chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sickness; Mobility decreased; Psoriasis flare-up; Chills; Lymphadenopathy axillary; Tiredness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), MOBILITY DECREASED (Mobility decreased), PSORIASIS (Psoriasis flare-up), CHILLS (Chills) and LYMPHADENOPATHY (Lymphadenopathy axillary) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received first 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness), MOBILITY DECREASED (Mobility decreased), PSORIASIS (Psoriasis flare-up), CHILLS (Chills), LYMPHADENOPATHY (Lymphadenopathy axillary), FATIGUE (Tiredness) and PYREXIA (Fever). At the time of the report, ILLNESS (Sickness) had resolved, MOBILITY DECREASED (Mobility decreased), CHILLS (Chills), LYMPHADENOPATHY (Lymphadenopathy axillary), FATIGUE (Tiredness) and PYREXIA (Fever) was resolving and PSORIASIS (Psoriasis flare-up) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication was provided.   This case was linked to MOD-2021-624374.
Localized redness, edema, warmth at site-left forearm. No treatment necessary.
Myalgia, NauseaVomiting, Muscle soreness to arm Narrative:
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/26/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Starting 3/30/21 head and whole body paresthesias with mild chest tightness.  Still present 4/2/21 and symptoms about the same.  No weakness, change in mental status, shortness of breath or loss of any function.
fatigue; had trouble getting her breath; blood pressure was all over the place; sick; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick), NAUSEA (nausea) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017821A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 4, Congestive heart failure and Drug allergy (allergy to pain killers).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick) and NAUSEA (nausea). On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with FUROSEMIDE for Hypertension, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 265/210 (High) high.         No concomitant medications were reported.Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-073042 (Patient Link).
Vaccine given at 1304. Patient reported feeling light headed and sweaty. Patient reported feeling nervous. 1310: Patient tried to stand and felt really dizzy. Patient transported via wheelchair to lay down and then syncopal episode lasting 30 seconds. Patient transported to cot. 1318: Blood pressure, in right arm, 110/52, heart rate 88 and oxygen saturation level 98% on room air. 1328: Blood pressure, sitting, 92/48. Patient reports that she took all medications this morning and has been exercising more. 1333: Blood pressure, lying, 110/72, heart rate 85, and oxygen saturation level of 99% on room air. 1339: Patient attempted to sit up. "Feeling a little better." "I'm definitely cooling off. I'm not sweating anymore." 1341: Blood pressure, sitting, 100/68, in right arm. 1349: Blood pressure 118/760, sitting, in right arm
On 9-24-09 started getting rash on face. Rash spread by morning of 25th. to chest back and abdomen. Also c/o headache. Went to family doctor- was given BENADRYL
Dizzy; Can hardly do anything; Sweat; Very hot; Really sleep; Hungry; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot) and SOMNOLENCE (Really sleep) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot), SOMNOLENCE (Really sleep), HUNGER (Hungry), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot), SOMNOLENCE (Really sleep), HUNGER (Hungry), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 20 minutes after the vaccination patient stated experiencing fever, dizzy, sweat, very hot, really sleepy, hungry, fatigue, and she can hardly do anything. She took Tylenol extra strength . She had COVID-19 in JULY 2020 and she has had more symptoms with the vaccine than when she had COVID-19. No concomitant medications were reported.
Injection site redness, swelling, itching, hot to touch and began to spread to 6 inches by 5 inches over left thigh.
Super fatigued; Post nasal drip; Lateral ankle joint pain; Headache; Paroxysmal fever; Face started to flushing; injection site pain that radiates through left arm; Chills; A spontaneous report was received from a healthcare facility staff member concerning a 30 year old, female patient who experienced fever, chills, face started to flush, injection site pain that radiates through her left arm, lateral ankle joint pain, super fatigued, headache and post nasal drip.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (LOT:  011L20A) on 29 Dec 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After being vaccinated, The patient experienced injection site pain that radiated through her left arm. At 18:00 the same day as the vaccine, the patient reported she experienced a fever (described as paroxysmal) and chills. At 18:30, her face started to flush. At 19:45, she experienced lateral ankle joint pain, described as being isolated to just that bone. The patient reported headache on 29 Dec 2020 and 30 Dec 2020. On 30 Dec 2020, patient reported  another spike in fever at 17:30 and felt super fatigued and had postnasal drip.   Patient stated that postnasal drip was relieved by the allergy medication.  Treatment for the events included allergy medication for the postnasal drip. and denied taking treatment for the fever as she did not want to mask any symptoms.    Action taken with mRNA-1273 in response to the events was not provided.   The out come of the events, fever, chills, face started to flush, injection site pain that radiates through her left arm, lateral ankle joint pain, super fatigued, headache, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded.
Noted blood from left ear. Began last night with swelling to node on left side of neck, and this am also to left axilla area. Some discomfort around left side of face near ear
SMALL, approximately 1 in. DIAMETER, ROUND, PALPABLE, NON-DISCOLORED, LUMP AT SITE OF INJECTION PRESENT FOR NOW 28 DAYS. PATIENT REPORTS NO PAIN DURING PALPATATION.
02/28/2021 after running after my dog I felt a dull pain in my chest, after that evening I felt worse about 2-3 in the morning and the pain had gotten worse, I went to the hospital, I was diagnosed with a heart attack.
PT threw up after receiving Pfizer vaccine first dose and complained of feeling lightheaded. PT felt better after throwing up, provided water and crackers and legs were elevated. PT tolerated well. PT left under stable condition ambulated with his father.
tested positive for Covid-19; headache; chest cold; A spontaneous report  was received from a consumer concerning a 84-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest cold, headache, and tested positive for COVID-19.  The patient's medical history was not reported by the reporter. Concomitant medication was not 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 number: 010M20A) in right arm for prophylaxis of COVID-19 infection.  On 30-JAN-2021, she experienced chest cold and headache. On 02-FEB-2021, she tested positive for COVID-19.  The event chest cold was considered as serious with criteria of medically significant.  Treatment for event was unknown.  Action taken with mRNA-1273 in response to the events was reported as unknown.   The outcome of events chest cold, headache and COVID-19 were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Left arm is with swelling, warmth and redness measuring approximately 7cm X9cm.  Client did relate that it hurts.  Was noticed as still being red when she got out of the swimming pool and is in the same area as her shot.
Patient had an anaphylactic shock reaction to the vaccine. Patient's wife gave him Epi-pen shot and took him to the Emergency Room. Hospitalization was not required.
Patient admitted to hospital with positive breakthrough case. Complaining of SOB x 1 week. Diagnosed with COVID on 10/23/21. Resp rate 26 and pulse ox 87 on RA.
Information has been received from a registered nurse concerning a 24 year old male patient who on 16-FEB-1999 and 21-JAN-2000 was vaccinated with two doses of VARIVAX (Merck) (lot #, dose and route unknown). In 1999, he had a negative varicella titer prior to receiving the vaccine. The patient's relevant past drug history and concomitant medications were unknown. On 24-DEC-2009 the patient's varicella titer was still negative. As of 28-DEC-2009, it was unknown if the patient would receive VARIVAX (Merck) again. Labs or diagnostic tests included varicella titer which was negative. At the time of the report, the outcome was not reported. Information has been received from a registered nurse concerning the 24 year old male patient who failed to seroconvert after 2 known doses of VARIVAX (Merck). It was noted he may have received one dose as a child but there was no record of that dose. It was reported that the patient had a negative titer in January 1999 so he received VARIVAX (Merck) (16-FEB-1999 & 21-JAN-2000). A titer done on 24-DEC-2009 was negative. This is a consolidation of two reports concerning the same patient. No further information is available.
achey last night:  had a hard time sleeping.  Head ache:  right behind my eyeballs.  Front of shoulders sore, shot area tender.  Mid section achy.  Feet sore.  I got up at midnight and took two tylenol.  It helped.  This is my fourth covid shot.  The last three I had similar symptoms--I called in sick once because I was washed out.  I think I will take a nap right now.  None of my friends or relatives have these symptoms.  I very seldom take medications.  I will be fine in a couple days.
SHIVERS; BIT OF A FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced shivers and bit of a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shivers and bit of a fever was not reported. This report was non-serious.
3 abscesses all formed in (L) axilla 3 days after vaccine. Then shingles to forehead 10 days after abscess required incision, drainage and antibiotics.
Patient who received the expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. The vaccine was refrigerated on 07-May-2021.
I had a routine doctor visit. It was discovered that there was a significant increase in my A1C level.
3:40pm received shot.  3:45pm started feeling severe tingling in both wrists thru hand thru finger tip s, and from knees to toes.  Also mild nausea for 10 minutes. Tingling for 15 minutes. Almost hyperventilating for 5 minutes. Could not move or bend left thumb for 10 minutes. Fingers wanted to curl towards palm for 10 minutes.  Symptoms went away after 15 minutes, no help given. I sipped water a few times during reactions. We left the building and the fresh air helped feel better. Able to drive home. No one checked on us while reaction occurred.
Information has been received from a pharmacist concerning a female (age unknown) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot#, Batch#, date, dose and route unknown). Pertinent medical history and concomitant medication was reported as unspecified. The reporter stated "client was vaccinated with pneumococcal 23v polysaccharide vaccine and developed an unspecified local site reaction." Unspecified medical attention was sought. It was reported that the client recovered. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a 77 year old male patient with an unknown history of varicella who was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to an office error. No adverse reactions reported. It's unknown if the patient had sought any medical attention. No further information is available as the nurse does not wish to be contacted.
pt awoke w/t103.8 R 2AM; 19AUG94 fever persisted entire day despite treatment w/APAP; was irritable & needed to be held all the time; 20AUG94 fever down to 100.4 R; was fine next day; pt father hx febrile sz;
Chills with low grade fever 100.5 Body aches Headache with most pain behind right eye
pt recvd vax; 15-20 mins p/ vax, exp n, v, dizziness, & palpitations; resolved
Case previously recorded as MA2009-4584. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse events was reported. Reference no: NA09-008308.
Covid arm. Injection site muscle firmness and pain, red splotch cover across large section of arm
Doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Treatment details were not reported by the reporter.
Delayed reaction rash. A week post injection arm began to itch in the evening, was slightly red. Next morning rash was prominent. Approximately  1.5 x 3? in size, warm to the touch, raised and more firm that the surrounding skin, also slightly bumpy. Not painful, just a mild itch.
Patient had excessive swelling and a white color around injection site, this went away after 3 days. Patient developed a hives like rash on neck and upper chest which she still has and placed hydrocortisone topical cream to the area to help with itching. Patient had a headache for about 5 days in which she took naproxen to help with this. The rash has not gotten worse and patient will follow up with doctor if it does not go away.
No additional AE's; VARIVAX and MMR II that underwent multiple temperature excursions had been administered to patients; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-MAY-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T020652, expiration date 16-JUN-2022, (exact dose, injection site, route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) lot # S035352, expiration date 05-NOV-2021 (exact dose, injection site, route of administration were not reported), both for prophylaxis.  Administered doses of vaccines experienced the temperature excursions of -14.03 degrees Celsius for 1 hour and 15 minutes, -14.9 degrees Celsius for 9 minutes, -10.3 degrees Celsius for 1 hour and -6.3 degrees Celsius for 2 hours. The digital data logger was involved in recording the temperature excursion details. Administered doses of vaccines experienced previous temperature excursions of -14.03 degrees Celsius for 1 hour and 15 minutes and of -14.9 degrees Celsius for 9 minutes. There was no adverse effects reported.
Pt had no problems reported with the vaccination #1 moderna received at her care facility on 2/7/21. Pt rec'd her second covid vaccination on 3/15/21 but it was administered at the above named facility the Center and received Pfizer vaccination instead of Moderna.
This spontaneous report as received from a pharmacist refers to a 1 year old female patient with no pertinent medical history or drug reactions/allergies. In April 2014 (reported as 1 month ago) the patient was vaccinated with the first dose of M-M-R II (dose, route and lot # not reported). There was no concomitant medication reported. The pharmacist reported the patient developed a red rash around her mouth and on her abdomen 7 days after administration of the first dose of M-M-R II 1 month ago. The rash resolved after an unspecified length of time without requiring medical treatment. Two weeks ago, the rash returned. There was no lab diagnostics studies performed. Patient sought medical attention by calling the pharmacy. There was no treatment given. At the time of report, the patient did not recovered from event. Additional information has been requested.
Mild case of hives-prednisolone- and BENADRYL. Hives lasted about a week then were gone.
Itching in throat and in nose, then headache and increasing cough, then joint pain.  Took Benadryl every 4 hours, started getting better and today went to Primary Care Md for evaluation/results of office visit not known.
I had swelling in armpit and lymph nodes on my left side. On December 21, 2021 called Telehealth spoke with doctor advised me to follow up with my doctor if  the stiffness and swelling didn't go away. I'm having the swelling as of today bend my left fingers still experiencing pain.
Mom called MD office on 01/07/04 at about 16:00 and reported that pt woke up with swelling to eyes at about 13:00 and as time went by, pt's upper lip swelled and became redness to face and spreading to entire body by 16:00.  Mother was advised to take pt to ER ASAP.  Pt seen at ER that afternoon and treated and released.