chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/30/2022 I had two surgeries. I had hernia repair and CTIF all for the GERD. The surgeries went well. On 01/01/2023 I went to the ER, wasn?t completely diagnosed multiple suspected it was TIA. I was having major migraine headache. I was not coherent; the right side of my face was starting to go numb. I was driven to the ER, by the time I arrived most of the symptoms went away. The symptoms started around 09:30 in the morning, I sat in my truck and called my nurse friend, and she suspected a TIA. I was sweaty and clammy as well. I didn?t reach the ER until that afternoon. When I got there, I had a EKG, CAT Scan of the Head. It was late in the evening and refused the MRI, It was suspected TIA, but hard to tell unless I under went the MRI. I end up having a colonoscopy on 03/15/2023, tumors were found. I need to have part of colon removed. During the visit for surgery, the found hardening of my arteries in my heart. Which is rare for a person of my age. I must wait on my cardiologist to give a go ahead before this surgery on my colon.
sore arm; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis and Pollen allergy (pollen count).   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, chills and headache was not reported. This report was non-serious.
Approximately 9 inch rash on left arm (at and below injection site), red in appearance that turns a shade of purple near the elbow. Patient reports no pain or itching, but area is raised and warm to the touch. Patient did not notice rash until shower, and states the rash appeared suddenly. Patient also reports body aches but no other systemic symptoms.
booster; Acute Respiratory Failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: FH8028) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tape" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "HBP" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; APIXABAN; PREDNISONE; ALLOPURINOL. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol". Vaccination history included: Bnt162b2 (Dose number: 02, Administration Date: 21Jan2021, Lot No.: EL8982), administration date: 21Jan2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "Acute respiratory failure", "Multiple unprovoked bilateral Pulmonary embolisms"; Bnt162b2 (Dose number: 01, Administration Date: 07Jan2021, Lot No.: EL3246), administration date: 07Jan2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: ACUTE RESPIRATORY FAILURE (hospitalization, life threatening) with onset 11Dec2021, outcome "not recovered", described as "Acute Respiratory Failure"; IMMUNISATION (medically significant) with onset 03Dec2021, outcome "unknown", described as "booster". The patient was hospitalized for acute respiratory failure (start date: 11Dec2021, hospitalization duration: 16 day(s)). The event "acute respiratory failure" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Dec2021) negative; (26Dec2021) negative. Therapeutic measures were taken as a result of acute respiratory failure. No other vaccine in four weeks. Clinical course: I received my last vaccine (injection #02) on 21Jan2021. On 27Jan2021 I was admitted to the hospital with acute respiratory failure. In Jul2021 I was admitted for multiple unprovoked bilateral Pulmonary embolisms. On 03Dec2021 I received my booster (injection #03). On 11Dec2021 I was again admitted to the hospital for Acute Respiratory Failure. Prior to the vaccines, I have never had any lung or respiratory issues. Now, I have to have supplemental O2. Adverse event start date: 27Jan2021. Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. No days hospitalization: 16. AE treatment: Supplemental O2 at home, Lifetime Eliquis for PE's. No covid prior vaccination. Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
injection site soreness lasting 2 d chills/sweats lasting 3 d body aches lasting 2 d diarreha lasting 1 d
Patient is a 41 yr/o female with a history of anxiety, hypothyroidism, and seasonal allergies, who presents to the emergency department for evaluation of chest pain.  She states that she received her Covid vaccination (Pfizer) yesterday. Roughly 2 hours ago, she developed a tingling sensation along her left upper extremity. She soon then developed midsternal chest pain, that she described as a pressure sensation.  Symptoms are improved with taking deep breaths.  She then felt lightheaded.  She ate a couple of lemon heads, and then her symptoms improved.  She has a history of anxiety, and is not sure if her symptoms could be related.  She had spoken with a friend on her way home from work, who encouraged her to come to the emergency department to be evaluated. She denies associate shortness of breath, nausea, vomiting, fever, chills, dizziness, back pain, or any other complaints at this time
Vaccine was administered beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 72 years 5 months.  No concomitant medications were provided by the reporter.  It was reported that vaccines were administered beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medications were provided by the reporter.
Imms on Fri, fussy, fever onset & Sat, continues til 9/18/12 when called office. S/S fever 101, fussy, loss of appetite. Advised MOTRIN & monitor to call back 9/19/12. Mom called back. Fever resolved.
REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77.  25MG BENADRYL GIVEN.
Patient reported being flushed, dizzy, and having blurred vision.  We gave her water and kept monitoring her to evaluate for 30 minutes to see if she needed to get checked out in the adjacent urgent care.  She felt better after waiting for 30 minutes and did not need to seek treatment.
Immunizations given 1000 hrs 11/20/03.  Almost immediate small, red, papular lesions, but had some present under right axilla.  At 1400 11/21/03, noted significant swelling, redness and pain at left deltoid area, including injection sites.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022). No concomitant medications were reported. The patient received half dose. The vial was initially stored in the refrigerator on 04-Jun-2022. Reportedly, the vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Vaccine given at 1600, immediately after pt had blank stare and was unresponsive to verbal stimulation. Pt unable to fix gaze and respond to verbal or stimuli for 60 seconds. Vitals taken. Pt started making eye contact and speaking, juice and chips given. Pt then playful.
it's been Hot to the touch for 3 days, on my left upper arm - its  elevated, tender and rock hard
mom relates 3-4 days p/vax pt began having hives intermittently; denies fever, malaise, joint pain, rash, or breathing problems; phoned own MD who prescribed DPH;advised poss declining of #2 MMR at school age;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have had exacerbated PMS symptoms and my period started today which is a week early.
This spontaneous report as received from a nurse, via company rep[representative, refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The patient received their first dose of GARDASIL 9 on 19-JUL-2015 (reported as "07/19 last year") and the second dose of GARDASIL 9 on 21-JUL-2016 (doses, lot# and routes were not reported). On an unspecified time after receiving the second dose of vaccine, approximately in July 2016, the patient developed muscle pain in both legs, "high fever", and an unspecified injection site reaction. The outcome of the events was not reported. The relatedness between vaccination of GARDASIL 9 and muscle pain in both legs, "high fever", and an unspecified injection site reaction was not provided. Additional information has been requested.
Has had lightheadedness. Will start at night, sometimes carries on until the next day.. She will wake up to go to the bathroom at night, will try to go back to sleep when she experiences episode. Improves when she sits up but worsens when she lays down. Has also had dizziness. Denies room spinning sensation. Denies syncope, headache, vision changes, blurred vision, ear pain or pressure, sinus congestion, fevers, chills, chest pain, palpitations, dyspnea, or recent head trauma. BP 128/76 and pulse 67 in office. Takes her BP medication at night. Her only change is that she had 1st dose of Pfizer covid19 vaccine on 11/10/21. She received it in her left arm, initially had swelling along her left neck/clavicle and axilla. She is scheduled for her 2nd dose on 12/1/21. Has tried OTC Dramamine chewable tablets. Physical exam normal. Continuing Meclizine and has been referred to ENT for further evaluation. Will have evaluated by cardiology +/- neurology if symptoms persist or worsen.
Information has been received from a woman in a health department concerning may patients (demographics unspecified) who were vaccinated with a dose of varicella virus vaccine live (site unknown). It was reported that there was an unspecified adverse event due to improper storage. It was noted that the vaccine was stored at 33 degrees F for 119 days. The patients did not seek medical attention.  Additional information has been requested.
A little red rash on the injection site  for a few days after first shot; A little red rash on the injection site  for a few days after first shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (A little red rash on the injection site  for a few days after first shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site  for a few days after first shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE RASH (A little red rash on the injection site  for a few days after first shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site  for a few days after first shot). On 07-Feb-2021, VACCINATION SITE RASH (A little red rash on the injection site  for a few days after first shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site  for a few days after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-418203, MOD-2021-418208 (Patient Link).
This spontaneous report as received from a pharmacist refers to a 73 year old female patient, who on 10-JUL-2013 was vaccinated with an expired 0.65 ml dose of ZOSTAVAX Lot # 0750AA, expiry date 18-AUG-2012. There was no concomitant medication reported. No adverse effect reported. Additional information has been requested.
The patient received the vaccine 7-10-16. The patient had no reaction on that day. She woke up the next morning with pain at the injection site. She had a large swollen, reddish rash at the site, about golf ball size and said it hurt.
Urticaria onset 9 hr after dose. Treated with Chlortrimeton 4mg every 4-6 hrs for 4 days with resolution of urticaria.
pt recv vax 3OCT97 initial pt had tenderness to vax site;next day reported numbness & pins/needles sensation to rt arm & forearm extending to wrist;affected area has dec somewhat but has persisted x1wk;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm and on 16Mar2021 as dose 2, single (Lot number: EP6955) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS (Polycystic Ovary Syndrome)" (unspecified if ongoing); "RSD (Reflex Sympathetic Dystrophy)" (unspecified if ongoing); "CRPS (Complex Regional Pain Syndrome)" (unspecified if ongoing); "Chronic, Non-Healing; Wound from recent surgery" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Raynauds Disease" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "ADHESIVES" (unspecified if ongoing); "Known allergies: CILANTRO" (unspecified if ongoing); "GERD" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine for allergies MORPHINE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Cinical course information: It was reported that the patient was not taking any other medications in 2 weeks.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
5/20/01 pt developed discomfort of left anterior thigh. 5/26/01 pt developed headache, fever, myalgias, arthralgias, upper back and leg pain. on 6/12/01, systemic symptoms had resolved but pt still had left leg pain.
When patient presented to get immunization she reported previous mild reaction of hives with flu immunization. She reported prior to receiving her flu immunization she would take 50mg diphenhydramine. We had her take 50mg diphenhydramine & then wait 30 minutes prior to receiving the first COVID-19 dose. After receiving the vaccine we had her stay in the room directly in front of us for 30 minutes so we could monitor her. It was noted she seemed to be having difficulty breathing & at that point we administered the first epinephrine 0.3mg dose. She reported feeling better & her color got better. We continued to closely monitor her & in approximately 7 to 8 minutes her breathing became labored again. A second epinephrine 0.3mg dose was administered & we called to have her transported to the hospital.
under bottom lip puffy; congestion; cheeks puffy; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (under bottom lip puffy), NASAL CONGESTION (congestion) and SWELLING FACE (cheeks puffy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug and Allergic reaction to drug.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LIP SWELLING (under bottom lip puffy), NASAL CONGESTION (congestion) and SWELLING FACE (cheeks puffy). At the time of the report, LIP SWELLING (under bottom lip puffy), NASAL CONGESTION (congestion) and SWELLING FACE (cheeks puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment details included children's Benadryl.
On 04/21/2022 around the 05:00AM. Similar to the 3rd dose, I had a rash around my neck going down my chest. It was hot and itchy. I reached out to my allergist and doctor. She prescribed the exact same regime 30mg of Prednisone for 3 days 20mg for 3 days, 10mg for 3 days. At the same time I was also prescribed 20mg of Pepcid a day and 10mg of Zyrtec daily. It did clear up the rash. I  have a follow-up with her 04/29/2022.
This spontaneous report as received from a health worker concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patient's were vaccinated with a dose of RECOMBIVAX HB (dose, strength, lot number, expiration date and route were not reported). The healthcare worker reported that an improperly stored RECOMBIVAX HB, "may" have been administered. Reporter stated that the RECOMBIVAX HB, were exposed to a temperature as low as 26F for a total of 238 hours over multiple excursions which started on 06-MAY-2014. No adverse effect reported. These case is one (1) of four (4) reports from the same reporter (MARRS 1405USA009827, 1405USA013153, 1405USA013154, 1405USA013155). Additonal information has been requested.
Fatigue, constant all over body aches, intermittent left earache and headache for 24hrs. Used Tylenol for relief every 6 hrs. beginning at 4:15am 9/22 until bedtime at 10pm. Arm still sore at vaccine site, when touched, until 2pm 9/23
I started having tremors and curling toes. This continued and then in the fall of 2022 I had a left arm tremor. I went to the doctor and was diagnosed with Parkinson's Disease. They prescribed rasagiline so far. No other medications have been prescribed. I was just diagnosed and haven't been taking the medication long, so I haven't noticed any progress yet.
I received the vaccine in the morning. At noon day I started with a lot. Started in the crotch on the right side. At night I had a bruise in it's place. The next day another bruise appeared but now on my knee.
Fever of 101 degrees F, nausea, stomach cramps, dry heaves. Lasted 24 hours. Self-care.  Patient believes illness was result of Tdap.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Redness at injection site. Hot to the touch. Skin thickening. 5-6 large fingerprint sized hives that were skin colored raised and platitude.