chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of chest pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several hours after receiving SHINGRIX, the patient experienced chest pain and heartbeats increased. On an unknown date, the outcome of the chest pain and heartbeats increased were unknown. It was unknown if the reporter considered the chest pain and heartbeats increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced chest pain and fast heart beats hours following administration. The reporter was agree to follow up from GlaxoSmithKline.
Information has been received from a physician concerning a 12 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced irregular bleeding and decided not to complete the series of injections. At the time of the report the status of the patient was unspecified. The patient sought unspecified medical attention. Additional information has been requested.
during our covid site visit from DOH on 12.15.22, it was discovered that we had a pfizer batch in the frig past BUD date. During the DOH investigation they went back through all the covid injections that were given and saw this patients lot number was given past BUD date. patient has been contacted and revaccination was offered. manufacture was notified and reports were filed pending outcome.
itchy, hive like rash on the arm of the injection. rash is present on the underside of my upper arm and goes onto my upper ribcage
Poison oak infection; This spontaneous case was reported by a consumer and describes the occurrence of POISON OAK RASH (Poison oak infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchitis.  Previously administered products included for an unreported indication: TRIAMCINOLONE ACETONIDE (for poison oak) on 15-Mar-2021.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced POISONING (Poison oak infection) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Potentially reduced efficacy due to treatment). At the time of the report, POISONING (Poison oak infection) and DRUG INEFFECTIVE (Potentially reduced efficacy due to treatment) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication not reported.  Treatment medication not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. on an unknown date these patients were vaccinated with improperly stored VAQTA (lot # K026529, expiration date: 02-JUN-2017 or lot # K019560, expiration date: 02-JUN02017; strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 39 year old male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of LYMErix on 4/20/99, 5/20/99, and 6/22/99 according to the client. This represents an inappropriate schedule of vaccine administration, in that the patient received LYMErix vaccinations on a 0, 1, and 2 month schedule rather than the recommended schedule of 0, 1, and 12 months. On 1/12/04, the patient's attorney alleged that the patient developed treatment resistant Lyme arthritis and/or treatment resistant Lyme disease, with symptoms including extreme knee pain and burning. The attorney further alleged that the patient suffered pain that was described as at times debilitating and which severely limited his employment options and opportunities. According to the attorney, the patient was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Patient received vaccine, less than 24 hours the injection site red silver dollar size, painful right deltoid. At 48 hr inj site larger red area and more painful. Patient was then put on antibiotic for infection. Resolving.
cut the inside of his mouth; This is a spontaneous report from Pfizer-sponsored program from contactable male consumer (Patient himself). A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown, Expiry Date: unknown) on 14Feb2021 via unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown, Expiry Date: unknown) on an unknown date via unspecified route of administration at single dose for COVID-19 immunization. On an unknown date, the patient had cut the inside of his mouth and was prescribed Penicillin 5 and is wondering if the antibiotic could decrease efficacy of the vaccine. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
the patient had chills and body aches for a day or two after.; the patient had chills and body aches for a day or two after.; As well as tenderness at the injection site; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 9-year-old female patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 2, 0.2 ml single (Lot number: FK5618, Expiration Date: 25Feb2022) at the age of 9 years, in left arm and on 22May2022 as dose 3 (booster), 0.2 ml single (Lot number: FL8094, Expiration Date: 30Sep2022), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:1, Lot: FK5127, Expiry: 28Feb2022 , Dose and Route: 0.2mL IM, left arm), administration date: 22Nov2021, for Covid-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "As well as tenderness at the injection site"; CHILLS (non-serious), PAIN (non-serious) all with onset 2021, outcome "recovered" and all described as "the patient had chills and body aches for a day or two after.".  Additional Information: It was reported as no Emergency Room, no Physician Office visit, but this patient's mother did mention the patient had an immune reaction after she received the 2nd and 3rd dose, the patient had chills and body aches for a day or two after. As well as tenderness at the injection site, caller said the usual stuff. The 2nd dose was back in the winter. No Prior Vaccinations (within 4 weeks). No, nothing documented for AE(s) prior vaccinations. No Family Medical History.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter.  No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
severe fatigue, mild lightheadedness, nighttime chills followed by sweats, unknown if fever present the day/night following the vaccine nighttime symptoms resolved after one night ,daytime fatigue with lightheadedness continued into third day mild arm pain for three days
no additional AEs; inadvertent administration of expired V AQT A to a patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 01-JUL-2021, the patient was inadvertent administration of expired hepatitis a vaccine, inactivated (VAQTA) (0.5 ml, lot # T008698, expiration date 04-JUN-2021; strength and route of administration were not reported) for prophylaxis (expired product administered). The administered hepatitis a vaccine, inactivated (VAQTA) had no previous temperature excursions and was supported by the post expiry memo. No additional adverse events (no adverse event). No product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
pt recv vax 2APR98 & pt reports pain @ inj site on lt arm w/pressure & w/arm abduction & elbow elevation;sx persist through the time of the report 18MAY98;f/u 6JUL98 reporter attempted to contact pt 30JUN98 & was unable to reach pt;
I anticipated the standard fever, chills, aches. I didn?t have them with the first injection, but I did have pretty intense joint pain in my fingers and left knee. The second injection, I had joint pain over my entire body. Between every knuckle, my tailbone, between every rib - even my feet.  What has be concerned is the face flush. My cheeks are hot to the touch and are tingling, though I don?t have a fever. It?s been going on since about 24 hours after my 2nd injection, and it?s rather unnerving. I?ve been outdoors in about 50 degree weather, drinking plenty of fluids. Also my gut health feels completely different. I have been gassy and my stool is sludgy and I go multiple times a day (I?m a very regular person).
Fever, trembling, weakness, dizzy (1st notice 3 days after injection) sugar level 220 (2 weeks after injection).
1st shot days after got rash from head to toe. 2nd shot 16 hrs after vaccine got severely ill. Fatigued, Nausea, & Vomiting, fever 100.6, headache, chills body aches, wheezing, heart rate rapid.  Day after better but still nausea  and fatigued for the  3 days, mild headache.
Normal upon awakening, normal breakfast of 16 oz decaf tea + Larabar, then fairly sudden onset of extreme grogginess/ foggy head and difficulty focusing on screen (working from home) ~9:30-10 AM. Upon standing to go lay on couch, experienced extreme dizziness with nausea.  Laying down made dizziness and nausea better, but not grogginess.  Tried Epley maneuvers, which seemed to help the only time I've had vertigo in the past (3.5 years ago).  The movement only made things worse.  After a quick call to coworker and text to husband, proceeded to go to sleep and continue sleeping until 3 PM.  Awoke still groggy/tired, but tried going to bathroom and getting water.  Standing still led to nausea.  Continued to rest and Slowly worked to sitting up in reclined position.  Around 5 PM, took BP with home unit and it was normal (127/77, 58 BPM).  Slowly ate a piece of whole wheat bread and drank water to avoid low blood sugar exacerbation or dehydration. After sleeping overnight, symptoms were resolved other than a slight weak/shaky feeling and reduced appetite, and I was able to drive to a 9:00 dentist appointment.  Around 10:30 started feeling mild numbness in and above the upper lip (maybe related to dentist?? though no numbing agent was used). The very mild upper lip numbness and some reduction in appetite continue, but the primary symptoms have resolved. Have never experienced symptoms like this before and only had one case ever of vertigo 3.5 years ago, which was different in that it was true vertigo (room spinning upon standing, had to hold door frame to avoid falling). No other cause is evident, pending upcoming CT scan. All prior COVID vaccines (and any other vaccines) have only produced normal symptoms - pain at site of injection, some flu-like achiness within 24 hrs., etc. Daughter was hospitalized with severe reaction to contracting RSV at age 2.5 years, so I wonder if this could be a reaction to the RSV vaccine, or possibly to having two vaccines on the same day.
Patient developed  diarrhea, chills and a measured fever 100.4 24 hours after receiving the vaccine.
pt recv vax 24OCT96 & on 7FEB97 pt devel a chickenpox rash on face, legs & trunk;
Narrative: Per Primary Care Secure Messaging 6/15/21, patient received 2nd dose of Moderna vaccine from pharmacy on 6/12/21 at 1315. Patient sent secure message to primary care team to notify them of the reaction and to make sure it was documented on her medical record. Per note, patient endorses taking "oral allergy medication" that is "holding the itchiness at bay". Unclear what allergy medication the patient was taking at the time, though patient had active loratadine prescription during that time. No vaccine lot numbers were provided upon review of further notes. Reaction to vaccine entered as "localized pruritus and erythema and tenderness at site of injection".
Local Reaction, blister sore on Rt. thigh, hives on forehead + Rt. eyelid, 101 degree fever, S.O.B. + Pruritus.
Initial and follow-up information has been received from a physician concerning a 9 year old male with no pertinent medical history or history of drug allergies or reactions who on 03-AUG-1999 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 12-JUN-2008 at 9:15 AM the patient was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Oka/Merck) (lot no. 660661/0176X) into the right arm. After receiving his second dose of VARIVAX (Oka/Merck) the patient felt pale, lightheaded, dizzy and passed out less than 30 seconds. On the same day as the second dose, the patient was recovered. On an unknown date P.D.D. test was preformed and no result provided. The patient sought unspecified medical attention. Additional information is not expected.
The vaccine administration was done 2 days after the beyond use date (bud). Once received, vaccines must be stored refrigerated for up to 10 weeks. These vaccines were received on january 26, 2022 and the bud was april 5, 2022. However, upon receipt the staff confused the date and documented the bud as may 4, 2022.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), May 2021, single dose, for COVID-19 immunisation. Medical history included stomach surgery, start date: 2017 (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunization. The patient experienced pain (having a lot of pain on right-side), onset May 2021, with outcome of unknown. Additional information: Patient had got the second vaccine on Monday. She has had lot of pain on her right-side. She had stomach surgery. They removed half her stomach in 2017. She can't tell if the pain is in her stomach, back or breast. It started on Wednesday. The first one was on Apr 14, 2021. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 12-Mar-2021, PAIN IN EXTREMITY (soreness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported    This case was linked to MOD-2021-077936 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 which contains batch number of first dose.
2 INCH AREA REDNESS AND SORENESS OF RT ARM, LOW FEVER DAY AFTER VACCINATION. DIFFICULTY MOVING RT ARM WITH DIFFICULTY PERFOMRING DAILY ACTIVIES. FATHER ADVISED TO TAKE CHILD TO PRIMARY CARE PROVIDER.
Patient received first dose of Pfizer Covid vaccine at 1320 on 2/9/21. At 1335, patient informed writer that his left arm where he received the injection felt warm and sore/achy. Patient denied any SOB, swelling of face or throat, heart racing, chest tightness, dizziness, or itching. Patients Left arm was warm to the touch below the injection site, and writer noticed flushed cheeks/neck. At 1335, HR was 72 and RR 18. Patient agreed to stay longer to be monitored.   1355. BP-158/94, SpO2-97%, RR-18, HR-82. Denied any changes in symptoms.    1425. No changes noted in patients symptoms. Writer spoke with Lead RN from vaccine clinic and Pharmacist. Patient feels comfortable going home and will call 911 if he develops any difficulty breathing, swelling of face/throat, fast HR, itching/hives, dizziness, or weakness. Patient also agrees to discuss symptoms experienced today with PCP prior to having the 2nd vaccine.
pt recv vax 16OCT95 & w/in 45min devel hypotension (80/35), tachycardia (pulse rate 100-110, resp 20), severe h/a, fever (initially 37.3  C), hypokalemia;n/v;pt acted like was in septic shock;adm to hosp;
10:00 a.m. A pinpoint size hive noticed on right deltoid where vaccine administered. hives spread to ankles, arms, face, and inside of lips. Lips became swollen, dizziness. Visited ER on 11/5/09. Treated with BENADRYL and PREDNISONE.
Shot site was sore for days that was in October 03. Jan04: Pain in chest and hurting under chest bone. Loose stool, discomfort, stress, anxiety, unwell feeling. Given antacid medication, but has not worked so far.
Patient started to feel dizzy/lightheaded about 10-15 minutes after vaccine.  She was nervous before the vaccine.  Had her sit in waiting area and gave her a bottle of water. She had not eaten since a small breakfast earlier in the day, gave her crackers and continued to have her sit.  She stated that the shaky/nervous feeling started to get better.  After about 45 minutes her and her husband left the pharmacy.  Called patient on 2/1/2021 and she stated that she is feeling fine today except for a sore arm.
Hivelike rash and itching, trunk, arms, upper legs, trunk. Treated 6/30 with topical steroids and oral antihistamines. Systemic steroids avoided as there are no respiratory or joint symptoms.
COVID; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000264793. This case, from the same reporter is linked to 20221257674 and 20221258686.
head ache, body aches, soreness in left arm and up into the neck, exhaustion, low grade fever for five days.
Fever, red hot swollen firm spot on buttock where she was given injection. Was seen on day 5.
Pt recvd vax & 3 days post inject exp a swollen thigh & sz;
10-27-2020    fever (101) & chills 10-28-2020    red rash at site of injection (right deltoid)
Patient developed rash starting on legs and spreading to armpits and neck. He rarely gets headaches and complained of a headache lasting a few days in the past week. The last 3 days his eyes hurt. Patient saw Dr. today and he suggested diphenhydramine 25mg four times a day.
Redness, swelling, hives local to injection site left upper arm. Tx: BENADRYL as needed; Steroids, cold compresses as tolerated.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patient were vaccinated with improperly stored doses of VARIVAX (Merck) (6 doses of lot # L011084, expiration date: 01-APR-2017 and 10 doses of lot # L006384, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.