chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reports of knots in the underarm area w pain; reports of knots in the underarm area w pain; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (reports of knots in the underarm area w pain) and AXILLARY PAIN (reports of knots in the underarm area w pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (reports of knots in the underarm area w pain) and AXILLARY PAIN (reports of knots in the underarm area w pain). At the time of the report, AXILLARY MASS (reports of knots in the underarm area w pain) and AXILLARY PAIN (reports of knots in the underarm area w pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.; Sender'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.
Around 6PM the evening after receiving the vaccine my arm became noticeably sore and I began to feel achy all over.  I became noticeably more tired than usual around 8PM and went to bed about 8:30.  At around midnight I woke up hurting all over, joints and muscle aches.  I felt suddenly very nauseated and got up to go to the bathroom toilet.  Once crouched down over the toilet I became very lightheaded and dizzy. My vision went white and starry and remained this way for my guess is around 5 minutes.  My husband says I was showing seizure like activity, moaning and "clenching up."  Once my vision cleared up I still felt awful,  lightheaded, weak, dizzy.  I sat up with a cold cloth on my head.  My husband  during the coarse of this was terrified and called an ambulance.  The EMT's arrived and informed me the episode had occurred because I was hyperventilating.   My chest was uncomfortable at this time and my fingers were tingling.  They calmed me down and check my vitals which were stable.  I went back to bed and slept after that.  I had another feeling of dizziness and nausea about 7AM the next day which resolved.  I felt very tired, weak, and achy all day the next day.
second dose on day 21; A Spontaneous report was received from a healthcare Professional concerning a 50-years-old male patient who received 2nd dose of Moderna COVID-19 vaccine (mRNA-1273) on day 21.  The patient's medical history was not provided. No concomitant medications or labs were reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A) on 06-Jan-2021. The patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the into right arm for prophylaxis of COVID-19 infection.   The reporter stated that physician at the facility received the 2nd dose of Moderna COVID-19 vaccine on day 21. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable  The outcome for the event was stated as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 030L20A for second dose) with no associated AEs reported.
Severe pains that felt like someone was stabbing me with an ice pick all over my body.  Ringing in the ears, sweating but no fever, weak legs--had to call a neighbor to help me walk.
Patient was initially presented on 2/15/2022 with a chief complaint of left flank pain and lack of appetite with decreased urine output.  Patient recently underwent 2 vessel CABG on 02/07/2022  and was discharged to home on 02/13/22.  Postoperative course was complicated by urinary retention and high PVR required straight catheterization.  Patient developed postoperative atrial fibrillation with RVR was started on amiodarone and was also started on Lasix.   Upon evaluation in the ED BP was 88/59, heart rate 70 with SpO2 93% in room air afebrile.  Patient appeared to be fatigued and subsequently he was found to have atrial fibrillation with RVR with a rate of 138 BPM.  Lab work revealed mild leukocytosis, elevated creatinine of 1.9 and BUN of 35.    Patient was subsequently admitted for dehydration and acute kidney injury.  Subsequently patient tested positive for COVID-19 PCR although patient denied any fever or chills or any sore throat or body ache.  He was placed on contact and droplet precaution.     Patient developed worsening renal function with elevation of creatinine possibly due to dehydration.  He was started on 75 cc/hour of IV fluid cautiously due to COVID-19 infection.  Patient reported to have no shortness of breath or fever or chills or any sore throat or any myalgias. CRP is elevated  on 2/17.  Patient had slightly low SpO2 on 2/18 and he was started on Decadron at the time.  He received another dose and the Decadron is discontinued on 02/19. Leukocytosis and CRP are improving.  Procalcitonin is negative.    The length of stay was prolonged due to acute delirium.  Patient remained stable and was discharged at stable condition.
Patient reports numbing pain at injection site. Patient was unable to lift arm above head. Pain persisted through the night and went to the ER.
A report has been received from a Pharmacist concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient stated that patient received the entire dose in one nostril. The outcome of the event of patient received the entire dose in one nostril is unknown. The report was considered to be non-serious.
Given MMR, 24 hours later developed fever, fatigue, swollen jaws, difficulty opening her mouth lasted 3 days.
1) pain and swelling in arm at/near injection site - started ~12 hrs after shot; much worse at 24 hrs after; still lingering at 7 days after. 2) pain and swelling of lymph node in armpit of arm that received injection - started ~24 hrs after shot; got worse over 2-3 days, then slowly started improving; still painful at 7 days after and worsened with exercise on day 7 (did not try to exercise until day 7). 3) fever, 99F to max of ~101 F - started ~24 hrs after shot; lasted ~1.5 days 4) headache - started ~12 hrs after shot; lasted ~2 days 5) body aches - started ~12 hrs after shot; lasted ~2 days 6) loss of appetite - started ~18 hrs after shot; lasted 1-2 days
No additional AE details or PQC.; Inbound call from HCP stating a patient was inadvertently administered an expired dose of MMR-II.; the patient was 21 years old; This spontaneous report has been received from a registered nurse, referring to a 21 years old patient of unknown gender. The patient's historical condition and current condition were not reported. The patient's concomitant drug included sterile diluent (manufacturer unknown).  On 02-NOV-2022, the patient was inadvertently vaccinated with an expired dose (1 dosage form) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin (rHA)) (lot # S039311 with expiration date: 04-DEC-2021, dose, strength and route were not reported) for prophylaxis (expired product administered and product administered to patient of inappropriate age). No additional adverse event (AE) details or product quality complaints (PQC).
Throbbing pain arm of injection site.  Muscle soreness inside of arm.  Has continued for last two months.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 5-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 05-FEB-2014 at 9:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). It was informed that vaccinated repeat was declined. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Immediate fatigue and fever lasting 36 hours. Rheumatoid Arthritis Flare, Hashimoto's flaire, Thyroid Flare, Sever unexplained pain in right foot that I cannot bear weight on. X-ray at hospital revealed nothing.
On January 22nd, I began to develop left upper quadrant pain. I was started on Cipro and Flagyl and took that for 7 days. After a couple days I was no better, pain was worse. I underwent a CT scan of abd/pelvis and was found to have Colitis. I have no history of this. I still was not improving so I was started on steroids (prednisone).  Pain improved somewhat, but did not resolve. I then underwent a colonoscopy that demonstrated active and focal colitis in multiple areas of my colon. Again, I have no history of this. I spoke with my PCP who recommended that I not take the second dose, and report this to CDC as a possible hyper immune response.
Redness, swelling, itching, stinging burn-like rash at injection site and a similar, not painful red spot underneath injection site. Applied Neosporin  Blood spots thru bandaid(s) -two Planning on taking a Benadryl when home
1 of 5 pts immunized from the same lot# who exp redness & swelling surrounding the immunization site;no further clinical details provided
PATIENT COMPLAINED OF FEELING HOT AND NAUSEATED.  PATIENT VOMITED AND ALSO HAD COMPLAINTS OF DIARRHEA.  PATIENT'S BLOOD PRESSURE SLOWLY INCREASED.
Cellulitis at site of injectionfor which antibiotics were started on 1/29/2021 with response to antibiotics.
soreness in their arm; hurt to raise arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in their arm) and LIMB DISCOMFORT (hurt to raise arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, ESCITALOPRAM OXALATE (ESCITALOPRAM [ESCITALOPRAM OXALATE]), CARVEDILOL, LISINOPRIL and FAMOTIDINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in their arm) and LIMB DISCOMFORT (hurt to raise arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (soreness in their arm) and LIMB DISCOMFORT (hurt to raise arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Boostrix vaccine (Tdap) was given to adults. It is licensed for administration to adolescents age 11-18. Both Boostrix and Adacel (licensed for ages 11-64) were kept in the vaccine refrigerator. No adverse reactions. Physician called CDC who informed her that there should be no adverse reaction other than local reactions one would expect from the vaccine itself; and re-vaccination of the patients was not needed.
CAN NOT FUNCTION; VERY TIRED AND EXTREMELY WORN OUT; This spontaneous report received from a patient concerned a female 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, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 21-AUG-2021, the patient experienced can not function, and very tired and extremely worn out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very tired and extremely worn out and can not function was not reported. This report was non-serious. This case, from the same reporter is linked to 20220803123.
Rash; Red blotches near the spine on the lower back, leg and also on the left shoulder/ Red spots as being "more like a blotch the size of a dime''; They are "itchy" although she tries not to scratch them; This spontaneous case was received on 10-Nov-2022 from healthcare professional (consumer-former nurse) via Communications (reference number: SEQW22-05776) and concerned a 71-year-old, female patient.  The patient's concurrent conditions included type 2 diabetes, hypertension, and hypercholesterolemia. The patient's concomitant medications included Atacand (candesartan cilexetil), metformin, hctz and pravastatin, all used for unreported indication.  On 08-Nov-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration and anatomical location: not reported) for the prevention of influenza disease. The batch number was not reported.  On 09-Nov-2022, one day after receiving Flucelvax Quadrivalent the patient developed a rash, red blotches near the spine on the lower back, leg and on the left shoulder. The patient described the red spots as being "more like a blotch the size of a dime'' adding that they are ''itchy'' although she tries not to scratch them. The patient did not take any medication because of the event at hand. The patient has been drinking a lot of water to mitigate the reaction and monitoring the blotches to make sure nothing is spreading.  At the time of initial reporting the patient had not recovered from the events. It was reported that the reaction has yet to stop.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The events of rash, red blotches, and itchy rash are assessed as possibly related to Flucelvax Quadrivalent due to temporal relationship.; Sender's Comments: The events of rash, red blotches, and itchy rash are assessed as possibly related to Flucelvax Quadrivalent due to temporal relationship.
Patient received Pfizer COVID vaccine on 6/3/21 (lot # EW0158), 6/24/21 (lot # EW0173), and 11/3/21 (lot # 30145BA). On 9/16/22, patient admitted to our inpatient facility (med/surg unit) with COVID-19 infection, generalized weakness, and diabetic foot ulcer of the left heel. As of today (9/20/22), patient is still admitted in the med/surg unit.
Fever 103 axillary, vesicles scattered with surrounding erythema (trunk, legs). Developed <24 after vaccinations.
pt recv vax & w/in 12-14 hr post vax pt exp h/a;w/in 24hr pt exp vomiting which lasted 24hr;h/a lasted 5 days;all sx resolved;
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L007226, expiration date 03-MAR-2017, Lot # L015047 expiration date 29-APR-2017 (dose and route were not reported). No co-suspect and concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Arm got all inflamed; Arm got swollen; Arm got all itchy; Arm got all red; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Arm got all inflamed), PERIPHERAL SWELLING (Arm got swollen), PRURITUS (Arm got all itchy) and ERYTHEMA (Arm got all red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced INFLAMMATION (Arm got all inflamed), PERIPHERAL SWELLING (Arm got swollen), PRURITUS (Arm got all itchy) and ERYTHEMA (Arm got all red). At the time of the report, INFLAMMATION (Arm got all inflamed), PERIPHERAL SWELLING (Arm got swollen) and ERYTHEMA (Arm got all red) outcome was unknown and PRURITUS (Arm got all itchy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender'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.
At 8.5-9 months pregnant I was recommended the MMR vaccine. My baby was born with a catract   Upon meeting with a specialist it seems as if the MMR could have played a part
evening of 14MAR97 arm started to swell, became red & hard & started to itch;progressively worsened, seen by MD 17MAR97;shoulder to elbow shows swelling redness & 1/2 dollar size induration;placed on DPH for itching;
Severe abdominal cramping, diarhea, nausea, fever, headache, vomiting, dehydration.
Severe Headaches, left arm pain, left neck pain, elevated blood pressure. Went to ER on 10/4/2021. Was out of work for 3 days. Prescribed Toradol for severe headache pain
Chills, severe aches, pain in my left arm down to my hand , neck, back, chest, keytones due to type 1 diabetes.
Numbness/Lost feeling in my left arm from the shot site to the tip of my thumb; Numbness/Lost feeling in my left arm from the shot site to the tip of my thumb; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 05Jan2022, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Aug2021 13:00 (Lot number: FA7485) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (disability, medically significant), VACCINATION SITE HYPOAESTHESIA (disability, medically significant) all with onset 13Aug2021 07:00, outcome "not recovered" and all described as "Numbness/Lost feeling in my left arm from the shot site to the tip of my thumb". It was unknown if therapeutic measures were taken as a result of hypoaesthesia, vaccination site hypoaesthesia. Additional information: The day after the first shot, patient lost feeling in the left arm from the shot site to the tip of the thumb. Prior vaccine in four weeks was None. Relevant test was none.
After 24 hours all joints hurt. A fever (99.6) came. Could not keep from shivering in spite of wearing a heavy jacket. Took a couple of pain killers. Later in the day the fever broke. and felt human again.  My upper left arm is reddish and itchy. I believe I have an allergy and feel pretty strongly that it was the third dose. The two first doses did not give me any problem.
Shortly after vax the pt felt lightheaded, became pale and nearly fainted. She sat in a chair with her head between knees for about 10 minutes then went back to work. A couple hours later it was reported that she felt much better and that it had happened last year when she got  her flu shot. She also stated she was having joint pain and swelling in her right hand and could hardly use it. She stated she could bare get up and down from sitting and had difficulty walking. It was advised that she doesn't take the vaccine again.
Twenty four hours post vax, pt developed swelling and erythema measuring 11 x 7.8 cm. At 36 hours, the swelling and erythema had increased to 20 x 11 cm. She was treated with oral diphenhydramine.
Ongoing soreness at injection site, becoming more pronounced in upper arm/shoulder/neck; restricted ability to move left arm to accomplish every day activities;  increased joint pain in R shoulder; increased general and chronic fatigue; brain fog; ongoing alteration and diminished senses  taste and smell; decreased tolerance for loud noises and bright lights.
Since 3rd COVID dose (booster) 2 weeks ago patient has had anxiety, mood disturbances, anxiety attacks, visual disturbances, frequent diarrhea, hypersensitive skin/contact dermatitis (treated with Prednisone). Patient is healthy and has no history of these episodes prior to COVID vaccine, which was administered Dec-Jan of 2020-2021.
5 minutes after injection I experienced tingling all over, nausea, sweating, dizziness and racing heart rate.  It lasted for about 2 minutes and gradually subsided over next 5 minutes.  Soreness in arm is only symptom 3 hours post injection.  I did not notify health department staff because it subsided.
This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. In July 2013, when the patient was 12 months of age, the patient was vaccinated with both dose of VARIVAX (Merck) (lot#, expiration date and dose not reported), subcutaneously, and M-M-R II (lot#, expiration date, dose and route not reported. Subsequently, this patient was administered another dose of both VARIVAX (Merck) (lot#, expiration date and dose not reported) subcutaneously and M-M-R II (lot#, expiration date dose and route not reported) on 23-OCT-2013, when the patient was 15 months of age. No adverse effect was reported. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 21-JAN-2016 the patient was inadvertently administered with an expired dose of M-M-R II (lot # J016232, expiry date: 19-DEC-2015) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse event reported. Additional information has been requested.
VOMITING/ THREW UP FOR AT LEAST 6 TIMES; ACHES ALL OVER BODY; FEELING WEAK; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 10808978, and batch number: 10808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced vomiting/ threw up for at least 6 times. On 02-APR-2021, the subject experienced aches all over body. On 02-APR-2021, the subject experienced feeling weak. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 106 F. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting/ threw up for at least 6 times on APR-2021, and had not recovered from fever, aches all over body, and feeling weak. This report was non-serious.
Pt. developed a rash 3-19-14. 3-22-14. He was seen at urgent care 3-22-14. They did a VZV/HSV w/DFA - skin scraping. Resulted 3-26-14: Positive for varicella zoster. Was reported to state dept of health services 3-27-14.
Head twitching; right arm twitching, upper extremities and upper body stiffness; no definite location; called ISCU. No treatment given.