chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm felt numb; arm hard to move due to pain; swollen arm; tender arm; arm hard under injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm felt numb), PAIN IN EXTREMITY (arm hard to move due to pain), PERIPHERAL SWELLING (swollen arm), TENDERNESS (tender arm) and VACCINATION SITE INDURATION (arm hard under injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (arm felt numb), PAIN IN EXTREMITY (arm hard to move due to pain), PERIPHERAL SWELLING (swollen arm), TENDERNESS (tender arm) and VACCINATION SITE INDURATION (arm hard under injection site). At the time of the report, HYPOAESTHESIA (arm felt numb), PAIN IN EXTREMITY (arm hard to move due to pain), PERIPHERAL SWELLING (swollen arm), TENDERNESS (tender arm) and VACCINATION SITE INDURATION (arm hard under injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Normal sickness, body aches and fatigue after the booster. The following week I donated blood. I sought medical care after my foot started hurting really bad on December 31, 2021. Not sure if it's related, but it's odd how my foot started hurting out of nowhere. I went to Urgent Care on January 2, 2022. Took x-rays. Didn't indicate anything wrong. Was given antibiotics and Prednisone in case it was an infection. Also a medical boot to wear so I could walk along with my hiking pole. Had a virtual and an in-person follow up appointments with my regular doctor. She's thinking it may be plantar fasciitis. But I do yoga and foot stretches, so it's weird it would be that. Also, I had some swelling/red marks along the side of my foot which doesn't align with plantar fasciitis. All very confusing, stressful and painful.
Patient was seen in the ER s/p fall without injury, cough and hypotension.  Placed on observation status on the general ward with a Dx of Covid 19, hypotension, weakness and hypo-osmolality and hyponatremia
Patient given Pfizer Bivalent booster when patient should have been given Pfizer monovalent/primary series dose.
Right arm remains red; Sweats profusely; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2; Lot number and expiry date not reported) via an unspecified route of administration to right arm from 15Jan2021 at 09:00 at single dose for covid-19 immunization. Medical history included arthritis from an unknown date. There were no concomitant medications. The patient experienced Right arm remains red and sweats profusely on 17Jan2021 at 12:00 AM. The events were reported as non-serious. No treatments were received for the reported events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Patient noticed small blisters around her left eye, on upper eyelid and under lower eyelid, along with redness in the eye and slight feeling of pressure in the eye which accompanied these symptoms. There is slight discomfort but no pain. She also noted some small bumps on her chin around the same time that she is not sure if they are related or if they are pimples. This began ten days after her 2nd dose of Shingrix. She saw the dermatologist today and the differential diagnosis at the moment is shingles. She began treatment with valacyclovir today.
Retinitis, AZOOR, Retinal vasculitis, loss of central and peripheral vision left eye.
Joint pain; Chills; I don't have the energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; CHILLS (non-serious), outcome "not recovered", described as "Chills"; ASTHENIA (non-serious), outcome "not recovered", described as "I don't have the energy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, headache, rapid heartbeat, abdominal pain, joint pain, muscle pain.
ERRONEOUSLY ADMINISTERED 1ML DOSE; This spontaneous report received from a health care professional concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included 4 months postpartum. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced erroneously administered 1ml dose. The action taken with covid-19 vaccine  was not applicable. The outcome of erroneously administered 1ml dose was not reported. This report was non-serious.
72 hours after shot and initial symptoms (fever, chills, etc); began vaginal bleeding, not at scheduled time of menses. Bleeding has continued since and is still occurring as of 9/29/2021.
Fever; Chills; Body ache; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9263) via an unspecified route of administration in the right arm on 19Feb2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified condition. The patient was not allergic to medications, food, or other products. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El1283) via an unspecified route of administration in the right arm on 29Jan2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021 at 16:00, the patient experienced fever, chills, body ache and lethargy. The patient had events of fever and chills for 24 hours, and body ache and lethargy for 3 days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever and chills resolved on 20Feb2021 at 16:00, and body ache and lethargy resolved on 22Feb2021.  No follow-up attempts are needed. No further information is expected.
pt recv vax & inj site red, hot, tender, inflamed, swelling-looked like cellulitis 3 inches x 2 inches;painful to touch; fever x 24hr;APAP given q 4hr;
DISCHARGE DIAGNOSES: Gastritis  Transaminitis Covid 19 infection DM II Hypertensive urgency Etoh abuse Hypokalemia Hyponatremia HOSPITAL COURSE:     Gastric/chest discomfort associated with persistent vomiting -Likely due to acute gastritis due to alcohol abuse -This is a second visit to the ER complaining of similar symptoms and last alcohol intake was 2 days PTA and symptoms had been there for 3 days now. -Started Maalox as needed and pantoprazole 40 mg IV every 12 hours -CT aortic dissection protocol is ordered at ER and showed no acute changes -Patient had abdominal ultrasound and showed no acute changes.  - Feeling much better now. Reports symptoms have resolved.    Covid 19 infection Patient returned positive for COVID-19.  He is relatively asymptomatic other than a mild cough.  Saturating well on room air. Advised to quarantine for 5 days.      Hypertensive urgency Resume PTA lisinopril. -CT aortic dissection showed no acute changes. - Follow up with PCP   Alcohol abuse -Started CIWA protocol including thiamine, vitamins and folic acid.  -CIWA scores have been low.  Advised to significantly cut back on his alcohol use and follow-up with his PCP.      Diabetes mellitus -Resume Jardiance and Metformin.    Transaminitis -AST is 100 and ALT is 71 likely secondary to alcoholic liver disease.  Advised to significantly cut back on his alcohol use and follow-up with PCP.    Hypokalemia -Resolved.     Hyponatremia -Follow up with PCP.     Patient is in stable condition and ready for discharge to home.  He will follow closely with his PCP.  All questions answered to the best my abilities and patient's satisfaction.
Information has been received from a registered nurse concerning an approximately 4 to 5 year old patient who was vaccinated with the second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (no lot number available). The patient had no fever. The patient developed 15 lesions. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
No adverse event; 5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, 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 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine).    No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 07-JUL-2023. The vial did not undergo any temperature excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732775:Master case
Reaction started with muscle pain and spasm on right forearm. Then muscle spasm occurred throughout the body with "swelling". Pt reported all muscle spasms were very painful. Went to pcp on Monday, after injection on Friday morning, and received a prescription for Flexeril and Motrin. All lab work WNL except possibly "eosinophils" elevated. As of 10/13/2017 patient experienced numbness in his arms. On 10/27/17 patient states now numbness only present on finger tips. Plans to have consult with neurologist concerning the remaining symptom.
Received vax 12APR91 that evening site was red & puffy 13APR91 whole upper 1/3 of outer aspect of lt arm & shoulder red & swollen fever of 101, 102F; Not painful but itchy MD notified given DPH;
Student reported to health office during school day with c/o red, raised pin sized rash over abdomen and neck area. Itching. Started 1-2 days ago.
Case number PHEH2013US021723, is an initial spontaneous report received from a nurse on 16 OCT 2013. This report refers to 11-year-old female patient. She was vaccinated with MENVEO (batch number A11082) at a dose of 0.5 ml intramuscularly into left deltoid on 13 MAY 2013 (16:00). The reporter stated that MENVEO was stored in refrigerator that dropped to 32.6 F for less than one hour on 19 APR 2013 (vaccine compromised due to refrigeration malfunction). He was re-vaccinated with another dose on 26 AUG 2013. No adverse reaction was following this administration error.
Pt received Bivalent dose as 2nd of series. Pt had no side effects. Pt given 2nd Monovalent dose as 3rd of series to complete series 2/15/2023. While given out of order, Pt received 2 monovalent doses and one bivalent dose.
Large swollen area surrounding injection site appeared 6 days after vaccine was administered.  The area is also red, warm to touch, and itchy.
It was reported that a 53 year old female pt received a Fluzone sv '00-'01 vaccination on 10/11/00. Reportedly, that same day the pt experienced a transient ischemia attack and was admitted to the ICU of the hospital for observation.
This literature marketed report as received from the authors of published literature article and refers to a 11-years old female patient. The patient's medical history included anaemia, adenoidectomy and tonsillectomy. The patient current condition was lactose intolerance, asthma, sinusitis, lower respiratory tract infection, lymph node palpable and hypermobility syndrome. On an unknown date, the patient was re-vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, frequency, lot# not provided) for sinusitis and lower respiratory tract infection. The patient was also vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) earlier and no adverse effects were observed. Other suspect therapies included tetanus toxoid. Lab data showed that all the lymphocyte absolute counts and percentages were within the normal range (CD4 and CDS T, B and NK cells). Immunoglobulins A, M and G levels were all detectable, but lower than two standard deviations of the normal levels adjusted for age. On an unknown date reported as six weeks later, blood samples was taken in order to determine post-vaccine antibody titres. It was found that both the pneumococcal (polysaccharide) and tetanus toxoid (protein) vaccine responses did not reach protective levels (vaccination failure). The outcome of vaccination failure was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
At site of injection patient's arm became swollen, red, hot and tender. Patient came and reported to pharmacy 1/16/2017.
I received the vaccine at 1230 pm on Thursday and felt fine til 900 am the next day, developed fever 101 , extreme chills , muscle and bone aches , headache, that lasted thru sat evening. Took only Tylenol  and stayed in bed
Initial solicited report received from non  healthcare professional (consumer) on 15 OCT 2014. A 36-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (lot number: UI200AB, dose, dose number, route of vaccination not reported) in deltoid, on 14 OCT 2014. It was reported that nurse might have given too high in deltoid and on 15 OCT 2014, the patient developed bruising. Lab investigation details and corrective treatments were not reported. The outcome of the event was reported as resolved. Documents held by sender: None. Follow up information received from non healthcare professional on 30 DEC 2014. No new information reported. Follow up information received from non healthcare professional on 30 JAN 2015. It was reported that this unknown report was not filled by the health center. The event is not reported by patient to the health center. No other information provided.
2 days p/vax pt exp some vomiting & diarrhea which did resolve p/3-4 days;
As per patient, 30 to 40 minutes after vaccine, patient developed rash on arms and neck.  12 hours after vaccine, patient felt numbness on left side  of face.. 2 to 3 days after vaccination patient was having trouble breathing and was admitted into hospital where she remained for 4 days.  Patient is now feeling fine.
Chills, shortness of breath, chest pain, swollen throat, trouble swallowing, extreme fatigue for the first month. Starting early January I became hoarse. I am still hoarse (today is January 25!!!) At EVERY doctor visit I told them first off these all started right after the vaccine!!!!!! Current symptoms: hoarseness, fatigue, chest pain, trouble breathing, swollen throat. I have been to my primary doctor 4 times, urgent care 1 time, my cardiologist once, my rheumatologist once, an Ear Nose Throat specialist twice. I first went to the doctor 12-11-18. Then to my primary 12-13-18 and 12-17-18. I was put on Colchicine for a month. I went to a different family doctor 1-2-19 who put me on Pantoprazole for a few weeks. They then put me on Indomethacin. None of the symptoms lessened. I went to city for an Echo 1-14-19. I met an Ear Nose Throat specialist 1-15-19 and they did an ultrasound on my thyroid 1-16-19 and another round of blood work. I met with my rheumatologist 1-18-19 who did more blood work. Symptoms still the same - not getting better. All are baffled and simply pass me on to a different doctor. My last follow up with the ENT on 1-28-19 I was told "Your tests are all normal (blood, ultrasound, ECHO) and your symptoms are in your head. There is no medical reason for them. They are caused by stress and anxiety and you need to go on anti-anxiety medications. I hope I didn't offend you." I meet with my family doctor this afternoon. None of the doctors know what to do to help me get better. The pharmacy yesterday told me to report this on your website.
Extreme fatigue, body aches, chills, fever (100-102), diarrhea, headache, sore throat, runny nose, cough, extreme lymph swelling (under left armpit - size of softball), extreme arm pain, injection site itchy/painful rash and swollen arm, severe change of taste & smell, loss of appetite. Spent 4 days in bed, ill. Advil/Tylenol & theraflu. Missed 2 days of work and at day 5 am still feeling pretty terrible but finally finding a little bit of relief.
Patient received vaccination on Friday, 6/30/23. Patient said she experienced some diarrhea and arm heaviness the first 3 days. She stated that she took Aleve to assist with some of the pain that she was having (she believes on Monday and Tuesday). On Tuesday and Wednesday after the vaccination, patient reported feeling like her arm was hot, so she put an ice pack onto her arm. She noticed her arm was swollen on the forearm part by her elbow (away from the vaccination site). Patient stated that the swelling goes 3/4 around her arm.
DVT and PE; don't know if it's related to the vaccine since it occurred in August - almost 5 months after first vaccine.
high fever (100-102); chills; severe fatigue; sweats; joint pain; malaise; lassitude;
Rec'd flu shot @ 7am 10/7/10.  At 11am, scratchy throat, watery eyes & headache started.
Type 1 diabetic and was having trouble controlling my blood sugars; Swollen lymph node in my armpit, which was tender; Swelling in armpit and left side of breast; Swollen lymph node in my armpit, which was tender; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Type 1 diabetic and was having trouble controlling my blood sugars) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Type I diabetes mellitus.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On 23-Feb-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Type 1 diabetic and was having trouble controlling my blood sugars) (seriousness criterion medically significant), TENDERNESS (Swollen lymph node in my armpit, which was tender), BREAST SWELLING (Swelling in armpit and left side of breast) and LYMPHADENOPATHY (Swollen lymph node in my armpit, which was tender). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Fever, at an unspecified dose and frequency. On 22-Feb-2021, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved. On 02-Mar-2021, TENDERNESS (Swollen lymph node in my armpit, which was tender) had resolved. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Type 1 diabetic and was having trouble controlling my blood sugars) and LYMPHADENOPATHY (Swollen lymph node in my armpit, which was tender) had not resolved and BREAST SWELLING (Swelling in armpit and left side of breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment included the patient adjusting her insulin multiple times to control her blood sugar.  Company comment: This case concerns a 50-year-old female with a serious unexpected event of diabetes mellitus inadequate control, and non-serious unexpected tenderness and breast swelling, and expected headache, pyrexia, chills and lymphadenopathy. Event latency 4 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 50-year-old female with a serious unexpected event of diabetes mellitus inadequate control, and nonserious unexpected tenderness and breast swelling, and expected headache, pyrexia, chills and lymphadenopathy. Event latency 4 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A Little Sore Arm; A spontaneous report was received from a consumer concerning a 68- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm. The patient's medical history was not provided.No relevant concomitant medications were reported.   On 06-Feb-2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 06-Feb-2021,the patient experienced a little sore arm. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the event pain in arm  was considered as not resolved at the time of the report.
patient presented to emergency department on 11/30/21 with acute respiratory failure due to covid-19 patient was admitted for further management of covid-19 patient tested positive for covid-19 on 11/23/21 patient di require treatment for symptoms associated with covid-19 infection. treatment included remdesivir patient was discharged to home on 12/6/21