chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has not administered the second dose/ to give the second dose but it is considered off-label; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label). At the time of the report, OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the Pharmacy staff did not notice the deviation until the patient came back to get her second dose on 03-OCT-2021. Pharmacist has not administered the second dose to the patient.  No relevant concomitant medications were reported. No treatment information was provided.
woke up with severe dizziness and the room was spinning, during the day it got better. I feel something's wrong about my right ear as well. When I move my head to any directions (up,down,right,left) especially right I felt uncomfortable, still spinning.  It got better day by day though.
I had swollen lymph nodes and pain that radiated down my left arm. This was for 2 days. On the third day the pain and swelling were gone but my right breast leaked clear discharge.
At lunch time after receiving shot in morning, started to feel dizzy, weak, headache, blurry vision, nausea, difficult speech, & suddenly very sleepy. Symptoms lasted 3-4 days.
COVID 19 vaccine received 12/23/20 left deltoid. She has been experiencing left jaw/TMJ joint pain since Sunday 1/3/20 worse in the morning,. patient describes it as a dullness on the left side of face. Denies any trauma to area. No hx of TMJ. Denies any facial droop, or dry eye, no weakness. She tried NSAIDs with no improvement, however pain with opening her mouth.
Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (no lot numbers available). The patient developed a varicella outbreak shortly after vaccination characterized by a generalized vesicular rash. It was unknown if medical attention was sought. Subsequently, the patient recovered and the rashes have since resolved. There was no product quality complaint. This is one of several reports from the same source.
4/18/20 Went to hospital. Had to be sedated. Intubated. Transferred to another unit. Spent 4 days in medically induced coma. Later diagnosed with serotonin syndrome.
Arms were painful & did not improve developed rash & itchy over entire body within month. Cont to have pain in both arms & then legs. Rash remained stated cont. to itch. 11/13 improvement 11/26 rash gone but (R) arm & leg pain cont. 12/4 - dry skin (L) arm, legs ache along with (L) & (R) arm. 12/10 - Dr follow-up. Took hydroxyzine & prednisone. 4/13 cont. prednisone, pain in arms & legs.
pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200
On right thigh, site is inflammed and redness of 17cm diameter and induration of 12cm diameter at site of DTAP, immediately onset less than 24 hours, post vax. At 72 hours, post vax, it is resolving.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 18-APR-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosing details, route of administration were not reported) lot#M010212, expiry:21-JAN-2019. It was reported that the vaccines were exposed to the temperature 49F during a time frame of 49 hours. No previous temperature excursion was reported. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Developed mild arthritic pain shoulder & ankles with 1st dose, 2nd shot arthritic pain worsened extended to shoulders, arm joints/wrist, legs & feet. Pain stiffness is getting progressively more advanced. On Gold tmts fr specialist.
pt fainted after vaccine, pt was conscious and speaking when pharmacist arrived, paramedics were already on the phone and on route, blood pressure obtained at 11:22am, paramedics arrived, assessed pt and though speaking and ambulatory without hives or rash took patient to the hospital for further tests
sore in one spot on shoulder & elbow lt arm; when move arm it hurts, pain when reaching, lost strength; red for 2 wks size of quarter p/receiving shot;
pt mom states pt devel a red skin rash all over body about 1wk p/got 2nd dose of vax;pt taken to MD & dx w/pityriasis rosea;MD not sure why pt devel the rash;pt not seen by pvt MD
Early that morning after the vaccination I felt a little sick with chills and fever. I took my blood pressure and 190 /110 was the reading, I have a journal that I keep them in. The whole year it was 128/82 except for the day after the 1st shot which was 190/110. The second day after the second shot it was 171/73. After the first shot when my blood pressure went up, I told my primary doctor and he told me to go back to taking the high bp medications. So, from Jan to the second shot the blood pressure came down to 150/73. After the 2nd shot (and first shot too), I feel tired with fatigue which I never had before. I was very energetic and active and never get tired. Except now I get the shot and I have fatigue and heart attack on May 23rd, and then they took me to the emergency room and to the OR and put stent in my right artery. I had 1 100% blocked artery and the others are fine. My cardiologist said 20-30% deposit in the other arteries but not anything they are concerned about at that time. I'm doing Cardiac rehab with 16 more sessions to go. My heart rate is almost back up when I was on the treadmill, I'm at 93/94 heart rate on the treadmill. I'm getting better but still have fatigue.
Pt recvd vax 2DEC92 & 4 hrs following inject pt exp aching from lt upper arm to shoulder; also devel a bruise about size of a quarter @ inject site & had a blister from where the bandaid covered the inject site;
patient indicated she noticed swelling in entire left side of face and neck no redness or rash swelling including lips not tongue
Client called the clinic today, 9/7/2021, at 11:00 AM to inform me that she became very light-headed from the vaccine after returning home from waiting 15 minutes at our facility.  She also stated that she completely passed out which scared her grown sons and they called for an ambulance.  The ER staff at the hospital (don't know which hospital) gave her fluids and told her this was a normal reaction to a COVID vaccine.  She just wanted to let me know that this happened.
During a review of the Regulatory Authority internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
1 month after 2nd Moderna Covid vaccine patient developed an acute LLE Deep vein thrombosis despite taking therapeutic warfarin
On 11/28/08, pt was in clinic and C/O welts on thigh; Shoulder reaction to flu shot; cough and sore throat. ONSET OF SYMPTOMS: Ongoing since flu shot on 10/14/08; cough and sore throat since 3 days. S/S: Welts to both thighs, left shoulder, and back; itching; swollen lips;  cough; sore throat.  ASSESSMENT: Vital signs noted.  Pt. presents to clinic with c/o above sx.  Pt. states that since receiving his flu shot, he has been experiencing these sx which last approx. 1 1/2 days, disappear, and then reoccur; itching but denies any pain; denies any SOB, chest pain, or throat swelling.  Pt. has not had a reaction to any other flu shot in the past.  Large circular, raised welts noted to bilateral upper thighs/hips, left side and shoulder; erythema noted to left shoulder.  Cough is noted as productive of white mucous.  Lung sounds clear bilaterally; respirations regular and non-labored; ears clear and WNL; nasal passages bright red with clear exudate; throat without swelling or erythema; no pain/tenderness noted with palpation to frontal sinuses or submandibular lymph nodes.  Pt. reports use of OTC Ibuprofen, Alka-Seltzer Cough and cold with some relief.   Pt was given Benadryl
Instructions for flumist doesn't state to push hard and quickly for mist to occur. I pushed syringe with normal force and immunization stayed in liquid form. Next day patient showed flu symptoms such as congestion and cough. Was not seen for having flu-like symptoms.
Started with bad full body aches around 9pm despite taking Tylenol around 6pm. Tylenol was taken again at 12am and I continued to experience bad body aching and chills throughout the night.
Redness and irritation at injection site that spread outward and around arm starting on 11/4/2013.  As of doctor office visit 11/5/2013 evening all the way around the upper arm just above elbow.  Patient reports no fever or other symptoms at this time, but states she is not able to raise arm more than halfway.
I had someone from the CDC contact me and tell me to report my COVID infection to VAERS which brought me to this site, I am not sure if this is the correct place to report?  I contracted COVID with symptoms beginning January 21, 2022 which progressed into a severe case. My symptoms included pain level 10 (on a scale 1-10); my pain was so severe that I could not bend my limbs and I had to have someone carry me around. I could not even bend my legs to reposition myself in my bed. My entire body felt like stone to the touch as if you had a charley horse in every joint.  I could not open my jaw. I could not bend my legs, my arms, my fingers.   I had sores all over inside of my mouth. The white part of my eyes were red like a zombie.  Nausea was severe. My body itched uncontrollably.   Constant fevers fluctuating 100-102.  Oxygen levels fine.   I did not go to the hospital per my doctor's recommendation as I did not get a positive PCR test or  a positive rapid test and she was concerned I may contract COVID if I went, but if I can be honest the pain was so bad I wished for death. I tested 4 times.  My severe symptoms lasted two full weeks.  No respiratory issues until around day 12 or 13 I had runny nose and developed a cough which I still have. Lingering symptoms of fatigue and cough are still an issue.
I went to bed about 9 pm and woke up at 10:30 with a pounding headache, fever and my left arm hurt so bad that I had to use my right hand to move it. After about 2 hours, I was able to get up and get some ibuprofen and take my temperature which 100.2. I couldn't get warm or comfortable and by 6 am, I managed to get up and send an email to my primary care doctor and lie back down. The phones were down at her office so by 10 am I went to the emergency room and was seen by Dr. He did blood work and gave me a shot for pain. After 2 1/2 hours there my temperature was 101.3 but I was sent home. I was really ill for 2 days and by the third day, was feeling better and the fever had gone. I don't know the manufacturer or any of the other information on the vaccine that I was given.
This spontaneous report was received from a nurse concerning a 11 yeas old patient of unknown gender. There was no information about the patients' medical history, concurrent conditions and concomitant therapies. On 10-JAN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number M017983 with expiration date of 30-MAY-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504.
This spontaneous report as received from a company representative via pharmacist refers to a 60 year old female patient. On 2014 the patient was vaccinated with ZOSTAVAX, 1 injection subcutaneous for prevention of shingles. On unknown date in June-2014 the patient called her physician reporting that she has experienced allergic reaction to ZOSTAVAX. The physician referred her to the emergency room and the physician found out later that the patient seemed to have allergic reaction to ZOSTAVAX. The patient needed sought of medical attention. No product quality complaint was reported. The patient was fine. The outcome of allergic reaction was reported as recovered/resolved on an unknown date. No additional AE information was provided. Additional information has been requested.
This spontaneous report was received from a physician via field representative refers to a 12 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patient was vaccinated with 2 doses of GARDASIL 9 injection, intramuscularly as routine vaccination for human papillomavirus (HPV), (lot#, expiry date and dosage details were not reported). On an unknown date, the patient experienced topical warts on the patient's fingers. The patient did not receive any treatment for the event. On an unknown date, within five months of receiving GARDASIL 9, the topical warts on the patient's fingers went away. No product quality complaint (PQC) was involved. The reporter did not provide any causality assessment.
REACTION; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced reaction, chills, and injection site pain. Treatment medications (dates unspecified) included: electrolytes nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and injection site pain, and the outcome of reaction was not reported. This report was non-serious.
Itchy hot rash on injection site uptil elbow; hot to touch rash on injection site which is extended uptil her elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy hot rash on injection site uptil elbow) and VACCINATION SITE WARMTH (hot to touch rash on injection site which is extended uptil her elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE WARMTH (hot to touch rash on injection site which is extended uptil her elbow). On 30-Mar-2021, the patient experienced RASH PRURITIC (Itchy hot rash on injection site uptil elbow). At the time of the report, RASH PRURITIC (Itchy hot rash on injection site uptil elbow) and VACCINATION SITE WARMTH (hot to touch rash on injection site which is extended uptil her elbow) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
This retrospective cohort study report has been received from the authors of a published literature, title as stated above. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV23).  A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 154 adult (60 year old to 64 year old) patients. On unknown dates the patients were concomitantly vaccinated with ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) and PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. The prescribing information stated that these vaccines should not be given concurrently. On unknown dates, the patients experienced incident severe herpes zoster. The outcome of drug the events was unknown. The reporter considered the vaccination failure and herpes zoster to be related ZOSTAVAX. This is one of several reports from the same literature (linked report MARRS # 1804USA010349, 1804USA010350, 1804USA010351, 1804USA010352, 1804USA010377).
patient inadvertently received 2 FLUZONE HD QIV vaccinations in a relatively short period of time with no reported adverse event; Initial information received on 31-Oct-2023 regarding an unsolicited valid  non-serious case received from a Pharmacist.  This case involves a 66 years old female patient where patient inadvertently received 2 influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] vaccinations in a relatively short period of time with no reported adverse event directly linked with extra dose administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included elasomeran (moderna covid-19 vaccine) for Prophylactic vaccination.  On 31-Oct-2023, the patient received 0.7 ml (TOTAL) dose of suspect influenza quadrival a-b high dose hv vaccine (lot- U8084BA and expiration date- 30-Jun-2024) via intramuscular route in the left deltoid (formulation, strength: not provided) for Immunisation (extra dose administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1/12: Nausea, mild vomiting (reflux), pain at injections site 1/13: More pain at injection site, nausea, mild vomiting, fever 99.7F, headache, sleeplessness 1/14: Less pain, no more nausea or fever
I became ill 24 hours after receiving my 2nd dose. I started with chills, cold sweats, headache,horrible body pain. No temp. I missed 6 days of work I was so sick.
"felt heavy" almost immediately p/receivng inject; 2 to 3 hrs later felt feverish, achey & exp congestion in throat & lungs, cough, chills;
pt recv vax  6MAR98 & devel gen rash, inc BP;tx w/DPH & sought medical treatment w/pvt MD;chem panels drawn & revealed inc glucose level;repeated 3wk later & glucose level nl;MD dx serum sickness;
Red spot at the injection site, 2-3 inches in diameter; Muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue) and VACCINATION SITE ERYTHEMA (Red spot at the injection site, 2-3 inches in diameter) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VARICELLA VACCINE in 2020.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue). On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at the injection site, 2-3 inches in diameter). The patient was treated with IBUPROFEN at a dose of unknown. At the time of the report, MUSCLE FATIGUE (Muscle fatigue) and VACCINATION SITE ERYTHEMA (Red spot at the injection site, 2-3 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Date of birth of patient, events, treatment drug and historical vaccine were added. On 13-Apr-2021: Email address and mailing address of the reporter added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified injection site reaction. At the time of reporting the outcome of the event was unspecified. It was reported that 3 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL. Another subject, A0949617A, experienced an entire arm reaction and chest reaction in addition to injection site reactions. This case was considered to be serious. Linked cases include A0949617A, A0950780A, A0950781A and A0950783A.
Increased post-nasal congestion, runny nose, sinus headache, reduced lung capacity.
Migraine headache began the next morning about 7am and increased as the day progressed including nausea and light sensitivity. Waves of nausea and headache continued into the next day. I had not had a migraine in over 2 years prior to this event. Treated with OTC Excedrin at first on Jan 10th, then when that was ineffective took butabital at lunch time and when that was ineffective took Maxalt with phenergan about 5p. The next day on Jan 11th, thought I was better but by 630a nausea returned in waves and headache began building again. Took Maxalt with phenergan about 930a and again at 9p.