chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had popped a vial of Moderna Covid-19 yesterday on 13APR2022 and doses wereadministered from the vial greater than 12 hours later.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she had popped a vial of Moderna Covid-19 yesterday on 13APR2022 and doses wereadministered from the vial greater than 12 hours later.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (she had popped a vial of Moderna Covid-19 yesterday on 13APR2022 and doses wereadministered from the vial greater than 12 hours later.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she had popped a vial of Moderna Covid-19 yesterday on 13APR2022 and doses wereadministered from the vial greater than 12 hours later.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The dose was administered >12/24 hours post puncture. Date the vial was initially stored in the refrigerator was on 04 Apr 2022. The vial was first punctured on 13 Apr 2022 at 8.53 AM and the vial was stored in refrigerated post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was less than 15 minutes.  No treatment medications were reported.   This case was linked to MOD-2022-540270 (Patient Link).
Very tired; The medication knocked him down; unable to do anything; Suspected vaccination failure; Shingles; Blisters; Shingles blisters were red; Shingles blisters were very itchy; Severe pain where the ribs touch the sternum; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2018, between 3 and 4 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, erythema, pruritus and pain. On an unknown date, the patient experienced tiredness, feeling unwell and activities of daily living impaired. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, tiredness, erythema, pruritus, feeling unwell and activities of daily living impaired were unknown and the outcome of the blister was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, tiredness, erythema, pruritus and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling unwell and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and 2nd dose of Shingrix and was diagnosed with Shingles. The blisters were on the left chest under the breast and continued around under the arm to the left back.  The blisters stopped at the spine.  He was prescribed acyclovir 800mg three times a day for two weeks and acyclovir ointment twice daily on the blisters.  The medication knocked him out, making him very tired and unable to do anything.  The patient had had no life for six weeks.  The shingles blisters were red, and very itchy.  The only pain he felt was 10 days prior to the blisters appearing, he had severe pain where the ribs touch the sternum. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter knew the manufacturer of the acyclovir - Camber pharmaceuticals, and will contact them to describe his experience with their product. The reporter consented to follow up.
Client was given an injection with a syringe and the vaccinator later realized after the client had left the building that the vial did not contain COVID-19 vaccine. The vaccinator was greater than 80 percent sure that she administered the dose without the vaccine in the syringe. She brought the problem to the clinic supervisor?s attention when it seemed that the vaccinator assistant was opening up syringes and placing them in the same bin as the vaccinator?s pre-drawn syringes. Both contacted the CDC to get guidance on whether the client can be administered the vaccine as a Dose 1. The CDC was seeking further guidance on the issue. Both contacted the client that evening and explained that it was very likely that the client did not receive COVID-19 in the syringe. The client voiced understanding. It was determined by Dr. that vaccinator would contact the client once per day to check signs and symptoms to help determine if the client may have received the vaccine. It was believed that 24 or more hours of soreness at the site may lead one to believe that she did receive the vaccine. Vaccinator monitored the client for three days following the vaccine and found that the client had not signs or symptoms following the vaccine. 1/16/2021 CDC responded by saying that there is no guidance on this issue but that the client should receive the vaccine, as Dose 2, 28 days from the initial administration. The earliest date would be Saturday, February 6, 2021. Vaccinator contacted the client and explained the guidance. The client voiced understanding. Vaccinator will monitor the Dose 2 to see if there are signs and symptoms following the vaccination. The results may give us more understanding of whether the client received COVID-19 in the first dose according to her signs and symptoms following the second dose.
p/vax w/in 24hr devel pruritic maculopapular localized rash in rt deltoid, lt deltoid, lateral trunk posterior thigh patches R>L;no accompanying SOB, throat swelling, fever, pain;rash persistent but resolving on 6/20/99;
Based on Significant Correction performed on 03-FEB-2015, this case initially considered as non-serious was upgraded to serious as the modified event term 'Pulmonary Congestion' existed in IME List. Initial report received from healthcare professional on 4 December 2014. A 30-year-old male patient, whose concomitant medications were not reported, had received first dose of FLUZONE (batch number UI198AD, intramuscular and anatomical site of administration was not reported) having expiry date 30 June 2015 on 3 December 2014. The patient is allergic to penicillin and hydrocodone. It was reported that on 3 December 2014, on the same day after receiving FLUZONE vaccine, the patient experienced chest congestion. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None. Follow-up information received from the healthcare professional on 03-Feb-2015. Patient was vaccinated with FLUZONE intramuscularly in left arm on 03-Dec-2014. Lab investigations were reported as unknown. Corrective treatments were reported as CRESTOR (10 mg) and Sertraline (100 mg). Patient appears fine now and no lasting adverse effects were reported. Documents held by sender: none. Addendum on 03-FEB-2015: Upon second medical examination of case at time of internal review a significant correction was performed to change the event coding for 'chest congestion' from respiratory tract congestion to pulmonary congestion. As the event was present in IME list, seriousness criteria and company assessment added to the case; however listedness remains the same.
Intense pain-headache, right ear and shoulder spasms-difficulty sleeping, followed by rash, open sores, crusting. Treatment: 3 Rx (anti-viral, pain narcotic, corticosteroid) over 3 weeks. Intense itching, difficulty driving, side effects.
Patient began to feel dizzy during after 15 minutes in waiting area. Took blood pressure and  visually monitored patient. Blood pressure was a little low.  Dizziness began to improve but then patient said distance vision began to seem a little blurry. Gave patient some orange juice. He had not eaten lunch before the shot. He soon  started feeling better and his blood pressure increased.  After 15 more minutes he felt well enough to leave and declined offer to call paramedics.
Starting day of injection, severe arm pain, fatigue, lymphnodes in that armpit so large I cannot put my arm down. Fever, chills.   Today Dec 6, tremors in hand with tingling
ACUTE DVT, UNSPECIFIED VEIN ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA ALLERGIC REACTION, INIT 8/24/2022  &  8/27/2022  --  RECURRENCE OF SAME SYMPTOMS
Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: pt stated couldn't breath, and took benadryl. Took blood pressure, pulse and O2 sat all were within normal limits.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 28-MAY-2016, the patient was inadvertently vaccinated with a third dose of VAQTA. The patient completed the series several years ago. No adverse events were reported. This is one of the two reports received form the same reporter. Additional information has been requested.
accidentally left the refrigerator door open too long/3 separate excursions with the same vaccines. Total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes with no reported adverse event; accidentally left the refrigerator door open too long/3 separate excursions with the same vaccines. Total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes/administered to the patient: Yes with no reported AE; Initial information was received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 6 months old female patient who experienced accidentally left the refrigerator door open too long/3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and accidentally left the refrigerator door open too long/3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes/administered to the patient: yes with no reported ae after receiving ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Jun-2023, the patient received a dose of 0.5 ml of suspect ipv (VERO) (Suspension for injection) (lot V1A021M, Expiry date : 27-Feb-2024) (strength: provided as standard) via intramuscular route in unknown administration site for Immunization and developed a non-serious event of accidentally left the refrigerator door open too long/3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) and accidentally left the refrigerator door open too long/3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes/administered to the patient: yes with no reported ae (poor quality product administered) (latency : same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event accidentally left the refrigerator door open too long/3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and was Unknown for the event accidentally left the refrigerator door open too long/3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes/administered to the patient: yes with no reported ae.  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 guidelines. 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.
felt miserable; arm very sore; chills; fever; headache; armpit sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003DR, 006C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and AXILLARY PAIN (armpit sore). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 16-Nov-2021, CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) had resolved. At the time of the report, MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore) and AXILLARY PAIN (armpit sore) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Lot number for booster dose was reported as 003DR?? (not readable).  This case concerns a 54-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Pain in Extremity and expected events of Chills, Pyrexia, Headache and Axillary Pain. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events of Chills, Pyrexia, Headache and Axillary Pain are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Pain in Extremity and expected events of Chills, Pyrexia, Headache and Axillary Pain. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events of Chills, Pyrexia, Headache and Axillary Pain are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Menstrual cycle changes. Breast pain and discomfort, stabbing headaches, dizziness.  Irregularity in cycle. Bleeding longer.    9 months later still experiencing occasional wobbly feeling, stabbing headaches that come and go. Memory issues. Disorientation for split seconds.   Brain fog.
Late that night I started to ache in every joint it seemed.  No fever, no respiratory problems, continuing with fatigue, and increased frequent urination throughout the day on April 8th  Felt almost normal by dawn Friday 9th of April.
Dose #1 Moderna Lot # 010M20A 01/29/2021
SEVER FLU LIKE ILLNESS OF FEVER, MUSCLE ACHE, JOINTS ACHES, CHILLS, SWEATING, HEADACHE, LOW APPETITE . SYMPOMS WERE DEFINITLY WORSE THAN REACTION I USUALLY GET AFTRT FLU VACCINE . HOWEVER, ITS SIMILAR OR MAY BE WORSE THAN REACTION I USUALLY GET AFTET TETANUS DIPHTERIA TD VACCINE. I AM NOT SURE IF HAVING HAD COVID1 9 IN MARCH 2020 MADE MY BODY OVER REACTING THE THE VACCINE DUE TO ALREADY PRESENCE OF ANTIBODIES.  TO RESTED FOR 48 HRS WITH HYDRATION AND TYLENOL. 90 %  OF SYMPTOMS ARE GONE AFTER 48 HRS.
Information received concerning a 72 year old female pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis.
Patient states they were seen by their primary care physician and diagnosed with reactive airway disease as a result of this RSV.
mom reports pt has cried on & off since 3hr p/vax;appetite dec, 15min induration @ site of inj;mom feels still has pain @ site;no rash;no breathing diff;loose stool this AM;fever through noc;
This spontaneous case reported by a consumer, describes the occurrence of rash (rash on torso, back, stomach and chest), erythema (redness on torso, back, stomach, chest) and pruritus (itchiness on torso, back, stomach, chest) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 052E21A) for COVID-19 immunization. No medical history reported. On Sep 20, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (rash on torso, back, stomach and chest), erythema (redness on torso, back, stomach, chest) and pruritus (itchiness on torso, back, stomach, chest). Patient treated with prednisone for itching, at an unspecified dose and frequency. At the time of the report, rash (rash on torso, back, stomach and chest), erythema (redness on torso, back, stomach, chest) and pruritus (itchiness on torso, back, stomach, chest): not resolved. Patient said about 10 days after he received his 3rd shot he developed a rash, itchiness and redness on his torso (back, stomach and chest). Patient doctor prescribed him prednisone to relieve the itchiness. And patient asked how long should this last. No concomitant medications mentioned.
The patient got the vaccine on 05/16/2021. Mom called on 05/17/2021 and informed that patient developed rash on inner thigh on the morning of 05/17/2021 .He was fine all day on 05/16/2021 and woke up with a rash in his inner thigh. Mom gave him Bendryl but he called mom again after few hours with a rash on his hand. Mom took the child to urgent care in the afternoon and the doctor was confused as to why he got a rash after more than 12 hours later. The doctor was not sure if it was due to the vaccine. The doctor advised Benadryl and gave a prescription of prednisone to keep on hand incase symptoms worsen.
vesicular rash and redness developed 2 days after covid vaccine.  Being treated for shingles/cutaneous herpes zoster; vesicular rash and redness developed 2 days after covid vaccine.  Being treated for shingles/cutaneous herpes zoster; This is a spontaneous report received from a contactable nurse (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0153), via intramuscular in left arm on 19Apr2021 at 13:30 (at the age of 51-year-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included myelodysplastic syndrome from an unknown date and unknown if ongoing, chicken pox from an unknown date and unknown if ongoing (as a child), thrombocytopenia from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and multivitamin taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine, demerol apap, vicodin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced vesicular rash and redness developed 2 days after covid vaccine (21Apr2021). being treated for shingles/cutaneous herpes zoster. Device Date was 27Apr2021. The case was reported as non-serious. The adverse events were resulted in emergency room/department or urgent care. Anti-viral, antipruritic, and pain medications were received as treatment for the events. The outcome of the events was reported as resolving.  No follow-up attempts are needed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist concerning a 64 year old female patient with no known drug allergies and a medical history of left knee replacement who was vaccinated SC with a 0.65 ml dose of zoster vaccine live (Oka/Merck) on 27-DEC-2007. It was reported that the patient also had a "flu shot (unspecified therapy)" on an unspecified date close to the time of the zoster vaccine live
Loss of appetite; Fatigue; Headache / headaches are intense / occur when going from a sitting to a standing position /  headaches are more constant at night and concentrated at the back of the neck and head; headaches are more constant at night and concentrated at the back of the neck and head; muscle soreness; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   In March 2021, the patient received the 2nd dose of Shingrix. In March 2021, 1 day after receiving Shingrix, the patient experienced muscle soreness, pain in arm, appetite lost, fatigue, headache and neck pain. On an unknown date, the outcome of the muscle soreness, appetite lost, fatigue, headache and neck pain were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the muscle soreness, pain in arm, appetite lost, fatigue, headache and neck pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient received second dose of Shingrix in left arm, 16 days ago from reporting day. The patient continued to experience residual side effects including headache, fatigue, muscle soreness, lack of appetite. On an unknown date, less than 3 weeks after vaccination, the patient also reported experiencing arm soreness, which went away after 3 days. The fatigue, headache, muscle soreness, and lack of appetite began the day after receiving second dose. The patient reported symptoms have gotten worse overtime. The headaches were intense and usually occur when going from a sitting to a standing position. The reporter reported headaches would subside when they begin walking around. The headaches were more constant at night and concentrated at the back of the neck and head. The reporter did not consent to follow up.