chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue, body aches, skin at injection site red, hard, swollen, possible "blistering".
Nine and a half hours after injection I started to feel fatigued with a mild sense of tight back muscles.  I began to feel slightly chilled, thought about putting on a sweater, even though it was 76 degrees in the house.  Within an hour I was so tired I didn't think I could get off the couch.  I went to bed and my right arm (injection site) began to ache and feel very heavy.  As it progressed the feeling went all the way to my right thumb.  This was significant achy pain.  Not throbbing, but heavy and achy.  Hurt a lot.  I took two Advil at about 13 hours after injection when it was not subsiding and fell asleep trying not to move my arm.  All achy sensation or fatigue was gone by the morning, approximately 22 hours after injection.   I definitely feel that if the symptoms continued I would not be able to conduct my daily activities the next day.  This was my second of 2 shots.  I did not have any side effects at all with my first of 2 shots.
Swelling, pain and weakness in right arm. The symptoms were diagnosed as lymphedema. Treatment consisted of 2 weeks of antibiotics and steroids and, eventually PT with a specialist in lymphedema swelling. This side of the patient has many of her lymph nodes removed in conjunction with a surgical removal of a right breast cancer lump removal some 25 years ago. No lymphedema symptoms had ever incurred in the patient prior to the covid vaccination. PT is ongoing but little improvement after 2 weeks of treatment.
Muscle where vaccine was given is still sore. Whenever she makes a fist or lays on that arm it is sore. Per patient, she consulted with physician, he told patient it will eventually go away. Patient tried applying heat to area and did not help.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  It was mentioned that the vial was initially refrigerated on 04-Nov-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medication was provided by the reporter.
Patient states that she has ringing in the ears that started about a day after receiving her first dose of Shingrix.  She stated that she never experienced any episode of tinnitus before.  She denies being sick or receiving any other vaccinations at the same time.  She did not experience any issues prior to leaving the pharmacy.  She saw her primary doctor, who advised her to still receive the second dose of the vaccine and advised seeing an ENT.  She said she saw an ENT but could not recall his name.  She received the second dose of Shingrix on 09/29/2019.  She noted that on the VIS under section it notes that ringing in the ears is possible.  I explained it was in relation to signs and symptoms of fainting as a result of vaccination.
Dotted red/bluish large areas under both eyes, like a rash but not itchy Difficulty breathing severe diarrhea vomiting fatigue fever chills body aches from occiput to ankles disorientation
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:49 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 59.34 years.  No Concomitant product use was reported.  On 03-Apr-2021, At excursion time 09:00 AM temperature was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP 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 F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Took the vaccine on 4/15/21 and next day 4/16/21 i have fever,whole body ache and nausea.. from 4/17/21 i felt like my left arm back shoulder part is hard and feel like muscle pull.cant move my head right or left because of pain.its been 3 days took the vaccine and still have fever and serious left back shoulder pain. If i try to move my head right left i felt like muscle pull..still taking Tylenol but didn?t get any relief of muscle pain..Tylenol helped fever but not muscle pain.
Severe headache; total body muscle aches; severe tiredness; injection area and arm was tender and sore; loss of appetite for one day.  Hot/Cold most of the day.  In bed the majority of day.  Mostly flu like symptoms.  By the next day, 8/24/19, able to move and eat.  Arm was still sore and slight red patch at injection area was present.
Hives, severe itching, and minor respiratory discomfort  12/11/09 Medical records received for DOS 11/18- 12/10.  Final DX: Urticaria, itching (pruritus) Diffuse uritcaria over torso, mid back and arm. Severe generalized itching of neck 12 hrs s/p vaccine.  diff taking deep breath. H/O  arm rash w/yearly flu vaccine x1. Not w/booster. Possible hypersensitivy rxn to H1N1. Resolved.
48 hours post vax, the pt experienced chills, fever, dizziness, weakness, paleness and hoarseness. The pt felt lousy for 2 weeks.
Arm above elbow very sore, lymph nodes came up a bit, onset within hours. Next morning, experienced sustained racing heartbeat, dizziness, weakness, slight nausea. Felt achy, weak, little appetite that day and night. Had to sleep with pillow under arm to be comfortable.
Vaccine given at 1729. At ~1805 pt. reported itching, rash. Evaluated by MD. 0.3 mg of Epinephrine IM  and 25 mg liquid Benadryl given at 1820. Pt. continued to report rash & itching, so she was transported via EMS to closest ED.
Case previously recorded as MA2009-4842. Initial case report received from a consumer's mother via Novartis Medical Communications, on 24 NOV 2009. A 19-year-old male patient was vaccinated for the first time with S-OIV FLUVIRIN (batch no. 102040P1) i.m on 14 NOV 2009. The patient experienced facial swelling, hives and lips tingling 2 hours after vaccination. The patient was treated with steroid injection and oral steroids. At the time of this report, the patient had not recovered. Novartis Medical Communication reference no.: NA09-008752.
cough; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Jan2021 (at the age of 57-years old) as a SINGLE DOSE for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported.  The patient was scheduled to get the second shot on 05Feb2021. Patient got COVID like symptoms, he had a cough and "all that stuff" starting about 3 days ago on unspecified date in 2021. He went to a pharmacy to get tested and waiting for results. He went to the hospital right after (pharmacy) and got admitted on 03Feb2021 and was still in hospital right now. His doctor suggested not to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 03Feb2021. Outcome of the cough was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age.     In July 2015, the patient was vaccinated with GARDASIL, and on 09-AUG-2017, the patient was vaccinated with GARDASIL 9 both for prophylaxis (interchange of vaccine products and inappropriate schedule of drug administration). No adverse reactions were reported.
3 inch circle at injection site; entire left arm got red; feel hot and has a temp; arm is a little swollen; feels nauseated; sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen) and NAUSEA (feels nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen), NAUSEA (feels nauseated) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE REACTION (3 inch circle at injection site), ERYTHEMA (entire left arm got red), FEELING HOT (feel hot and has a temp), PERIPHERAL SWELLING (arm is a little swollen), NAUSEA (feels nauseated) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Diarrhea, NauseaVomiting, fatigue and runny nose. sent home for the day  Narrative:
muscle cramps in my hand and then my right foot/muscles and joints were cramping; feeling cold; lips felt a little tingly; heart was beating very fast; mouth was dry; felt very weak; cold; completely dehydrated; short of breath; blood pressure was 146/84; temperature at 100.6; finger tips started to feel tingly; very bad headache; full blown chills; very tired suddenly; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Nov-2021 and was forwarded to Moderna on 12-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired suddenly), FEELING COLD (feeling cold), CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping) and PARAESTHESIA ORAL (lips felt a little tingly) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced FATIGUE (very tired suddenly), FEELING COLD (feeling cold), CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping), PARAESTHESIA ORAL (lips felt a little tingly), PALPITATIONS (heart was beating very fast), DRY MOUTH (mouth was dry), ASTHENIA (felt very weak), NASOPHARYNGITIS (cold), DEHYDRATION (completely dehydrated), DYSPNOEA (short of breath), HEADACHE (very bad headache), HYPERTENSION (blood pressure was 146/84), BODY TEMPERATURE INCREASED (temperature at 100.6) and PARAESTHESIA (finger tips started to feel tingly). On 30-Oct-2021, FATIGUE (very tired suddenly), FEELING COLD (feeling cold), PARAESTHESIA ORAL (lips felt a little tingly), PALPITATIONS (heart was beating very fast), DRY MOUTH (mouth was dry), ASTHENIA (felt very weak), DEHYDRATION (completely dehydrated), DYSPNOEA (short of breath), HYPERTENSION (blood pressure was 146/84), BODY TEMPERATURE INCREASED (temperature at 100.6) and PARAESTHESIA (finger tips started to feel tingly) had resolved, CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping) and NASOPHARYNGITIS (cold) outcome was unknown. On 01-Nov-2021, HEADACHE (very bad headache) had resolved.        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 medication was reported NO treatment medication was reported
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant mediations were not reported. The patient was vaccinated with the doses of GARDASIL (intramuscular; dose, lot # and expiration date were not reported) on 05-DEC-2008, 23-MAR-2009 and on 22-APR-2015. No known adverse effects. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown dates the patients received doses of (Oka/Merck) PROQUAD (dose, route of administration, lot# and expiration dates not reported), that were exposed to temperatures outside of the proper storage range. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Became light headed, Fainted, Turned Pale, Sweated.   EMTs were called who took BP, Blood Sugar, and ran EKG (I think). and was told all were normal.
15th Jan-1200-nausea, migraine 16th Jan-1800-nausea, fatigue, migraine, weak body, slight dizziness 17th Jan-laid down all day-spotted vision, dizziness, taste was off-threw-up x times-his words 18th Jan-same as above.  night slight fever@99.3 19th Jan-woke-up, low fever, gastric reflux x 2-not feeling well
swollen gland under his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (swollen gland under his arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen gland under his arm). At the time of the report, LYMPHADENOPATHY (swollen gland under his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received and contain no new information.
Pt reported a "chest sensation" "warm,tingly" Vitals: 168/108, 83, 16, 100% -- > 152/102, 80, 14, 99%RA MAR called 09:40.  Pt observed for 30mins.  Pt states symptoms resolved.  Pt stable and released from the vaccination site.
Patient exprienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient exprienced COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No known allergies were reported. No relevant medical history reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (Patient exprienced COVID). At the time of the report, COVID-19 (Patient exprienced COVID) had not resolved.            The co-suspect indication was reported as moderate to severe rheumatoid arthritis.  Concomitant drugs were not reported.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  No treatment medication was provided.  Reporter's causality for co-suspect product was reported as reasonable possibility.  Company comment: This is a spontaneous case concerning a female adult patient of unknown age, with no reported medical history and with vaccine history of receiving first and second dose of mRNA-1273, with unknown dosage and dosage interval. Adalimumab (Humira) for moderate to severe rheumatoid arthritis was reported as co-suspect product, with unknown therapy dates. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurrence was unknown with respect to the booster dose of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The concurrent Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female adult patient of unknown age, with no reported medical history and with vaccine history of receiving first and second dose of mRNA-1273, with unknown dosage and dosage interval. Adalimumab (Humira) for moderate to severe rheumatoid arthritis was reported as co-suspect product, with unknown therapy dates. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurrence was unknown with respect to the booster dose of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The concurrent Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PATIENT STATED THE AREA AROUND THE INJECTION SITE BECAME INFLAMMED, RED, ITCHY, PAINFUL, WARM TO THE TOUCH. SWELLING INCREASED INSTEAD OF DECREASED. NO LONGER ITCHY. PT ADMITTED SHE SCRATCHED THE INJECTION SITE. PT USED IBUPROFEN 400MG 1-2 TIMES A DAY, PLUS APPLIED ICE TO AREA, PATIENT TAKES ZYRTEC. PATIENT HAD A VIRTUAL VISIT WITH THEIR DOCTOR TODAY 1/13/21, DR STATED IT WAS PROBABLY A REACTION TO THE INJECTION BANDAID THAT WE USE TO INJECT THROUGH. HE PRESCRIBED ANTIBIOTIC OINTMENT, BENADRYL AT NIGHT AND TO CONTINUE IBUPROFEN. FOLLOW UP WITH PRESCRIBER ON FRIDAY 1/15/21.
pt recvd vax;on 18oct has diffuse rash & fever;21oct adm to hosp w/ fever & pancytopenia(WBC=0, platelets 60,000);bone marrow biopsies;rx'd w/ ATBs; recovered;
Pt was given 6yr-11 yr old and needed to be Moderna Bivalent
The first day after vaccine my arm was really swollen.  On the second day my arm was really swollen; i couldn't lift my arm as it was double my size of my regular arm; i couldnt lift my arm above my waist and it was pain 10/10 on movement.  Also I felt like I had a stroke like symptom as I felt groggy, confused.  I was really tired and fatigued for next few days.  After the 3rd or 4th day the swelling went down and I didnt feel groogy and confused.  But I did feel tired for the rest of the week
Information has been received from a registered nurse concerning a 21 month old female patient who on 10-FEB-2011 was vaccinated SC into right arm with the first dose of VARIVAX (Merck) (lot # 667814/1307Z) at 16:00. Concomitant therapy included the first dose of MMR II (MSD) (lot # 668987/1249Z) given SC into left arm at 16:00. On 10-FEB-2011 the patient experienced local reaction immediate to subcutaneous (subQ) injection to deltoid, large, hive-like swelling-seemingly itchy. No systemic symptoms. The patient was given BENADRYL, and observed for 30-40 minutes. Redness and swelling had gone by discharge from office. The patient experienced identical reaction to MMR II (MSD, WAES # 1102USA01867) given opposite deltoid subcutaneous (subQ). Additional information has been requested.
09/23/22 presents to ED for "Failure To Thrive" "generalized weakness, and AMS". PMHx of  "CAD, CHFrEF 30% s/p ICD, RUE DVT on Eliquis, ESRD on HD TTS, still makes urine, CVA, HTN, Hyperlipidemia, DM, COPD on Home O2 at 2 L/min per N/C, Anemia, GERD, Hypothyroidism and Breast Cancer"
Day 1: Sore injection site. Headache Day 2: headache, chills, night sweats, muscle aches, sore arm, extreme fatigue-could not function. Couldn?t focus on anything, had lay down and keep eyes closed, slept most of day and all night. Occasionally wake up with night sweats every few hours.  Day 3: some tiredness and slight headache , sore arm
Redness at injection sites, pain from injection sites down to elbow and muscle tightness.
On 11/01/2021 I was working, and I was trying to look up some information and saw some squiggly lines and some blind spots in my vison, that lasted for 15 mins. After about an hour I had some pressure on the right side of my head, and nausea, but it didn't last long. 11/02/2021 it repeated itself again, but with pressure around my right eye. 11/03/2021 symptoms also repeated, it lasted longer this day for half an hour.   I saw my optometrist on 11/03/2021-nothing was abnormal. I have a visual field test scheduled for the end of November. 11/04/2021 just last night I had the symptoms returned just in the left eye at this time and lasted 35 mins. The lines this time got brighter in the left eye.
COVID arm.  Upper left arm itching, red, and developed big welts near and around injection site.  Just reporting this as a matter of record.  I am thankful to have the vaccination.