chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse concerning two unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. The nurse reported that the patients received the 1st and 2nd doses of the GARDASIL (dose, frequency, route, lot # were not provided) on an unspecified dates. No concomitant therapies were reported. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Pt seen for 2 month well check on 2/5/13. Given 2 month vaccines: DTap-Hep B- IPV, Hib, PCV, Rotavirus. That night pt started having a faint rash which became generalized. Pt was seen again 3 days after vaccines in office. Found to have generalized confluent, blanching rash; Pt otherwise at baseline & afebrile. Given prednisone (15/5) 1.7ml PO BID x 3 days.
Pt received 2nd moderna dose on 3/12/21, only 3 weeks after first dose, administered 2/19/21, instead of 4 weeks as per EUA/CDC guidelines
Allergic reaction on arm.   Initially arm not very painful, but a couple days after injection arm seemed to be getting worse - swelling, redness spreading in a rectangular shape, white around edges, and slightly itchy.   After telehealth visit with immunologist on 2/8/21 I began steroid cream, and it is getting better.   As of 2/13/21 still large red area but more pink now, practically no swelling, pain or itching.
Has to make a conscious effort to open hands; joint pain- stiffness; joint pain especially in hands and knees but all joints / joints very painful; pain at shoulder; Fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASTICITY (Has to make a conscious effort to open hands) and JOINT STIFFNESS (joint pain- stiffness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MUSCLE SPASTICITY (Has to make a conscious effort to open hands) (seriousness criterion medically significant), JOINT STIFFNESS (joint pain- stiffness) (seriousness criterion medically significant), ARTHRALGIA (joint pain especially in hands and knees but all joints / joints very painful), ARTHRALGIA (pain at shoulder), FATIGUE (Fatigue) and MYALGIA (muscle aches). On 22-Mar-2021, ARTHRALGIA (pain at shoulder) had resolved. At the time of the report, MUSCLE SPASTICITY (Has to make a conscious effort to open hands), JOINT STIFFNESS (joint pain- stiffness), ARTHRALGIA (joint pain especially in hands and knees but all joints / joints very painful), FATIGUE (Fatigue) and MYALGIA (muscle aches) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant medications were not reported.  Treatment was reported as ibuprofen 2-3 tablets per day.
Received Pfizer Covid Vaccine - Had fever of 102 and flu like symptoms. Took Tylenol and temp resolved to 99.
patient signed up online for an appointment to get covid vaccine. the patient received Pfizer COVID vaccine from another healthcare provider on 3/10/2021.  Our system did state 1st dose appointments but the patient knowingly signed to get 2nd dose.  The nurse who was administering the vaccine at our locations did not verify the card that the patient had given her. on the card it dose state that the 1st dose was Pfizer.  We only give Moderna vaccine at our facility and the patient did not verify what type of vaccine we are giving.
PT states that she went home after receiving the vaccines to take a nap.  At "some point" several hours later she woke up dizzy and fell down then vomited.  She did not seek medical attention stating that she felt better the next day.  Will speak with dr before administering second dose of shingrix.
Severe nausea, vomiting and diarrhea lasting for 1 day and then again 1 week later, lasting for 1 day.
redness size of fifty cents piece, long pinkish color; swelling around inject site size of an egg; no fever; not feeling well; listless c/o back hurting; sx w/in 24 hrs of inject; given APAP;
Within 24 hours of immunization, veteran developed strong muscle spasms in neck and shoulders.  04/09/2007 MR received for ER visit of 11/19/2006 for c/o SOB, subjective fever and sweats.  Txd with antibiotics and Tylenol. PE: unremarkable. Temp. 102.2. DX:  Pneumonia-acute.  Dyspnea-acute. Spoke with reporter.  Pt. did not seek outside treatment for AE.  Just mentioned AE symptoms to reporter on homecare visit for other issues.
Started period 2 weeks early; Started period 2 weeks early, very heavy bleeding; Bad cramping; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 at 09:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 09:00, the patient started period 2 weeks early, very heavy bleeding, bad cramping and very unusual. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started period 2 weeks early, very heavy bleeding, bad cramping was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I fainted about 5 minutes after the injection. When I awoke, my fingers tingled, I was hot, and my breathing was labored.
Myalgia, SkinRash, Tachycardia, fatigue Narrative: elevated heart rate for 1 day; soreness at injection site for 4 days; fatigue for 2 days; rash on 7th day.
Muscle aches, headache that last for 3 days, chills and hot flashes throughout day that last three days. nausea
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:53 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 70.82 years.  No concomitant product use was reported.  It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 2, on 17-Feb-2021, Excursion Temp at 8 AM: 20, 9 AM: 22, 10 AM: 37, 11 AM: 41, 12 PM: 42, 1 PM: 39, 2 PM: 40, 3 PM: 42, 4 PM: 41.  On 17-Feb-2021, excursion time at 09 am temperature was 22, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vial was moved to clinic. Vaccine BUD date was 13-Mar-2021.  Vials only punctured right before administration.  Temperature recordings were taken at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Received Vaccine at 2:30pm on 2/19. I felt fine that night and went to bed as usual. When waking the next morning, I had arm soreness, and whole body muscle aches. These lasted throughout the day. I went to bed that night and woke up fine the next day. I did not take Tylenol or other medications during this time.
It was reported in a published article, that a 2-month-old female infant was vaccinated with a first dose of hepatitis B (manufacturer unknown). Suspect vaccination included a first dose of included hib (manufacturer unknown). Other concomitant vaccinations included a first dose of diphtheria toxoid and pertussis (unspecified) and tetanus toxoid. Subsequently, the patient developed bullous pemphigoid after vaccination. The patient developed bullous lesions on the palms and soles, which appeared one week after receiving the vaccinations. The patient was treated with sulphated water, dexamethasone (manufacturer unknown), and fusidic acid, and the lesions disappeared. One month later, she presented with a new, more generalized outbreak after the second dose of the same vaccines. The skin eruption completely subsided three months after treatment with deflazacort (1 mg/kg/day) was initiated. After five years of follow-up, the patient has not presented with lesions again, despite having received the rest of the vaccines on the official schedule. It has been determined that case 0605USA05337 is a duplicate of case 0507USA03414. Therefore, case 0605USA05337 is being deleted from our files and the cases consolidated into case 0507USA03414. The following information was consolidated from case 0605USA05337 into case 050703414: in case 0605USA05337, received from business partner Sanofi Pasteur, the second outbreak bullous pemphigoid was considered to be medically significant by the reporter. TETRACOQ was also a suspected medication, as well as PEDVAXHIB. The more generalized outbreak occurred three days after administration of the suspect drugs. Furthermore, this outbreak was reported to improve, but disappeared in 15 days after treatment with deflazacort (1 mg/kg/day), however, the patient had a little outbreak when the corticoids dose were decreased. Therefore, treatment with oral corticoids (0.3-1 mg/kg/day) was continued for 3 months. Additional information is not expected.
Her nose was running like a waterfall; Chills; knees and legs ached; Headache; Sinus pain; didn't feel very good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6205, Expiration Date: 01Jun2021) at the age of 70 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia;diagnosed twenty to twenty five years ago; "Diabetes mellitus" (ongoing), notes: Verbatim: Diabetes; diagnosis for at least 8 to 10 years; "blood pressure high" (ongoing), notes: Verbatim: high blood pressure; "Arthritis" (ongoing), notes: Verbatim: Arthritis;they call it inflammatory arthritis; "Irritable bowel syndrome" (ongoing), notes: Verbatim: Irritable bowel syndrome; "water pill" (unspecified if ongoing); "blood sugar" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for blood glucose abnormal (ongoing); ATENOLOL taken for blood pressure abnormal (ongoing); HYDROCHLOROTHIAZIDE taken for polyuria (ongoing). Vaccination history included: Bnt162b2, administration date: 04Mar2021, when the patient was 70 years old, for covid-19 immunisation; Shingles vaccine, reaction(s): "pustules". The following information was reported: RHINORRHOEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Her nose was running like a waterfall"; CHILLS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "unknown", described as "knees and legs ached"; HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Headache"; SINUS PAIN (non-serious) with onset 13Mar2021, outcome "unknown", described as "Sinus pain"; MALAISE (non-serious) with onset 13Mar2021, outcome "unknown", described as "didn't feel very good".  Additional information: Patient was on a diet. Her weight is approximately 240 pounds. She gained the COVID fifty pounds. They say from quarantine you gain 15 pounds, but that is not true it is 50 pounds. On Saturday evening, 13Mar2021. It is not nearly as bad now and she was able to exercise. She does not feel bad. Patient did get these pox marks on her face after she got the vaccine that is something related to chicken pox. Caller clarified that she got pustules after getting the Shingles vaccine. That was seven years ago, and she does not have the lot number.   No follow-up attempts are possible. No further information is expected.
SkinRash, UrticariaPruritus & NauseaVomiting Narrative:
Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Manufacturer Expiration date 02/12/23 and one dose was administered on 2/13/23.).    No concomitant medications were reported.  It was reported that Moderna vaccine was placed in fridge on 19-Jan-2023. The vaccine has not experienced any temperature excursions.   No treatment medications were reported.
Patient received the SHINGRIX vaccine and was advised to wait in the store for 20 minutes to make sure she didn't have a reaction. She was okay about 15 minutes but then stated she was getting lightheaded/dizzy. She sat down for a few more minutes and became flushed. She then stated her throat felt like it was getting tight. Patient had her own EPIPEN with her and administered it to herself. Pharmacy called 911 and the paramedics arrived and took her to the ER. They did not give her another dose of EPIPEN but may have given her BENADRYL.
3 patients under 65 years of age accidently received Fluzone High Dose/no AE; 3 patients under 65 years of age accidently received Fluzone High Dose/no AE; Initial information received on 11-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 3 patients under 65 years of age accidently received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patients received a doses of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  It was of actual medication error due to Inappropriate age at vaccine administration and overdose accidental..  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-OCT-2007, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications.  In or about 19-OCT-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.  The outcome of the events was unknown.  Causality assessment was related.  Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 72 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Chills, fever, deep (R) upper arm pain. Tender and enlarged lymph nodes. Approx. 7.6 cm x 8 cm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Dec2020 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 02Nov2023 to 06Nov2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug to the reported drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300367333 Same reporter/patient, different drug, different event.;
About a day after the shot my arm was sore and red and a bit swollen but about three days later I began to develop a rash on that arm which proceeded to spread across my chest to my other arm and all the way down my body. I went to my PCP who sent me to a dermatologist. The dermatologist didn't know what it was but he prescribed a cream which didn't really help. I went to another dermatologist after that who thought it may be an obscure virus that has been dormant in my system until now. She advised that I watch it for a few weeks and be careful of what products that I use in case of an allergic reaction. It did eventually get better after a few weeks.
This spontaneous case, initially received from other health professional on 18-Oct-2018, concerning a 43-year-old, adult female patient. The patient had no medical history and did not receive any concomitant medications. On 18-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: subcutaneous, anatomical location: left upper arm, batch number: 252227 (reported as 25227) and expiry date: 31-May-2019). At the time of this report, the patient did not experience any adverse events. The reporter assessed the case as non-serious.
8 days following my Moderna Booster, I began experiencing itchy hives all over my body. I tried multiple antihistamines OTC, and eventually saw urgent care and was prescribed prednisone which did not help. I decided to see a dermatologist on 1/10 who suggested I try 4 Zyrtec daily. That helped for about one week, and then the hives stopped responding to Zyrtec. When I followed up with the dermatologist on 2/3, he diagnosed me with urticaria, likely chronic, and likely a result of the booster as no other changes were made in to my diet or lifestyle to cause them. He put me on a course of prescription antihistamines to be taken for the next three months, after which we will follow up.