chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumovax23 was administered Sub-Q in left arm, Blistering, redness, swelling at injection site started on 9-13-16 and has progressed to a large 3cm consolidated blister surrounded by a 10cm by 12cm roughly circular erythematic swollen area. Diphenhydramine 5omg IM and Solumedrol 125mg IM was given on 9-14-16 @1450PM.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Medical assistant reported that on 30-AUG-2016, the patient received improperly stored dose of VARIVAX at a dose of 0.5 ml, subcutaneously for prophylaxis (lot number L015046 with expiration date of 29-APR-2017). Lot number and expiration date of sterile diluent could not be obtained. At the time of call. No adverse effect was reported. No further information was provided. Administered doses of vaccines experienced the temperatures of excursion from 20-AUG-2016 through 21-AUG-2016 of 47 degrees Fahrenheit to 77 degrees Fahrenheit (53 degrees Fahrenheit) for 24 hours 15 minutes and 32 degrees Fahrenheit to 35 degrees Fahrenheit (33 degrees Fahrenheit). Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
I suddenly have tinnitus in my left ear. My hearing has been reduced by 50% in that ear. I have had 3 doses of the Pfizer Covid19 vaccine. I have had no test yet.
Right thigh became dark red and hard 28 hours after vaccine administered. Began resolving within 12 hours.
Patient stopped menstruating. Doctor wanted lab work done. Test results can back abnormal. Prescribed birth control pills to help regulate her cycle. Wanted to do lab work again in 4-6 weeks and see a pediatric endocrinologist. Returned for lab work and again the results were abnormal. Saw a pediatric endocrinologist who think she has a pituitary tumor. Wants to get an MRI done. Appointment coming up for MRI.
Mild, mostly constant, ringing / buzzing in head / ears. Tinnitus. I have never had an issue with constant ringing in ears and I am not sick, nor do I have any other symptoms. As a health care provider am tested twice per week and have currently been testing negative for Covid at my work place. I had Covid last Christmas and recovered, only having mild symptoms. I really want to know if this is normal and when it may pass. I am due for the second shot and am mot sure if I should get it. I do not want this symptom to worsen. Any additional info re this side effect would be greatly appreciated.
1st vaccination had little after effects. 2nd vaccination: terrible leg pain...within 2 hrs. of the 2nd shot left knee swelling and one week later right knee swelling to where I can't hardly walk or bend either. Knee pain persists to today (06/16/2021).
No issues with the first vaccine other than a slight soreness in the ejection area. After the second dose approximately 12 hours later my arm became very sore and swelled up the size of a goose egg, it was difficult to even move my arm. As time progressed I developed a fever, intense body aches, severe headache that could not go away even with Tylenol or advil, chills, severe fatigue, dizziness
Swollen and red, very hot ,  sore and very hard ar site of injection., disappeared within 2 days. 5 days later  swelling, very hot and very itchy and muscle very largando-nos hard came back. Find random bumps, itchy and sores in the mouth going away within a day . Symptoms still active as of today 4/25/2021
pain at the injection site in his right arm.; nausea; upset stomach; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Right on 18Jul2021 10:30 (at the age of 68 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included 2 stents in the heart , blood disorder, cerebral disorder. Concomitant medications included donepezil hcl 10mg has been on the medication probably 6 months from 18Jul2021 for the brain; clopidogrel 75mg once a day as blood thinner has been taking forever. The patient received pneumonia shot 11 days ago. Reporter stated that her 68-year-old husband received his first dose of the Pfizer Covid-19 vaccine on 18Jul2021 and started having complaints of nausea, upset stomach from afternoon until evening on 18Jul2021 15 to 20 minutes after the shot. Is not experiencing this anymore. It lasted from the afternoon to the evening, then it stopped. Today, he started having pain at the injection site in the right arm this morning and is not so bad. Reporter was unsure if she has reported husband's AE and wanted to know if these complaints are normal and have been reported before after receiving the Pfizer Covid-19 vaccine. No treatment was received for the adverse events. No additional vaccines were administered on Same Date of the Pfizer Suspect. The adverse events did not require visit to emergency room nor physician office. The outcome of the events nausea and upset stomach was recovered on an unspecified date in 2021 and pain at the injection site was not recovered.  Information about the Lot/batch number has been requested.
Patient states last night she was experiencing dizziness and chills.  This caused her to have trouble with balance as she is blind.  She stated that she felt fine today though.
Chills,  high temperature Atrocious headache stomach pain and nausea BLURRY VISION THAT LASTED OVER 2 WEEKS and eye prescription increased drastically ( from 0.5 to 3.25)
This spontaneous case, was initially received from other health professional (nurse) on 06-Oct-2017, concerning a 50-year-old adult male patient. The patient did not receive any concomitant medications. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128 (reported as 195198), expiry date: Apr-2018, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine after the multiple temperature excursion over a week. It was reported that, the storage temperature of the vaccine fluctuated between 36-degree F and 48.18-degree F, which reached to maximum 49-degree F over a week instead of storing between 36-degree F to 46-degree F and no adverse event was reported. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 06-Oct-2017: Batch no. (195128) was captured in the case form and narrative was amended accordingly.
really bad arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad arm pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (really bad arm pain). At the time of the report, PAIN IN EXTREMITY (really bad arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are provided, treatment to the events are not listed   This case was linked to US-MODERNATX, INC.-MOD-2021-061114 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061114:dose 2
Hospital Principal Problem / Discharge Diagnosis: COVID-19 virus infection  Recent covid-19 infection with acute hypoxic respiratory failure. Ordered for comfort care regimen with morphine, ativan, and scopolamine patch. Morphine was ordered around the clock. She was kept comfortable and expired peacefully on 12-12-2022 at 20:20. Called guardian today and passed on condolences.
sensitive nose; sore arm; tested positive for COVID; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), RHINITIS (sensitive nose), PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L204) for COVID-19 vaccination.     No medical history was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (fever). On 10-Feb-2021, the patient experienced COVID-19 (tested positive for COVID). On an unknown date, the patient experienced RHINITIS (sensitive nose) and PAIN IN EXTREMITY (sore arm). At the time of the report, COVID-19 (tested positive for COVID), RHINITIS (sensitive nose), PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: (Negative) On 26Jan2021, he tested negative for COVID.. On 31-Jan-2021, SARS-CoV-2 test: (Negative) On 31Jan2021, he tested negative again for COVID. On 10-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Aches and pains; Felt very weak; Tiredness; Chills; Aches in her joints, specifically behind her knees; Felt sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Felt sick), PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness) and CHILLS (Chills) in a 73-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.     The patient's past medical history included Joint pain (Patient experienced joint pain after taking levofloxacin.). Previously administered products included for an unreported indication: LEVAQUIN. Concurrent medical conditions included Hypertension and High cholesterol.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ILLNESS (Felt sick). On 06-Feb-2021, the patient experienced PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness), CHILLS (Chills) and ARTHRALGIA (Aches in her joints, specifically behind her knees). The patient was treated with PARACETAMOL (TYLENOL) for Pain joint, at an unspecified dose and frequency. At the time of the report, ILLNESS (Felt sick), PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness), CHILLS (Chills) and ARTHRALGIA (Aches in her joints, specifically behind her knees) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator
Numbess at injection site; Large red welt at injection site; Soreness at the injection site; Fatigue; Muscle aches; Body/Joint/bone aches; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Body/Joint/bone aches), DIZZINESS (Dizzy), INJECTION SITE HYPOAESTHESIA (Numbess at injection site), INJECTION SITE RASH (Large red welt at injection site) and VACCINATION SITE PAIN (Soreness at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis (Improvement has been observed) since 01-Jun-2009. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from 01-Jun-2021 to an unknown date for ADHD, DULOXETINE HYDROCHLORIDE (DULOXETINA ALTER) from 30-Apr-2021 to an unknown date for Depression.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (Body/Joint/bone aches), DIZZINESS (Dizzy), INJECTION SITE RASH (Large red welt at injection site), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On 22-Jun-2021, the patient experienced INJECTION SITE HYPOAESTHESIA (Numbess at injection site). On 09-Jun-2021, PAIN IN EXTREMITY (Body/Joint/bone aches), DIZZINESS (Dizzy), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. On 16-Jun-2021, INJECTION SITE RASH (Large red welt at injection site) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved. At the time of the report, INJECTION SITE HYPOAESTHESIA (Numbess at injection site) had not resolved.            No treatment information was provided   This case was linked to MOD-2021-258005 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Reporter information, demographic details, race and ethnicity were updated. Medical history ,dose information, concomitant medications were added. New events were added.
nodes on my left hand side of the arm are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (nodes on my left hand side of the arm are swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Jun-2021, the patient experienced LYMPHADENOPATHY (nodes on my left hand side of the arm are swollen). At the time of the report, LYMPHADENOPATHY (nodes on my left hand side of the arm are swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 contains non significant information. Contact details updated for the reporter and the event verbatim term was updated from lymph node on my right hand side to lymph nodes on my left hand side.
It was discovered that on 5/21/18 the ROTARIX was ordered by Dr. The Medical assistant documented that only the ROTARIX diluent was documented as given to the patient. The actual ROTARIX vaccine wasn't given.
1.5 HOURS AFTER PT RECEIVED DTP/OPV/PROHIBIT IMMUNIZATION, SHE DEVELPD FEVER TO 103.4. CHILD WAS SPONGED IN ER AND GIVEN TYLENOL. MOTHER STATES SHE GETS SHAKY WHEN UPSET. NO OTHER PROBLEMS.
2nd vaccine (SHINGRIX 50 mg) caused pain, itchiness and red rash at injection site.....also feeling tired, weak, headache, shivering and muscle aches which lasted two days.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821281 expiry: 21-OCT-2021) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211047292.
J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 ANEMIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 ANEMIA R09.02 HYPOXIA 5/14/2022 ANEMIA J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 ANEMIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 ANEMIA R09.02 HYPOXIA 5/14/2022 ANEMIA J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 SHORTNESS OF BREATH J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 SHORTNESS OF BREATH J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 SHORTNESS OF BREATH R09.02 HYPOXIA 5/14/2022 SHORTNESS OF BREATH J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART R09.02 HYPOXIA 5/14/2022 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 PNEUMONIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 PNEUMONIA R09.02 HYPOXIA 5/14/2022 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 RECTAL BLEEDING J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 RECTAL BLEEDING J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 RECTAL BLEEDING R09.02 HYPOXIA 5/14/2022 RECTAL BLEEDING J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 ACUTE RESPIRATORY FAILURE R09.02 HYPOXIA 5/14/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 PNEUMONIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 PNEUMONIA R09.02 HYPOXIA 5/14/2022 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 5/14/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 6/5/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/14/2022 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/6/2022 ACUTE RESPIRATORY FAILURE R09.02 HYPOXIA 5/14/2022 ACUTE RESPIRATORY FAILURE
In the fall I went to my primary care physician with what I thought was my allergies. He gave me some allergy medications, but it was not helping. He referred me to an ENT who said I had a condition called a silent reflux, laryngopharyngeal reflux. He gave me ipratropium bromide nasal spray, fluticasone propionate nasal spray, famotidine to use every day. Every once in a while, I cough, and I have to spit out what comes up.
About 6 hours after vaccination I experienced soreness at the site of the injection (scale of 4-5).  Overnight the pain got worse (scale 6 or more).  The pain at the site was more than I have experienced with a tetanus shot.  It was uncomfortable to sleep or rollover.  The pain was more than I have had with any previous injection.  The next morning which is today, I examined the site of the injection and saw that the injection site was at the top of the deltoid muscle approaching the bursar.  I am not a large individual at 5' 8" and 140 pounds.  My deltoid is not very large and the injection was above the thickest part of the deltoid.  I am a pharmacist and give injections, I also had my wife look at it, she is also a injection administering pharmacist.  We both determined the injection site was outside the normal injection location of the deltoid.  It is now over 24 hours since the injection, and the pain/discomfort is subsiding.  At this point the pain is similar to a tetanus shot and acceptable (scale 2-3).
Soreness at injection site (left arm) with difficulty moving arm. Chills and so tired that I slept all day.
OFF LABEL USE; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-SEP-2021, the patient experienced off label use. On 17-SEP-2021, the patient experienced drug administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and drug administered to patient of inappropriate age was not reported. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of seizure in a 19-year-old female patient who received BEXSERO (batch number 166901, expiry date 30th November 2018). Concomitant products included Tuberculin PPD. On 23rd January 2018, the patient received BEXSERO .5 ml. On 23rd January 2018, 2 min after receiving BEXSERO, the patient experienced seizure (serious criteria GSK medically significant), syncope, movements abnormal and nodding of head. On 23rd January 2018, the outcome of the seizure, syncope, movements abnormal and nodding of head were recovered/resolved. The reporter considered the seizure, syncope, movements abnormal and nodding of head to be related to BEXSERO. Additional details were provided as follows: On 23rd January 2018, the patient received Tuberculin purified protein derivative (PPD)  on left arm concomitantly before receiving BEXSERO. At 2:30 hours, the patient received BEXSERO on the left arm. The patient experienced head bopping and head movement. The reporter was not certain if it was syncope or possibly a seizure as the patient's eyes were closed during the event. It happened 30 minutes before the time of reporting and within 2 minutes following the administration of the vaccine. It resolved quickly on its own. The reporter believed that the events were caused by BEXSERO as the timing was closer to the administration of BEXSERO.
No AE; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved PROQUAD X013909 11/10/2024        ?    Temperature 8.1°F        ?    Time frame 3 hour; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 28-SEP-2023, the patient was vaccinated with first dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection,  (lot #X013909 has been verified to be valid, expiration date: 10-NOV-2024), administered for prophylaxis (strength, and route of administration were not provided) after temperature excursion (product storage error). No adverse events reported.    Moreover it was reported, temperature 8.1°F, time frame 3 hours 0 minutes 0 seconds, with no previous temperature excursion