chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm pain at injection area and  tip of shoulder. Also pins and needle feeling in left hand fingers.
At approximately 17:15, time of discharge ,(15 minutes after vaccination) client stated that her left arm was itchy as well as both hands. Injection site area with pink hue but no hives. She also stated she felt a little something in her throat.  Vital signs at this time were 143/85 BP, Heart rate 100 and O2 sat 96%.  No sob. 17:19 she complained of a sensation of tongue swelling.  VS 138/82, HR 90, O2 sat 96% and no SOB.  Continued to monitor VS every 3 minutes.  Pt offered IM Benadryl but refused. 17:22 132/87, HR 99, O2 sat 95%, 17:25 133/85 HR 90 O2 95% 17:29 132/82 HR 93, O2 sat 96%, denies any new symptoms at this time. 17:34 128/89 HR 88, O2 sat 96%, 17:38 134/85 HR 93 O2 sat 95%. States symptoms improving.  17:41 129/84 HR 93 and O2 sat95%,  17:73 133/83 HR 86 , O2 sat 96%.  Pt. symptoms cont. to improve. 17:55 131/83 HR 86 O2 sat 95%.  Pt states she feel better. Planes to take oral Benadryl as soon as she gets home.  She was advised to consult with primary physician regarding this event and will follow up with physician if she chooses to receive a second dose of  Moderna COVID 19 vaccine at her doctors office.  She left at 17:56.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353241USA. (8 patients in the exposed cohort experienced epilepsy, of the 8 patients in the exposed group age: 5 were in age group 19-24. Sex: 6 male. A male patient between the ages of 19-24 years experienced SEIZURES, (EPILEPSY, UNSPECIFIED) (confirmed). Patient was hospitalized from 06-Mar-2012 to 08-Mar-2012. The patient was an recruit. Adenovirus vaccine was administered on 07-Feb-2012. The patient also received meningococcal, Tdap, and influenza (inactivated or live attenuated) vaccines on 07-Feb-2012. The patient did not receive polio (inactivated), varicella, hepatitis B vaccines, pneumococcal, smallpox, yellow fever, MMR, hepatitis A, hepatitis B booster, TWINRIX, TWINRIX booster, or HPV vaccines. Medical History: G6PD Deficiency: 21-May-1992-ongoing. Nervous attacks; unknown start and stop date. Low grade headaches: unknown start and stop date. No history of alcohol abuse or tobacco use. Adverse events within 42 days of vaccination: Nausea: --2012 to --2012, no treatment given, outcome of adverse event is unknown. An EEG (electroencephalogram) was done and was abnormal. The results showed rhythmic theta activity consistent with partial onset seizures. The patient was treated with levetiracetam 500mg orally twice per day starting on 12-Mar-2012 and is continuing, Naproxen 250mg orally as needed, starting on 12-Mar-2012 and is continuing, and DILANTIN (start date and stop date not specified). The outcome of the event was not specified. This case was considered serious due to "Hospitalization". The severity of this event was not assessed. The medical monitor has assessed the causal relationship of this event as "Unassessable" to the adenovirus vaccine.
Patient presented with hives day of vaccine and is experiencing hives throughout her body after 5 days. She has failed therapy with BENADRYL and prednisone.
Eczema on the top side of both elbows Triamcinolone 0.1% ointment?2  times a day for 2 weeks, then 1 time a day for 1 week I just started the treatment
Information has been received from a physician concerning a 16 year old female patient who "a couple of months ago" was vaccinated with the first and second dose of GARDASIL vaccine (Lot # not reported). It was reported that the patient experienced heavier menstrual cycle after receiving the first and second dose of GARDASIL vaccine. The patient was seen by the physician. The outcome of the patient was unknown. It was reported that the therapy with GARDASIL was discontinued on an unspecified date. Additional information has been required.
RECEIVED ADDITIONAL VACCINE.  3/18/2021: RECEIVED MODERNA VACCINE (LOT5/4/#027A21A) @  CLINIC 4/15/2021: RECEIVED MODERNA VACCINE #2 (LOT# 027B21A) @ CLINIC 5/4/2021: RECEIVED JANSSEN (LOT#201A21A)
Cough, sore throat, bad head-ache (not bone-related), vision change, dizziness, but my concern is two weeks later, my left arm aches badly, is weak, hurts to move. Hurts from neck to elbow.
Severe nausea and Vomiting,  excessive  migraines that don't get better with any of my migraine medications or sleep, sleeping 14-18 hours a day, extreme muscle soreness, injection site pain, bleeding randomly from injection site, dark bruising at injection site, feeling dizzy and light headed upon any motion at all...even the slightest motion such as turning my head from one side of the pillow to the other.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (dose, expiration date and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Development of reactive arthritis. Swelling in joints, consistent moderate pain disrupting all daily activities and sleep. Redness, swelling is obvious in fingers, thumbs, and blanches when digits are extended.
TOTAL BODY ITCHING ON DAY ONE. TOOK 25 MG BENADRYL.  ON DAY 2, ITCHING AND REDNESS ONLY AROUND INJECTION SITE.
Patient presented to the pharmacy approx. 12 days after receiving PREVNAR 13 shot on 6/13/17, complaining of her arm being red and hot to the touch from the injection site to her elbow. She was advised to put ice on it and contact her PCP. Pt returned approximately 1 month later, still not having seen PCP. Her arm is still red but also has a rash all over injection site to elbow.
experiencing arm soreness; fever blister on the lip; fever blister was hard and painful; fever blister was hard and painful; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fever blister (prior to getting a different, earlier Shingles vaccine). Previously administered products included Shingles vaccine (received in 2004).   On 18th May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than a week after receiving Shingrix, the patient experienced fever blister, pain and induration. In 2018, the patient experienced pain in arm. The patient was treated with valaciclovir hydrochloride (Valtrex Cream) and valaciclovir (Valacyclovir). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the fever blister, pain and induration were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever blister, pain and induration to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR112021, US2022AMR112249   Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comments: The patient called and reported that he received vaccine in the left, upper arm.  The patient reported had experienced fever blisters prior to getting a different, earlier Shingles vaccine that only required one dose (caller was unsure of the name of earlier vaccine received) in what they believe was 2004.  The patient had not experienced anymore fever blisters in the years following the administration of the first, unknown Shingles vaccine until he received his first dose of Shingrix.  The patient reported experiencing a fever blister on the lip within a week of receiving first dose of Shingrix.  The fever blister was hard and painful.  The patient reported that he was using Valtex cream to treat the fever blister.  The patient was continuing to experience fever blisters, which were managed with a generic form a valacyclovir.  The patient experienced arm soreness after receipt of both doses of Shingrix. In 2018, less than 6 months after receiving Shingrix, the patient experienced pain in arm. The reporter consented to follow up. Additional Supportive Information: for tolerance of 2nd dose refer linked case US2022AMR112021.; Sender's Comments:  US-GSK-US2022AMR112021:Same case US-GSK-US2022AMR112249:Same patient, split case
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (got singles for four time). On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the two shingles shots last year (2020) and two weeks ago from reporting date he/she had shingles now again for fifth time, this time on his/her face near his/her eye. The doctor said it would be worse if he/she had not had shot and would be mild because he/she had the shots and patient stated so far it had been. The follow up would not possible as no contact information was available. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Dramatic swelling of lymph node under arm. This is very painful and still has not gone away; Dramatic swelling of lymph node under arm. This is very painful and still has not gone away; My arm was much more sore as well and my shoulder joint was painful too; My arm was much more sore as well and my shoulder joint was painful too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 11:30 (Lot number: FF4481) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Narcolepsy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypo thyroid" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: nitrile gloves" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing); "sjogrens" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM; FENOFIBRATE; LEVOTHYROXINE; OMEPRAZOLE; FLU VACCINE VII, start date: 15Sep2021, stop date: 15Sep2021. Past drug history included: Known allergies: prednisone, reaction(s): "Known allergies: prednisone"; Known allergies: ghb, reaction(s): "Known allergies: ghb"; Known allergies: demerol, reaction(s): "Known allergies: demerol"; Known allergies: morphine, reaction(s): "Known allergies: morphine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 15Mar2021, when the patient was 54 years old, for covid-19 immunization, reaction(s): "As with the first two doses I was exhausted for about three days."; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 05Apr2021, when the patient was 54 years old, for covid-19 immunization, reaction(s): "As with the first two doses I was exhausted for about three days.". The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 08Oct2021 23:30, outcome "recovering" and all described as "Dramatic swelling of lymph node under arm. This is very painful and still has not gone away"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 08Oct2021 23:30, outcome "recovering" and all described as "My arm was much more sore as well and my shoulder joint was painful too". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, pain in extremity, arthralgia. Additional information: No Covid prior vaccination. No Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
pt has bruised area where inj given below inj area;pt has red area 5in x 3in;pt state had hives yesterday;pt states better today;red area sl warm to touch;
A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that none of the six patients presented an adverse reaction after receiving expired FLUMIST Quadrivalent vaccine. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
Patient reports 2nd dose of Varicella vaccine given on 5/25/22 at 1430, states she went home and developed nausea and right arm redness and pain.  Reports nausea has continued.  Reports right arm injections site red, warm, painful, and minimal swelling.  Has taken OTC Motrin and Tylenol as needed for pain without relief.
4 years 2 month old female patient vaccinated with Adacel instead of Dtap vaccine with no reported adverse event; 4 years 2 month old female patient vaccinated with Adacel vaccine with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Physician and other healthcare professional via Medical Information (MI) (Reference number- 00828641).  This case involves a four year two month old female patient who inadvertently vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 ml third dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) (Frequency: once) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of ADACEL and DTAP) and inappropriate age at vaccine administration (with respect to use of ADACEL) (latency on same day).  It was reported "Caller reported that a patient inadvertently received a dose of Adacel (TDap) instead of DTap, as her last dose of the three-dose series. She requested guidance on how to proceed".   At the time of reporting, no adverse event was reported.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There will be no information available on the batch number for this case.
developed rashes on the chest area, not spreading; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), via an unspecified route of administration into the left deltoid on 18Dec2020 as the first single dose for covid-19 immunization.  Medical history was reported as none.  Concomitant medication included rosuvastatin calcium (CRESTOR).  The patient developed rashes on the chest area, not spreading on 22Dec2020.  The event as reported between not serious and medically significant by the reporter.  Details were as follows: and patient was a nurse  that had her vaccine through her workplace on 18Dec2020, so she was 10 days out, and noticed a rash on her chest on day 4, which was still present. It did not seem to be spreading, and she could not  think of any reason for the reaction. She was scheduled to receive the second dose in three weeks.  The outcome of developed rashes on the chest area, not spreading was not recovered. The relatedness of the event to the suspect drug was reported as unknown from the reporter.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of rash. 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.
A swollen, itchy, quarter-size erythema appeared seven days post vaccine about one inch lower than the injection site on the left arm. The lesion started growing the following day, reaching a maximum of about three inches in diameter by the third day after onset. The lesion cleared by day 10 after onset. Diphenhydramine 25mg was taken once the evening after onset.
I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I had a 100.5 fever for one day; nasal congestion; aches and pains; stomach cramps; acid reflux; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, as being a health care provider, a music therapist at a nursing home.  The patient medical history and concomitant medications were not reported.  The patient was tested positive for covid 19 on 19Jan2021 so she has been quarantining. In Jan2021 she had a 100.5 fever for one day, nasal congestion, aches and pains, stomach, acid reflux. The patient underwent lab tests and procedures which included body temperature: 100.5 fever, Sars-cov-2 test: positive on 19Jan2021. On 25Jan2021 was the best she has felt, where she was getting my energy back.  As of 25Jan2021, her symptoms have been diminishing. She was told that if feeling better she could go and get retested on 29Jan2021, at urgent care. The outcome of was tested positive for covid 19 was unknown, of ad a 100.5 fever, nasal congestion, stomach cramps and acid reflux was recovering.  Patient queried if she should still get second dose after testing positive after the first dose. She was scheduled for the second dose on 03Feb2021.    Information on the lot/batch number has been requested.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/26/2023 HTN (HYPERTENSION)
bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (bronchitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced BRONCHITIS (bronchitis). The patient was treated with AMOXICILLIN ongoing from February 2021 for Bronchitis, at an unspecified dose and frequency. At the time of the report, BRONCHITIS (bronchitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided by the reporter  It was reported that on 11Feb2021 have the appointment for the second shot of moderna covid-19 vaccine. Patient asked if she can get the vaccine with this antibiotic, if the antibiotic will make any difference. Patient asked if she can postpone the date and administer it a week later.
This spontaneous case reported by a consumer, describes the occurrence of device connection issue (small amount leaked out of the injection site), off-label use (needed an additional shot in the same sitting) and incorrect dose administered (possible over dose/some of the first leaked out) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 25, 2021, patient experienced a device connection issue (small amount leaked out of the injection site), off-label use (needed an additional shot in the same sitting) and incorrect dose administered (possible over dose/some of the first leaked out). At the time of the report, device connection issue (small amount leaked out of the injection site), off-label use (needed an additional shot in the same sitting) and incorrect dose administered (possible over dose/some of the first leaked out) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. No concomitant medication or treatment information reported.
Fever 101F after Second Shot; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101F after Second Shot), CHILLS (Chills) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, ESTRADIOL (ESTRACE), TACROLIMUS, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMINS NOS (MULTIPLE VITAMIN) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever 101F after Second Shot), CHILLS (Chills) and NAUSEA (Nausea). On 02-Apr-2021, PYREXIA (Fever 101F after Second Shot), CHILLS (Chills) and NAUSEA (Nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101 (High) 101 Fahrenheit.         Treatment information, if any, was not provided by the reporter.   This case was linked to MOD-2021-037370 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional information included patient demographics (race, height, ethnic group, weight), medical historyand concomitant medications.; Sender's Comments:  MOD-2021-037370:1st dose