chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) 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 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 an unknown date, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported Treatment information was not provided
pt to ED with c/o SOB, cough, decrease in appetite, fatigue; found to be positive for COVID; admitted to hosp; NSTEMI; hypoxemia, anemia, AKI, CHF exacerbation; given remdesivir, dexamethasone, baaricitinib; O2 supplementation; respiratory status worsened; hypercapnia; on BiPAP; pt found by staff with BiPAP pulled off, unresponsive, agonal breathing; code blue called; ACLS protocol x 1 hr with brief recurrence of ROSC; family opted to hold any more resuscitative support and pt passed away
No adverse reactions were reported. The Vaccine was given posterior to ideal vaccine administration site. When given posterior to center of mass of deltoid, there is a question on whether the vaccine was given in subcutaneous tissue or in muscle. When we learned of this, we did a qualitative IgG test , and IgG was present. This leads us to the conclusion that it was given intramuscularly and an immune response has been mounted. We also called Moderna for advice and their response was to NOT repeat the dose and to continue with the second dose as normal. We gave the second dose intramuscularly 28 days later as planned.
Extreme arm and shoulder pain for more than 24 hours.  Fever for more than 24 hours.
Received annual flu vaccine and had left arm pain a few hours after.  Pain continues and ROM is decreased. Painful to lift arm up, pain while trying to steer vehicle, pain while trying to lift objects such as gallon of milk, painful to sleep. 01/03/22 seen by provider and steroid injection was given.
Sore; Higher fever; headache; Nausea; A spontaneous report was received from a consumer concerning 59-year old, female patient who received Moderna's COVID-19 vaccine and experienced headache, fever, soreness, and nausea.  The patient's medical history was not provided. The concomitant medications included Baby aspirin, Zyrtec, Sertraline, Atorvastatin and Hydrochlorothiazide.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (037K20A) intramuscularly in upper left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient experienced high fever, headache, nausea and soreness during the night. On 06 Jan 2021, the patient's fever improved, but was still present. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of headache, fever, nausea, and soreness were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
felt gagged; felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (felt gagged) and NAUSEA (felt nauseated) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included METOPROLOL, CHLORTALIDONE (THALITONE), ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RETCHING (felt gagged) and NAUSEA (felt nauseated). At the time of the report, RETCHING (felt gagged) and NAUSEA (felt nauseated) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not Applicable Treatment information wa snot provided.   This case was linked to MOD2021-221040 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: FH8028), in right arm and on 09Nov2021 as dose 2, single (Lot number: EN6205) at the age of 68 years, in left arm 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) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Experienced a significant rebound after taking Paxlovid. Started taking Paxlovid one day after symptoms first appeared. The last dose was Sunday morning. On Monday tested negative, and again tested negative on Wednesday. On Thursday very bad cold-like symptoms appeared. Went back into isolation, then tested positive on Saturday. Rebound symptoms were similar to and slightly worse than the original symptoms. The patient did not receive any other medications/product within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. The patient did not received any other medication in 2 weeks
Fever unresolved by medication, redness and swelling at injection site, warm to touch.
Patient under 18yrs of age was given a booster dose of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18yrs of age was given a booster dose of Moderna) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18yrs of age was given a booster dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18yrs of age was given a booster dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
On April 1, 2021, in the middle of the night, it started with a pulsing sensation in my right calf. It was not painful but it woke me up and got my attention. As I laid there the sensation turned into something not painful but it was a warm sensation which traveled systematically up my leg into my groin area. Then it spread to my pelvis area and then up through my back. Then it went through my chest area and then down both my arms. Then it went up through my esophagus to the very top of my head at the crown. It lasted for 10 minutes.  It migrated from each place then it went away. That was something I've never experienced before. I told the doctor, but he wasn't concerned. A few days later it happened again. The odd sensation came back and it was shorter this time. It may of have happened a few more times as well.
A patient received a Pfizer covid-19 vaccination (lot number: EL3249) on 01/30/2021. This was her second dose (first dose: 01/08/2021).  The patient reported no history of serious adverse events following vaccine administration during her vaccine screening. After receiving the vaccination, the patient developed cellulitis on her arm and chest. Based on my chart review, the patient does not have an encounter documenting the reaction, and no antibiotics were prescribed. The ADR report has a severity of harm ? temporary, intervention needed, but I do not see a documented intervention in EPIC. It is unclear how long after the immunization that the patient developed cellulitis.
Pt had grand mal sz 12-18 hrs p/vax sz lasted 5 mins; pt taken to ER; eval w/EEG & referred to neuro who placed on Tegretol x 3 1/4-4 mos; med d/c due to hyper-activity; No further sz but pt's behavior in school aggressive & disruptive;
SWELLING IN ARM; STABBING PAIN IN THE ARM SLIGHTLY LOWER THAN THE INJECTION SITE (MILD IN NATURE); STRESS HEADACHE AT THE TEMPLES; This spontaneous report received from a patient concerned a 22 year old male. The patient's weight was 135 pounds, and height was 72 inches. The patient's concurrent conditions included: non-alcoholic, and non-smoker, and other pre-existing medical conditions included: Patient had no pre existing medical condition and no usage of any medications. No known allergies. No illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced swelling in arm. On 04-OCT-2021, the patient experienced stabbing pain in the arm slightly lower than the injection site (mild in nature). On 04-OCT-2021, the patient experienced stress headache at the temples. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in arm, stabbing pain in the arm slightly lower than the injection site (mild in nature), and stress headache at the temples. This report was non-serious.
Swollen lymph nodes in the neck on the side of the injection.  Swollen underarm near arm pit area on the side of the injection.  Both started just a day after receiving the injection.
she started to feel really bad; weakness; fatigue; light headed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 93-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 93 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: controlled by diet and exercise no medicine. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EN6199; Anatomical location: left arm, She has never had a bad reactions.), administration date: 06Mar2021, when the patient was 92-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 2; Lot Number: ER8730; Anatomical location: left arm), administration date: 27Mar2021, when the patient was 92-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER); Lot Number: 33025BD; Anatomical location: left arm), administration date: 05Jan2022, when the patient was 93-year-old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 13May2022, outcome "not recovered", described as "she started to feel really bad"; FATIGUE (non-serious) with onset May2022, outcome "unknown"; DIZZINESS (non-serious) with onset May2022, outcome "unknown", described as "light headed"; ASTHENIA (non-serious) with onset May2022, outcome "unknown", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, asthenia, fatigue, dizziness.  Additional information: The patient experienced some side effects as a delayed reaction, stating that she felt well the first few days after getting the vaccine and the on 13May2022 she started to feel really bad. On 10May2022 in late afternoon (when vaccine was administered) She was fine the next day and in fact she felt good. The 3rd day and 4th day were really bad days including today. She feels about the same. She feels pretty bad. At her age she does have a bad day every once and a while. Now she has been going on sick for almost 4 days. No additional vaccines administered on same date of the Pfizer suspect. No events require a visit to emergency room or physician office. No other product administered prior vaccinations (within 4 weeks). No relevant tests.
Systemic Allergic Reaction 20 minutes after injection.  Felt it hit my spine, torso and head felt flush and hives started on torso.  Had I not taken the Allegra D that morning and Famotidine 1 hour before the shot, I would have gotten hives all over my torso and face and swelling would have started in my face.   I had an anaphylactic reaction but the histamine blocker and anti histamine kicked in after about 10-15minutes and I felt better.  Had I not taken the medicine I would have ended up in the Emergency Room.  That night I developed Oral Lichen Planus.  This became extremely bad and uncomfortable for the next 48 hours.  Then it started to heal.  It fully went away after 6-7 days.
She was out of breath; She couldn't walk upstairs.; She couldn't eat much.; She felt even more fatigued after receiving 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She was out of breath), GAIT DISTURBANCE (She couldn't walk upstairs.), FEEDING DISORDER (She couldn't eat much.) and FATIGUE (She felt even more fatigued after receiving 2nd dose.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 01L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, 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 experienced DYSPNOEA (She was out of breath), GAIT DISTURBANCE (She couldn't walk upstairs.), FEEDING DISORDER (She couldn't eat much.) and FATIGUE (She felt even more fatigued after receiving 2nd dose.). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and DOXYCYCLINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (She was out of breath), GAIT DISTURBANCE (She couldn't walk upstairs.), FEEDING DISORDER (She couldn't eat much.) and FATIGUE (She felt even more fatigued after receiving 2nd dose.) outcome was unknown.            Concomitant medication include cholesterol medication. Safety team can follow-up by email or phone call.   This case was linked to MOD-2021-291562 (Patient Link).
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On 24-JAN-2014 the patient was vaccinated with M-M-R II (dose not reported, lot # 1768AA, expired date: 10-NOV-2013). No adverse effects. Additional information has been requested.
Tingly feeling on face, hands; White patches on entire both hands,nose; Woke up through night; Chills; Left hand cramping; Left arm hurt; Sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt), HYPERHIDROSIS (Sweats), PARAESTHESIA (Tingly feeling on face, hands) and SKIN DISCOLOURATION (White patches on entire both hands,nose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (since then she has mucus in her throat.) in May 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Thick nasal mucus.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt) and HYPERHIDROSIS (Sweats). 02-Feb-2021, the patient experienced MIDDLE INSOMNIA (Woke up through night) and CHILLS (Chills). On 03-Feb-2021, the patient experienced PARAESTHESIA (Tingly feeling on face, hands) and SKIN DISCOLOURATION (White patches on entire both hands,nose). The patient was treated with FLURBIPROFEN (ANSAID) at an unspecified dose and frequency and LORATADINE at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt), HYPERHIDROSIS (Sweats), PARAESTHESIA (Tingly feeling on face, hands), SKIN DISCOLOURATION (White patches on entire both hands,nose), MIDDLE INSOMNIA (Woke up through night) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, COVID-19: positive (Inconclusive) positive.         No information regarding corrective treatment was reported by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received and reporter information was updated, patient demographics, Dose 1 added.
Information has been received from a health professional concerning a 65 year old female with allergies to penicillin and erythromycin who on 23-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651404/0619F), in the left arm. There was no illness at the time of vaccination. On 24-OCT-2006 in the AM the patient's arm became red, hot and swollen (also reported as localized swelling and erythema). Subsequently, the patient recovered. No product quality complaint was involved. There were no relevant diagnostic tests or laboratory data. Additional information is not expected.
-Body aches, tiredness, swelling of the throat, back pain starting about 3 hours after shot administration - treated by toradol IV.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On an unspecified date of November 2014, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, lot number and route not reported). Concomitant medications were unknown. On an unknown date within a year after (approximately in 2015), the patient was hospitalized for an unspecified reason. During this hospitalization, the patient may have received another dose (dose 2) of PNEUMOVAX 23 less than one year after the first dose. The pharmacist was reporting the information on behalf of a physician who was attending the patient. The reporting pharmacist did not have any additional information at the time of this reporting. The outcome of the unspecified adverse event was unknown. The causality assessment was not provided. Additional information has been requested.
Itchy red bumps appeared on forehead the night of vaccination. Over the next few days the rash had spread to whole face & neck and right eye became swollen. She went to walk-in clinic and received Hydrocortisone cream and cephalexin.
Entire right side of my body, every muscle and joint aching, especially my right wrist, neck and buttock. As day went on the massive headache started and now extremely fatigued.
Patient said that she is experiencing pain in her left arm where the shot was given. She received the shot on 10/2/09 but she called us on 10/26/09.
Desquamating rash of hands, feet, groin/legs after covid vaccine.  Patient received his first COVID-19 vaccine dose on 5/2/2021.  Patient initially had sore throat that started 5/4/2021 followed by rash 5/6/2021. He had TAV with on 5/8/2021 and reported headache, sore throat, swollen glands, tactile temps, chills, nausea, vomiting, loss of appetite. Prescribed amoxicillin for 10 days.  TAV on 5/13/2021 complaining of diffuse itchy rash all over body, started on face, but now everywhere including groin.  Video appointment on 5/17/2021; sore throat better after antibiotics, rash continues to itch. Advised to stop antibiotics and pending in person clinic visit. Seen in clinic on 5/18/2021; antihistamine and hydrocortisone ointment has not helped the rash. Rash by this time less erythematous than when started and skin starting to dry/peel. Rash on bilateral palms, axilla/neck, groin. Telederm appointment probable atypical viral exanthem and recommended moisturizers, low potency topical steroids.  Came to the ER on 5/20/2021 for continued skin peeling. Discussed with dermatology and prescribed prednisone 40mg daily for 7 days.  Returned to the ER on 5/21/2021 for continued progression of the rash, started on clobetasol ointment, a higher dose steroid than what he was previously on.  Presented 5/23/2021 of burning, itching, flaking off of rash and uncontrolled pain. States it hurts to sit due to the rash behind his thighs and buttocks.
felt achy; tired; confusion; pain in face; numbness in face; Pain in head (almost like a migraine); Temples feel sore & stuffy; Extreme fatigue (couldn't keep eyes open); This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion), FACIAL PAIN (pain in face), HYPOAESTHESIA (numbness in face), MIGRAINE (Pain in head (almost like a migraine)) and MUSCULOSKELETAL STIFFNESS (Temples feel sore & stuffy) in a 28-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 March 2020.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (confusion), FACIAL PAIN (pain in face), HYPOAESTHESIA (numbness in face), MIGRAINE (Pain in head (almost like a migraine)), MUSCULOSKELETAL STIFFNESS (Temples feel sore & stuffy) and FATIGUE (Extreme fatigue (couldn't keep eyes open)). On an unknown date, the patient experienced MYALGIA (felt achy) and FATIGUE (tired). At the time of the report, CONFUSIONAL STATE (confusion), FACIAL PAIN (pain in face), HYPOAESTHESIA (numbness in face), MIGRAINE (Pain in head (almost like a migraine)), MUSCULOSKELETAL STIFFNESS (Temples feel sore & stuffy), FATIGUE (Extreme fatigue (couldn't keep eyes open)), MYALGIA (felt achy) and FATIGUE (tired) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, the reporter did not provide any causality assessments. No concomitants were reported. Treatment includes Vitamins.
Flu-like symptoms: aching, pains, joint and muscle pain, headache, fever
Fever (100ºF  to 104ºF) and vomiting began 2/8/2022. Visited urgent care 2/11/2022.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/5/2023 ACUTE NON ST ELEVATION MI  I21.4 ACUTE NON ST ELEVATION MI 3/29/2023 ACUTE NON ST ELEVATION MI  G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/5/2023 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY  I21.4 ACUTE NON ST ELEVATION MI 3/29/2023 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY  G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/5/2023 HX OF LEFT BELOW KNEE AMPUTATION  I21.4 ACUTE NON ST ELEVATION MI 3/29/2023 HX OF LEFT BELOW KNEE AMPUTATION