chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain/ache near left breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain/ache near left breast) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LEVOTHYROXINE, ONDANSETRON, CALCIUM ACETATE, OXYCODONE, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.    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 BREAST PAIN (pain/ache near left breast). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, BREAST PAIN (pain/ache near left breast) outcome was unknown.            No treatment information was provided. Other concomitant medications include linakane cream, diorite, mitidrain before dialysis, panaprosol 40 mg, c-pap, carisoprodol 350mg BID for an unknown indication. Action taken with mRNA-1273 in response to the event was not applicable.
I had high fever of 102 degrees, coughing, bad congestion, chills, fatigue. I didn't have shortness of breath. I tested negative on 7/10. That first month post COVID-19 I had lots of coughing that's why I went on the SYMBICORT. I also had extreme fatigue. The last two months it's just been fatigue that has been inconsistent. I have noticed that I can only do one activity a day. I have an echo scheduled in March of next year.
RSV vaccine given at 12:15pm 10/19/20223, arm was sore that evening, a week later severe pain, redness, swelling and bruising began.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 7/25/2022 -- RECURRENCE OF SAME SYMPTOMS
Within 3 minutes, I started feeling hot, I thought I was having a hot flash, then my heart started racing and my face became red. I got the nurse they watched me for 20 minutes and I was released. I still felt hot, I got a mile from work, my heart started racing again. I got back to my work location, we got my supervisor and they took me back to hospital because they could not treat me so I went to local clinic. The NP did an exam, my heart rate was elevated. The NP gave me Benadryl every four hours. I went home, I called my doctor and he advised me to take my antihistamine. When I would take the antihistamine and my heart would race, so I only took Benadryl every four. When the Benadryl would wear off, I would get those same symptoms hot, flushed, heart racing. I took Benadryl for 2 weeks and at times the symptoms would come up and I would take another Benadryl and hot flush and racing heart will subside. My doctor advised me not to take any MRNA vaccines again and so I received the J&J for my 2nd dose.
Patients fainted 3 times after the 2nd dose administration; This is a spontaneous report from a contactable consumer.  A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 05Jun2021 10:30 (Batch/Lot Number: EW0189) age at vaccination of 14-years-old, as single dose, for covid-19 immunisation. Medical history included was none. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 15May2021 9:45 (Batch/Lot Number: EW0182) age at vaccination of 14-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patients fainted 3 times after the 2nd dose administration on 06Jun2021, at 1:30 am, 7:00am and then at 10:00am. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. He went to an urgent care and EKG, complete blood work, head cat scan and all result were OK. No treatment was given for the event.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests which included sars-cov-2 test negative on 06Jun2021.  The patient recovered in Jun2021.
Patient experienced soreness. inflammation, redness at site of injection.  The swelling and redness start at site down to almost the elbow area.
01/11/22 presents to ED for "SOB and positive COVID". PMHx of "recurrent pneumonia, bronchiectasis, paroxysmal atrial fibrillation on Eliquis, HFpEF, aortic regurgitation, SSS, CKD stage II, HLD, dementia, anemia, malnutrition, hypothyroidism"
January 27, 2021, I received the second dose of the Moderna Vaccination. I began to feel cold chills and a high fever 101.2 around 2:35am. I notified my doctor and went to the ER January 28, 2021.
body shakes; nausea; tachycardia; had a headache  10/10; vomiting; hypotension; Initial information received on 19-Nov-2021 regarding an unsolicited valid serious case from an other health professional via Global Media Information (under the reference 00865883).  This case is linked to case 2021SA393667 (same reporter).  This case involves a 16 years old female patient who had body shakes (tremor), nausea, tachycardia, had a headache 10/10 (headache), vomiting and hypotension after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) (Lot number and expiration date not provided for both) via unknown route in an unknown administration site for prophylactic vaccination.  On 17-Nov-2021, the patient received a dose of suspect MENACTRA (0.5 ml, total, once, lot U7207AB and expiration date: 08-FEB-2023) via intramuscular route in the left deltoid for prophylactic vaccination.   On 17-Nov-2021, the patient developed a serious body shakes (tremor), nausea, tachycardia, had a headache 10/10 (headache), vomiting and hypotension, one day following the administration of vaccine.   This events were assessed as medically significant.  No laboratory data reported.  It was reported that adverse reactions with two patients after they received the MENACTRA vaccine. Caller was wanting to know if the vaccine is safe to continue to use. Both patients were seen in the emergency room. The status of the first patient had only been reported so far from the emergency room and released.  The patient was treated with IBUPROFEN (second dose, Intravenous fluids) at home.  The patient recovered from the all reported events on an unknown date.; Sender's Comments: This case concerns a 16-year-old female patient who had tremor, nausea, tachycardia, headache, vomiting and hypotension after vaccination with MENACTRA. Concomitant medications included TRUMENBA and FLUZONE [INFLUENZA VACCINE]. The time to onset is compatible. However, patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Left arm swelling of forearm, old L wrist tattoo because raised and lifted out of skin approx 3 mm, whole arm was itching with several red dots; reaction resolved within 8 hours without intervention body wide itching persisting now
24 hrs p/vax pt devel 7x10 cm area erythema w/minimal tenderness rt anterior thigh; tx cool compresses & APAP
SYMPTOMS GOT WORSE; NOT FEELING TOO GREAT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included: immunocompromised, and other pre-existing medical conditions included: patient was on immunosuppressant medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Not reported. On an unspecified date, the patient experienced symptoms got worse, and not feeling too great. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling too great and symptoms got worse was not reported. This report was non-serious.
an overwhelming sound in my left ear, tinnitus; pressure in the ear, like when flying on an airplane, pressure still present; nausea, like I was going to throw up, nauseated again; tired; headache; Missed second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), TINNITUS (an overwhelming sound in my left ear, tinnitus), EAR DISCOMFORT (pressure in the ear, like when flying on an airplane, pressure still present), NAUSEA (nausea, like I was going to throw up, nauseated again) and FATIGUE (tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D NOS for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), NAUSEA (nausea, like I was going to throw up, nauseated again), FATIGUE (tired) and HEADACHE (headache). On an unknown date, the patient experienced TINNITUS (an overwhelming sound in my left ear, tinnitus) and EAR DISCOMFORT (pressure in the ear, like when flying on an airplane, pressure still present). The patient was treated with CORTISONE (oral) for Symptomatic treatment, at a dose of bid for 14 days. On 14-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine) had resolved, NAUSEA (nausea, like I was going to throw up, nauseated again), FATIGUE (tired) and HEADACHE (headache) outcome was unknown. At the time of the report, TINNITUS (an overwhelming sound in my left ear, tinnitus) and EAR DISCOMFORT (pressure in the ear, like when flying on an airplane, pressure still present) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Burning throughout my right nostril, right side of my throat and loss of taste and smell on the right side of my mouth. Headaches everyday since.
Information has been received from a health professional concerning a 56 year old female pt with COPD and asthma and a past medical history of numerous hospitalizations for asthma who on 9/25/06 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651373/0320F). On 9/27/06 the pt telephoned the physicians office with complaints of a sore back and shoulder, headache, nausea, vomiting, could barely move, arms were very weak and sore, and she was hot and cold. She was seen at the physicians office that day and instructed to go to the ER. She was hospitalized that same day with a diagnosis of cellulitis. On 9/30/06 she was discharged and had recovered. It was reported that the pt had a similar reaction 10 years ago after receiving Pneumococcal 23v polysaccharide vaccine. The reporter asked for a lot check for this lot number. No product quality complaint was noted. Additional information has been requested.
pt vax w/2 doses of hepatitis B vax & developed adentitis, arthralgia, fever & fatigue after each dose.
pt recvd vax 4PM 19JAN94 & 10PM started to shake-mouth frothy, difficult breathing-taken to local ER; according to mom given DPH, Epi & APAP;
Uncontrolable screaming-Next day fussy. 4-5 pm got bad again screaming, no T. 3rd day still fussy. Dec appetite. Both nights screaming until exhausted.Still fussy 26Mar.
Pt recvd Hep B vax 14MAR91 & 2 days later devel intractable h/a; Pt was placed on APAP w/therapy & Fioricet; On 15JUN91 devel paresthesia;
swelling and pain around left eye, blurry vision left eye treating with steroid ad antihistamine outcome is pending with good prognosis
Rec'd #1 Hep A 6/27/13 #2 Hep A 7-24-13 - Returns for final inj. today. Reports had "reaction" approx 8 hrs after rec'q #2. At work and experienced severe fatigue and weakness, "almost passed out". Sent home from work, slept well and had no further problems. Did not report event to clinic or dr. Uncertain if lack of sleep.
Patient had syncopal episode, was diaphoretic , pale, hypotensive and bradycardic. EMS was called but patient refused to go to hospital .
Information has been received from a consumer concerning her 17 year old grand-daughter with allergy to penicillin and no pertinent medical history reported who on 28-OCT-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included NUVARING, flu vaccine (unspecified) (also given on 28-OCT-2008) and unspecified antibiotic.  After receiving her first dose of GARDASIL, on 28-OCT-2008, in the physician's office, the patient almost fainted and her head was flopping around.  The consumer stated that she thought it looked like a seizure.  At the time of reporting, the patient was recovering.  Upon internal review, seizure was considered to be other important medical event.  Additional information has been requested.
Felt achy & drained, didn't sleep well due to sinus congestion; slight fever; treated w/TYLENOL & hydration.
I check my blood glucose twice a day. I noticed after about 36 hours my glucose was running higher then normal, 150's,  with the same diet and exercise routine.  This evening, March 8, it is still a little high at 120, but better and closer to my normal.  I had read online that the vaccine could cause glucose levels to rise so I have waited it out.
Mom reported sx of dec urination, rash around mouth where OPV given, blue lips following, irritable, not feeling well; startled look, disoriented, dec appetite; darker stools painful gas, crying w/laying on lt side; pt seen 7d later nl exam
Patient got more than half of the dose; Beville disengaged from the needle; Some of the liquid squirted in to her eye; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient got more than half of the dose), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Beville disengaged from the needle) and PRODUCT ADMINISTRATION ERROR (Some of the liquid squirted in to her eye) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient got more than half of the dose), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Beville disengaged from the needle) and PRODUCT ADMINISTRATION ERROR (Some of the liquid squirted in to her eye). On 18-Jun-2021, ACCIDENTAL UNDERDOSE (Patient got more than half of the dose), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Beville disengaged from the needle) and PRODUCT ADMINISTRATION ERROR (Some of the liquid squirted in to her eye) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
This spontaneous report as received from a nurse via Poison and Drug Center refers to an unknown number of patients of unknown age and gender. The patients' history and concurrent conditions were unknown. On an unknown date, the patients were vaccinated with unknown doses of (Oka/Merck) VARIVAX (route was not reported, lot #L005298, expiry date 17-FEB-2017), that underwent temperature excursions as follows: 8.9 degrees Celsius for 1 hour and 28 minutes on 07-JUL-2015 and 0.4  degrees Celsius for 1 hour and 25 minutes on 28-JUL-2015. Concomitant medications were unknown. Additional information has been requested.
PATIENT WALKED TO OBSERVATION AREA AND SAT DOWN. AFTER 1-2 MINUTES PER MOM HE SAID HE FELT LIKE HE WAS GOING TO PASS OUT AND BECAME UNRESPONSIVE. I RAN OVER. AND PATIENT WAS STARTING TO BECOME RESPONSIVE. I ASKED IF HE WAS OK, HE SAID HE WAS VERY HOT AND SWEATY. I ASKED IF THEY (PATIENT/MOM) WANTED US TO CALL 911. PT WAS COMING OUT OF IT AND BECAME FULLY AWARE OF WHAT WAS HAPPENING. BP WAS 78/56 AND PULSE WAS 70. HE ASKED FOR WATER, ASST STORE MGR BROUGHT HIM A COLD WATER AND HE STARTED TO FEEL BETTER. WHEN ASKED, PATIENT HADN'T EATEN IN AWHILE;  WE GAVE HIM A CANDY BAR PER HIS REQ. HE FELT MUCH BETTER. RETOOK BP - 123/79 AND P-67 (VASOVAGAL REACTION) BUT WAS STILL A LITTLE SWEATY. HE STAYED FOR 30 MINUTES AND FELT MUCH BETTER. HE LEFT WITH HIS MOM (AND BROTHER?). 911 WAS NOT CALLED.
Patient's Mother notified RN of complaint on 5-12-16. Mother reports her daughter has had a Constant, Daily Headache, that is unrelieved from OTC medications: Tylenol/Motrin. The family notified their PMD at some point and was reportedly instructed to contact the local health department. No treatment, assessment, etc completed per Mother's account.
Rash appeared evening of vaccination - has not resolved to date. (Rash on chest & arms). Large fist-sized bruises appeared 3 days post - vaccination - still present but better. (Bruises on legs - approx. 9 bruises).
Client fainted and felt nausea and dry heaves. Was put on Cot, gave sips of water and recovered quickly.
Swollen R thigh and knee. No fever. Nausea when woke up yesterday.
Fever; severe body aches and pain; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 44-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Unknown) via an unspecified route of administration from 29Jan2021 10:00 (at the age of 44-years-old) at single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included lurasidone hydrochloride (LATUDA), lisinopril and metoprolol. The patient experienced fever and severe body aches and pain on 30Jan2021 at 12:00 AM. No treatment was received for the adverse events. The outcome of the events was reported as recovered. The events were assessed non-serious.  Information on the lot/batch number has been requested.
injection site tenderness; chills; injection site tenderness that progressed causing repeated awakening during the night; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 06Jan2021 (Lot number: EL1283) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2019 (ongoing); "Polycythaemia vera", start date: 2020 (ongoing); "depression" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Rhinorrhea" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for asthma, start date: 2020 (ongoing); HYDREA taken for polycythaemia vera, start date: Oct2020 (ongoing); SYMBICORT taken for asthma, start date: 2019 (ongoing); VENLAFAXINE taken for depression, start date: 2010 (ongoing); AZELASTINE HCL taken for hypersensitivity, start date: 2019 (ongoing); IPRATROPIUM taken for rhinorrhoea, start date: 2019 (ongoing); IRON taken for anaemia, start date: 2015 (ongoing); ASA taken for anticoagulant therapy, start date: 2019 (ongoing); NASONEX taken for hypersensitivity, start date: 2019 (ongoing). Vaccination history included: Bnt162b2 (Dose:1st, Date/Time: 16Dec2021 Time: 09:30, Site and Route of injection:, Anatomical site of injection: Left Deltoid , Route of administration: Intramuscular, Batch/Lot number: EH9899), administration date: 16Dec2020, when the patient was 63 years old, for COVID-19 immunisation. The following information was reported: INJECTION SITE PAIN (non-serious) with onset Jan2021, outcome "unknown", described as "injection site tenderness"; CHILLS (non-serious) with onset Jan2021, outcome "unknown", described as "chills"; INSOMNIA (non-serious) with onset Jan2021, outcome "unknown", described as "injection site tenderness that progressed causing repeated awakening during the night".   No follow-up attempts are possible. No further information is expected.
Developed hearing degradation in left ear (echoing and distortion), sever rash on left side of neck and head, tenderness on left side of body.  Diagnosed as a "shingles like rash"
Eleven days later pt still complains of sore muscle in arms. No heat or redness present. Just painful to move arm.
On 4/26/01 the pt experienced  a maculo-papular erythema eruption over the extremities.
Following administration of dose, discovered the children's dose was left in the adult bin in the refrigerator. Drew-up undiluted dose and administered - NDC 59267-1055-4 batch/lot# FL8094 expiration (per supervisor); use-by date 8/9/2022. Reported to supervisor who will contact manufacturer. Had patient wait for 30 minutes for safety and will follow-up with them at home tomorrow. Patient instructed to contact office with any side effects. Once contact has occurred with the manufacturer, will determine if another dose is needed or if dosing is sufficient.
began 4JAN99 w/T103.5 ax, runny nose (fever x 2d), petechial rash, bruises;adm to hosp;platelet count 6;Dx ITP following MMR vax 8DEC98;
Patient received 5 doses of Janssen vaccine instead of 1 dose. This was an administration error. Dr. did follow up with the patient who had no symptoms aside from soreness at the sight of vaccination and mild fever. Patient shows no extensive side effect of the multiple doses. Aside from pre existing chronic conditions patient is in good health.
SWOLLEN LYMPH NODE UNDER ARM OF INJECTION SITE. SEVERE PAIN ON INJECTION SITE. HEADACHE. BODY ACHES. SOME CURRENT RESIDUAL SWELLING AND SORENESS OF LYMPH NODE.
3 weeks and 2 days after my 2nd vaccine, I woke up with Bells Palsy on the left side of my face.
Headache, fever (101.7), apparent symptoms of sertraline withdrawal (inhibited cytochrome p450 enzyme? )
constant vomiting, nausea, heatburn enlarged stomach, weight loss,dehydration. 4 trips to the hospital lots of iv's reglan,protonix, carafate, zantac,benadryl,ativan
Left deltoid muscle and tender pain sustained since TWINRIX injection 05/04/09.