chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was placed in refrigerator on 25 Sep 2021 and vaccine was administered on 10 Dec 2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 25 Sep 2021 and vaccine was administered on 10 Dec 2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 25 Sep 2021 and vaccine was administered on 10 Dec 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 25 Sep 2021 and vaccine was administered on 10 Dec 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.Reporter stated that the vial did not undergo any temperature excursions and on 25 Sep 2021 the vial was placed in refrigerator and patient did not experienced any adverse event. No treatment medications were reported.
Red rash at site of injection - 2 days after injection upper arm swelling, itching & heat - 3 days after inj - 8/24/12 (1) 25 mg BENADRYL 8/25/12 (1) 25 mg BENADRYL 8/26/12 (1) 25 mg BENADRYL } help ease discomfort itching and burning.
Patient got vaccinated at about 6-7 weeks gestation and 2-3 hours after vaccine had a napkin full of blood come out of her and then has been spotting since. Came in for appt 4/27 and was still spotting. Ultimately hcg levels kept increasing and as of 5/11 baby has HR 150 and is doing well.
Flu-like symptoms that persisted more than two weeks. Body aches. Nausea. Lethargy. Sadness. Hopelessness.
Given 2nd dose of Hep B on Thursday 4/25/03. Employee was asymptomatic until 4/29/03 when she states hands, knees and ankles swelled. No associated pain, redness, etc.
Patient is a 64 y.o. male patient of CNP with history of MRDD, CKD, seizure disorder, hypertension, tracheostomy/GJ tube placement, who resides at nursing facility, presented with cough, shortness of breath and increased tracheal secretions, found to have acute hypoxemic respiratory failure.   Patient unable to provide history due to MRDD, I met with one of her caregivers at bedside, noted 2 days of cough, increased secretions/suctioning requirements, and shortness of breath in addition to hypoxia.    Acute hypoxemic respiratory failure Concern for pneumonia, multidrug-resistant S/p tracheostomy but no oxygen at baseline History of prolonged hospitalization secondary to pneumonia Chest x-ray 1/4 reviewed low lung volumes.  Some atelectasis versus opacities within the lower lobe bilaterally.     Chest x-ray 1/11 personally reviewed?low lung volumes with some bronchovascular crowding.   Echocardiogram in August reviewed?normal EF normal diastolic function. Some pulmonary congestion due to IV fluids. Status post 10 days of IV Zosyn.   Tracheal cultures and antigen negative. Now down to room air just using T-piece oxygenation for humidification. Okay to discharge back to group home.   Covid-19 Virus Infection Pneumonia secondary to COVID Date of onset of symptoms: 1/3/23 Symptoms present on admission: Shortness of breath  Date of covid positive test: 1/4/2023 Vaccination status: vaccinated status post 3 doses of Pfizer Imaging: Chest x-ray, past reviewed, lower lobe airspace disease Oxygen requirements on admission: Trach mask, 10 L Current oxygen requirements: RA Medical therapy: steroids Consultants following: Infectious disease starting remdesivir  Anticipated special isolation end date: January 14 LDH ESR and CRP 23.5    S/p remdesivir and dexamethasone.   AKI resolved Resolved with IV fluids.   GJ feeding tube Status ISOSOURCE HN at 20ml/hr w/ 100ml free water flush q 4 hours; ADVCANCE 10ml/hr q 4 hours to GOAL: ISOSOURCE HN at 70ml/hr w/ 100ml free water flush q 4 hours(HOLD 1 hour before and after synthroid) Abdominal x-ray reviewed satisfactory position of jejunal feeding tube
04/04/22 I began to feel a headache coming on. My nose then began to drip, throat began to get very sore and congestion began to come on. On the 9th of April I took the covid-19 test and came out positive. I then contacted my physician who instructed me to get rest and drink plenty of fluids, and I also called the covid-19 hotline that stated the same recommendations and to stay isolated 5-7 days. I am starting to feel much better than I was before but I am slightly tired.
Chills; general Fatigue; developed on bump on her right cheek / near her right ear; bright red round pink growth near her ear / as the size of a pencil erasor; she broke out and a big pimply rash appeared on her right cheek; bright red round pink growth near her ear / as the size of a pencil erasor; This case was reported by a consumer via call center representative and described the occurrence of chills in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 3 months after receiving Shingrix, the patient experienced papular rash and erythema ear. On an unknown date, the patient experienced chills, fatigue, rash and ear swelling. The patient was treated with nitrogen (Nitrogen, Liquid). On an unknown date, the outcome of the chills and fatigue were recovered/resolved and the outcome of the rash and ear swelling were unknown and the outcome of the papular rash and erythema ear were not recovered/not resolved.   It was unknown if the reporter considered the chills, fatigue, rash, papular rash, erythema ear and ear swelling to be related to Shingrix.  Additional details was reported as follows: After getting the first Shingrix injection, the patient developed on bump on her right cheek and near her right ear, she began having chills and general fatigue. The patient broke out and a big pimply rash appeared on her right cheek. She states that this had not resolved. She also reported a bright red round pink growth near her ear appeared. She described this growth as the size of a pencil erasor. She stated that her dermatologiest burned this growth off with liquid nitrogen on an unknown date. All those symptoms resolved without intervention. No further information was provided. Consented to follow up was unknown. The patient was unable to report the lot number, expiration date, or dosage of the shingrix dose she received.  For tolerance of 2nd dose, refer linked case US2021AMR063209.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063209:same reporter
Received PREVNAR two days ago, left arm became swollen and fever to 101.0 sweaty chills, body aches and headaches.
Every time patient got one patient got sick; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who got one and got sick (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that every time patient got one patient got sick (illness), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Shoulder pain, hard to move the arm, pain 8/10, red raised spots on arm in area of injection site.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No adverse reactions were reported by patient. No concomitant and treatment medications were reported.
sore arm,  fatigue,  muscle and joint pain in the body full day after the shot
Same day post vax, pt reported "muscle soreness and spasms" and a "terrible weak feeling" in both of her legs while undergoing post exposure treatment to rabies.  Left leg continued to experience symptoms. Also reported numbness and tingling in the fingertips. On 09/02/98 pt reported to have "chronic anxiety. It is felt that symptoms were likely on that basis rather than vaccine reaction."
Palm-sized dry rash localized to the injection site (injection site rash). Subject is a military person who had received 4 previous doses of Anthrax vaccine (last does in 2004) prior to receiving his 5th dose on 7/11/08. Approximately a day later he developed a palm-sized dry rash localized to the injection site area. The rash was nearly resolved when the subject returned for plasma collection on 7/25/08 and he proceeded with the plasma collection. No latex sensitivity, no prior immunization AE. He has a history of psoriasis/ eczema like condition until approximately age 10. 6/18/08 Subject has recovered no further issues.
Loss of taste; Loss of smell; sore throat; symptoms of COVID-19; suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose; Headache; fever; This spontaneous case was reported by a physician and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose), HEADACHE (Headache) and PYREXIA (fever). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose), HEADACHE (Headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 information was provided.
Patient got her 2nd Pfizer Covid-19 shot at 5:45 PM on Tues 6/8. She had some of the typical side effects the next day- a sore arm, flu-like body aches, a headache and fatigue. In the middle of the night Wed night/Thurs morning at 3AM she woke up with chest pain and difficulty breathing. In her words, her "heart really hurts and it is hurts to breath." I gave her 1 (500 mg ) capsule of Tylenol. This was the first pain reliever she had received post shot. She also applied Frankincense oil over her heart. Patient was unable to go back to sleep for a few hours because it hurt too much. She did finally fall back asleep in the early morning hours. Yesterday (Thursday 6/10) she reported that she was feeling a lot better. Her heart was still a little painful but by today, Friday 6/11, she says she feels fine.  When I heard on the news about a number of other children between 12-15 who reported heart pain, I thought we should let you all know. I am a little worried that there might be some kind of long term complication for her heart.
rash near and around the site of injection; hard, red, solid, itchy injection site; hard, red, solid, itchy injection site; hard, red, solid, itchy injection site; swelling near around her site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard, red, solid, itchy injection site), VACCINATION SITE PRURITUS (hard, red, solid, itchy injection site), VACCINATION SITE SWELLING (swelling near around her site of injection), VACCINATION SITE RASH (rash near and around the site of injection) and VACCINATION SITE ERYTHEMA (hard, red, solid, itchy injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard, red, solid, itchy injection site), VACCINATION SITE PRURITUS (hard, red, solid, itchy injection site), VACCINATION SITE SWELLING (swelling near around her site of injection) and VACCINATION SITE ERYTHEMA (hard, red, solid, itchy injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (rash near and around the site of injection). At the time of the report, VACCINATION SITE INDURATION (hard, red, solid, itchy injection site), VACCINATION SITE PRURITUS (hard, red, solid, itchy injection site), VACCINATION SITE SWELLING (swelling near around her site of injection), VACCINATION SITE RASH (rash near and around the site of injection) and VACCINATION SITE ERYTHEMA (hard, red, solid, itchy injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication not provided by the reporter.  Treatment information was not provided by the reporter.
This spontaneous report was received from a Licensed Practical Nurse concerning 2 patients of unknown age. On 12-MAR-2014, the patients received the 1st dose of RECOMBIVAX HB 10 Y (lot number and other details unspecified), the 2nd dose of RECOMBIVAX HB on 24-APR-2014 and the 3rd dose of RECOMBIVAX HB on 30-MAY-2014. No concomitant therapy was reported. It was reported that, "the spacing between the 2nd and 3rd dose was too close". However, no adverse effects were reported. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to RECOMBIVAX HB. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 17 year old female with no medical history and drug allergies who on 31-DEC-2008 was intramuscularly vaccinated with the third 0.5 ml dose of GARDASIL. She had no problems after receiving the 1st and 2nd doses of GARDASIL. At 22:30 on 02-JAN-2009, 48 hours later, the patient experienced seizure type activity and convulsions, 2 more occurred by 23:30 during which time she was taken to the hospital. It was decided in the emergency room to take the patient to a hospital early on 03-JAN-2009. The patient had a total 13 seizures type activities or convulsions but it was unclear the specific time frame. Laboratory tests included an magnetic resonance imaging, ultrasound of the kidney, and "lots of unspecified lab work" (one of the results were normal kidney function). The patient has one more episode after being discharged from the hospital on 04-JAN-2009. The patient was put on XANAX and her mother felt it had helped control the seizure type activity and convulsions. The patient started KEFLEX and AZO for urinary tract infection on 02-JAN-2009. The seizures type activities or convulsions was considered to be disabling. Additional information has been requested. 2/2/09-records received for DOS 1/3-15/09-DC DX: Spells. presented to ED with difficulty breathing, rash and episodic jerking. Rash on back, chest and neck and felt short of breath. Rash would come on with shaking and improve when shaking stopped.
Pt reported experiencing a relapse of MS symptoms after receiving second dose of the Moderna COVID-19 vaccine. Pt was hospitalized for four days. PAE reported by Pt. Pt did consent to follow up.
had second dose of shingles vaccine this date.Have had severe diarrhea associated with fluctuating abdominal pain, anorexia, headache, severe fatigue, chills, low grade fever with diarrhea, fatigue and chills continuing to this date.Symptoms begun 10/23/19. Also had site injection pain immediately which has diminished significantly. 1st vaccine only had site soreness and itching. This reaction was very unexpected. Missed 2.5 days of work.
This spontaneous report as received from a healthcare worker refers to a 15 month old patient of unknown gender. Information regarding the patient's medical history and current conditions were not provided. On 25-JAN-2016 the patient was vaccinated with improperly stored dose of VARIVAX (Merck), lot number-L035129 and expiry date-14-SEP-2017). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report was received from a licensed vocational nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter informed that on an unknown date in March 2014 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular, (lot # and expiration date were not reported) and on an unspecified date in March 2015 received the second dose of GARDASIL 0.5 ml, intramuscular, (lot # and expiration date were not reported). No adverse experience reported. Additional information has been requested.
Skin cancer; 1st dose: 22Apr2021, 2nd dose 03Jun2021; Tightening of the neck muscles; A lot of headaches; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (Skin cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 22Apr2021, 2nd dose 03Jun2021). In June 2021, the patient experienced MUSCLE TIGHTNESS (Tightening of the neck muscles) and HEADACHE (A lot of headaches). In September 2021, the patient experienced SKIN CANCER (Skin cancer) (seriousness criterion medically significant). The patient was treated with MARIJUANA for Adverse event, at an unspecified dose and frequency and Surgery (Removal surgery) for Skin cancer. On 03-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 22Apr2021, 2nd dose 03Jun2021) had resolved. At the time of the report, SKIN CANCER (Skin cancer), MUSCLE TIGHTNESS (Tightening of the neck muscles) and HEADACHE (A lot of headaches) outcome was unknown.            No concomitant medications were provided.  Company comment: This Spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, serious (Medically significant) event of skin cancer. Inappropriate schedule of product administration is also reported. The patient experienced tightening of the neck muscles and headaches on an unknown date after the second dose of mRNA-1273 vaccine. He took OTC marijuana which helped him relieve the symptoms. He also stated that he had skin cancer in 3 months after vaccination and had removal surgery. The patient denied providing further information. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405966 (Patient Link).; Sender's Comments: This Spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, serious (Medically significant) event of skin cancer. Inappropriate schedule of product administration is also reported. The patient experienced tightening of the neck muscles and headaches on an unknown date after the second dose of mRNA-1273 vaccine. He took OTC marijuana which helped him relieve the symptoms. He also stated that he had skin cancer in 3 months after vaccination and had removal surgery. The patient denied providing further information. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.