chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:33 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 4:33 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 47.32.  Concomitant medication information was not provided by the reporter.  Vial was moved to fridge on 19-Apr-2021. Product moved to clinic on 29-Apr-2021. Batch number 007C21A administered on 29-Apr-2021 had  temperature 33 at 10:00 AM. Beyond use date for the vial was reported as 19-May-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Pain in arm when moving over a week later.  The pain is especially bad first thing in the morning and during the night but has been painful since flu shot.
Extremely bad period cramps came about week or so after the 1st shot. The pain made me physically ill. I never experienced this before in my life. So unsure what caused it.
Overnight the night of the vaccine:  severe chills, body aches, next day severe headache/migrane, mild nausea, weakness, winded, fatigue
Her shingles virus "woke up", she had the same nerve pain; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Her shingles virus "woke up", she had the same nerve pain) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced NEURALGIA (Her shingles virus "woke up", she had the same nerve pain) and HEADACHE (Headaches). At the time of the report, NEURALGIA (Her shingles virus "woke up", she had the same nerve pain) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received and outcome of the events were updated.
tiredness; Nausea, wanting to throw out; I was trying throw up I wasn't really throwing out; I was starting to gag; symptoms of COVID all over; Nausea, wanting to throw out; I was trying throw up I wasn't really throwing out; I was starting to gag; Today (May 07, 2021) feeling sick today; She couldn't move; I was unable to get up of my bed and get medicine or anything; couldn't get up; Mostly I feel lousy all over around; Bad headache; My arm was hurting a little bit then it started getting worsen, worsen and worse; It was very painful; dizziness/ I couldn't rest; I felt dizzy; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179) dose 1 via an unspecified route of administration, administered in Arm Right on 05May2021  as SINGLE for covid-19 immunization. Medical history included anxiety, depression, foot amputation, hand amputation and thyroid. Concomitant medications includ levothyroxine sodium (LEVOTHYROXINE) taken for thyroid disorder, clonazepam (CLONAZEPAM), duloxetine  and morphine sulfate (MORPHINE SULPHATE). The day when patient came home Wednesday her arm was hurting (stinging) a little bit then it started getting worsen, worsen and worse. It was very painful. When she tried to go to bed, she started getting the feeling symptoms of COVID all over that bad headache, dizziness, nausea, wanting to throw out and was feeling sick. She was trying throw up I wasn't really throwing out, but I was starting to gag and I couldn't rest, she felt dizzy. She was unable to get up of my bed and get medicine or anything, couldn't get up. Mostly She felt lousy all over around. She took medication last night and it helped her. She was going really badly was unable to get up to get my medicine. She couldn't move. Oxycodone (treatment) 30 mg no 10 mg. When asked If she have there was my blood doctor. She did lab test last week and there was her doctor of oncology it was blood work that they checked in everything checked out good. She just wanted to let they know that she was having these severe reactions and she did not know what to do. It was asked if it was ok to take medication and make her feel better, and she doesn't know what to do and was there anything she could do to make herself feel better or no she just had to wait it out. It was stated that 2nd dose will be 26May2021. The outcome of the events was not recovered.  No Follow-up attempts are needed. No further information expected.
SWELLING AND REDNESS AROUND THE INJECTION SITE . PATIENT HAD THE DISCOMFORT OF PAIN IN THE UPPER ARM AND THE MUSCLE AROUND THE INJECTION SITE FELT WARM AND INFECTED.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received COVID-19 treatment of Paxlovid from 15Oct2022 to 20Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial misuse report received from a healthcare professional on 27 September 2013. The case was received on 21 March 2014. A patient wanted FLUZONE HD but received regular FLUZONE. No adverse event was reported. List of documents held by sender: none.
sleepy; didn't have much energy; experienced jaw pain on his left side; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), ASTHENIA (didn't have much energy), PAIN IN JAW (experienced jaw pain on his left side) and MYALGIA (soreness in arm) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Stroke and Defibrillator/pacemaker insertion (had a stroke and has a defibrillator) since an unknown date.    On 16-Mar-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 SOMNOLENCE (sleepy), ASTHENIA (didn't have much energy), PAIN IN JAW (experienced jaw pain on his left side) and MYALGIA (soreness in arm). At the time of the report, SOMNOLENCE (sleepy), ASTHENIA (didn't have much energy), PAIN IN JAW (experienced jaw pain on his left side) and MYALGIA (soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    This case was linked to MOD-2021-211520 (Patient Link).
3 INCH SWOLLEN, RED BUMP ON LEFT ARM (SAME SIDE AS INJECTION), HOT TO TOUCH AND ITCHY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced 3 inch swollen, red bump on left arm (same side as injection), hot to touch and itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 3 inch swollen, red bump on left arm (same side as injection), hot to touch and itchy. This report was non-serious.
Fever, Headache, Shortness of Breath, Nausea, Body aches, difficulty tolerating drinking
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unknown doses of VAQTA (lot # L042631 with expiry date 16-DEC-2016; route was not reported), which were exposed to the temperature of 1.5 degree Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable nurse (Patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on30Dec2020 to 30Dec2020 at single dose for COVID-19 immunization. She had a history of pancreatitis and was hospitalized with elevated lipase levels one and a half weeks prior to getting her first dose in Dec2020. When she received the first dose she had recovered and her lipase levels were normal in Dec2020. Her gastroenterologist has scheduled her for a colonoscopy and upper endoscopy but would like for her second dose to be spaced out a week from her first dose. She is asking if there is any data to support efficacy of the second dose of the vaccine between days 28-32. The doctor stated she is okay as long as she gets the second dose of the vaccine within 5 months from the first dose. She had pancreatitis and needs to have a procedure for it. She was scheduled for second dose on 18Jan2021. She has an endoscopy and colonoscopy scheduled for 21Jan2021 and her GI doctor advised to postpone her second dose which she was told she should get 17- 21 days after her first dose since it would coincide with her procedure. She does not have a problem with the vaccine. She had a sore arm on an unknown date and was totally fine. The outcome of the event sore arm was recovered on an unknown date. Information on the lot/batch number has been requested.
Bell's palsy; Flu like symptoms; This is a spontaneous report from a non-contactable consumer reported that a female patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that the patient got Bell's palsy four days after the vaccine and had flu-like symptoms for two weeks. Added that patient is completely symptom free at the time of report. The outcome of the events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had firmness, heat, redness in arm. Had 100.1 fever. Had difficulty breathing that night (felt like she couldn't take in a full breath)  This was followed by a red strip below the injection site, from one side of the muscle to the other.
Patient reporting pain in left arm that she attributes to her flu shot. She experienced pain 1-4 hours after vaccination that resolved in 3-4 days, but she says the pain has returned now. Pain is "almost 6" on 1-10 scale and she is going to see MD about it. Does have arthritis in other shoulder per patient.
Patient started having chills for about 2 months in her arms, shoulders throughout her body, to her legs/Chills went away and started back up again; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Patient started having chills for about 2 months in her arms, shoulders throughout her body, to her legs/Chills went away and started back up again) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced CHILLS (Patient started having chills for about 2 months in her arms, shoulders throughout her body, to her legs/Chills went away and started back up again). At the time of the report, CHILLS (Patient started having chills for about 2 months in her arms, shoulders throughout her body, to her legs/Chills went away and started back up again) had not resolved.            No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Patient stated that she was oncerned with chills recur and may not get the 3rd dose.
Report 2001003649-1 describes joint pain in a male (age not provided) who received Lyme disease vaccine (Lymerix). The patient received an injection of Lymerix in October 2000. At some later, unspecified date, he experienced knee joint pain. The pain persisted as of 02/08/01. Additional information has been requested. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
NO ADVERSE EVENT OCCURRED. PATIENT RECEIVED A BOOSTER DOSE OF THE PFIZER VACCINE AT AN OFF-SITE CLINIC. PATIENT WAS UNDER THE AGE OF 18 AT THE TIME OF ADMINISTRATION.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 10-JAN-2014, the patient was vaccinated with improperly stored VARIVAX (merck). No adverse event reported with the administration. Causality assessment was not provided. This case linked to MARRS# 1401USA008069 (same reporter link). Additional information is not expected.
Infection inflammation - cellulitis. Treated with Clindamycin. Contacted pt - arm is healing - swelling going down.
Menactra given 9-11-07, repeat dose given in error on 4-10-08.  No adverse reaction noted.
Probable cellulitis; A spontaneous report was received from a consume concerning a 86 year old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed cellulitis, described as itchy arm/pruritus, red arm/erythema, inflamed arm/inflammation, hot arm/feeling hot, and sore arm/pain in extremity.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 30 Jan 2021, approximately ten days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient's arm began feeling itchy, red, inflamed, hot, and sore.  The patient was diagnosed with probable cellulitis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events itchy, red, inflamed, hot, and sore arm and cellulitis were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Very limited information regarding this events has been provided at this time.
Rash; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event rash on her both arms and her chest/rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M204) for prophylaxis of COVID-19 infection.  On 21 Feb 2021, nine days after receiving the vaccine, the patient experienced the event rash on both arms and her chest.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Mar 2021 the outcome of event rash was resolved.
I started having what I would describe air hunger, not SOB, I felt like did not feel right when I took breaths. There was something going wrong with my breathing. I started to have a lot of heart palpitations, I felt like my heart was having an extra beat, pounding and it would come and go for several months this was going on. I wore Z-patch a cardiac monitor. My blood pressure was elevated when I went to doctor's office and I do not know what caused this if it was due to the air hunger symptoms. The palpitations have gone away but the air hunger thing has improved but occasionally I still have it, and I don't feel right unless I take a deep breath. I do not have lot# to provide.
About 8 hours after receiving the vaccine, felt chills and muscle/joint aches as I did with the first Shingrix vaccine.  About 12 hours after receiving the vaccine, felt a very strong sense of hunger.  As I was preparing something to eat, I started feeling more feverish and heart was racing.  After eating a few bites, I could feel my temperature rise very fast (although I do not know my temperature), started breathing very fast and hard, and started feeling dizzy.  I called to my husband who was in another room.  He told me to slow down my breathing and I said I could not and then I fainted.  I woke up less than a minute later on the floor and my husband was calling EMS.  Paramedics arrived - temperature was fairly normal, glucose was in the 170s (normally it is in the 80s or 90s and sometimes low including a blood draw on 10/10/23 when it was 60), EKG was fine.  Suggested I go to the ER and was transported to the hospital.
Second dose past day 35 from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose past day 35 from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose past day 35 from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose past day 35 from first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
arms are hurting; shoulders are hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arms are hurting) and ARTHRALGIA (shoulders are hurting) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0342250) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (arms are hurting) and ARTHRALGIA (shoulders are hurting). At the time of the report, PAIN IN EXTREMITY (arms are hurting) and ARTHRALGIA (shoulders are hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
very inflamed; sore arm; red rash on left arm, stomach and legs; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (very inflamed), PAIN IN EXTREMITY (sore arm) and RASH ERYTHEMATOUS (red rash on left arm, stomach and legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced INFLAMMATION (very inflamed). 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH ERYTHEMATOUS (red rash on left arm, stomach and legs). On 28-Feb-2021, INFLAMMATION (very inflamed) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash on left arm, stomach and legs) outcome was unknown.            Treatment includes Triamcinolone.
diarrhea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PAIN IN EXTREMITY (sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), PRAZOSIN, VITAMIN D NOS and LORAZEPAM for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications include Allergy medicine. No treatment information was provided.
chills, lt shoulder myalgia; pt instructed to take Advil/APAP;