received other medications within 2 weeks of vaccination. The patient received a COVID positive diagnosis on 29Dec2020, 8 days later. The events led to a doctor or other healthcare professional office/clinic visit. The patient underwent COVID tests post vaccination on 29Dec2020 - Nasal Swab (NAA nasal swab) and Rapid COVID test, both showed positive test results. The patient was not diagnosed with COVID-19 prior to vaccination. Outcome of the events was recovering. No treatment was given for the events. The events were assessed as non-serious.   Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
got horrible vomiting; got horrible headache; tired; illness with the headache and upset stomach; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (illness with the headache and upset stomach), ABDOMINAL DISCOMFORT (felt like I had high altitude illness with the headache and upset stomach), VOMITING (got horrible headache and was vomiting), HEADACHE (got horrible headache and was vomiting) and FATIGUE (I was tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Altitude sickness.   On 13-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ILLNESS (illness with the headache and upset stomach). 13-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (felt like I had high altitude illness with the headache and upset stomach). 13-Jan-2021, the patient experienced FATIGUE (I was tired). On 13-Jan-2021 at 2:00 AM, the patient experienced HEADACHE (got horrible headache and was vomiting). On 13-Jan-2021 at 4:30 AM, the patient experienced VOMITING (got horrible headache and was vomiting). On 15-Jan-2021, ILLNESS (illness with the headache and upset stomach), ABDOMINAL DISCOMFORT (felt like I had high altitude illness with the headache and upset stomach), VOMITING (got horrible headache and was vomiting), HEADACHE (got horrible headache and was vomiting) and FATIGUE (I was tired) had resolved.            No concomitant medication were provided by the reporter.   Patient took one Advil and Sinus tablet for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: first dose details, patient demographics  and events were updated and second dose details were added.
-injection site reaction. raised skin around injection. Swollen. Sore. -headache
By 12noon on the day of the injection I noticed pain when lifting the injection arm. By 6pm I began to experience body aches.  At this point I took 500  mg of Tylenol, but received little relief.  By 9pm I began shivering and had CHILLS and the body aches became SEVERE, though my temperature was only 99.1 degrees. I had difficulty sleeping due to the body aches and chills.  I felt a little better in the morning, but very fatigued.  The fatigue lasted  3 days, though the body aches and chills were gone.  I felt back to normal for 3 days, and then, 7 days after the shot, the body aches, chills, and fever returned.  My temp was 99.2 degrees, and these symptoms lasted about 8 hours.  This time the symptoms were accompanied with diarrhea for 3 days.
She got her vaccine at another facility. She presented to our urgent care with the following: rash on right shoulder and chest.
flu vaccine administered instead of Covid vaccine with no reported AE; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 87 years old female patient who experienced flu vaccine administered instead of covid vaccine with no reported ae while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine rha 3v (baculovirus) (flublok) for Immunisation.  On an unknown date, the patient received a  dose of suspect influenza quadrival a-b high dose hv vaccine lot UJ933AA via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious flu vaccine administered instead of covid vaccine with no reported ae (wrong product administered) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported "Nurse reports that a patient received 2 different flu vaccines, 1 week apart. Nurse states that they had a vaccination clinic yesterday, and an 87 year-old woman received a FLUBLOK vaccine. This morning, that patient's daughter called. The woman had already received a FLUZONE HIGH-DOSE QUADRIVALENT last week, at the facility where she lives. The daughter stated that she had made the appointment at the vaccination clinic for a Covid vaccine, but when the patient's son-in-law brought her to the appointment, he misunderstood and requested the the Flublok instead".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event flu vaccine administered instead of covid vaccine with no reported ae.  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.
On 10/13/2022 an employee administered the pfizer monovalent 0.2ml vaccine instead of the pfizer 5-11 yr bivalent vaccine. The Dr. on site called and spoke to the parent.  Staff in the office has been spoken to and more verification in specific is to be done before a vaccine is administered.
still are not feeling quite back to normal; lump the size of a softball, that was injected; fatigue; chills; fever; a swollen armpit under the arm that was injected; body aches; could not bend fingers; hard time sleeping that night due to fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (could not bend fingers), INSOMNIA (hard time sleeping that night due to fever), FEELING ABNORMAL (still are not feeling quite back to normal), VACCINATION SITE LYMPHADENOPATHY (lump the size of a softball, that was injected) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (could not bend fingers), INSOMNIA (hard time sleeping that night due to fever), VACCINATION SITE LYMPHADENOPATHY (lump the size of a softball, that was injected), FATIGUE (fatigue), CHILLS (chills), PYREXIA (fever), VACCINATION SITE SWELLING (a swollen armpit under the arm that was injected) and MYALGIA (body aches). On 12-Apr-2021, the patient experienced FEELING ABNORMAL (still are not feeling quite back to normal). At the time of the report, MUSCULOSKELETAL STIFFNESS (could not bend fingers), INSOMNIA (hard time sleeping that night due to fever), FEELING ABNORMAL (still are not feeling quite back to normal), VACCINATION SITE LYMPHADENOPATHY (lump the size of a softball, that was injected), FATIGUE (fatigue), CHILLS (chills), PYREXIA (fever), VACCINATION SITE SWELLING (a swollen armpit under the arm that was injected) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-073728 (E2B Linked Report).; Sender's Comments:  MOD21-073728:CROSSLINKED
Within 5 hours started with a fever of  101.8,  and 9 hours after shot started vomiting (more than 10 times) and fever reached 104.6, headache and chills
HEAD SEEMS LIKE IT WANTS TO EXPLODE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. the company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-AUG-2021, the subject experienced head seems like it wants to explode. On 02-AUG-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and head seems like it wants to explode was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant via a field employee refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-JUN-2014, the patient was vaccinated with RECOMBIVAX HB lot # 0387AE, expiration date 31-MAY-2014. Dose and route were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that the patient received an expired dose of RECOMBIVAX HB. No adverse effects reported. Additional information has been requested.