chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after 30-day use by date; No adverse event; Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). On 24-Mar-2023, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date).    Concomitant and treatment medications were not reported.  It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The registered nurse called to find out what should be done if a Moderna COVID vaccine monovalent dose was given after the best use date. The lot number was same for both dates of administration. The fridge expiration date was 03-Feb-2023, the website expiration was 01-Apr-2023, and the pharmacy was saying 30-Apr-2023. Vial size was 5.5 ml. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  Company Comment: This spontaneous case concerns a 24-year-old female patient, with no medical history reported, who experienced non serious unexpected Maternal exposure during pregnancy and Expired product administered with No adverse event that occurred in association with second dose of mRNA-1273 vaccine.  Details regarding gestation period, Last menstrual period and estimated date of delivery were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Redness and swelling at injection site. Hematone at injection site 1.5 inch. Nausea and upper GI distress for 3 days (12/30, 12/31, 1/1). Skin "hot spots isolated...severe itching, redness, no swelling (groin) lasted one day. Inflamed oral cavity-redness, burning, raw, swelling for 3 days. Unable to wear dentures.
3" redness (right arm) onset 2/23/08.  Resolved 2/26/08.  Minimal redness (left arm) 2/23/08.  Resolved 2/26/08.
SX = sudden onset of pain and swelling on day 8 post small pox vaccination.                                      O = lymphadenitis/ lymphangitis Left upper arm and axillae
Starts by feeling heat in the face, head and all over the body, then itchiness develops and then redness and hives across the body. The skin turns red and bumpy and it's impossible to stop scratching  because is needed to relieve itchiness. It started on 12/24. Had never this in the past. It's impossible to sleep or do anything during the day if left untreated. The only allergy med that has worked well is Zyrtec (10mg). After one week  (12/30) I tried stopping Zyrtec. After 24 hrs when the med wore out hives started appearing again and in the timeframe of 32-48hrs after the last med was taken hives become so intense that was impossible to sustain it anymore. Doc appointment is scheduled for 1/11 because I am currently not in my home area where my insurance covers me but I am taking Zyrtec daily. It's impact usually starts wearing off around 18-20hrs
Client began vomiting around 2 hours after vaccine was administered. Client's parent called the Health Dept and spoke with a nurse. Denies fever, denies sickness, denies any and all other signs and symptoms at this time. Educated on visiting urgent care provider or ER as needed. Educated on side effects and adverse reactions to TDap and when to seek further medical care. Verbalized understanding.
anxiety; low estrogen; can't sleep; can't focus/can't concentrate; depressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-160641 (Moderna).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization. The following information was reported: ANXIETY (non-serious) with onset Apr2021, outcome "unknown", described as "anxiety"; BLOOD OESTROGEN DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as "low estrogen"; SLEEP DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "can't sleep"; DISTURBANCE IN ATTENTION (non-serious) with onset Apr2021, outcome "unknown", described as "can't focus/can't concentrate"; DEPRESSION (non-serious) with onset Apr2021, outcome "unknown", described as "depressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient who believed that she received the Moderna vaccine, stating that since receiving her 2nd dose in Apr2021, she has low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. She was tested and test proves that she has low estrogen. She went on to state that she is aware of 10 people who experienced the similar reactions. 5 of which are (Withheld) and she is (Withheld) and did not mention the nationality of the other 5. Upon request of date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called the wrong number because she received both doses of the Pfizer vaccine. Age was not captured. Limited AE filed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8/15/14-started running low grade fever Friday evening. Saturday normal playful self with temp of 99.5 went stiff drooling BM + also went to Emergency Dept in another city and Dx with febrile seizure, ran temperature 8/18/14 rash started 8/18/14.
12-16-08 mom presents with note of child low grad tem 100 degree F, then increased to 101 - until this am 103.8 am to pm hospital ER - noted treating tem with infant Tylenol .04 ml - ER gave appropriate dose of Tylenol 1.2 ml and sponge bath - tem at present 97.8 - voices concerns with recent vaccines and excessive sleeping - child difficult to arrouse - dx otitis by ER - RX antibiotic - this RN advice - continue observation temp for 4-6 hours - appropriate dose Tylenol every 4-6 hours and RX antibiotic - 12/17-08 TC to mom - states child cont sleeping - temp subnormal - 94.8 12-18-08 attempted TC no answer 12-22-08 TC to mom child behavior and tem returned to normal 12-20 temp 98
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 12:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 12:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   Age of patient was reported as 50.60 for dose administered on 14-Feb-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM 10:00 AM and 11:00 AM and 35 degrees Fahrenheit from 02:00 PM to 03:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were reported.
Injection site hardness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
This is a spontaneous case, initially received from other non-health professional on 12-Nov-2018 and follow-up received on 22-Nov-2018 (being processed together), concerning a 45-year-old, adult, female patient. On 09-Nov-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: deltoid, dose: 0.5 ml, batch number: 195250 and expiry date: 01-Jun-2019 (as reported)]. It was reported that while administering the vaccine, the plunger was stuck while the needle was in the patient's arm. The patient did not have any discomfort or pain and was not harmed in any way. The product technical complaint (PTC) of batch 195250 was provided as 1035617. The reporter assessed this case as non-serious.
This spontaneous report as received from a nurse refers to a 10 months 2 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot @ K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient received Moderna Bivalent Booster without having received the Primary 2 dose series
Information has been received from a medical assistant through the Pregnancy registry for GARDASIL concerning a 17 year old female with no previous pregnancies who on 17-Sep-2008, was vaccinated with the second dose of GARDASIL (lot# 659180/1758U) and then discovered that she was pregnant. There was no concomitant medication. No adverse effects reported. Late last menstrual period 16-Aug-2008. Estimated delivery date 23-May-2009. A routine ultrasound was performed on 15-Oct-2000, which was normal. The patient was placed on prenatal vitamins. The patient did not receive the first 2 doses of  HPV at the medical assistant's physician office. Follow up information has been received from the physician who reported that in 2009, the patient experienced mild anemia and was treated with ferrous sulfate 325 mg, daily from 11-Feb-2009 to 17-May-2009. Concomitant therapy during pregnancy included vitamins. On 17-May-2009, the patient delivered a normal female baby, at 39 weeks of gestation. The baby weighed 6 pounds, her length was 10.0 inches, and had on APGAR score of 9/9. There were no congenital anomalies and no complications or abnormalities reported. No further information is expected.
5min post vax pt became unresponsive, perspired profusely, color ashen, breathing irregular-eased into semi fowler position & pt began to regain consciousness;pt also incontinent;warm sensation in chest;
Pt came in to get her pfizer booster shot during her visit.  the ma administering the vaccine was not aware that the vaccine had not been properly reconstituted prior to administration.  On 09/29/21 the MA who reconstituted the vaccine the day prior was watching another MA doing it and realized that she had done it wrong the day prior.     The MA thought that the pfizer covid 1- vial was a single dose vial so she took the 1.8ml of of the diluent and divided it amongst the 6 vials thinking they where single dose.  the MA drew up the vial and administered the entire content to the patient for a total of 6 doses and .3ml of diluent.    The provider was made aware and he called the patient to inform her of the incident and to ensure there where no adverse reactions that the patient would need to come in for.  Pt stated that she was just having localized soreness around the vaccine site.  the provider advised patient to call our office if any symptoms become severe.   Discussion with the team included what had happened as well as what we can do to prevent the issue from happening in the future.  we agreed that when ever possible we will have the clinic RN reconstitute and draw up the  vaccines and if not available we will have 2 MA present during the reconstitution and drawing up of the vaccines as a double check.
IT WAS ITCHING AT NIGHT MONDAY (2/8/21). REMINDED PATIENT OF PHLEBITIS/CELLULITIS. WENT TO DR OFFICE AND NURSE LOOKED AT IT. NURSE SAID IT WAS RAISED AND WARM. HURT WHEN PRESSED ON. NURSE RECOMMENDED ICE AND BENADRYL ORAL AND TOPICAL. 2 BENADRYL EVERY 4 HOURS FOR A DAY. 2/10/21 IT WAS CLEAR; ONLY BRUISE REMAINDED.
headache, congestion, runny nose, sneezing, burning eyes, watery eyes, higher than normal blood pressure, fever, chills, body aches, shortness of breath, coughing, muscle pain, injection arm pain, tiredness, feeling unwell, no energy, swollen lymph nodes under arm and below ear lobe,
MAIN- Intense mechanoreceptor hypersensitivity- pain with sitting in bed/down at all, persistent sensation of feeling clothes I was wearing, most severe in the lower extremities bilaterally- even pain with just covers over pare legs ^ Pain so severe it woke me up in the middle of the night- 8/10 in severity- somewhat alleviated with Tylenol extra strength 500mg x2 PO Q6hr Also- joint pain/aches, cold, exacerbation of Reynauds (pre-existing), facial pallor, chills Over 24 hours post 2nd vaccine- intense hypersensitivity mostly resolved with mild sensitivity remaining on continues Tylenol regimen, other symptoms about 80% resolved
This spontaneous report as received from a physician regarding his wife's relative via company representative refers to a 17 year old non pregnant female patient. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with first dose of GARDASIL (strength, route unspecified) and experienced migraines, swollen lymph nodes, malaise and fatigue on an unknown date. It was reported that the adverse effects continued for ten days (dates unspecified) and the patient was feeling better and was recovering from the events reported. The patient had not sought medical attention. No product quality complaint was involved. Additional information has been requested.
pregnant and got 3 shots of moderna; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and got 3 shots of moderna) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 007C21A and 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Dec-2021. On 13-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and got 3 shots of moderna). On 13-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and got 3 shots of moderna) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-422830 (Patient Link).
This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age. On an unknown date unspecified number of the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD, 0.5 ml dose, subcutaneous (Oka/Merck) VARIVAX and (Oka-Merck) PROQUAD, have been exposed to -14 degree centrigrade for 60 hours. No adverse effects reported. The outcome of the event was unknown. The causality of the event was unspecified. There was no PQC reported. The case has been linked with the case 1406USA007434 (same patient link). Additional information has been requested.
Injection site pain began was initial at time of injection and never has subsided.  Physicians office recommended heat and Ibuprofen. This was done.  Now almost 3 months out, no change, pain is 24/7 at a Level 6 and increases, to a shooting pain, with normal movements of life such has reaching forward or up, turning  the wheel of a car, lifting, working with equipment, doing my normal yoga routine, rolling on to Left side when sleeping. It has completely altered in a  negative way my life, my daily joy of life is tainted   due to constant pain.  I am a healthy women.  I am an active women. I am a women in constant pain now due to this injection.
Patient reporting foul taste in mouth after vaccine administration.  Since vaccine, having trouble eating and drinking because everything tastes rancid. Able to tolerate oranges. Symptom is consistent, unchanged. Has increased water consumption and started a daily multivitamin.
Pt had difficulty breathing, wheezing, shortness of breath, worsening voice hoarseness decrease in O2 saturation from 99% to 94%. Pt given 2 IM Epi injections, 25 mg oral Benadryl before being transferred into EMS care. They administered an additional 25mg IM Benadryl, placed pt on oxygen and transferred her to the E.D.
On unknown dates, the pt received 2 doses of HepB vaccine but missed the third dose. On 01 Sep2021, the Recombivax Adult Hep B Vaccine was administered as her third dose./Pharmacisthad not received his third dose back then as recommended; the patient had not experienced any issues and she was doing fine when she left the clinic/No additional information/o additional adverse events reported; Recombivax Adult Hep B Vaccine, 10mcg, was administered as her third dose. After the dose was give, the physician realized that, due to her age, she should have received 5mcgs./ The pt came into the clinic and received a dose of 1.0 ml; This spontaneous report has been received from a physician and a pharmacist, concerning a 18-year-old female patient. No information was provided regarding the patients' pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.   On an unspecified date (reported as when she was younger, and as an infant), the patient was vaccinated with the first and second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (also reported as HepB vaccine) at a dose of 0.5 milliliters (ml) or 5 micrograms (mcg); then on 01-SEP-2021 (inappropriate schedule of product administration), she was vaccinated with the third dose (and final dose of a series) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of 10mcg or 1.0 ml (also reported as 0.1ml, conflicting information), instead of 5mcg or 0.5ml (incorrect dose administered); all the vaccines as prophylaxis (product formulations, route of administrations, anatomical locations of vaccination, lot numbers and expirations dates were not reported). The physician stated that she was fine when she left the clinic; no additional information or adverse events reported (no adverse event).
The pt developed a fever of 99-100 the day of vaccine. Pt had a high-pitched wailing 24-48 hours post vaccine and was unconsolable, fussy, diarrhea, red swollen leg at site of vaccine. Tylenol given. 48 - 72 hours pt had less wailing, some diarrhea and leg was getting less red.