chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to a 62 years old female patient with allergy to amoxicillin and none medical history. The patient was vaccinated subcutaneously with a 0.6 ml dose of ZOSTAVAX lot # (671611/1161AA), on 02-MAR-2012. The nurse reported that the patient had a rash and blister for a couple of days in 2012 (exactly onset date not provided). The patient was diagnosed with shingles. The patient sought unspecified medical attention via clinic visiting and received unspecified antiviral for adverse event treatment. None lab diagnostic tests were performed. At the time of the report the patient's state was not recovered. Additional information has been requested. PQC has been involved.
This spontaneous report as received from a pharmacist refers to unspecified number of unknown patients. On an unknown dates on or after 09-AUG-2017, patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number and expiration date not reported) for prophylaxis which were stored in the range of 78 Fahrenheit degrees to 79 Fahrenheit degrees for 120 hours. No previous temperature excursion was reported. No adverse effects were reported. It was unknown by reporter if a digital data logger was involved.
11/27 - talked to mother getting better w/ice and ibuprofen 400 mg.
Pt. seen 8/21/07 for physical, given vaccines. Noted (R) arm pain, swelling, redness the next afternoon. Pt seen for reaction 8/24/07- (R) arm with redness, edema, warmth and tenderness. Pt. treated with Keflex x 7D
Patient in observation approximately 20 minutes after receiving the 1st dose of Pfizer presents with c/o chest tightness and dry cough. Patient has a history of anaphylaxis to multiple causes and was advised to stay in observation for 45 minutes. Patient was given oral fluids and evaluated by EMS. Patient requested to be transported to Hospital. Patient was alert and oriented x 4, denies difficulty breathing, shortness of breath, wheezing. Clear Lung sounds. Patient was started on Duo nebulizer at 09:05AM and transported to RGH 09:08AM. Initial Vitals (08:53AM): 130/88, HR 118, O2 Sat 93%, RR 20; Discharge Vitals (09:08AM): 127/83 HR 111 O2 Sat 100% RR 20.
Within first 24 hours, I experienced headache and fatigue.  Then a red rash somewhat like hives appeared on my chest, stomach and on my legs.  I visited the dermatologist and was prescribed a steroid cream.  The rash was less irritating but did not go away for about 6Months.
pain swelling at injection site; pain swelling at injection site; fatigue; myalgia; headache; shivering; fever; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain swelling at injection site), injection site swelling (Verbatim: pain swelling at injection site), fatigue (Verbatim: fatigue), myalgia (Verbatim: myalgia), headache (Verbatim: headache), shivering (Verbatim: shivering) and fever (Verbatim: fever). The outcome of the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever were resolved (duration 36 hrs).   It was unknown if the reporter considered the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, fatigue, myalgia, headache, shivering and fever to be related to Shingrix.   Additional Information: GSK receipt date: 31-JUL-2023 The patient self reported that pain and swelling at injection site, fatigue, myalgia, headache, shivering and fever post 2nd dose of Shingrix. The reporter did not consent to follow-up.
She began experiencing hot flashes about every two hours; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (She began experiencing hot flashes about every two hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (She began experiencing hot flashes about every two hours). The patient was treated with AMBEREN for Hot flashes, at a dose of 1 dosage form once a day. At the time of the report, HOT FLUSH (She began experiencing hot flashes about every two hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was stated that, beginning July or August 2021 she started experiencing hot flashes. She further stated that she had not had a hot flash in years.
Immediately after I received the shot, I felt a lot of pain in my left arm, more than any other vaccine. The next day, I could hardly move or lift my arm at all. By Monday July 4, I noticed my entire upper left arm was red and warm to the touch. I visited the doctor on Tuesday (since Monday was a holiday). I was diagnosed with cellulitis in my left arm and prescribed a course of antibiotics and antihistamines.
Pneumonia; flu like symptoms; Night Sweats; Malaise/fatigue; occasional cough or two; Malaise/ fatigue; intermittent Chills; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NIGHT SWEATS (Night Sweats), MALAISE (Malaise/fatigue), COUGH (occasional cough or two), FATIGUE (Malaise/ fatigue) and CHILLS (intermittent Chills). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), INFLUENZA LIKE ILLNESS (flu like symptoms), NIGHT SWEATS (Night Sweats), MALAISE (Malaise/fatigue), COUGH (occasional cough or two), FATIGUE (Malaise/ fatigue) and CHILLS (intermittent Chills) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  As per report in the month March 2021 patient started experiencing flu like symptoms and On the 06May2021 and currently he is feeling the same flu like symptoms.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Added new event added. This case is upgraded as serious as event pneumonia is added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
At 2:00AM on 1/25 I had my CPap on and could not breathe very well because my nasal passage was blocked. On that morning  I called my PCP and was advised to come in at 10:00AM. Was given a physical and was prescribed prednisone. After 7 days called my PCP back and was prescribed a Z-pak. It mostly worked and it felt like something remained in my nasal passage. I also used a new neti-pot and it cleared the remaining blockage and right now I feel I am clear.
Information has been received from a registered nurse concerning a 21 year old female with pertinent medical history reported as none and allergic reaction to some antibiotics who on 06-SEP-2006 was vaccinated with the first dose of Gardasil. Concomitant medication was reported as none. On approximately 06-SEP-2006, the patient developed injection site pain that lasted 3 days following vaccination with Gardasil. On an unspecified date, the patient sought unspecified medical attention. On approximately 08-SEP-2006, the patient recovered from injection site pain. The patient had not received her second dose of Gardasil. Additional information has been requested.
Vaccine received at 3:19 PM. Pt reports "my throat feels like it is closing up" and c/o dizziness. at 3:38. Pt tearful, but able to speak in complete sentences without dyspnea. BP 104/72, hr 120, O2 sat 95-96% RA, RR28.  Minor edema to throat visible. No wheezing or stridor noted. 50 mg Benadryl and 0.3 mg Epinephrine administered IM at 3:42.  Pt  verbalized relief.  O2 sat 99-100%, RR 22, BP 110/70, hr 84. Pt refused EMS. Pt  monitored for 45 minutes and released  with her friend driving her to the ER
Hypertension, headache (squeezing to throbbing), lightheadedness, extremity shaking
Initial unsolicited report received from pharmacist on 30-Jul-2018. This case involves a 55-year-old female patient who was vaccinated with fourth dose (expired) of IMOVAX RABIES (expiration date: 24 Jul 2018, batch number, dose and site of administration was not reported) via intramuscular route on 30-Jul-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired drug administered. It was unknown if patient had any adverse event. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Looked like an allergic reaction; localized swelling, redness, at the injection site; localized swelling, redness, at the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: DR0570, Expiration Date: 28Feb2023) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "recovered", described as "Looked like an allergic reaction"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "localized swelling, redness, at the injection site". Therapeutic measures were taken as a result of hypersensitivity, vaccination site swelling, vaccination site erythema.   Additional information: The pharmacist reported that there were 2 patients (Age and Genders not available to Caller) who had "very similar adverse reactions" to pneumococcal 13-val conj vac (dipht crm197 protein). The pharmacist stated it "looked like an allergic reaction", both patients had "localized swelling, redness, at the injection site". Both patients cleared up with cream and hydrocortisone. The pharmacist expressed concern since this came from the same lot number. Since both patients had the same localized reaction "redness, swelling, and pain as well" from the same lot number, the pharmacist asked if there are any other type of report from this lot number of similar issues or the adverse reaction rate per lot number.  No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100956498 Same Reporter/Drug/AE, Different Patient
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 26-FEB-2014 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JUN-2016 the patient was treated a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient has been prescribed famciclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
severe allergic reaction; swelling of her joints specifically on the right middle finger around the knuckle area; thrombosis; swelling of her joints specifically on the right middle finger around the knuckle area; swelling of her joints specifically on the right middle finger around the knuckle area/extreme pain in that area and was sore for weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 18Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "blood coagulation issues" (unspecified if ongoing); "borderline type 2 diabetes," (unspecified if ongoing); "weight gain due to pregnancy" (unspecified if ongoing); "miscarriages" (unspecified if ongoing); "weight gain due to pregnancy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset Oct2021, outcome "unknown", described as "thrombosis"; JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Oct2021, outcome "unknown" and all described as "swelling of her joints specifically on the right middle finger around the knuckle area"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "swelling of her joints specifically on the right middle finger around the knuckle area/extreme pain in that area and was sore for weeks"; HYPERSENSITIVITY (non-serious) with onset 18Oct2021, outcome "unknown", described as "severe allergic reaction".  Clinical course: The Consumer wanted to know what to do as the pharmacist refused to administer the second dose of the Pfizer BioNTech Covid-19 Vaccine due to the severe allergic reaction she experienced a few minutes to 1 hour after she got the first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7 days after first shot, left arm had a rash, was hot and swollen.   Rash lasted 3 days.
Tachycardia, dizziness, weakness within 5 minutes of receiving injection.  Moderate tinnitus several weeks following injection.
Narrative: Pt is a 77y.o. male who died on 02/16/2021 w/ h/o prostate cancer, glaucoma, lung cancer. Pt received Moderna Covid-19 Vaccination 2/2 on 02/09/2021. Pt died on 02/16/2021 w/ wife stating unsure if passed out or fell going to mailbox, EMS was called however unable to resuscitate. Pt announced DOA at HOSPITAL. Unlikely that Moderna Covid-19 caused/contributed to pt death.
Cough      "for a while" ? Anorexia     loss of appetite x1 week          This is a 83y.o. male with significant past medical history of HTN, CKD, multiple myeloma, prostate cancer, and severe MR that presented to the hospital with chief complaint of malaise. For the past week the patient endorses complaints of generalized weakness, fatigue, cough, and loss of appetite. He denies any fever, chills, headache, lightheadedness, dizziness, chest pain, palpitations, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, constipation, or urinary symptoms. He did previously receive the Moderna vaccine in February and March 2021.    In the ED, patient borderline hypertensive, afebrile, stable SPO2 on room air. COVID confirmed on NP swab. Significant labs: Cr 2.38, troponin 0.08. CXR concerning for pneumonia. He has been admitted for further evaluation and management with ID consultation.    Patient seen and examined only by the attending physician; NP only responsible for chart review given the patient's COVID positive status.
Presented with chest pain that was determined to NOT be related to ACS. Myocarditis (no troponin) and pericarditis (no EKG changes, no effusion, no friction rub) remained in the differential with costochondritis.   Her symptoms resolved with NSAID and colchicine and was sent home after a three day hospitalization.
Client began to feel dizzy and lightheaded. She also complained of nausea. Nurse observed client appeared pale. Nurse took pt's vitals over the next 18minutes and they remained stable. After about 18min client stated she was feeling better and was released to personal vehicle shortly after that.
He developed slight rash underneath injection site 1-2 weeks after receiving vaccine/ Rash went away in 1-2 weeks; He also developed stiffness in left finger joints that started 1-2 weeks after receiving 1st dose/ The stiffness in his left hand's fingers is still there; He is electing not to receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He developed slight rash underneath injection site 1-2 weeks after receiving vaccine/ Rash went away in 1-2 weeks), MUSCULOSKELETAL STIFFNESS (He also developed stiffness in left finger joints that started 1-2 weeks after receiving 1st dose/ The stiffness in his left hand's fingers is still there) and PRODUCT DOSE OMISSION ISSUE (He is electing not to receive 2nd dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 10-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He is electing not to receive 2nd dose). On an unknown date, the patient experienced RASH (He developed slight rash underneath injection site 1-2 weeks after receiving vaccine/ Rash went away in 1-2 weeks) and MUSCULOSKELETAL STIFFNESS (He also developed stiffness in left finger joints that started 1-2 weeks after receiving 1st dose/ The stiffness in his left hand's fingers is still there). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, RASH (He developed slight rash underneath injection site 1-2 weeks after receiving vaccine/ Rash went away in 1-2 weeks) had resolved and MUSCULOSKELETAL STIFFNESS (He also developed stiffness in left finger joints that started 1-2 weeks after receiving 1st dose/ The stiffness in his left hand's fingers is still there) and PRODUCT DOSE OMISSION ISSUE (He is electing not to receive 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Gave AFLURIA first in one arm, followed by ZOSTAVAX in other. Immediately upon finishing admin for shingles, Pt reported sharp, stinging, metallic taste and to be watching the room spin. Then a severe headache set in. For next 3 days severe headache, body ache, fever and chills. Unable to eat  d/t rash, stinging and metallic taste in mouth. Started Prednisone pack - helped resolve but exhausted.
This was my Moderna booster shot.  Slight fever of 99.4 for two days and a rash below injection site for one week.  The fever and rash were less severe than my first two Moderna vaccines.
Body aches, cold and hot chills, high fever of 101, fatigue, vomiting
No adverse event; Temperature excursion occurred on 29Nov2022.; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. A total of 16 doses were administered in 6 days. 5 doses on 29-Nov-2022, 4 doses on 30-Nov-2022, 2 doses on 01-Dec-2022, 2 doses on 02-Dec-2022, 1 dose on 03-Dec-2022 and 2 doses on 05-Dec-2022. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-687690, US-MODERNATX, INC.-MOD-2022-687786, US-MODERNATX, INC.-MOD-2022-687785, US-MODERNATX, INC.-MOD-2022-687787 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687690:Original Case : MOD-2022-687690 US-MODERNATX, INC.-MOD-2022-687786: US-MODERNATX, INC.-MOD-2022-687785: US-MODERNATX, INC.-MOD-2022-687787:
PATIENT SAID HE FELT LIKE FAINTING SENSATION FOR A FEW SECONDS AND TINGLING SENSATION IN HIS ARM FOR A FEW SECONDS. HE SAID HE  WAS FINE AFTER THOSE FEW SECONDS.