chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 74BL5, expiry date 30th June 2019) for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 19th October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced pain in arm, muscle spasm, movement disorder and swelling arm. On an unknown date, the outcome of the pain in arm, muscle spasm, movement disorder and swelling arm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, muscle spasm, movement disorder and swelling arm to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The pharmacist reported that the patient received FLUARIX QUADRIVALENT in the left arm and the next day her arm was sore and swollen and it felt like the muscle in the arm was knotted up. The day before the time of reporting, the patient visited her gynecologist for a routine appointment and had a blood draw as part of the appointment. After the blood draw her arm swelled up even more and was puffy above the elbow. The symptoms were continuing to get worse and it was difficult for her to rotate her arm outward and she did not want to move her arm very much because it was sore.
first dose on October 23. 2020 and has not received the 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. Thee reporter refused to answer any additional questions. The reporter did not consent to follow up. This case was linked with case US2021097926, reported by same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097926:Same reporter
Tested positive after eight days; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive after eight days) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 1) and PFIZER BIONTECH COVID-19 VACCINE (Dose 3 (first booster)). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive after eight days) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Tested positive after eight days) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative on day, positive (Positive) tested positive after eight days and negative (Negative) tested negative on 14.         No Concomitant medication were reported. No treatment drug were reported.  Company Comment: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred on unspecified interval after receiving mRNA-1273 taken as second booster dose of COVID-19 immunization series. Interchange of vaccine products is noted in the case as patient received three doses of Tozinameran prior the mRNA-1273 administration with no adverse event reported.  The clinical course and treatment details were not reported. Repeat COVID-19 test showed negative result. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred on unspecified interval after receiving mRNA-1273 taken as second booster dose of COVID-19 immunization series. Interchange of vaccine products is noted in the case as patient received three doses of Tozinameran prior the mRNA-1273 administration with no adverse event reported.  The clinical course and treatment details were not reported. Repeat COVID-19 test showed negative result. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient received 0.2 ml of undiluted Pfizer Covid vaccine 5-11yrs. No symptoms reported to date
I had a cough that was not productive, I felt really cold, I was getting tired from doing anything. I took a home COVID-19 test, that came back positive. Once it came back positive, I called my doctor's office, spoke to the NP, who gave me the state sponsored number so that I could get a prescription for PAXLOVID. I started feeling within three to for days of taking the antiviral medication, I did not get rebound COVID-19.
34 year old / patient / was inadvertently given a pediatric dose instead of an adult dose; 34 year old / patient / was inadvertently given a pediatric dose instead of an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number 77B59, expiry date 22nd September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th July 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 6th July 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and accidental underdose. On an unknown date, the outcome of the adult use of a child product and accidental underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was inadvertently given a pediatric dose instead of an adult dose.  Pharmacist believed this was the patient's first dose in the series, which led to adult use of child product and accidental underdose. The reporter consent to follow up via email. Pharmacist granted permission for safety to follow up via email.
Pt recvd vax & devel diarrhea & became dizzy, shaky & devel weakness; events lasted 2-3 wks causing the pt to miss 3-4 days of work;
pt recvd Engerix-B & exp hives, redness, SOB; tx w/steroids; resolved p/a few days;
loss of conscientiousness; patient as he was falling; This is a spontaneous report from a contactable other health professional (HCP). A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 15Apr2021 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Apr2021, the patient was brought to emergency department (ED) immediately after vaccination. The patient had two minutes of loss of conscientiousness. As per his father who caught the patient as he was falling. The patient did not hit his head and the patient was stable. The patient did not receive treatment for the events. The outcome of the events was recovered on an unspecified date. It was unknown if the patient had COVID prior to vaccination and was unknown if tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the reported event cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
10/23-arm sore 10/24-redness, edema and warmness to arm the redness and edema reached 5 inches in diameter lasting until 11/3
There was no adverse reaction. Advised Patient's guardian to wait the 15 Minutes after injection.
Rash on upper torso on the eve of 1-1-07. Rash is itchy.
patient says he developed a lump in arm that was growing and had itching. he called md and doctor told him to take Benadryl. Benadryl resolved symptoms
EYE INFLAMMATION GETTING WORSE; This spontaneous report received from a patient concerned a 6 decade old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, first dose (1 in 1 once), 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 54 years old. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, second dose (1 in 1 once), 1 total administered on an unspecified date for prophylactic vaccination.  The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 Vaccine) (Dose number in series: 3) (form of admin not reported, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 27-FEB-2022 for covid-19 vaccination, and non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate posterior panuveitis, and moderate to severe ulcerative colitis. No concomitant medications were reported.  On an unspecified date, the patient experienced eye inflammation getting worse (Dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s (Dose number in series: 1), covid-19 vaccine ad26.cov2.s (Dose number in series: 2),  (Moderna Covid-19 Vaccine), and adalimumab was not applicable. The patient had not recovered from eye inflammation getting worse. This report was non-serious.
April 1st, I had leg pain and swelling. I went to the doctor - I had a blood clot in my leg. I had to go on blood thinners.
Patient received the incorrect vaccine.  She received Pfizer Covid-19 vaccine intended for 5-12 yr old patients.  I contacted the patient and she received the correct Moderna Spikevax vaccine later the same day at 7:10pm.  No adverse effects were reported by patient.
This spontaneous report as received from a Nurse refers to a patient of unknown demographics. The patient concurrent condition and medical history were not reported. On 15-DEC-2017 the patient was vaccinated with improperly stored PROQUAD lot # N016119 (expiry date: 21-NOV-2018) for prophylaxis and VARIVAX Lot # N007930 (expiry date: 03-MAY-2019) (incorrect product storage). Concomitant therapies included sterile diluent (STERILE DILUENT) lot # N006322 (expiry date: 11-JUL-2019). No adverse effect reported. The temperature was reported as 18.9F. Time frame was reported as 3 hours 10 minutes. There was previous temperature excursion with 15F to 46F for 5 hours 20 minutes. No product compliant reported.
No reaction to vaccine but had diagnosed with sepsis. I left the hospital and went back 4Oct2021, sounded like I had pneumonia and had sepsis. Patient left the hospital. Pt did not have lot number, has no vaccination card.
This spontaneous, non-valid report was received from a nurse and concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly doses of: VARIVAX lot number N019822, expiration date: 13-JUL-2019 or lot number N019131, expiration date: 22-JUN-2019 or lot number N012619, expiration date: 21-APR-2019 or lot number N012131, expiration date: 17-APR-2017, for prophylaxis (dose and route of administration were not reported) or ZOSTAVAX, lot/batch number, reported as "N009643", expiration date: 17-MAR-2018, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included sterile diluent (MERCK) which did not undergo a temperature excursion. The vaccines underwent a temperature excursion between 6 to 14 (also reported as "13.3") Fahrenheit degrees for 245 minutes. The previous temperature excursion were between 6 to 14 Fahrenheit degrees for 115 minutes and between 15 to 46 (also reported as "19") Fahrenheit degrees for 35 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported.
Information has been received from a 54-year-old white female consumer licensed practical nurse (L.P.N.) with allergies to CECLOR, morphine, DEMEROL, codeine, TEQUIN and a history of herpes zoster through secondary exposure (WAES# 0611USA01550) who on 09-AUG-2007 in the PM was vaccinated in the left arm with a first dose of ZOSTAVAX (lot# 658207/0883U). Immediately, on 09-AUG-2007 the patient experienced a local reaction which included a large, red inflamed area that was hot and painful and a rash. The patient was treated with BENADRYL, ice and CATAFLAM. The outcome is reported as ongoing and recovered. It is also reported that the patient was experienced an unspecified adverse event from a vaccination in 1994 with a first dose of PNEUMOVAX 23. Additional information has been requested.
Physician Discharge Summary    37 y.o. 12/1/1984   Admit Date:  7/8/2022   Discharge Date: 7/9/22   Principal Dx/ Final Dx: Precordial pain   Relevant Inpt Dx: Principal Problem:   Precordial pain Active Problems:   Primary hypertension   Diabetes mellitus   CAD, multiple vessel       HPI:   Hospital Course:   This 37 year old man was admitted with chest pain.  He did not have MI.  He had recent normal stress test.  Echo did not show concerning abnormalities.  He was seen by cardiology and they did not plan further evaluation.  D-dimer was noraml so very unlikely PE.  He will follow up with pcp.     He did test positive for covid but no treatment needed
Nurse at vaccine clinic injected subcutaneously and did not reach the muscle. Did not have information to know what to do. Observed patient who was asymptomatic.
Patient was seen on 10/7/08 for his 4 year well child exam at which time he received his vaccinations.  Returned to the office on 10/10/08 with cellulitis of the left thigh.
This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient were vaccinated with improperly stored RECOMBIVAX HB (dose strength and route was unknown). No concomitant medication was reported. Patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Swelling, redness, heat at the injection site after 8 days. No swelling before.
Patient received Moderna vaccine on 3/8/21, 4/6/21, and 11/11/21. Presented to ER on 1/3/22 and found to be COVID-19 positive. Admitted on 1/20/2022 for presented with fever, cough. Patient is vaccinated against COVID-19. Tested positive for COVID-19 on January 3rd, 2022. Symptoms onset 1 day prior. Nausea vomiting diarrhea improved. Cough persisting with clear mucus. Underwent CT angio on 01/13/2022, no PE, bilateral ground-glass changes most consistent with COVID pneumonia. Immune compromised. Non-Hodgkin lymphoma on chemotherapy, WBC 1.1. Oncology consulted. Chronic pancytopenia and neutropenia since Bendamustine chemo for NHL. NO g-CSF (might aggravate inflammatory response especially in the lungs). Hypokalemia supplemented. Patient maintain oxygen saturation on room air throughout hospitalization. Not required any COVID related treatment. For neutropenic fever treated with IV antibiotic. Clinically improving. Remain afebrile. Blood cultures no growth. 6 minute walk test done and no recommendation for oxygen. Patient is medically stable to be discharge Home. Discharged on 1/25/22.
This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a 9-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline, Engerix B for prophylaxis. There was no relevant medical history or concurrent medications. The subject had not experienced any adverse events following previous vaccinations. On 5 February 2002, the subject received 1st dose of Havrix (unknown), 1st dose of Engerix B (unknown). According to the subject's mother, both vaccines were mixed into one syringe and given as one injection, however, the medical records indicated that hepatitis A vaccine in the right thigh and the hepatitis B vaccine was given in the left thigh. It was unknown which method of administration was correct. On an unspecified day in 2002, at an unspecified time after vaccination with Engerix B and Havrix, the subject presented to the physician with fever, headache, nausea, dizziness, and swelling below and above the jaw on either side of her mouth. At the time of first seeing the subject, the physician thought she looked as if she had mumps. The subject's tongue was swollen and it was hard for her to swallow. Anaphylaxis to the vaccine (s) was diagnosed. The subject was treated in the emergency room. It was unknown if the subject was hospitalized. It was unknown to which vaccine or ingredient the subject reacted. At the time of reporting, she had not received any subsequent doses of Havrix or Engerix B since these events occurred. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.
Arm was hot; Large area of redness; Arm was a little tender; A spontaneous report was received from a consumer concerning a  male patient of unknown age, received Moderna's COVID-19 vaccine (mRNA-1273 and experienced large area of redness/ erythema, arm was a little tender/ tenderness and hot feeling hot  The patient's medical history was not reported. No irrelevant concomitant medication were reported   On 9 feb 2021, the patient received their first dose of mRNA-1273 (Lot number: 029K20A) intramuscularly in left  arm  for prophylaxis of COVID-19 infection. On 9 feb 2021, prior to receiving mRNA-1273 the patient experienced erythema, tenderness and feeling hot . The patient did not receive any treatment  Action taken with mRNA-1273 in response to the event was unknown  Outcome of the events,  large area of redness/ erythema, arm was a little tender/ tenderness and hot /feeling hot were unknown
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 22Mar2021 at 10:45 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included essential tremor. The patient was allergic to sulfa drugs. Concomitant medication included birth control pill (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to vaccination. On 22Mar2021 at 22:00, the patient experienced sore arm. The patient did not receive any other treatment for the adverse event. The clinical outcome of sore arm was not recovered at the time of this report.  Information on lot number has been requested.
Left arm redness, swelling around site of injection 2 days with 13 X 10 cm. Keflex rxn if symptoms not resolving.
Had local rxn 3cm, warm to touch red on 18JAN91 tx antibiotics; 2nd HIB vax 16APR91 on 19APR 5cm rxn red swollen afeb;
Developed type 1 diabetes. 9/16/09 MR received from PCP.  Initially presented 2/1/08 with c/o increased thrist and elevated BS.  DX:  Latent autoimmune Diabetes of Adult. DM Type 1.
PATIENT STATES  SHE HAS HAD PAIN ON HER LEFT SIDE. SHE STATES THE PAIN HAS MOVED UP AND DOWN HER ARM AND INTO HER SHOULDER. SHE HAS FELT WEAK AND EXHAUSTED SINCE 9/28/19. SHE DESCRIBES IT AS FEELING FLU-LIKE WITH ACHES AND FATIGUE.  SHE STATES SHE IS FEELING SLIGHTLY BETTER BUT HAS FATIGUE THAT WORSENS IN THE AFTERNOON. SHE ALSO HAD A COLD SORE DEVELOP FOR THE FIRST TIME IN HER LIFE. I SUGGESTED SHE SPEAK TO HER PHYSICIAN SINCE IT SOUNDS LIKE SHE IS HAVING NERVE PAIN AND HER IMMUNE SYSTEM IS HYPER-RESPONDING TO THE VACCINE.  SHE STATED SHE HAD A YEAR LONG REACTION TO A HEPATITIS B VACCINE, BUT DID NOT REPORT THAT TO US AT THE TIME OF HER SHINGRIX VACCINATION.
8 days after injection (9/17/2020)  developed rash on sides of face along hairline with small pustules, on 9/19/2020 his injection site on L thigh had a bright red spot around it approx  2.5 cm diameter.  The spots along the sides of his face and forehead seemed to be itchy as he would rub at them.  Dosed with Tylenol and Benadryl, and cool compress to site on leg.  The red spot around injection site became darker red over the next 2 days, then began to fade.  The rash spots on his face became dark red flat spots, and this was reported to the Dr office and had phone conversations with care givers. Also treated with cortisone cream.  The spots on his face faded around Oct. 3,2020, a little over 2 weeks after they appeared.
2 episodes of seizure-like activity lasting about 30 seconds each. First episode was eye and head deviation to the left and second that happened 3-5 minutes later invoved dilated pupils, upper extremity flexor posturing, glassy stare, perioral cyanosis frothy drool. Unresponsive/limp for 30 min past 2nd episode. On 10/26 also had 30 sec episode of head & eye deviation to the left.