chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nasal congestion; BS elevated tto 200, the 3rd night after up to 300; Weakness; Fatigue; Fever of 100.9; Headache; Pain at injection site; Swelling at injection site; Redness at injection site; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300), ASTHENIA (Weakness), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (20 years,Taking metformin). Concomitant products included METFORMIN for Type 2 diabetes mellitus.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced DIZZINESS (Dizziness). On 30-Dec-2020, the patient experienced NASAL CONGESTION (Nasal congestion), BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever of 100.9), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, NASAL CONGESTION (Nasal congestion), ASTHENIA (Weakness), DIZZINESS (Dizziness), FATIGUE (Fatigue), PYREXIA (Fever of 100.9), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood glucose increased: 200 High. On 31-Dec-2020, Blood glucose increased: 300 High. On an unknown date, Blood glucose increased: 150 normal. On an unknown date, Body temperature increased: 100.9 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events was unknown.   Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
RESPIRATORY COMPLAINTS, SHORTNESS OF BREATH, COUGH BODY ACHES, LOSS OF TASTE AND SMELL
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2017 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had a temperature excursion of 34 F (1.11 Celsius Degrees) for 56 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
"1/15/21 arm a little red  and swollen,  tongue feels like sand paper and looks white  with few blotches"
Patient states she has intense pain in left arm after injection. No redness. Appearance is fine but pain is still present days after injection. Pain improved slightly with steroid treatment. Pain returned after steroid was finished. Patient is on second round of steroids now.
On 1/19/2022 patient presented to ER for mild hypoxemia associated with SARS CoV-2 infection. Patient described feeling poorly for several weeks. Patient developed covid pneumonia. Patient was treated with Remdesivir and Decadron and was discharged on 1/25/2022. Patient returned to ER 1/28/2022 with ongoing weakness, low grade fevers 99.0. Patient readmitted to hospital.
Interior parts of both elbows were swollen; Intense pain in the legs; Swollen lymph nodes in the injection arm; Intense pain in the breast; Intense pain in the forearm up to finger; At night has tingling sensation in the body; Pain in the interior part of the knees; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast) and PAIN IN EXTREMITY (Intense pain in the forearm up to finger) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, 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 experienced JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast), PAIN IN EXTREMITY (Intense pain in the forearm up to finger), PARAESTHESIA (At night has tingling sensation in the body), ARTHRALGIA (Pain in the interior part of the knees) and FATIGUE (Feels tired). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Interior parts of both elbows were swollen), PAIN IN EXTREMITY (Intense pain in the legs), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the injection arm), BREAST PAIN (Intense pain in the breast), PAIN IN EXTREMITY (Intense pain in the forearm up to finger), PARAESTHESIA (At night has tingling sensation in the body), ARTHRALGIA (Pain in the interior part of the knees) and FATIGUE (Feels tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-092103 (Patient Link).
Muscle weakness in the legs, nausea, and body temperature of 99.9 degrees F.
This spontaneous report as received from an immunization official (also reported as health care worker) refers to an unspecified number of patients (demographics unspecified). The patient might have received doses of GARDASIL (lot number, expiry date unspecified) and LIQUID PEDVAXHIB (lot number, expiry date unspecified) that were exposed to unknown temperatures from 01-NOV-2012 to 15-NOV-2012. Immunization official reports that the practice had no vaccine temperature storage records for the time period in question; it could not be determined if a vaccine temperature storage excursion actually occurred. No adverse effect reported. The outcome was unknown. It was unspecified if the patients had sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Mycoplasma pneumoniae pneumonia; Chills; Violently sick; labored breathing; Oxygen saturation low; vaccination site pain; immunodeficiency; A spontaneous report was received from a consumer concerning a 79-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced mycoplasma pneumoniae pneumonia, chills, illness, labored breathing, vaccination site pain, immunodeficiency, and oxygen level saturated.  The patient's medical history included congestive heart failure, pulmonary disease, immune system disorder history of 22 stents placed in her heart, peripheral artery disease, coronary artery disease, regurgitating food  and covid-19 test. No relevant concomitant medications were reported.    On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 15 Feb 2021, approximately 1day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, she developed chills and became violently sick. Her oxygen was 94 at home but dropped into the 80s at the facility. She has had to have 40-50% oxygen. At first, they thought she might have aspiration pneumonia because she has had problems keeping food down and regurgitating in the past. They did tests and told us she has Mycoplasma pneumonia. The doctor said if she had a normal immune system, she could just take something over the counter, but not with her because her immune system is low. They did four COVID tests because they thought she might have had a false negative, but all of them have been negative. So, at least we know she doesn't have COVID. Her oxygen has been in the 90s, but she still says she is having a hard time breathing and it is labored. She continues to be in intensive care. Treatment for the event included oxygen .   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events mycoplasma pneumoniae pneumonia, chills, illness, labored breathing, vaccination site pain, immunodeficiency, and oxygen level saturated were unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events (chills and vaccination site pain) and the administration of the mRNA-1273 cannot be excluded. However, the event of Mycoplasma pneumonia is Unlikely related to mRNA-1273. The events- illness, dyspnoea, oxygen saturation decreased could be due to mycoplasma pneumonia.  However, the subject's history of weak immune system may remain as a risk factor.
Headache on top R-side, Two days after same pain above L-ankle radiating to the knee. Day after numbness, tingling, and burning sensation on entire left side of the body and got worst.
Arm is red, itchy and swollen, feels hard to touch. Started in the evening after vaccination and has gotten worse. I'm trying Benadryl today because it's more swollen and itchy than previous days. I'm scheduled to see my primary care doctor 2/22/21.
No reported adverse event.  Dose 1 was given 10/2.  Pt returned on 10/11 and marked form as having never received a prior COVID vaccine.  She was given a second COVID vaccine on 10/11 with an improper interval.
Swelling around the injection site - localized reaction.  tx - cool compresses/Tylenol.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. The Licensed Practical Nurse reported that a medical office might had administered VARIVAX (Merck), which may have under went an unsupported excursion, to an unspecified number of patients. No adverse effects reported. At the time of report, the event outcome was unknown. Additional information has been requested.
Sore arm - began about 4 hours after shot, lasted about 24 hours. Fever, chills, body aches - began 12 hours  after shot, lasted about 36 hours. Fatigue - began 12 hours after shot, lasted about 48 hours.
Pt has had progressive weakness in hands, feet - resulting in inability to walk, control arms, to swallow, speak clearly. Breathing affected. Pt has been intubated at Hospital due to imminent respiratory failure.
Had vaccine 4/20/04 on 4/21/04 had 2 episodes of stiffening of the body and rolling of eyes-5AM lasting 2 min., 6AM lasting 3 min., temp 105 degrees F.  Medical records on 05/05/04 states no new information. Nurse follow up on 05/13/04 states no new information.
Pruritic rash, decreased PO intake x 5+ days starting 14 days after MMRV vaccine. Symptomatic care, outcome pending.
Approximately 1 hour after the shot, I raised a hive on my upper lip.  It very quickly (within 2 minutes) got to its maximum size.  Not noticeably swollen to an observer, but it felt swollen, red and throbbing. It was not a serious adverse reaction.  After about an hour, it was NOT going away, but it was NOT getting worse.  I never experienced trouble breathing. The office where I had the shot is "not available" on Friday afternoon, and my personal physician is not in the office on Friday.  I was advised by another doctor friend to take benadryl, which I did.  While looking at the CDC website, he also advised me that (having had this reaction) I should not receive the second shot.
HOSPITALIZED FOR BLOOD CLOTS, UNRESPONSIVE AND TAKEN TO HOSPITAL
Ischemic CVA 3 weeks prior, 2nd dose due on the day of symptom onset
patient complained because her leg hurt; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (patient complained because her leg hurt) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     The patient had no allergy.  The patient's past medical history included COVID-19 (Hospitalized for 3 days and was sick for almost 2 weeks) in August 2021.   On 28-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022, the patient experienced PAIN IN EXTREMITY (patient complained because her leg hurt). On 30-Jun-2022, PAIN IN EXTREMITY (patient complained because her leg hurt) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   The concomitant and treatment medication was not reported. The patient received flu shot the same day, 17-Oct-2022, with the third dose of Moderna.   This case was linked to MOD-2022-661333, MOD-2022-661338 (Patient Link).
diarrhea; upset stomach; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, upset stomach/abdominal discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Feb 2021, approximately 3 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, the patient experienced the event(s) diarrhea, upset stomach.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), diarrhea, upset stomach was unknown.
lt upper arm local redness, generalized body itching x 3 days in spite of DPH;no hives;sl SOB;pt recv 2nd dose of vax w/no rxn;
Swelling over the left side of the upper neck with some diffuse erythema seen. Enlarged lymph node in the left upper cervical chain around 3.5 cms x 1.5 cms felt with minimal discomfort.
Shingles rash on left shoulder, on same side as vaccine, but not at injection site. Headache, body aches.
HOSPITALIZATION COVID-19 BREAKTHROUGH CASE; ON VENTILATOR. TRANSFERRED TO HOSPITAL 12/19/21
Fever and chills - starting at 1:00 a.m. on 12/1/19 continuing through 12/2/19 until end of day Fatigue- same start time  as fever and chills and extended through 6 a.m. on 12/3/19 Redness at injection site noted initially on 12/2/19 extending through 12/5/2019 Soreness at injection site through 12/6/2019
DEATH; This spontaneous report received from a consumer via social media and concerned two male patients 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) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients died from unknown cause. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died (due to unknown cause) on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20210843032- Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
No adverse events reported. Just documenting the vaccine was given on 04/07/2015 and the expiration date was 03/2015.  7 days after expiration date.
This spontaneous report as received from a nurse refers to her 87 year old mother with diabetes. On 30-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (deltoid, lot # was not reported). Concomitant therapies included an unspecified FLU vaccine in a different arm on the same date. The patient was experiencing tenderness, itching and redness that was approximately 4 inches down from vaccine site. The nurse reported that the itching and tenderness started approximately 2 to 3 days after vaccine was administered, no specific date provided, and they noticed the redness for the first time yesterday on 08-OCT-2014. The patient did not seek help and no treatment was given. No lab was performed. The outcome of the adverse events was unknown. Additional information has been requested.
Abnormal mammogram; This spontaneous case was reported by a consumer and describes the occurrence of MAMMOGRAM ABNORMAL (Abnormal mammogram) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced MAMMOGRAM ABNORMAL (Abnormal mammogram). On 22-Mar-2021, MAMMOGRAM ABNORMAL (Abnormal mammogram) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Mammogram: abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
arm puffy; arm red; arm itchy; arm hot; arm was sore; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain (arm puffy), vaccination site erythema (arm red), peripheral swelling (arm was sore),  vaccination site pruritus (arm itchy) and vaccination site warmth ( arm hot).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient reported experiencing arm was sore. On 7 Feb 2021, the patient experienced the events of arm red, arm puffy, arm itchy and arm hot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 30 Jan 2021 the outcome of event, arm was sore was resolved. The outcome of events, arm red, arm puffy, arm itchy, arm hot was unknown.  Based on MSA comment, change listedness to listed and unlisted for monograph and factsheet
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX Lot # N031004, expiration date 03-NOV-2019, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent (concomitant therapy). The temperature excursion was of 6 Fahrenheit degrees (°F) to 14 °F, during 15 minutes. However, a previous temperature excursion of 6 °F to 14°F for 15 minutes was also reported. A digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA003518.
This spontaneous report as received from a licensed practical nurse refers to an unspecified patients of unknown ages and genders who between 06-MAR-2015 and 15-APR-2015 were inadvertently vaccinated with an improperly stored of LIQUID PEDVAXHIB (lot # reported as K011077, expiration date 30-MAR-2017) (dose and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Redness, hotness, itchiness at injection site area and most of upper arm that turned to bruising. Symptoms lasted about 1 week.
Had fever became irritable that evening.  Next day started crying, crying continued for 5 days.  History of feeding problems and choking from birth worsen after vaccination, stopped eating and choking increased in frequency and severity and did not go back to normal until 3-4 weeks.  At 6 months check-up doctor diagnosed it as encephalitis related to Pertussis in DTAP.
Sore arm; Nausea; Throwing up; Slight fever; Not able to keep "regular food"; This spontaneous case was reported by a consumer and describes the occurrence of FOOD INTOLERANCE (Not able to keep "regular food"), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Slight fever) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FOOD INTOLERANCE (Not able to keep "regular food"), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Slight fever). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with GUAIFENESIN (MUCINEX) for Nausea, at an unspecified dose and frequency. At the time of the report, FOOD INTOLERANCE (Not able to keep "regular food"), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Slight fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  On 07-Jul-2021, the patient reported that he was doing a lot better at the time of the report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up report received included information about outcome of the events and was updated to recovering/ resolving.