chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received form a health professional concerning a 62 year female pt with a hx of chronic obstructive pulmonary disease who in November 2003, was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently in November 2003, the pt experienced injection site reactions which included injection site swelling, soreness and erythema. It was reported that the swelling went past her elbow. She was treated with Benadryl and cold compress The reporter indicated that three other pts had similar experiences following exposure to dose of pneumococcal 23v polysaccharide vaccine . The reporter indicated that the pt's swelling "was more sever than the others and went past here elbow". as of 03DEC2003, the pt's adverse events abated. There was no product quality complaint involved. Additional information has been requested.
On 2/23/00, the pt developed breakthrough chickenpox that consisted of approximately twenty-five lesions and no fever.  The pt sought unspecified medical attention. Additional information has been requested. Follow up data states the patient's symptoms had resolved by 02/29/2000.
Chills; Fever between 100.4 to 100.6 F; Body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever between 100.4 to 100.6 F) and MYALGIA (Body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever between 100.4 to 100.6 F) and MYALGIA (Body aches). On 25-Mar-2021, CHILLS (Chills), PYREXIA (Fever between 100.4 to 100.6 F) and MYALGIA (Body aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatments were taken because patient was allergic to Tylenol, so said she took it easy and put cold compress in her head.   This case was linked to MOD-2021-135386 (Patient Link).
Information had been received on 29-MAR-2017 from a medical assistant who reported that an unspecified infant patient (age and gender not reported) was inadvertently administered a dose of ZOSTAVAX vial 19400 PFU (dosage, route of administration and lot#/expiration not reported) with diluent instead of an intended dose of VARIVAX on an unknown date. No adverse effect reported. Medical assistant declined to participate in AE intake, therefore most required AE fields are "Refused to Answer". All AE fields apply to ZOSTAVAX; no dose of VARIVAX was administered. No additional information is available. Additional information is not expected.
patient expired Daptacel today by mistake/no AE; Initial information received on 27-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 21 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Expired vaccine used).  The patient's past vaccination(s) included three doses of Pentacel (no doing details reported).  The patient medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and HEPATITIS A VACCINE (HEPATITIS A).  On 27-Feb-2020, the patient received a single 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA (expiry date: 07-FEB-2020) via intramuscular route in the left thigh.  It was of actual medication error due to Expired vaccine used (Expired product administered).  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Subsequent to receiving vax, the pt experienced a painful, red, enlarged knot at the injection site which lasted for 2-4 hours and then subsided. The pt sought unspecified medical attention. The pt had a similar experience following exposure to haemophilus b conjugate vaccine. Additionally it was noted that another pt had a similar experience following exposure to haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). Follow up information for a health care professional reported that the pt is recovered.
his friend's mother got the injection and shortly after had A-Fib; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIAL FIBRILLATION (his friend's mother got the injection and shortly after had A-Fib) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (his friend's mother got the injection and shortly after had A-Fib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (his friend's mother got the injection and shortly after had A-Fib) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported. Company Comment: This is a spontaneous case concerning an elderly female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of atrial fibrillation, which occurred on an unknown date after a dose mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. It was reported that patient got the injection and shortly after had A-Fib. No further information was disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747570 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2023: Nonsignificant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747570:Master case
'rash' at injection site that was 2" in diameter, itchy, and red. Went away in 4 days.   Swollen lymph node under armpit in the arm of the injection. Still have it after 2 weeks.
Nauseated after received immun. (10:30am). Vomited at 1:40 pm. Home with parent.
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The nurse had documented that the patient was vaccinated with her first dose of GARDASIL on 18-JUL-2013 and her second dose on 12-FEB-2014. The patient informed her that she received another dose of GARDASIL between 18-JUL-2013 and 12-FEB-2014 on an unspecified date. All dose and route for three doses were 0.5 ml intramuscularly (lot # for three doses not reported). No adverse effect reported. The patient's outcome was unknown. Additional information has been requested.
First dose  Tongue went numb for two hours, breathing became labored within 10 minutes. Itchy on arm shot was given. Was given Benadryl. Second day I had terrible abdominal cramps that caused pain for about 4 hours, then gradually went away.  Second Dose  I'm sitting in the waiting area right now after having my second dose. I have numbness on my tongue, a slight headache, and my head is mildly itchy.
Patient seen by me on 9/24/2013 at approx 6 pm. She had been having sypts since the morning. She received her vaccine on 9/23/2013 at approx 12 noon. She had soreness of (L) arm, erythema and pruritus of (L) arm, erythema and pruritus of back, facial swelling and pruritus.
side effects of covid-19 vaccinations; neutropenic fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4491485-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEBRILE NEUTROPENIA (medically significant) with onset Jul2022, outcome "recovered" (Jul2022), described as "neutropenic fever"; IMMUNISATION REACTION (non-serious), outcome "recovering", described as "side effects of covid-19 vaccinations". The action taken for ibrutinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "neutropenic fever" and "side effects of covid-19 vaccinations" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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
pt recv vax 13AUG96 & devel 10 pox-type lesions on 29AUG96 & fever by 1SEP96 had gen rash & started on med;pt required multiple ER & office visits & missed work d/t infect;MFR confirmed vaccinia-rash based on swabs of pt lesions;
Information has been received from a consumer concerning her daughter, a 16 year old patient with no pertinent medical history or drug reactions/allergies, who at the "beginning of 2010", was vaccinated with the first dose of GARDASIL. On 29-APR-2010, the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. "Less than 12 hours after receiving her second dose", the patient experienced stomach pains, nausea, fever, tingling and she cannot eat. It was reported that therapy with human papillomavirus vaccine was discontinued. At the time of the report, the patient had not recovered. The patient did not seek medical attention. No laboratory diagnostics studies were performed. Additional information has been requested.
Less than 5 minutes of receiving vaccine patient dropped to the floor fainting. Prior to fainting, trouble hearing and seeing, could not stand. Next day headache, stomach ache, arm sore.
Approximately 2 days after receiving her vaccine, she began to develop swelling and tender spots on both legs, mostly around the knees. These spots continued to grow in size, swelling and got more red in color. She developed more around the ankles. Edema of both legs worsened. approximately 20 days after receiving the vaccination she developed a similar spot over the right thumb. She also complained of scratchy throat, especially when lying down at night although she is noted to have chronic allergies. On March 25, she was re-evaluated. Given that her symptoms were worsening, and lab tests were abnormal she was treated with prednisone.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA001345: US-009507513-2207USA004691: US-009507513-2207USA004707: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004709: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 "10Pk 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 32F (0 Celsius) for 104 hours; also there were reported temperatures of 34f (1.1 degrees C) and 48F (8.8 degrees C). The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.
devel shingles day p/ on same dermatone as inj of lt deltoid;has had prev flu vax x1yr ago no adverse rxn then 6OCT97;pt exp blisters & sore arm beginning day p/vax;BP 118/62;T96.9;got classic shingles;
Quarter size swelling at injection site, entire deltoid became quite sore, firm, warm and extremely tender with significant decrease in ability to perform abduction and extension over the next hour. Pain and stiffness progressed to right shoulder blade and right trapezius. At this time these areas remain somewhat tender and sore, however ROM has improved. Of note, also developed some SOB and redness to neck and chest within 30 minutes of injection, Fexofenadine was taken and the SOB and redness to chest resolved by 4pm day of injection.
pt recvd vax;very irritable,fussy;mom described pt to be violent;awoke in am w/ hives in feet,legs,hands;PC to MD;no tx;sxs subsided afternoon 8dec;
Fever, which varied for three days, up to 103, severe pain in the left arm, chills, redness and swelling in the left arm.  The left arm is where the pneumonia shot was administered.
On 8/28 mother came to HD reporting "patient" developed headache right after shot, now has severe headache, fever and rash. Mom also reports "patient" had disease (chickenpox) when he was 3 years old (form is marked (yes) but at time of appt was unable to remember if "patient" of his sibling had chickenpox and requested immunization to be given. Mom has only been giving 1 tsp Children's Tylenol for "patient" (see back of form); Mom reports "patient" 5'4". Advised to purchase OTC adult Tylenol tablets and give 1-2 tablets every 6 hours to help with headache and irritability. Encouraged to call PCP for further evaluation.
NOTICED RASH ON LEFT FOREARM ON 11/10/205. NOTICED RASH ON UPPER LEFT THIGH ON 11/11/15. NOTICED RASH ON UPPER RIGHT THIGH 11/12/15. TODAY FACE IS ITCHY AND BEGINNING TO GET A RASH ON MIDDLE BACK.
WEIRD FEELING ON LEFT LEG BELOW THE KNEE ON THE FRONT OF THE LEG WHILE AWAKE OR WALKING OR SITTING DESCRIBED AS FELT LIKE GENTLE TOUCHING WITH THE FEATHER OR A LITTLE WORM CRAWLING UNDERNEATH OF SKIN; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified disability. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced weird feeling on left leg below the knee on the front of the leg while awake or walking or sitting described as felt like gentle touching with the feather or a little worm crawling underneath of skin. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weird feeling on left leg below the knee on the front of the leg while awake or walking or sitting described as felt like gentle touching with the feather or a little worm crawling underneath of skin was not reported. This report was non-serious.
PT STATED THAT A FEW DAYS AFTER THE VACCINE (2ND DOSE) SHE HAD A FEW PIMPLE-LIKE RASHES THAT DISSAPPEARED IN A FEW DAYS. THEN A FEW DAYS AFTER THAT, SHE DEVELOPED A LARGER AREA OF PIMPLE-LIKE RASHES THAT ITCHED BUT DID NOT BURN. SHE APPLIED ICE TO THE RASH BUT DID NOT RESOLVE THE ITCHING. THAT IS WHEN SHE CALLED THE PHARMACY. SHE WAS ACTUALLY AFRAID THAT SHE WAS BREAKING OUT IN SHINGLES. I TOLD HER WE HAD NOT HEARD OF PEOPLE GETTING SHINGLES AFTER RECEIVING THE VACCINE SINCE THIS IS NOT A LIVE VACCINE. I INFORMED HER THAT I WOULD CONTACT OUR IMMUNIZATION DEPARTMENT AT CORPORATE TO FIND OUT IF THEY HAD HEARD OF PATIENTS GETTING SHINGLES AFTER RECEIVING THE VACCINE. SHE WAS ADVISED TO TAKE SOME BENADRYL TO HELP WITH ITCHING UNTIL WE HEARD BACK FROM CORPORATE. IMMUNIZATION DEPARTMENT RESPONDED THAT THE RASH DESCRIBED BY THE PATIENT WAS NOT CONSISTENT WITH CLINICAL TRIAL ADVERSE EVENTS DESCRIBED IN PACKAGE INSERT AND RECOMMENDED THAT THE PATIENT BE REFERRED TO HER PHYSICIAN FOR EVALUATION AND DIAGNOSIS. PATIENT WAS ADVISED TO SEE HER PHYSICIAN TO HAVE THE RASH EVALUATED. WE HAVE NOT HEARD FROM PATIENT REGARDING THE OUTCOME Patient has not returned our calls regarding the final outcome of MD visit.
Sore shoulder, fever, chills (at one point the chills caused me to shiver uncontrollably for a moment), headache, tiredness- low energy, feeling generally gross, needed to urinate every few hours, foggy brain
Late period, heavier than usual menstrual bleeding, prolonged spotting and disruption in subsequent menstrual cycle (early and heavier flow)
pain down both arms; h/a; "nausis"; facial edema; treated for cellulitis w/Keflex
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Anxiety-Medium, Systemic: Hyperventilation-Mild, Additional Details: Patient was extremly anxious about getting the vaccine prior to the administration
Pt presented with rash ,swelling and reddened area at injection site Dx Cellulitis Treated with Keflex, Kenalog Cream, Medrol dose pack  Pt contacted on 3/17 and area had much improved
4cm x 2cm erythematous area on R deltoid.  Treated with BENADRYL & cool compress.
LUE cellulitis s/p PNEUMOVAX injection 3/11/15 at health center. ED 3/13/15 for redness, warmth, swelling from shoulder to below elbow. Given TORADOL and IV ANCEF. D/C 3/15 from hospital and seen in f/u at health center 3/17/15.
My arm turned red & sore from elbow to top of shoulder Sore-red top of arm
Information has been received from a 30 year old female with a penicillin allergy who on 15-NOV-2005 was vaccinated "subdermally" with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown).  Concomitant therapy included hormonal contraceptives (unspecified).  ON 15-NOV-2005 the patient administered the pneumococcal 23v polysaccharide vaccine in error.  She was "supposed to receive a TB test".  On 15-NOV-2005, a few after vaccination, she "developed a severe skin irritation, swelling, pain in wrist, tingling sensations in her fingers, skin redness and skin edema".  Unspecified medical attention was sought.  The patient's present status was reported as not recovered.  no product quality complaint was involved.  No further information is available.
At approximately 0945 this nurse witnessed patient sitting in the observation area with her head tilted to the left side and her body leaning to the left. The medical assistant was with her holding her body up. Her eyes were closed and she had no color to her face and lips. She was not able to respond to questions being asked. As her head was shaking she was making grunting noises. She was diaphoretic and tremulous. This episode lasted for approximately 60 seconds. Pt then opened her eyes and was able to respond to questions asked but with a delayed response. Pt was moved to the stretcher to lay down. Her color came back to her lips and her blood pressure improved. She was responding to questions appropriately. Pt was diaphoretic for approximately 10 minutes. Ice packs and water were provided. Pt was observed by the medical assistant for 30 minutes. Her HOB was elevated gradually until she was able to dangle her feet and sit on the side of the stretcher.  Pt stated that she was feeling better and was ready to go be with her roommate.    Vital signs were taken and BP 91/54, HR 70, O2 97%.  At 0952 HR was 62. 1005 BP 102/67, HR 57 O2 99%.
This spontaneous report was received from a nurse and refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 03-FEB-2016, the patient was vaccinated with an expired dose of PROQUAD (Merck) (lot # K009470, expiration date 03-JAN-2016) 0.5 ml, subcutaneously, in the right thigh. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information is not expected as the reporter did not want to be contacted.
13 yo with 1 1/2 - 2" indurated hot, red, tender & pruritic area at site of TDAP vaccine (done 2 days prior). Seen today (3rd day) - is much smaller; less tender, less red & smaller area of induration with BENDADRYL alone.
Extreme Nausea, strong sensation of egg taste, fatigue. Unable to move arm where PT got the injection.
This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with GARDASIL (lot number, concentration and dose were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.