chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced fatigue. The patient had taken Advil for treatment of fatigue. The reporter did not  provided the information about date of birth, full mailing address and additional question in regards to filling a symptomatic AE (such as lot number, expiration date, dose, route of administration. date of administration, formulation, outcome, etc.). The reporter refused when asked for consent to follow-up with his healthcare provider. The reporter did not consented to follow up.
Headache, Sedation, Myalgia, Chills Narrative:  Other Relevant History:
Heart palpitations,  bubble in chest, indigestion & chest pains, low & high pulse.  Low blood pressure
left side tingly, sorenes on left side, rib cage very sore, when breathing lungs hurted (sore) mild headache, and left eye,cheek,lip swollen and very very sleepy could not open my eyes felt a little spacey.. sore body the third day.
5SEP97 in the afternoon, mom noticed rash on both thighs 9SEP97;rash on both thighs disappeared rt p/the mom reported the incident;parents will check w/MD prior to next immun;
This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a adult patient who received RABAVERT. Co-suspect products included RABAVERT and RABAVERT. On an unknown date, the patient received the 1st dose of RABAVERT, the 2nd dose of RABAVERT and the 3rd dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, RABAVERT and RABAVERT, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to RABAVERT, RABAVERT and RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that an employee who received the pre exposure series of RABAVERT had a low titer, and at the reporting time they would like to have information on how to proceed with this employee. The health care professional stated that this employee was in a position where they are continuously at risk for exposure to rabies. The health care professional had no information on when the employee had the series or when the titer was drawn in relation, nor any information about this specific employee. No further information was provided.
I remember my exposure being on 01/12/2023. I began having severe body aches and pains as the onset of the first case. I also had exhaustion and no fever. My first COVID-19 test was on 01/16/2023 and that came back negative. I tested again and was positive for COVID-19 on 01/17/2023. I began taking PAXLOVID on the Monday 01/17/2023. After 48-52 hours, the symptoms declined to bare minimum. I live in a senior conjugate living facility. I was asked to quarantine for 10 days and had no symptoms but just stayed out of the way from everyone. I was out of quarantine on 01/26/2023 and started having symptoms again on 01/28/2023 and tested positive again on 01/28/2023. The rules lightened up a little bit and I had 7 days quarantine. I took PAXLOVID again. The symptoms were entirely different. I had exhaustion, sore throat, and a really bad cold and upper respiratory congestion. I was still testing positive on 01/31/2023 and finished my last dose again on 02/01/2023. I would say that I am experiencing long COVID-19. I'm currently in PT for continued muscle aches and pain, and exhaustion.
PCV 20 vaccine given on 7/11/22 subQ instead of IM. Pt experienced vaccine site reaction per patient phone call report on 7/12/22 with erythema, fatigue, mild itching to affected area, pain that started at R triceps area then slowly spread to R bicep and R elbow, swelling, and fever. Pt was evaluated by Dr. in-person on 7/15/22  and pt had some redness, tenderness, warmth, R bicep/tricep/elbow pain, and palpable area of induration approximately 4 cm x 5 cm on underside of right upper arm with no fever. Pt prescribed prednisone x 5 days. Pt returned to clinic on 7/19/22 for follow up and erythema resolved, swelling improved, and presented with approximately 1 in. diameter area of mild induration on underside of right upper arm near triceps with minimal tenderness and no fever present.
This spontaneous report was received from a Licensed Practical Nurse, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 22-APR-2016, the patient was vaccinated with a improperly stored dose of VAQTA (which had the lot number reported as L033316, with expiration date of 26-MAY-2016) (strength, dose and anatomical site were not reported). The patient's concomitant medication was not provided. Additionally, no adverse effects were reported. The vaccine experienced temperature of 50F, time frame 2 hours and 30 minutes, there had been no previous temperature excursions. Furthermore, no product quality complaint was involved. Additional information has been requested.
cough; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 47 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 18Feb2021, when the patient was 46 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 28Jan2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: COUGH (non-serious) with onset 22Feb2022, outcome "unknown", described as "cough". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cough. Additional Information: Prior vaccination within 4 weeks was reported as unknown. Prior to vaccination, it was unknown the patient was diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
red, itchy, hard, warm rash at injection site.  Painful to touch.  Rash appeared 8 days after injection.  Symptoms improved by day 9.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial did not undergo any temperature excursions.  No relevant concomitant medications were reported.  No treatment information was provided.
Dose 2 of Pfizer COVID-19 vaccine administered at 1344 into left deltoid. Client was in post-vaccination room when at 1357 she started complaining of chest and throat tightness and difficulty swallowing. EMS was called at 1400 and 0.5 mL 1:1000 epinephrine was administered at 1402. Client stated that her shortness of breath was worsening, but breath sounds were clear bilaterally at this time. EMS arrived at 1406 and transported client to hospital.
Pt reports feeling nausea and dizziness after vaccination, exercised with trainer at gym for a short time, unable to complete workout as she felt nauseated & dizzy. Started having cold chills, husband took pt to ER, had convulsions (?seizures), tachycardia, fever of 101. Treated in ER and released same day.
Moderna COVID 19 vaccine EUA. Vaccine administered to 17 year old, when only labeled for 18+.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-OCT-2013, the patient may had received a partial dose of ZOSTAVAX that was administered intramuscularly (dose, and indication were not reported). The pharmacist stated that he realized he was administering ZOSTAVAX incorrectly and withdrew the needle from the patient's arm. The reporter did not think any of the ZOSTAVAX was administered, but he was not sure. The reporter stated that he re-prepared ZOSTAVAX and administered it subcutaneously. No adverse symptoms reported. Additional information has been requested.
RA flare; COVID; COVID; Sick Last Year with Pneumonia; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non-HCP), Program ID:  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (ongoing); "arthritis pain" (ongoing). Concomitant medication(s) included: XELJANZ XR oral taken for rheumatoid arthritis, start date: Jul2021 (ongoing); VOLTAREN [DICLOFENAC SODIUM] taken for arthritis; ADVIL [IBUPROFEN]; FOLIC ACID; METHOTREXATE. Past drug history included: Penicillin vk, reaction(s): "allergy", notes: 500 mg tablet; Hydroxychloroquine sulfate, reaction(s): "allergy". The following information was reported: PNEUMONIA (medically significant) with onset Apr2022, outcome "recovered", described as "Sick Last Year with Pneumonia"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "COVID"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA flare". The patient underwent the following laboratory tests and procedures: Pain assessment: 5.  Clinical course: Patient had Covid Oct2022. Patient Stated that prescriber was aware and  she did not take Xeljanz Xr For 3.5 weeks. Resolved. No Additional Details Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded. The event "RA flare" is not considered related to the suspect vaccine BNT162B2 but more likely related to aggravation of the underlying medical condition of ongoing "Rheumatoid Arthritis". The other event "Sick Last Year with Pneumonia" is more likely a coincidental event so that is not likely considered related to the suspect product. 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. This case will be reassessed once additional information is available.
in 2019, a patient was given MENACTRA doses one month apart instead of 5 years apart, , no AE; Initial information received on 29-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographics) who received doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] one month apart instead of 5 years apart, (Inappropriate schedule of product administration).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date (in 2019), the patient received a doses of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was case of actual medication error case due to drug dose administration interval too short (inappropriate schedule of product administration).  It was also reported that Caller has questions because she discovered today that in 2019, a patient was given MENACTRA doses one month apart instead of 5 years apart. Caller had other questions regarding this incorrect dosing but the call was disconnected before transfer was completed.  At the time of report, 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 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.  There will be no information available on the batch number for this case.
Patient reported: i received a FLU shot from store employee at my job they came out every year and i am not the only one who stated this lady had hurt us to give that vaccination and i just got in from my doctors appointment and i was told that i have encapsulation adhesive basically there is something wrong and i have to take physical therapy this shot has left my arm hurting for 4weeks and i am unable to take off my own shirt and it has effected my job performance as well because i work inventory i have to lift boxes and i have to ask for help it was not my fault that this lady inject me the wrong way and i need physical therapy and is going to be expensive and i work for employer where we make  products to drink if that could help with finding out who came to my employment to give the Flu shot
bad cold; upper respiratory infection; rhinitis; nose was severely congested; greenish phlegm; Initial information was received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 72 years old male patient who experienced bad cold, upper respiratory infection, rhinitis, nose was severely congested and greenish phlegm after receiving 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.   On 30-Sep-2023, the patient received a 0.5 ml, total dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot number, expiry date, strength, was unknown) via intramuscular route in unknown administration site for Immunization. The information on the batch number was requested.  On 07-Oct-2023 the patient had bad cold (nasopharyngitis), upper respiratory infection (upper respiratory tract infection) (Latency: 7 days)following the administration of influenza quadrival A-B high dose HV vaccine. On an unknown date in oct-2023  the patient had  rhinitis, nose was severely congested (nasal congestion) and greenish phlegm (sputum discoloured) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  It was reported"Patient called to report that he experienced a bad cold and upper respiratory infection 7 days after receiving FLUZONE HIGH DOSE QUADRIVALENT on September 30, 2023. He also inquired whether the vaccine contains inactivated flu strains, as his son suggested confirming this because they suspect it might be the reason for the flu-like symptoms he experienced if the vaccine contained an activated virus. He mentioned having greenish phlegm, a bad cold, and rhinitis but did not experience a fever. He stated that he was prescribed Doxycycline 100mg, to be taken 2 times a day for 10 days, for his upper respiratory infection and is still taking it up until now. He mentioned that his nose was severely congested during the first 2 days of treatment but has since reduced to 80-90% congestion due to the antibiotic. He also stated that he is still experiencing the symptoms but they have largely reduced."  Action taken: not applicable.  The patient was treated with doxycycline for event upper respiratory tract infection ,nasal congestion and was not known if corrective treatment was received or not for other events.  At time of reporting, the outcome was Recovering / Resolving for all the events.
12/14/22 presents to EC ED for "fever, cough, SOB". PMHx of "severe non-CF bronchiectasis with secondary severe COPD s/p bilateral lobectomy."
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71468) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 12:59 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 12:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any of these patients.  The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.
Information has been received from a female consumer who in November 1999 "10 years ago", was vaccinated with the first dose of PNEUMOVAX 23. On 07-NOV-2009 the patient received her second dose of PNEUMOVAX 23. The patient reported that she developed redness at the injection site of the left upper arm the day after receiving her second dose. The redness resolved on 10-NOV-2009 without requiring medical treatment. No laboratory diagnostics studies were preformed. The patient did not seek medical attention. Additional information has been requested.
A father alleges that his son received a dose of Rota Shield on 6/25/99 and subsequently developed an infection. He was hospitalized where the child died on 6/30/99. The father alleges that his don died as a result of the infection. No further information was available at the date of this report. Death Certificate received on 12/19/2002 indicates respiratory failure and group B strep sepsis as the cause of death.
Area is tender , but not painful; at the site of the injection, there is an approximate 3" circular red rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash) and VACCINATION SITE PAIN (Area is tender , but not painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (Area is tender , but not painful). At the time of the report, VACCINATION SITE RASH (at the site of the injection, there is an approximate 3" circular red rash) and VACCINATION SITE PAIN (Area is tender , but not painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were unknown. It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The health care professional reported that, the patient experienced sore arm after both doses of Shingrix vaccine. Soreness seemed to be more pronounced after 2nd dose. The patient also complained of chills. These symptoms were lasted for a few days. This case was linked with case US2018156102, reported by the same reporter for the same patient.
24 hours after shot,Body aches. & headache day of. After shot face swelling sore cheeks like I was have an allergic reaction. Sleepiness