chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a dose from a vial more than 30 days on the fridge; Inappropriate Schedule of vaccine administered; The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  Date the vial was initially stored in the refrigerator 20 Apr 2021. Patient had no adverse events.  No treatment information was provided.  The reporter stated that they received some vaccines on 20-Apr-2021 and on the same day they moved the vaccine and stored the vial into the fridge. On 14-Jul-2021, a patient received their second dose from the same vial which was stored more than 30 days in the refrigerator. The vial did not undergo any temperature excursions. HCP mentioned that there were 14 patients instead of 18 because of some duplicates.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Added reporter's fax number and no adverse events were updated.
Tingling, progressive weakness of legs. Seen 11/11/10 by neurologist that felt it was not Guillain Barre, but a strange reaction to flu vaccine. Resolved on own.
Redness at site right arm, pain at site right, swelling at site right arm, red streaks from site pm of 10/26/06 gone on 10/27/06.
within in 8 hours, flu-like symptoms; not taking the 2nd dose; chills all during the night; extreme muscle ache, especially in the shoulder; slight fever, estimated to be 100-101 (did not take temperature); felt like he was going to throw up but didn't; overall weakness or fatigue whatever you want to call it; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (within in 8 hours, flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (not taking the 2nd dose), CHILLS (chills all during the night), MYALGIA (extreme muscle ache, especially in the shoulder) and PYREXIA (slight fever, estimated to be 100-101 (did not take temperature)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SOTALOL, ALLOPURINOL, ASA and VITAMIN D3 for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (within in 8 hours, flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (not taking the 2nd dose), CHILLS (chills all during the night), MYALGIA (extreme muscle ache, especially in the shoulder), PYREXIA (slight fever, estimated to be 100-101 (did not take temperature)), NAUSEA (felt like he was going to throw up but didn't) and FATIGUE (overall weakness or fatigue whatever you want to call it). On 26-Feb-2021, INFLUENZA LIKE ILLNESS (within in 8 hours, flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (not taking the 2nd dose), CHILLS (chills all during the night), MYALGIA (extreme muscle ache, especially in the shoulder), PYREXIA (slight fever, estimated to be 100-101 (did not take temperature)), NAUSEA (felt like he was going to throw up but didn't) and FATIGUE (overall weakness or fatigue whatever you want to call it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes intreso 49-50 mg.  Treatment information was not provided. /unknown.
Admitted to hospital with subtle patchy left infiltrates and COVID-19 Antigen +, came in with known + test 6 days prior, developed severe headaches and fevers, dyspnea.
she continued to take her methotrexate and xeljanz medications; I am very upset; This is a spontaneous report from a contactable retired nurse/other hcp (patient herself). A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in left arm/left upper arm on 24Feb2021 (at the age of 71-years-old) as single dose for COVID-19 immunization. She previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, (Expiration date: It says First 31May2021, second it says 30Jun2021) on 03Feb2021 as single dose for COVID-19 immunization. The patient received TOFACITINIB CITRATE (Xeljanz, Batch/Lot Number: Unknown, Expiration Date: Unknown) and METHOTREXATE SODIUM (Methotrexate Sodium, Batch/Lot Number: Unknown, Expiration Date: Unknown) via an unspecified route of administration on an unspecified date for Rheumatoid arthritis. Medical history included rheumatoid arthritis and little higher on hearing from an unknown date and unknown if ongoing. Concomitant medication(s) included blood pressure medicine, Arthritis medicine, cholesterol medicine; however, unspecified and a medicine-Tegretol 200mg.  Retired Nurse stated that she was little higher on hearing. She was a Rheumatoid arthritis patient. She had been on Xeljanz and Methotrexate. She took the Pfizer shot in early 03Feb and then repeated again in 24Feb. She was never told to stop her medication and so she got antibody test on Friday and it said that she was negative for antibodies.  And she was just wondering could she get a third shot, and asking suggestion. She stated that "I am very upset about all this. My rheumatologist never told me to stop my medication, never get a hold on me anyway". She reported that she continued to take her methotrexate and xeljanz medications the entire time while receiving her vaccinations. She underwent a surgery recently. She was very upset about all this. She wants to know if her medications caused her not to have an immune response and how her antibody test can be negative. The patient underwent lab tests and procedures which included blood test: unknown and sars-cov-2 antibody test: negative with levels less than 100. The outcome of the event was unknown. The reporter stated about causality that retired nurse stated, she thought it was due to the medications (Xeljanz and Methotrexate).  Information on Lot/Batch number was available. Additional information has been requested.
The patient was found dead on 28th September. The deceased seemed to have struggled to stand up and fell onto the floor. There was a great deal of blood. The medical investigator immediately declared this death to be natural causes and refused to file a Vaers report stating that it had been too long (6 months and 2 weeks) and she would only file one up to 6 months; or carry out an autopsy which was requested by the various next of kin who were contacted, stating the body wasn't 'fresh enough'. Communications suggest the death occurred on 20th of September on the evening that the deceased had attended (and lead) a Meeting.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
One week, plus one day after getting the vaccine a rash appeared on my arm that itches and it hard to the touch. I am currently pregnant and am due on April 26th.
At approximately 3:10 AM on 4/24/21, three days after my second shot, my menstrual cycle came on, which was unexpected since it had just gone off on 4/4/21.  Also, prior to my cycle coming on on 3/29/21, I hadn't a cycle since November 2020.  I also begin having sharp pains in the calf muscle of my left leg at approximately 9:05 AM on 4/24/21 as well.
Dose number 1 start of drug 08Jan2021/Dose number 2 start of drug 25Jan2021; Rash at injection site, upper back, back of knee on right leg; generalized itching all over; This is a spontaneous report from a contactable 40-year-old female other healthcare professional reporting for herself   A 40 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medicao history included allergies to Latex, peniccillin, Tomatoes, and  Pineapple, diabetes mellitus and hypertension. The patient received first dose of BNT162B2 (Lot number:EJ1685) on 08Jan2021 intramuscular on left arm. Concomitant medications were not reported. On 26Jan2021 the patient experienced rash at injection site, upper back, back of knee on right leg and generalized itching all over. The patient did not received treatment for the events. The patient also experienced inappropriate schedule of vaccine administered as second dose was administered 17 days after first dose with outcome unknown. The patient had not yet recovered from other reported events.
Tired; This case was reported by a physician via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 29th July 2019, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and had very tired since then and asked did you know how long that was supposed to last because read that it was a side effect. The reporter did not consent to follow up. The potential adverse event unsure if it was a GlaxoSmithKline vaccine or Zostervax as no additional information was provided by the anonymous health care professional.  The health care professional refused to provide any contact information or further description of potential adverse event. Anonymous the health care professional disconnected chat prior to completion of chat.
Chills, body ache, inj site sore approx  12 hrs, followed by clammy, headache, fatigue, inj site sore for approx 12 hrs, then headache, fatigue, inj site sore for approx 12 hrs.     OK for 36 hrs then overnight chills followed by headache, lightheaded, slight sore throat to present
Traveling hives all over body, primarily on hips, scalp, forehead, chest, neck, elbows, and knees. Some hives on cheeks, shins, and stomach. Ears feel hot.  99 degree fever.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted, lost consciousness for a second and slid off administration chair. He regained consciousness & sat up immediately after even after recommending to him to stay laying flat. He assured us he was ok. He reported not eating before coming and having h/o fainting after shots and blood draws. NP took vitals T=96.4 F, P=58, R=16, BP 130/82. Glass of water given and patient walked out on own after about 30 minutes.
Pt recv vax on 5/17/98; on same day pt exp red & swelling at vax site
Information has been received from a Licensed Practical Nurse referring to a 6 months old infant of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-AUG-2015, the infant received an improperly stored dose of ROTATEQ (lot# K023535, dose and expiration date were not reported) orally. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Large, red, hard, hot area on arm where vaccine placed. Pt described area "increasing" since injection area measured at 3" in diameter and very hard and hot.
Information has been received from a licensed practical nurse and a nurse practitioner, concerning a 32 year old male patient with multiple sclerosis and no drug reactions or allergies reported, who on 11-MAY-2011 was vaccinated intramuscularly in the right deltoid, with a 0.5 ml dose of PNEUMOVAX 23 (Lot #: 668008/1157Z) (It was unknown if it was the first or the second dose). Concomitant vaccination included: a tetanus vaccine (manufacturer unknown) in his left arm. Concomitant therapy included REBIF, 44mcg in 0.5 ml subcutaneous syringe 1/2 ml, 3 times per week and oxycodone/acetaminophen, one 5mg/325 as needed. Licensed Practical Nurse reported that patient developed a reaction to the PNEUMOVAX 23. Nurse practitioner reported that on 12-MAY-2011, the patient noted that his right arm was "red, swollen, and painful to touch'. He had a rash at the injection site that continued to spread over the next few days. Nurse also reported that patient's temperature was 102.6 F up to 103 F and that he had muscle aches and malaise. She stated that patient also experienced discomfort with movement of his right arm. Nurse reported that the fever continued into 13-MAY-2011, and on 14-MAY-2011 patient was feeling better. His fever had subsided and his arm pain improved. His rash, however, had become worse. TYLENOL and STERAPRED  DS 10 mg tab in a dose pack for 6 days, were given as treatment for the events. No lab/diagnostic studies were performed. Patient sought medical attention through office visit. At the time of the report the patient was recovering. Additional information has been requested.
A non-serious spontaneous report of "gave H1N1 to children less than two years old and runny nose" has been received from a registered nurse concerning a 12-month year old male patient subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 29-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 29-Oct-2009, the patient experienced runny nose and was resolved on 30-Oct-2009. The outcome of the event was resolved.
fever started noon on 2SEP94, feeling sick to stomach; slept until around 8PM; temp then 101-102 R; started having convuls; taken to ER;
Headache, Sedation, Myalgia, Arthralgia, shortness of breath, pain and redness at the injection site
The first event involved my waking up with my face being bright red, itchy and extremely dry. It last for several days. I went to the doctor and he gave me a shot of cortisone in the hip and it did not help at all. The second event started, maybe, three days after I saw the doctor. The pain started in my joints. I couldn't raise my right arm. My fingers felt extremely painful. The pain went up my right arm, up to my shoulder and down to my left arm. I slept with my hand curled, I woke up and could barely move my hand. I noticed that the pain moved to my knees. I felt better if I kept moving. I went to the doctor for that and the doctor gave Ibuprofen 600 and the second doctor gave me Diclofenac. After receiving the diclofenac, I started to feel better. As of today, I feel fine, even though my face is still dry and itchy. There is going to be a procedure with carpal tunnel.
Pain onset about 2 hours after the injection from shoulder to elbow. Ongoing shoulder pain. Orthopedist treated with prednisone, celecoxib. Internist just increased gabapentin dose. Physical therapy. Continues to have shoulder pain interfering with pain.
Pt was placed for 30 mins watch after vaccination due to shellfish allergies. Pt began to complaint of itchiness in her abdomen, feeling of fatigue. Pt given diphenhydramine oral, 12.5 mg and 25 mg after 10 mins. Pt verbalized symptoms subsided. Pt educated with common side effects and advices if symptoms worsen to seek medical attention right away. Pt able to leave the vaccination site in stable conditions.
Patient was administered vaccine on 12/20/22that expired  12/2/22.  No adverse events reported from the vaccine or known issues.  The event is being reported due to the patient receiving a vaccine that was expired
The patient exhibited a vagal response to the Flu Vaccine, whereby he felt woozy, and biefly fainted, but quickly regained consciousness.  The patient was walked to a chair, elevated his legs, and was given water and cookies.  No medications were warranted.
36hr p/vax devel swollen, erythematous area of upper arm from shoulder to mid arm;
Adult publicly funded dose (1 mL) administered mistakenly instead of pediatric publicly funded dose (0.5 mL). No adverse reaction observed in clinic  or reported by child or parents upon notification via telephone approximately 1 hour later. Parents and child notified. Primary care physician of patient notified.
Briefly, this is a 75-year-old female with COVID-19 who is requiring high-flow nasal cannula oxygen to maintain her oxygen saturations above 92%.  She otherwise appears comfortable and is doing well.  Today in the emergency department, she had a CT of her chest which is negative for acute pulmonary embolism.  Pulmonary opacities are compatible with COVID-19 pneumonia. I have spoken with the CCOD and a reviewed the patient's care and current clinical status with him.  At this time, there is no vacancy in the ICU.  The patient has been deemed too high risk to go to the general medical floor.  We will continue to care for her here in the emergency department, wean her FiO2 as allowed.  Will continue to plan for critica Briefly, this is a 75-year-old female with COVID-19 who is requiring high-flow nasal cannula oxygen to maintain her oxygen saturations above 92%.  She otherwise appears comfortable and is doing well.  Today in the emergency department, she had a CT of her chest which is negative for acute pulmonary embolism.  Pulmonary opacities are compatible with COVID-19 pneumonia. I have spoken with the CCOD and a reviewed the patient's care and current clinical status with him.  At this time, there is no vacancy in the ICU.  The patient has been deemed too high risk to go to the general medical floor.  We will continue to care for her here in the emergency department, wean her FiO2 as allowed.  Will continue to plan for critical care admission once an appropriate bed becomes available.
flu-like symptoms with a loss sense of smell; flu-like symptoms with a loss sense of smell; This is a spontaneous report from a non-contactable consumer, reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date in Jan2021, the patient developed flu-like symptoms with a loss sense of smell and was wondering what she should do. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Case number PHEH2011US01170 is an initial spontaneous report received from a nurse on 05 Aug 2011. This report refers to an 18 years old male patient. He was vaccinated with MENVEO (batch number: A10047) intramuscularly on an unknown date. He was also vaccinated with three other unspecified vaccines on the same day as MENVEO but no information about these shots were provided. After vaccination he experienced redness, pain and swelling at the injection site which progressed to tingling in the fingers of the same arm and numbness in the same armpit, which later progressed to fatigue and weakness the next day. The reporter did not know if the reactions were related to MENVEO or other vaccines administered, since there were fainting and other similar types of reaction with other patients after other vaccinations. However, the reported did not have any specific details about any other patients that experienced reactions to other vaccines or the name of the vaccines. This event was also reported to vaccine adverse event reporting system (VAERS) website.
Sharp abdominal pains for two days.  Headache, swollen glands and unsteadiness for two weeks, off and on.
administered only the liquid portion of Menveo; administered only the liquid portion of Menveo; This was the booster dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA758A, expiry date 31-OCT-2024) for prophylaxis.   On 08-SEP-2023, the patient received Menveo. On 08-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid portion of Menveo), inappropriate dose of vaccine administered (Verbatim: administered only the liquid portion of Menveo) and extra dose administered (Verbatim: This was the booster dose).  The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt date: 08-SEP-2023 The reporter stated that she administered only liquid portion of Menveo to a patient. The reporter reported that this was a booster dose of Menveo that was given to patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter stated that she administered only liquid portion of Menveo to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter reported that patient received Menveo as booster dose, which led to extra dose.