chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications detail were not reported by the reporter. Treatment details was not reported by the reporter.
Dizziness, headaches, body aches started 2 days after vaccination and continued for about 9 days.  Took Tylenol.
Fever, muscle aches, upset stomach, vomiting, severe diarrea, fatigue, sweating - all now on second day
Soreness in arm within range of normal. But then I had flu-like symptoms, i.e. body aches, mild headache, tiredness, feeling like I was coming down with flu off and on for the next 3 weeks. The body ache seemed to move around from neck and should areas to feet, etc. I have continued to experience this a 3 more times for 3 -4 days at a time. I'm now worried about going in for the second shot in the series and have been putting off. I've not reported to my healthcare provider at this point because I can't be certain the vaccine is the causative factor and it does go away after 3 - 4 days.
I have had severe pain in my right leg, it feels like nerve pain. Its very uncomfortable to sit and drive. I saw my PCP ( Kip ) who ordered two rounds of oral steroids. I was then referred to an Ortho who ordered PT, I completed 4 weeks with little to no improvement. I had an X-Ray and MRI of lower back and just received an cortisone injection last Friday.
Pt recvd vax on 3JUN92 & on 10JUN92 devel conjunctivitis, irritability & t104;
Patient had hives on her entire chest and under her chin. She had a couple of other spots on her face. It is now 2 days since the vaccination -- that did contain Thimerosal -- and she still has hives.
c/o h/a, joint aches, & elevated temp 104 per os; developed rash on 23MAY91; Seen by Md sore throat, eyes hurt, dry & light sensitive, dx viral infect;
This case was reported by a consumer via call center representative and described the occurrence of sleep excessive in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sleep excessive. On an unknown date, the outcome of the sleep excessive was recovered/resolved. It was unknown if the reporter considered the sleep excessive to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that, the patient was slept for 9 hours after vaccination. The reporter did not consent to follow-up. This case has been linked with case US2019069987, reported by the same reporter.
A mother who is a nurse, reported that her 10 month old daughter received an injection of Prevnar on 11/13/00 which may have inadvertently been given SC. The child subsequently developed an injection site reaction characterized by redness and a bump.
improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 08-SEP-2021, the patient was vaccinated with an improperly sored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Pt p/t ED on 6/6/21 w/multi trauma injuries 2/2 MVC. Was medically stabilized and admitted to inpt rehab (6/10). Readmitted on 6/25 for add'l procedures and ultimately discharged to inpt rehab on 6/28. Despite having a COVID negative test upon admission (6/6) and had received Pfizer COVID vaccines (1/13 & 2/3), pt developed a cough on 7/26 and her COVID test returned positive (7/26).  She was ultimately discharged home on 7/26/21 w/add'l follow-up.
11 pm day of vaccine, fever extreme chills.  Very bad muscle pain through the night (felt worse than the worst flu I had ever had) it hurt to move in the slightest.  Sweating alternating with freezing cold.  Next day fever 102 or 103.  Around noon, started VERY intense chills, causing extreme shaking.  Then started having muscle spasms with the shaking.  The spasms are intensely painful.  I have to lie down.  The cold  feeling is so bad blankets are piled on me and heating pad is put in the bed.  Hands shaking so bad I cannot hold phone to dial.  I am now starting to be fearful that something bad is going to happen to me, the spasms are so strong and painful.  These last several scary hours.  They subside and I have a fever for a week.  The headache probably started the second day.  I start taking tylenol around the clock.   I go to the doctor and get prescribed something.  I continue with tylenol around the clock.  Mid December I cut back to tylenol twice a day.  Christmas day was my first day without tylenol.
On 2/22 area became itchy, noticeable darker red in color and area of erythema extended further down arm from deltoid area. Tuesday area wider and extended further down arm,  more itchy. Wednesday am area again extending somewhat further down from earlier measured area . At no time was area warm to touch. painful to touch( area sore first 36 hrs post injection), area blanches, a febrile.
5 min after vaccine infant became limp, pale after eyes rolling back, no cyanosis, no tremors or shaking of extremities. Lasted about 1 min. Initial weak cry then nl. No wheezing or swelling. Observed 20 min. Recovered.
pt recv vax & pt devel a varicella-like rash consisting of eight lesions;
Information has been received from a doctor of psychology concerning an unknown number of patients of unknown age and gender. The patient's relevant medical history, past drug therapy and concomitant medications were unknown. On an unknown dates, were vaccinated with unknown doses of GARDASIL with frequencies and for indications unknown (route, dose and lot number not reported). On an unknown date, the doctor of psychology reported that she heard a report on the news on 13-SEP-2011 in which the speaker mentioned that GARDASIL caused mental retardation. It was unknown if the patients sought medical attention and if there was any laboratory data. At the time of the report it was unknown if these patients continued on GARDASIL and the statuses of their mental retardation. This is one of several reports received from the same source. Upon internal review, mental retardation was determined to be an other important medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient.
Arm is a bit sore and red; Arm is a bit sore and red; even a bit of illness; This case was reported by a consumer via media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR202814).   In September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced erythema of extremities, pain in arm and illness. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the erythema of extremities and pain in arm were not recovered/not resolved and the outcome of the illness was unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm and illness to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The reporter reported If he/she were vaccinated 5 plus years ago, they want to check with their doctor as the previous one had been found to not be effective. The patient received 2nd dose of Shingrix 2 months apart from the 1st dose and arm was bit sore and red.It was better than the 1st dose that hurt more. The patient stated that It was known to cause a sore arm, redness, and even a bit of illness. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202814:same patient
Erythematous and edematous area 6 3/4in by 5 3/4in on right thigh.  No breaks in skin.  Even this has become erythematous, has increased today.
No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) 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. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-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 30-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date).    No concomitant medication information provided. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was 30-Dec-2022.  The vial did not undergo any temperature excursions. No treatment information provided. This case considered of 2nd patient of 5 adult patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-694396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694396:Master case
in early eve feverish temp not taken couldn't touch body; screamed 3 hrs or more; then periodically for 24 hrs;
PATIENT COMPLAINED OF MALAISE. ONSITE EMS/PHYSICIAN REQUESTED BP 126/78  HR 702 HE REFUSED FURTHER EVALUATION OR CARE
Localized Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Localized Rash at injection site) in a 21-year-old male patient who received mRNA-1273 (batch no. 002c21a) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Heartburn, VITAMINS NOS (DAILY MULTIVITAMIN) for an unknown indication.    On 23-Apr-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE RASH (Localized Rash at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Localized Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.   For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "known allergies: Adhesive tape" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; ZOLOFT; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Symptoms were gone and my positive test line was very faint; (2022) Positive, notes: Now my positive line is very dark. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Dec2022 to 16Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
IMMEDIATE PAIN/BLEEDING AT INJECTION SITE OCCURRED UPON RECEIVING INJECTION. BANDAIDE SOAKED THROUGH AND CONTINUED TO BLEED FOR APPROX. 5 MINUTES FOLLOWING INJECTION. PAIN LEVEL 7 (0=NONE,10=MAX) AND LIMITED RANGE OF MOTION LASTING 48HRS. APPLIED ICE COMPRESSES WITH RELIEF.
Severe itching, chest heaviness, cough beginning 15 min after shot and lasting for 24 hours. Saw Dr. and treated with loratadine then Benadryl and albuterol inhaler.  No lab work or CRX done.   Pt had VAERS1 a year earlier - blamed on MMR.  She had + ANA 1:640 speckled/homogenous.  Repeat pending.
Vaccination site pain; fever of 101 to 102 at times; site was warm to touch; arm felt like it was going to fall off; Fatigue; headache; Hot to touch; Itching; Tender; Arm-red rash; Injection Site swelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), TENDERNESS (Tender), VACCINATION SITE WARMTH (site was warm to touch), INJECTION SITE JOINT WARMTH (Hot to touch) and VACCINATION SITE PAIN (arm felt like it was going to fall off) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Drug allergy (Allergy to Naproxen.). Concomitant products included CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), RALOXIFENE HYDROCHLORIDE, BIOTIN and FISH OIL for an unknown indication.   On 03-Feb-2021 at 3:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 3:29 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (Itching), TENDERNESS (Tender), INJECTION SITE JOINT WARMTH (Hot to touch), INJECTION SITE RASH (Arm-red rash) and INJECTION SITE SWELLING (Injection Site swelling). On 30-Mar-2021, the patient experienced VACCINATION SITE WARMTH (site was warm to touch), VACCINATION SITE PAIN (arm felt like it was going to fall off), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever of 101 to 102 at times). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3) (oral) ongoing since an unknown date at a dose of 1 dosage form. On 21-Mar-2021, INJECTION SITE JOINT WARMTH (Hot to touch), INJECTION SITE RASH (Arm-red rash) and INJECTION SITE SWELLING (Injection Site swelling) had resolved. On 31-Mar-2021, VACCINATION SITE WARMTH (site was warm to touch), VACCINATION SITE PAIN (arm felt like it was going to fall off), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever of 101 to 102 at times) had resolved. At the time of the report, PRURITUS (Itching) and TENDERNESS (Tender) had resolved and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: high (High) fever of 101 and 102.    Treatment medicines were not included.   This case was linked to MOD-2021-251554, MOD-2021-043307 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 08-JUL-2021 and contains significant information updated patient demographics, medical history, added concomitant medications, added new events headache, vaccination site pain ,vaccination site warmth, updated event outcome of all the events. On 30-Jul-2021: Non-significant follow up appended
high pitched screaming beginning 11-12 post vax & lasting x 24 hrs;
After second dose, 24 hours later I could not feel my legs.; I got my menstrual cycle for every two weeks for two months following the second dose  vaccine.; This is a spontaneous report from a contactable consumer (patient). A female non pregnant patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: Ew0161) via an unspecified route of administration in left arm on 11Apr2021 at 13:00 as single dose for COVID-19 immunization. Medical history included stroke (cerebrovascular accident) at 39 years old and eclampsia at second birth, allergies to sulfa and singulair. Concomitant medication(s) (within 2 weeks of vaccination) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: Ep7534) via an unspecified route of administration in left arm on 21Mar2021 15:00 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The patient experienced after second dose, 24 hours later i could not feel my legs, i got my menstrual cycle for every two weeks for two months following the second dose vaccine on 12Apr2021 14:00. The patient reported that, she got her menstrual cycle for every two weeks for two months following the second dose vaccine. Also, after second dose, 24 hours later she could not felt her legs. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR): negative on an unspecified date. The patient did not receive any treatment for the events. Device Date: 24Jul2021. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reaction and concomitant medications were unspecified. On 10-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II lot # M016234, expiry date 31-MAR-2018, dose, dose number, vaccination site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Meniere's disease; 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 medical history, concurrent conditions, or concomitant medications. In or around September 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered Meniere's disease. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient's symptoms had resulted in physical limitation not presented prior to zoster vaccine live (ZOSTAVAX) vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of the patient's condition. As a result of zoster vaccine live (ZOSTAVAX) vaccination, the patient sustained severe and permanent personal injuries; suffered serious progressive permanent and incurable injuries as well as significant conscious pan and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; suffered and incurred damages, included medical expanses; the loss of accumulations and other. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of Meniere's disease was considered to be disabling. Upon internal review, the event of Meniere's disease was considered to be medically significant.