chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 3:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 75.00 years.  Concomitant products were not provided.  On 23-Mar-2021, the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021, 15 vials were moved to the clinic. On 28-Mar-2021, at 10 AM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 22-Apr-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
On January 25, 2021 I developed extreme tinnitus primarily in my right ear 8 hours after my injection ( although sometimes in both ears or just left ear). It stopped at times and varied in the quality. Sometimes pounding like a bass drum beating in random Morse code, sometimes in sync with my heart beat. Sometimes I could stop it by tipping my head back, though not always. It was so loud it affected my ability to hear what others were saying. I had a sinus infection and probable lung infection (was coughing up a lot of  dark green phlegm at the time I got the injection and had coughed up blood a few times the week before my vaccination + had had a minor bloody nose with the coughing up blood.) Started antibiotics on January 27. This helped with the sinus/lung infection but the tinnitus continued for 5-1/2 weeks. It stopped about 3 days before I got my 2nd vaccination. (Because of supply shortage, I had to wait almost 6 weeks before getting dose #2.) I did not have this reaction to dose #2. Today I occasionally hear minor bass drum-like beats, but is rare and much quieter.
This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient got vaccinated and 4 to 6 weeks later had shingles. The reporter stated that, the vaccine was not safe. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Redcolored, swelled, itching.  Benedryl, Cortisone for 7 days.
This case was reported by a consumer and described the occurrence of injection site redness in a 2-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 02 May 2006 the subject received 3rd dose of Infanrix in the right thigh. On 03 May 2006, 1 day after vaccination with Infanrix, the subject experienced injection site redness, injection site blisters and "yellow/purple spots" at the injection site. The subject was seen at the physician's office. At the time of initial reporting, 05 May 2006, the events were ongoing.
The day after the second Moderna shot I had a fever of 100.8, aching bones throughout my body. Arms ,neck back, legs and feet. Headache and burning and stinging eyes. I called the hospital and they advised that I follow up if there was no improvement. I have very little energy and am resting.
after about 1 min after vaccine pt stated she did not feel well and fainted. pt seated at all times provider called to room and was notified of reaction, provider spoke w/mother and patient, once patients vitals were stable and pt appeared better provider gave ok to discharge
Saturday evening injection sight started hurting.  Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness
05/14/2021  Sudden hearing loss in left ear.  Pressure in ear.   Sound amplified in right ear.  In evening schirping starts in left ear.  Progresses to constant static and sound of trickling water by next morning.  As of 05/20/2021 conditions have remained stable: hearing loss and tinnitus the same.   No history of hearing related issues.
Immediately after the injection I had a metal taste in my mouth however no other symptoms. I was told I may have a sore arm and have flu like symptoms the following day. I waited 15 minutes after the injection at the pharmacy to ensure I didn't have any life threatening effects which I did not. On my ride home, I started having a shooting acute pain in my right leg with pressure. The pain persisted for 20 minutes or so then subsided. Later that evening, I started having more shooting acute pains all over my body like the one I had in my leg and they would subside as well like the first instance. The next day I felt ok except for the metal taste in my mouth and the pains but felt ok enough to engage in physical activity (swimming). By that afternoon the pains increased in frequency coupled with migraines. That evening, I was awoken by my heart racing in addition to pains all over my body. The next day 8/26/21 I had a telemedicine appointment with my doctor's office. The pain and racing would subside so I did not feel it was appropriate for a ER visit. The office requested I have blood work done to confirm I did not have any blood clots. The results came back negative (everything was ok from the tests). The next few days the pain, racing heart and metal tastes continued but were slowly decreasing in frequency however I started feeling mentally foggy (difficulty recalling words/speaking). 8/31/21 I had a follow-up telemedicine appointment and was told I should have an in-office EKG done to confirm my heart was ok. 9/1/21 I went to my doctor's office and had the EKG done. My results were normal. My doctor advised me to reduce my activity level and ease back into my prior routine (running, swimming, biking, walking - daily) and I should report what happened to the CDC as I had an adverse event. Over the next few days the pains were decreasing in frequency, the metal taste went away and my heart was not racing as often. My last episode of my heart racing with a concurrent migraine was 9/14/21 and occurred only once that day. As of today, 9/17/21 I feel ok and plan on trying to workout again (at a moderate pace, though).
This case was reported by a consumer via call center representative and described the occurrence of blackout in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced blackout (serious criteria GSK medically significant), nausea, difficulty in standing, migraine, erythema, pruritus, swelling arm and pain. On an unknown date, the outcome of the blackout, nausea, difficulty in standing, migraine, erythema, swelling arm and pain were recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the blackout, nausea, difficulty in standing, migraine, erythema, pruritus, swelling arm and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced nausea, had hard time standing up, and migraine post vaccination. This lasted for one day and she had to take medicine for her migraine.  The patient blacked out for about a minute. The patient experienced redness, itching, pain and swollen arm which lasted for total of 3 days. The reporter did not consent to follow-up. No further details were provided. The reporter would follow up with her physician as required. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK003476.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: PATIENT BLOOD PRESSURE DROPPED TO 103/67 BUT PT STATES BLOOD PRESSURE USUALLY AROUND 120/80 NORMALLY.
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored doses of M-M-R II (lot #N031294 with expiration date 21-AUG-2019) and VARIVAX (lot # N031002 with expiration date 03-NOV-2019), both for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered dose of M-M-R II experienced a temperature excursion in the range between 47 degrees F to 77 degrees F (52.7 degrees F) during 2 hours and 15 minutes. While the administered dose of VARIVAX experienced a temperature excursion in the range between 6 degrees F to 14 degrees F (7.2 degrees F) during 5 hours and 10 minutes. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005; US-009507513-1808USA011006; US-009507513-1808USA011007; US-009507513-1808USA011008; US-009507513-1808USA011009; US-009507513-1808USA011011; US-009507513-1808USA011012; US-009507513-1808USA011013; US-009507513-1808USA011014; US-009507513-1808USA006003.
Improper storage of product in use; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 23-DEC-2021, the patient was vaccinated with improperly stored , mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (Lot# T027936 and expiration date 18-AUG-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of 27.4 degree Celsius. Time frame was 52 hour and 30 minutes. There was no previous temperature excursion.
VOMITED 8 TIMES IN 12 HOUR PERIOD, BODY ACHES, NAUSEOUS, LOW GRADE FEVER, FATIGUE
On about 11/01/2022, in the afternoon after work, I noticed I could not sleep on my right side. I had no intensive studies done. It is being treated as an inflammation in the Bursa. The difficulty is when I am trying to sleep. I have had physical therapy.
This spontaneous report as received from a consumer refers to her 60 year old daughter. The patient had "environmental allergies". The patient developed shingles on an unspecified date approximately one year ago (In approximately February 2013). On 19-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J008434, expiry date 11-OCT-2014) vial 19400 PFU "to prevent recurrence of shingles" (dose and route not reported). Concomitant therapies included levothyroxine, gabapentin and cetirizine. The consumer reported that her daughter received ZOSTAVAX to prevent a recurrent case of shingles and later (on 21-DEC-2013) broke out with blisters on her chin and a red, "fiery", burning rash all over her arms. The patient sought medical attention through unspecified way. An unspecified blood work was performed. VALTREX, MEDROL and clindamycin were given to treated the adverse events. At the time of reporting, the outcome of the events was not recovered. The consumer declined providing physician contact information, so a Varicella Zoster Virus Identification Program (VZVIP) packet was not sent. Additional information has been requested.
could not move arm without severe pain; could not move arm without severe pain; soreness 10 days after shot; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in left arm on 29Mar2021 at 13:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Medical history included hyper tension. Concomitant medications included eplerenone (MANUFACTURER UNKNOWN), minoxidil (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); all for unspecified indications from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. 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 4 weeks prior to the COVID vaccine. The patient had no known allergies to medications, food or other products. On 08Apr2021 at 15:00, the patient started getting soreness 10 days after shot. On 09Apr2021, on 11th day, the patient could not move arm without severe pain. The patient called doctor who said to take tylenol and use hot compresses. The patient felt much better after 4 days and had easy movement, still a little sore. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which included tylenol and hot compresses. The clinical outcome of the events, soreness and could not move the arm without severe pain was recovering at the time of report. The clinical outcome of the event soreness 10 days after shot was recovered on an unknown date of Apr2021.    No follow-up attempts are needed. No further information is expected.
For 3 weeks now, I have had loose stools.  I have had between 3 to 5 bowel movements a day. They are usually immediately following eating. Because of my dairy allergy and some anxiety I have been experiencing, I didn?t think about this all being connected to the vaccine. I have never had loose bowel movements that have lasted like this unless I was sick with something else. Today, I am experiencing some cramping with it as well. I read about an ingredient in the vaccine that may cause this so I decided  to contact someone.
at about 6PM on 2/8/2021 I started to have symptoms including chills, fever, body aches, and headache. These symptoms lasted for approximately 12-18 hours. Since having these symptoms I am now fully better.
Rash on legs; rash on chest; rash on ankles; red dots; Rash on arms; this spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of rash (rash on ankles), erythema (red dots), rash (rash on arms), rash (rash on legs) and rash (rash on chest) in a 78-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) for covid-19 vaccination.     the patient's past medical history included chronic kidney disease stage 3 (patients report stage 3 kidney disease), cardiovascular disease, unspecified (patients report cardiovascular disease), hypertension (patients report hypertension), hypercholesterolemia (patients report hypercholesterolemia), hyperkalemia (patients report hyperkalemia) and obesity (patients report obesity). concomitant products included hydrocodone, paracetamol (tylenol), cholecalciferol, diclofenac sodium, diltiazem, furosemide, hydralazine, magnesium oxide, omeprazole, simvastatin, venlafaxine, hydrocortisone (hydrocortisone 1% in absorbase) and hydrocortisone (hydrocortisone 1% in absorbase).  the action taken with mrna-1273 (moderna covid-19 vaccine) (intramuscular) was unknown. Treatment medication include hydrocortisone cream.  on 22-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 rash (rash on ankles), erythema (red dots), rash (rash on arms) and rash (rash on chest). on an unknown date, the patient experienced rash (rash on legs). at the time of the report, rash (rash on ankles), erythema (red dots) and rash (rash on arms) outcome was unknown.        for mrna-1273 (moderna covid-19 vaccine) (intramuscular), the reporter did not provide any causality assessments .
aches; fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (had multiple sclerosis for years, though they not taking any medications for it at the time.). Concomitant products included ESTRADIOL, VITAMIN D NOS, BUPROPION, CITALOPRAM, VALACYCLOVIR [VALACICLOVIR], OXYBUTYNIN and MAGNESIUM OXIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MYALGIA (aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 04-Apr-2021, MYALGIA (aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-120216 (Patient Link).
Family noticed onset of partial seizure like activity the night after vaccines were administered.  Episodes of shaking the head and shaking one arm without loss of consciousness.  No tonic-clonic activity.  Brought into office 3 days after vaccine administration for these symptoms.  Not in any distress in office.
Affected all my joints with great pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Affected all my joints with great pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 12-JUN-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route of administration were not reported). It could not be determined whether the patient received the product with lot # L007531 with expiration date: 04-NOV-2016 or lot # K007264 with expiration date 02-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Atrial flutter; Fatigue; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Deltoid Right on 09Mar2021 (Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included Bladder issue, Elevated cholesterol, Elevated BP. Received BNT162B2 dose 1 on 16Feb2021 for COVID-19 immunization when he was 61 years old. Concomitant medications included rosuvastatin taken for Elevated cholesterol; losartan potassium taken for Elevated BP; oxybutynin taken for Bladder issue; tamsulosin taken for Bladder issue. The patient experienced fatigue on 12Mar2021, dizziness on 12Mar2021, shortness of breath on 12Mar2021, atrial flutter on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram with atrial flutter on 05Apr2021, electrocardiogram with atrial flutter on 01Apr2021. After he saw the cardiologist, he was prescribed a betablocker and a blood thinner in the interim. He clarifies he was prescribed Metoprolol tartrate 25mg, twice a day. He was also prescribed Eliquis 5mg, twice a day. There were no additional vaccines administered on same date of the Pfizer. Events require a visit to physician office. prior vaccinations within 4 weeks was none. The outcome was unknown.  No follow-up attempts are needed. No further information is expected.