chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
I have a pain in my right thigh that is like having shingles without the rash. I have a CT and an ultrasound. I now I see a pain doctor. I have my right eye twitches and my right cheek twitches down to my jowls. I have hair loss. I have severe fatigue. I have weight loss about 25lbs. These symptoms are continuous. I have female abnormalities like a cyst. An ultrasound showed an enlarged uterus. They want to do an ultrasound biopsy but I chose not to due to expenses and the pain it would put me in. Vaginal issues. Also have a racing heart up to 170 and it is hard to get it to come down. Short of breath as well. Diagnosed with stenosis in my back.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, swollen , s/s lasted approx48 hrs after administration with gradual onset. Narrative:  OTC tylenol attempted, reported seemed ineffective, s/s resolved after 48hrs.
Started with dx of contact dermatitis to right upper chest traveling up neck line, next day noted hives to abdomen (less itchy, but not raised), next day noted to right arm and intermittent flushing to face and upper extremities with itching increasing during these moments, hives noted to scalp and face by day 5.  Benadryl PO helps at night and Benadryl cream during day to avoid drowsiness (I would prefer to dig my skin off, however the rash worsens if I do that) miserable.
Information has been received from a registered nurse concerning a white adult patient who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot650330/0748P).  Subsequently, the patient developed a very sore arm to the point of having trouble lifting the arm.  The patient recovered in 4 to 5 days.  No additional information is expected.
sore left arm at night after several hours from time of shot.  Pain increased the next day.  Felt very tired on the second and tiredness and sore on left arm increased on the third day after the shot.  Took excedrin twice a day for 4 days after the shot.
Approximately after 2-3 hours of getting the 2nd dose of the Moderna Covid-19 vaccine, I experienced moderate side effects which included chills, body aches, headache, tiredness, nausea.  It lasted about 28 hours.
Day 8 developed raised, red, itchy circular shaped rash (erythema)  at injection site. Lasted 3 days (day 8-10). Day 11 mostly resolved, only slightly red. Day 12 resolved. Day 13 (today) developed wider red circular rash, I can feel that it's present but not itchy.
Patient age 16 received Janssen vaccine (approved for ages 18+) at vaccine clinic on 4/12/21. Error was discovered on 4/15 during processing - pharmacist was unaware of age at time of administration.
Information has been received from a physician concerning an approx 6 yr old male who on 05Aug99 was vaccinated with a dose of varicella virus vaccine live. In 2004 the pt developed chickenpox and again in Feb 2005. It was reported that the lesions in Feb 2005 were located on the pt's scalp and trunk. Unspecified medical attention was sought. Treatment included loratadine (Claritin) and bacitracin zinc (+) neomycin sulfate (+) polymyxin B sulfate (Neosporin). At the time of the report the pt had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date; No adverse event; 14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and PRODUCT STORAGE ERROR (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date).    Concomitant medication was not reported.  No patients have been administered monovalent vaccine after the beyond use date. Doses were administered from 08-Dec-2022 to 10-Jan-2023. Date the vial was initially stored in the refrigerator is 24-Oct- 2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Follow-up received included patient demographics and narrative updated. On 24-Jan-2023: Follow-up received included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case - 1st adult
Patient came to a public vaccination clinic  on 11/18/21 where he stated he had not yet received a covid-19 vaccine. He was then given the Pfizer vaccine as a "1st dose". When charting his vaccination, it was found out that patient received the Moderna Covid-19 vaccine on 11/10/21. Patient was too early for his second dose and received the wrong manufacturer. Unknown if patient experienced any side effects at the time of submitting this VAERS report.
thrombocytopenia; This is a Literature report. The full publication has been requested.  A patient of unspecified age and gender received BNT162B2 (lot number unknown), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced thrombocytopenia and eventual death on an unknown date. The patient died on an unknown date. The cause of death was thrombocytopenia. It was unknown if an autopsy was performed. The outcome of the event was fatal.  The recent report of thrombocytopenia and eventual death of a healthy person who received an mRNA-based COVID-19 vaccine has again raised concerns about whether vaccines trigger ITP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a very limited information provided in the report, lacking time to onset, history of pre-existing medical conditions, baseline laboratory data, conmeds and course of events, the Company did not consider the event, fatal thrombocytopenia, as secondary to BNT162B2.; Reported Cause(s) of Death: thrombocytopenia
Case number PHEH2015US026924, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 24 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 26 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). No adverse event was reported following this medication errors. The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information provided. No adverse event was reported following this medication errors. Follow up report received from a nurse on 26 Jan 2016: Updated reporters comments.
Redness; extreme pain; hot; hard size of a quarter at the injection site; fatigue; Diarrhea; fever; headaches; hot flash; chills; This is a spontaneous report from a contactable consumer. A 20-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: En6199) via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:30 (age at vaccination 20-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On 06Mar2021 11:30 AM, patient experienced Redness, extreme pain, hot, and hard size of a quarter at the injection site, fatigue, Diarrhea, fever, headaches, hot flash, chills. No treatment was received for events. Patient has not taken any other vaccine with in four weeks and other medication in two weeks was Prescribed medicines. Patient has no known allergies reported. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and unknown if tested since the vaccination. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HISTORY OF PRESENT ILLNESS: Patient is a 90 y.o. male with history of myasthenia gravis, OSA, seizure disorder, cervical spinal stenosis, s/p right hemicolectomy who presents with acute hypoxic respiratory failure secondary to covid 19.  Patient resides in nursing home.  Per chart review, patients PCP obtained covid test as patient was expressing URI symptoms, which resulted positive on 4/30/2022.  Paxlovid was ordered and sent to patients nursing home, though patients wife refused this medicaiton.  She instead asked for ivermectin for which patients PCP refused to prescribe  Patient however became hypoxic and was urged to go to the ED.  Oxygen saturations were reportedly in mid 90s.
Couple of hours after shot she experienced soreness in both shoulders, muscle aches, sweating, nausea/vomiting, next day she experienced the same and did feel better till 3 days later.
SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTION SITE PAIN; ROOF OF MOUTH TENDER; EAR ACHE; RIGHT KNEE AND SHIN BONE PAIN; SORENESS FROM LEFT SIDE TO LEFT WRIST; FLUSHED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included severe allergies to grass, severe allergies to cat, and severe allergies to bees.  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 08-APR-2021 08:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced sore neck. On 08-APR-2021, the subject experienced roof of mouth tender. On 08-APR-2021, the subject experienced ear ache. On 08-APR-2021, the subject experienced right knee and shin bone pain. On 08-APR-2021, the subject experienced soreness from left side to left wrist. On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced left shoulder injection site pain. On 10-APR-2021, the subject experienced sore entire upper back. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced right shoulder sore. On 10-APR-2021, the subject experienced headache. Laboratory data on 08-Apr-2021 included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore neck, sore entire upper back, roof of mouth tender, ear ache, sore throat, and headache on 12-APR-2021, and flushed on 08-APR-2021, and had not recovered from right knee and shin bone pain, left shoulder injection site pain, right shoulder sore, and soreness from left side to left wrist. This report was non-serious.
Runny nose and cold symptoms, testing positive again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Runny nose and cold symptoms, testing positive again) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination.    Concurrent medical conditions included Drug allergy (unknown drug).   On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 14-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Runny nose and cold symptoms, testing positive again). At the time of the report, COVID-19 (Runny nose and cold symptoms, testing positive again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: negative (Negative) negative.         The patient race was given. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had runny nose and cold symptoms. No treatment was received.  Company Comment: This is a spontaneous case concerning a 39-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient reported runny nose and cold symptoms with positive test again for COVID after testing negative. Clinical course, other relevant diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 39-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient reported runny nose and cold symptoms with positive test again for COVID after testing negative. Clinical course, other relevant diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
flushing and rash- maculopapular- without itching. fatigue. Neck and chin and chest is the areas affected. Still present at 72 hours post vaccination.
got the tdap on 10-02-23 and then in the afternoon of 10-03-23 started to chill and laid down and been in bed every since tuesday afternoon and did not get up until this morning except to use the bathroom or to get a drink or to take a shower.  Had aching and not sure of fever. Also c/o numbness in left hand and hurts to open and close it.  not excruciating, but it does hurt and that started yesterday.  and it is getting better since has been up and moving more today.  Has not been tested for covid and does not have any kits to test,  will discuss with our MD and if needs to come in, will call him back and get him in.  If worsens, to go to er or walk-in clinic.
10APR97 fever >102 rt arm swelling pain;11APR97 fever >101, rt arm swelling pain;14APR97 to MD dx cellulitis, on ATB will RTC MD may lance if not improved;
pt recv vax 17AUG95 & 9APR97 pt devel chickenpox consisting of less than 50 lesions;A visit to MD was required;pt recovered from sx on 11APR97 & 12APR97;
New loss of taste or smell  Congestion or running nose Headache ? Sinusitis  COUGH
Patient stated left arm was sore after getting vaccine. She said that night it got swollen and when she woke up it was swollen down to her elbow. Has taken NSAIDS and iced the area and the swelling has gone down but it is still sore to the touch.
right arm rash , Diphenhydramin 25 mg's and zantac 150 mg.
Muscle pain left arm and left side Dizziness Generalized muscle weakness Excessive salivation/drooling Moderate continuous throbbing headache Frequent dark odorus urination Symptoms gradually cleared over 72 hours
Vaccines administered after 12 hours puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after 12 hours puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after 12 hours puncture). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after 12 hours puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported. Did the vial undergo any temperature excursions? No Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): It was not, it was kept in the fridge the whole time.
At 1613 patient reports `tingling and pain to fingers` bilateral. VS bp 148/94 pulse 102 and oxygen 99%. At 1630 BP 145/86 pulse 93 and oxygen 98%. At 1642 patient cleared by medical director and discharged. As per patient, symptoms resolved.
1/12/21 6:30AM - swollen lymph node on left side of throat (same side as vaccine) + headache 11:30AM - (temp 98.8F) extreme tiredness and chills 7:00PM - full body muscle aches+ chills  1/13/21 6:50AM - (temp 98.8F) left side throat lymph nodes more swollen, headache.  10:00AM (temp 98.0F) + malaise and body aches 4:15PM (temp 100.8F) + nausea and headache 6:30PM took one acetaminophen  7:00PM (temp 99.5F)_ tiredness, malaise, sore throat 10:15PM (temp 100.7F) tiredness, achey, feverish, nauseous   1/14/21 12:30AM (temp 102.1) 3:50AM (temp 102.2) + nausea then vomiting for about 10 minutes 8:45AM (temp 97.2) 10:35AM (temp 98.7) + sore throat 11:30AM (temp 99.9) 1:30PM (temp 100.1) 4:45PM (temp 100.9) + sore throat and malaise 6:30PM (temp 102.2) + coughing
Injection site- pain, tenderness, very warm General: fatigue, headache, muscle pain, joint pain, chills, nausea, fever as high as 101.4 Length of time: 48 hours Treatment: Extra Strength Tylenol
Dizziness; Sneezing; Diarrhea; Chills; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), SNEEZING (Sneezing), DIARRHOEA (Diarrhea) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DIZZINESS (Dizziness), SNEEZING (Sneezing), DIARRHOEA (Diarrhea) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), SNEEZING (Sneezing), DIARRHOEA (Diarrhea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are were reported.  Patient reported her temperature to be around 96.9 Patient had not used any medications for treatment at the time of report.
Nausea, Shivering, Diarrhea Redness around injection site
Onset of blotchy non-raised erythema, approx. 30 minutes, post vax. Pt referred to physician for possible treatment. No treatment required. Rash resolved within the hour.