chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered after 30 day beyond use date on 09-Jan-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date on 09-Jan-2023) 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. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, 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 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date on 09-Jan-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date on 09-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date on 09-Jan-2023).    No concomitant medications were reported.  No symptoms were reported.  No treatment medications were reported.  This case contains information for the 1st of 2 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697393 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697393:vaccine administered on 12-Jan-2023 case.
The adverse side effect started on my second vaccination but I am unable to read the # too clearly.  I have had insomnia ever since I received my second shot on 2/21/21/.   I treasure my sleep and never have problems sleeping.
48hr later rash broke out on both legs front & back, back of arms hands, but (no hx of rash in past from food or meds);
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced vaccination site erythema, rash vesicular and vaccination site swelling. The outcome of vaccination site erythema, rash vesicular and vaccination site swelling was unknown. The causal relationship between the adverse events and the suspect therapies was not assessed.
30 min. after shot,  I got a tingle in my left arm, fingers, face, throat, and head.  Then my lips,  tongue, and throat began to swell.  My voice changed.  I  was driving home.  I went to a store , bought Benadryl,  took 4 tablets, waited 35 min.  then drove home.   My swelling started going down.  I was nauseated for several days after the shot.
PATIENT C/O FEELING VERY ILL THE NEXT MORNING. C/O SEVERE HEADACHE, NAUSEA, CHILLS AND BODY ACHES. SEEN BY HER PCP AND WAS PRESCRIBED ZOFRAN FOR NAUSEA AND GIVEN A TORADOL SHOT FOR PAIN.
First dose of Moderna was administered on 01-FEB-2021 and second dose on 12-MAR-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna was administered on 01-FEB-2021 and second dose on 12-MAR-2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient has ever been diagnosed with or tested positive for COVID-19.  It was unknown whether acute illnesses at the time of vaccination and up to one month before and chronic or long-standing health conditions.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna was administered on 01-FEB-2021 and second dose on 12-MAR-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna was administered on 01-FEB-2021 and second dose on 12-MAR-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was unknown.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-598060 (Patient Link).
Lack of efficacy; breakthrough COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (breakthrough COVID) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (breakthrough COVID). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (breakthrough COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: This case concerns a 73 year old female , with no medical history reported , who experienced Non-serious , Unexpected , AESI event of Covid 19 and Drug ineffective which occurred 6 months and  27 days after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be administered and also the outcome of the events was unknown. The age of the patient can be considered as confounder for this case ( elderly people are vulnerable to Covid 19 infection and its complications because to the altered immune response). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 73 year old female , with no medical history reported , who experienced Non-serious , Unexpected , AESI event of Covid 19 and Drug ineffective which occurred 6 months and  27 days after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be administered and also the outcome of the events was unknown. The age of the patient can be considered as confounder for this case ( elderly people are vulnerable to Covid 19 infection and its complications because to the altered immune response). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Left worsen day by day; Dizzy; Some migraines; Lost control and put my head down"; Random duration two hours headaches; Slight dizziness; Arm pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Lost control and put my head down"), DIZZINESS (Slight dizziness), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy) and MIGRAINE (Some migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DIZZINESS (Slight dizziness), PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache). On 22-Apr-2021, the patient experienced BALANCE DISORDER (Lost control and put my head down"), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy), MIGRAINE (Some migraines) and HEADACHE (Random duration two hours headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MINERALS NOS, VITAMINS NOS (CENTRUM BALANCE) at an unspecified dose and frequency. On 19-Apr-2021, DIZZINESS (Slight dizziness) and HEADACHE (Headache) had resolved. On 21-Apr-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, BALANCE DISORDER (Lost control and put my head down"), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy), MIGRAINE (Some migraines) and HEADACHE (Random duration two hours headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.
! day after receiving vaccine, had symptoms of achiness, flu-like symptoms, temperature 100.1(1 hour after TYLENOL) dry hackey cough. Put on antibiotics, ZITHROMAX 250mg by mouth times 7 days( 5days after vaccine administered. Patients brother had similar reaction).
C/o redness soreness and swelling right deltoid beginning 12/22/99, 4P c/o pain at site, taking Acetaminophen with some improvement. Redness 1 1/2" in diameter. Advised to continue cool compresses and Tylenol prn.
*** ONLY reporting incident of non-indicated repeated dose of Fluzone high dose at Pharmacy on 10/1/22 *** Report is being submitted on Day 1 ; no adverse reaction on Day 1
I started to feel achy, headache, feverish.  I started to cough and feel very weak and tired. The next morning my COVID-19 test was negative but I felt terrible, achy all over and my fever was 100.5 degrees.  I called my doctor who told me to go to an urgent care facility and get Paxlovid.  I couldn't get in until the next morning.  The next day I test positive.  I went to the urgent care.  They prescribed Paxlovid and I started it about noon that day.  Within 5 - 6 hours, my symptoms were 90% better.  We were traveling and in a hotel room. The next day we flew back home.  I felt ok walking through the airport and rolling my suitcase.  That day my appetite came back.  We got home that night.  I felt tired but better.  About 5 - 6 days later, I had a rebound.  Not bad but I had a cough and low fever which lasted about 5 - 6 days.  I test myself and the line was dark.  Everything was approximately three weeks.  I started slowly getting back to my activities.
Vaccination site hot to touch; Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now; Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site hot to touch), VACCINATION SITE ERYTHEMA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now), VACCINATION SITE URTICARIA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now) and VACCINATION SITE RASH (COVID arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot to touch), VACCINATION SITE ERYTHEMA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now), VACCINATION SITE URTICARIA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now) and VACCINATION SITE RASH (COVID arm). At the time of the report, VACCINATION SITE WARMTH (Vaccination site hot to touch), VACCINATION SITE ERYTHEMA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now), VACCINATION SITE URTICARIA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now) and VACCINATION SITE RASH (COVID arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included anti histamine
Pt rc flu vaccine Tues afternoon. No redness Tues night. Wed afternoon 1cm reaction around site, Wednesday evening with increasing redness warmth and induration. 13 cm redness nearly circumferential, LE no red no swelling.
Weakness 24 hours. Body shakes with standing. Fatigue 10 days after. Chills alternating with hot flashes. Increase BM. Early onset menstraul by 1 week. right roof mouth and right tongue feels burned
Pt called stating her arm was horribly sore, could barely lift it, developed chills. Went to bed at 6:00 pm & woke up the next morning feeling better, although arm was still slightly sore.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. On 19th July 2018, not applicable after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The received her first dose of SHINGRIX on an unspecified date months ago and less than a year after vaccination, the patient experienced a sore arm. The arm was sore for just a day and then resolved. The patient received SHINGRIX vaccine on left arm. The patient received a second dose of SHINGRIX on 19th July 2018. The pharmacist did not use the liquid suspension to mix with the powder that came with the total dose of SHINGRIX. The pharmacist used an unknown liquid diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The patient was instructed after the error was found to return for another dose. The wife of the patient was the reporter. This case has been linked with case US2018134654, reported by same reporter.
pt recv 2nd dose of vax & @ 4 & 8 wk p/vax lab eval revealed that pt did not seroconvert;No further details were provided;
Information has been received from a nurse practitioner concerning a 17 year old female who on 13-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot not reported). Subsequently the patient experienced tenderness near her inguinal lymph nodes. On 14-JUL-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot not reported). On an unspecified date, the patient recovered. Additional information has been requested.
Was seen in emergency on 9/4/11 - arm was swollen, hurting, itching, & red from PNEUMOVAX injection - patient was asked several times if it had been more than 5 years since last dose, she insisted it had been more than 5 years.
pt recv vax JUL98 & 3mo later pt still c/o about soreness @ inj site;
This spontaneous report as received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-SEP-2011, the patient was vaccinated with the first dose of  GARDASIL for prophylaxis (lot number and expiration date were not provided). On 04-JAN-2018, the patient was vaccinated with GARDASIL 9 as second dose, for prophylaxis (lot number and expiration date were not provided). No adverse effects were reported.
Information has been received from a physician concerning female with drug hypersensitivity to NEOMYCIN, CLARITIN, sulfa drugs, erythromycin, CECLOR and TETRACYCLINE, and a history of zoster and goiter, who in December 2007, was vaccinated with ZOSTAVAX (Oka/Merck). The patient was not feeling well, developed a flat rash around her lips and under her breasts. The patient also developed ulcers on the bottom of her tongue. The patient reports feeling jittery and tired most of the time. The patient has occasional heart palpitations. The physician treated the rash under the breast with LOTRISONE and that made the rash worse. The physician did not feel that the rash was a varicella or zoster like rash. The patient sought unspecified medical attention. As of 26-AUG-2008, the patient had not recovered. The physician considered the rash around lips and under breast, the ulcers on the bottom of the tongue, feeling jittery and tired most of the time and occasional heart palpitations to be disabling. Unspecified blood tests were performed (results not reported). Additional information has been requested.
1 inc. diameter red ring rash around injection site, 3 in. lighter ring rash on outside.
sore arm after second dose; extremely tired after second dose/was tired for 2 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm after second dose) and FATIGUE (extremely tired after second dose/was tired for 2 days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M2DA) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm after second dose) and FATIGUE (extremely tired after second dose/was tired for 2 days). The patient was treated with Manual therapy (good sleep and hot water bottle to sore arm) for Pain in extremity. On 04-Mar-2021, PAIN IN EXTREMITY (sore arm after second dose) and FATIGUE (extremely tired after second dose/was tired for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-350343, MOD-2021-350398 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: No new information
Nine hours of off/on vomiting, severe case of the chills, severe joint pain/back pain; by about 4:00 AM on June 7, I was finally through the worst of it. Looking back on my situation, I should have gone to the ER.
Information has been received from a nurse concerning a 8 year old female who on 05-JUN-2007 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). It was reported that within 36-48 hours after receiving  the vaccination the patient experienced soreness and a larger than normal red area around the injection site. Unspecified medical attention was sought. No product quality complaint was involved. This is one of two reports from the same source. Additional information is expected.
Sore arm got significantly worse overnight. Pain is severe. Painful to move arm. Ice is not helping.
Developed a red rash on my left arm. The shot was given to me on my left arm.
Prior to this never had an allergic reaction. Took 1st dose pill at 4 pm ate dinner around 5:00 pm feeling ok. When to bed at midnight woke up at 4 am with swelling tongue. When to hospital emergency room. Treated with IVP - SOLU MEDROL 125 mg, PEPCID IVP 40 mg , BENADRYL IVPB - 50 mg at hospital. They gave me prescription for prednisone 20 mg & PEPCID 20 mg for 5 & 10 day after.
Patients who received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 1/13/2022 and dose administered to patient on 2/17/2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/2022 and dose administered to patient on 2/17/2022) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/2022 and dose administered to patient on 2/17/2022). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/2022 and dose administered to patient on 2/17/2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-491752 (Patient Link).
pt recvd vax;severe asthma,sinusitis infect, whelps,rash on legs & arms;still under MD's care;sick since 29jan95;not responding to tx;tx:atb's,pred & 2 kinds of inhalers;
Presented to the Medical Clinic on 6/25/07 with c/o general malaise, shortness of breath and redness to vaccination site. Urticaria wheals noted to upper left arm and some on right arm. Blister to upper left arm measured 2cm with thick exudate present. Given Ibuprofen, Claritin, and Z-pak.
Although we knew to expect some swelling and redness at the injection site, within 30 minutes, there was an inch wide ring around the site. Within 6 hours, the redness increased to 2" in diameter. By the next morning (7/15/14), the diameter was 4" and the redness had deepened. By 3 pm that day, the site was an angry red, 6" in diameter, raised, hardened, and itchy. On the 3rd and 4th days (7/16-7/17/14), it covered his entire upper shoulder....so approximately 8" in diameter. The redness, itching, and swelling gradually subsided, but it took almost 2 weeks!
Administered MMR and Varicella around 3:30 PM in patients left arm per mothers request to have both in 1 arm to avoid right arm being sore.  Immediately upon administration, there was redness and swelling. No pain. MD evaluated patient and rec cool compress, ibuprofen. Follow up call 5 PM - patient is doing well. No increased swelling.
I just noticed that evening that I felt really nauseous after work. So, I drank some coca cola. It would happen all throughout the day and sometimes it would go away. I took Dramamine and that would help a little bit because it made me sleepy, but I only took that once and I haven't taken anything for the nausea since. I was taking antibiotics for my ear as well (Amoxicillin) for my ear infection, so I thought it was that and stopped taking the medication, but the nausea still came back. Around the time I did have nausea, I broke out in hives for a week. Recovered from hives since then. Went to urgent care for nausea but was not prescribed anything for it.