chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced BACK PAIN (Back pain). The patient was treated with HYDROCODONE for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.
Symptoms: Low-grade fever (99.2), muscle aches, fatigue, rapid pulse (92 bpm), elevated blood pressure, chest congestion. Treated with antibiotic, cough suppressent, tylenol.
I had the first of 2 SHINGRIX shots (the new shingles shot). The shot was in my left arm. The location of the shot hurt for more than 3 days. Very painful. I was unable to sleep on my left side for 3 nights in a row. In addition, on the second day I felt like I was coming down with the flu. I hurt all over. Took an aspirin and went to bed at 6pm. Felt bad for about 2 or 3 days. As a result of the pain and other side effects, I am not planning to take the second shot.
Pt. had excessive crying for 5 days following administration of 4 m immunization including Pentacel, Prevnar, Rotateq fussy after 1st doses at 2m x 24 hours.
None. Patient given vaccine of ROTATEQ and had expired date of 11/20/14 no reactions. Spoke with Merck no further action needed.
pt recvd vax & 24hrs later pt exp erythema, swelling & itching in 5cm area;no further details were provided;
Patient reports a "goose egg" red bump at the injection site that hurts and itches.
HEADACHE; DIZZINESS; COUGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient had experienced headache.  On 06-MAR-2021, the patient had experienced dizziness. On 06-MAR-2021, the patient had experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, dizziness, and cough. This report was non-serious.
Hypertension more than 35-40 points above normal for both systolic and diastolic
Patient received Pfizer COVID vaccine on 3/30/21 and 4/27/21. Patient tested positive for COVID on 9/3/21. On 9/6/21, patient was brought in by EMS with worsening shortness of breath of the last 3 days and  8 days symptoms of fever, cough, SOB, and diarrhea. Patient admitted for acute hypoxic respiratory failure and COVID pneumonia. As of 9/9/21, patient is still admitted in the med/surg unit.
Became paralyzed; Every single muscle became tensed; Sore arm; severe reaction/ vaccination adverse reaction; Nauseous; A spontaneous report  was received from a consumer concerning herself, a 22-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced every single muscle became tensed, became paralyzed ,sore arm, nauseous and a severe reaction.  The patient's medical history was not provided. Concomitant medication use was not provided by reporter.   On 02 Mar 2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 023A21A) intramuscularly for COVID-19 infection prophylaxis.   On 02 Mar 2021, after first dose of the Moderna vaccine, the patient experienced every single muscle became tensed, became paralyzed ,sore arm, nauseous.  Treatment details included acetaminophen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, every single muscle became tensed, became paralyzed ,sore arm, nauseous, and a severe reaction was considered unknown at the time of this report.; 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.
severe chest pain like a crashing pain that comes and goes; pain at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (severe chest pain like a crashing pain that comes and goes) and VACCINATION SITE PAIN (pain at the injection site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 21-Feb-2021, the patient experienced CHEST PAIN (severe chest pain like a crashing pain that comes and goes). On 21-Feb-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, CHEST PAIN (severe chest pain like a crashing pain that comes and goes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHEST PAIN (severe chest pain like a crashing pain that comes and goes) to be related. No further causality assessment was provided for VACCINATION SITE PAIN (pain at the injection site).    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Followup information was received on 17-Apr-2021.Patient demographic details was reported. Causality was reported for chest pain.
Local reaction including: moderate erythema, edema, pruritus in a 20 x 10 cm area surrounding injection site.
Increase tempeture, redness and swelling at injection site within 24 hours of immuniztion.
Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.; Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) and VACCINATION SITE ERYTHEMA (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) and VACCINATION SITE ERYTHEMA (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.). At the time of the report, VACCINATION SITE PAIN (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) and VACCINATION SITE ERYTHEMA (Developed a large, red, hot area at the site/ It was smaller, less hot but still sore.) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  This has remained to this day. It was smaller, less hot but still sore. Patient was asking what this meant and when will it go away.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2023: Live follow-up received: Reference number added.
Patient started feeling tired around 8:00 and went to bed early. Throughout the night she woke up feeling hot and achy. She took her temperature and she did have a fever. She took ibuprofen and went back to sleep. When she woke on Friday 5/18, her arm hurt really bad, she felt feverish (hot and then chills), nauseous and extremely fatigued. Throughout the day her symptoms continued. She ended up leaving work early to go home and rest.
Patient admitted to hospital 9/22/22 and tested COVID+ on 9/29/22  Patient vaccinated x3 (Pfizer: 2/22/21, 3/15/21, 11/17/21)
Woke up 10/20/09 with severe dizziness, body aches, muscle aches. Referred to physician regarding dizziness.
Rash started in left armpit and around left armpit. Two reddish/purple spots below waistline. As the days after onset the rash continued to spread and the reddish/purple spots enlarged. Eventually after 2 weeks there is one large red spot between bellybutton and privates stretching between the hips. Rash has spread to mouth, neck, both upper arms, both armpits, front and back of upper torso, and is on the upper legs.  Used benadryl pills and cream, hydrocortisone cream 1% and 2.5%, permethrin cream, Zyrtec, hydroxyzine HCL 25mg, prednisone, and montelukast 10mg
Swelling, redness and tenderness, warmth to the area that is spreading, started on 5th day after the injection
Patient said it was her 3rd shot. I checked after giving the shot. The system said it was her 4th shot.
Vaccination not given at our facility. Unable to determine manufacturer, lot, route, or site. Could be Havrix or Vaqta.  Pt presented to ED 06DEC22 @ 20:29 w/ mother for c/o rash to face and itching s/p HEP A vaccine at 1100. Diphenhydramine 25mg administered @ 20:39. Mother stated reaction started shortly after injection and pt had an axillary fever of 101.2F. Mother administered APAP 10mL and fever resolved. No prev rxns to other vaccines or medications. No breathing issues or tongue swelling. 1st HEP A vaccine 2017, no rxn. ED provider note indicates possible reaction to vaccine, will need to be cautious in the future with prolonged observation after injections. Mom aware. Pt discharged w/ diphenhydramine 12.5mg/5mL take 10mL PO TID PRN itching and prednisolone 15mg/5mL take 10mL PO daily x3 days.
He got 1ml dose instead of 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (He got 1ml dose instead of 0.5ml) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LORAZEPAM (ATIVAN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (He got 1ml dose instead of 0.5ml). At the time of the report, ACCIDENTAL OVERDOSE (He got 1ml dose instead of 0.5ml) 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 treatment medication was reported.  Patient gave consent for safety to Follow-up.
57 yo patient received 10 year TDaP booster on Thursday 4/13/2017 about 1330. Later that day, about 1500 hr (3.5 hr later) while at home he C/O his vision began to blur and he was experiencing other migraine like S/S such as photophobia and soreness to neck muscles similar to past migraines. But these symptoms - sore muscles in neck and pain with moving eyes did not progress as his past migraines did, he didn't take abortive migraine meds. He was a bit fatigued and went to bed early (930pm) feeling achy all over and just "not right". He awoke about 430 AM with severe migraine (pain in temporal region bilaterally) and every joint in his body both large and small "on fire". He rated pain as 8/10 unrelieved with meds (MAXALT, TYLENOL). He went to work but left early (11am) and his wife took him to ER at 1430 hr where he was told "he was okay" and that this was some "type of migraine". ER labs show normal CBC and CRP was 14.5 with ESR of 3. He was treated with a pain med cocktail with some relief but pain did not resolve. He recalls when he shook ER MD hand when discharged, his elbow was extremely painful (never felt like this before). Pain was described as a sharp jabbing pain. He advised his past CRP done in Nov 2014 was 5 (5-9.9). Last ESR in 2008 and 2014 were both 1. (labs verified in database). Over next few days, his joint pain (to bilateral hips, knees, ankles, shoulders, elbows, wrists, fingers, neck) and diffuse temporal HA persisted with intensity waxing and waning 6-8/10. He was able to perform his duties at work and saw HCP today-4/18/2017. Pain was given a 5-7/10 depending on joint hurting (especially hips) or if head hurting - he admits to chronic pain syndrome with normal daily pain at 3-4/10 since 2010 MVA (run over by SUV with multiple Fx's). He questions if symptoms were related to receipt of TDaP vaccination as he has not had this degree of pain since 2010 MVA.
A 53 year old man, with a history of thyroid cancer and renal carcinoma, was diagnosed with bladder cancer in February 2004. Subsequently he received weekly OncoTICE instillations. After approximately three weeks, some abnormal lab values were seen (uric acid increased, creatinine clearance 1.2, glucose low, TSH decreased). According to the patient's MD's, these were either due to the patient's diet or his kidney. For the decreased TDH the patient's Synthroid dose was decreased to 150mcg. Since before completing the OncoTICE treatment he experienced flu-like symptoms and worsening of his arthritis.
Frequent Urination. I only started noticing it after 10 hours because I fell asleep.
Tenderness; Pupil contracted to almost nothing; Arm hurting little bit; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit). On 04-Feb-2021, TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Approx 5 min of admin of C19 vax, pt with facial swelling, sob, tongue edema and reported dysphagia due to swelling. EMS assessment with HTN, 02 sat 100%, however pt states getting worse, followed by bronchospasms. Pt given epi, follwed by benadryl.  Pt not hypotensive, no urticaria, no and remained hemodyamically stable, ambulatory. Sent to ED via paramedics. Report elucidates pt sx resolved prior to reaching ED.
My blood pressure has been 80 over 120 range for years (all my life). It want up to 90 over 145 after second shot (March 2021). I was bitten by tick in August (with bite mark) and was treated within a week. I was told it compromises immune systems so I got third Moderna shot.  My blood pressure is consistently 90 over 180 to 200.
13 Nov 2021 2000 Sore arm and irritable, gave 7 mL Tylenol   14 Nov 2021 0930 Extremely fatigued, eating very little except sips of water  1000 Temperature ? 103.5 degrees F (All temporal temps with a minimum of 3 reading values.  Average temp recorded) Tylenol ? 320 mg (2 tablets)  1145 Temperature ? 100.9 degrees F  1510 Noticed rapid respiration and pulse while child sleeping (HR 220+, Resp 40) Temperature ? 106.4 degrees F  1515 Tylenol ? 320 mg (10 mL) Lukewarm bath  1535 Temperature ? 101.0 degrees F  1625 Temperature ? 100.9 degrees F  2010 Temperature ? 102.8 degrees F  2015 Tylenol ? 320 mg (10 mL)  2045 Temperature ? 105.8 degrees F  2100 Temperature ? 103.6 degrees F  2125 Temperature ? 101.1 degrees F  2145 Temperature ? 105.2 degrees   2215 Temperature ? 99.8 degrees F  2235 Temperature ? 101.4 degrees F  2320 Temperature ? 103.1 degrees F  2340 Temperature ? 103.2 degrees F   15 Nov 2021 0020 Temperature ?  103.4 degrees F Tylenol ? 320 mg (10 mL) ? did not stay down, vomited within mins of medication administration and few sips of cool water Appears unwell; puffy eyes, fatigued Sips of water  0024 Vomiting ? water + Tylenol  0050 Temperature ?  104.2  degrees F  0120 Temperature ?  104.1  degrees F Tylenol ? 320 mg (10 mL) readministered   0140 Temperature ?  102.4  degrees F  0530 Temperature ?  normal to touch while sleeping  0915 Temperature ?  99.5  degrees F Tylenol ? 320 mg (10 mL)  1345 Temperature ?  98.3  degrees F  Completely healthy prior to vaccine, including all household members.  No other illness after conclusion of the above reported vaccination reaction.
Chills; Muscle Ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Muscle Ache) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle Ache) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), MYALGIA (Muscle Ache) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided   This case was linked to MOD-2021-053064 (Patient Link).
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Patient meeting case definition for MIS-A with evidence of myocarditis. She is 27 weeks pregnant, Estimated fetal weight 1116g  Patient proceeded to progress to cardiogenic shock requiring inotropes and vasopressors.  Her hospital course has been complicated by a ventricular fibrillation related cardiac arrest and acute respiratory failure from which she recovered and was successfully extubated.  She was treated with aspirin 162 mg, 2.5 mg/kg of IVIG, 400 mg of Tocilizumab, 6 mg twice daily of dexamethasone followed by 1 mg/kg of methylprednisolone.
Patient lethargic with high fever (102 after Tylenol it would come down, but not normal), decreased appetite.
No adverse event, only reporting that he receive Moderna booster under age 18. Patient did not expireince any event.
completely sweating; broke out in red, whelpy, described as with whelps, and itching rash; broke out in red, whelpy, described as with whelps, and itching rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (broke out in red, whelpy, described as with whelps, and itching rash), HYPERHIDROSIS (completely sweating) and VACCINATION SITE ERYTHEMA (broke out in red, whelpy, described as with whelps, and itching rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Itch. Concomitant products included AMLODIPINE, ATORVASTATIN and ASCORBIC ACID, COLECALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (MULTIVITAMIN HP) for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced RASH PRURITIC (broke out in red, whelpy, described as with whelps, and itching rash) and VACCINATION SITE ERYTHEMA (broke out in red, whelpy, described as with whelps, and itching rash). On 22-Mar-2021, the patient experienced HYPERHIDROSIS (completely sweating). At the time of the report, RASH PRURITIC (broke out in red, whelpy, described as with whelps, and itching rash), HYPERHIDROSIS (completely sweating) and VACCINATION SITE ERYTHEMA (broke out in red, whelpy, described as with whelps, and itching rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment. Already had some previous medications for itching which she used to treat the rash yesterday 23Mar2021, including triamcinolone ointment and hydroxyzine 10 mg.
No treatment. Pt experienced swelling, redness and warmth at injection site - still present two days after.
Considered as grade 3 level headache that prevented daily activity per employee. Arm sourness at injection site. T102.0 1/19/21 at 1300 on 1/19/2021. fatigue, chills, myalgia. Took tylenol with no relief.
Pt describes pain at time of vaccination. Pain persisted in area at injection site which was treated with morphine. Also says she was given an antibiotic. Symptoms improved although lingering pain.
MODERNA VACCINE WAS ADMINSTERED 12/13/21 IN RIGHT DELTOID.  PATIENT WOKE UP THE NEXT MORNING WITH GROUPINGS OF BLISTERS ON RIGHT CHEEK, LOWER RIGHT ABDOMEN, AND RIGHT LEG.  PATIENT DESCRIBED THE BLISTERS AS LEAKING CLEAR FLUID,  ITCHY AND BURNING. SHE DID NOT RUN A FEVER.  AS OF 12/16/21 THE BLISTERS ON HER FACE, ABDOMEN, AND LEG HAVE DRIED UP AND CRUSTED OVER
No adverse reaction. Pt was administered a Zoster vaccine instead of a PROQUAD.