chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen, redness, warm to touch, left upper arm. (Deltoid area). Painful at injection site.
BODY ACHES; NAUSEOUS; MUSCLE ACHES IN BOTH ARMS; TIRED; CHILLS; This spontaneous report received from a patient concerned a 71 year old female. 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: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-MAR-2021 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced body aches. On 28-MAR-2021, the subject experienced nauseous. On 28-MAR-2021, the subject experienced muscle aches in both arms. On 28-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on MAR-2021, and nauseous on 29-MAR-2021, and had not recovered from muscle aches in both arms, and tired. This report was non-serious.
swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient received both doses of COVID vaccine. Unfortunately, he was among the few people who experienced swollen lymph nodes as a side effect on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360008 same reporter/drug/event, different patients
Syncope episode with seizure. Constant migraine. Low blood pressure. Chest pains, Heart palpitations, Pulsating to the brain. Weakness. Unable walk or stand for short periods. Dizziness.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.  No Medical History information was reported. On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 reported. No vial had went any temperature excursions and vials were stored in refrigerator till dates administered as indicated. This case was linked to MOD-2021-392458 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up was received, updated reporter details (address, state, city and postal code) and suspect dose number.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Joint Pain-Mild, Additional Details: patient came in with localized redness at injection site area. complains of fatigue and joint stiffness in morning. reviewed common side effects from prevnar 20 up to first 10 days. patient was naive to previous pneumonia medication.
MIGRAINE; EMESIS; SEVERE HEADACHE; SUBJECTIVE FEVER; This spontaneous report received from a health care professional concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, and other pre-existing medical conditions included: The patient had No known allergies. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced migraine, emesis, severe headache, and subjective fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, emesis, severe headache and subjective fever was not reported. This report was non-serious.
Vaccination site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8734) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient had no allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 18:00, the patient experienced vaccination site pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures included treatment with tylenol for the reported events. The clinical outcome of the events vaccination site pain and headache were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
A consumer report has been received via medical representative. The report concerns male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient received nasal FLUMIST QUADRIVALENT (intranasal) for unknown indication. During 2013, the patient had influenza. He was in the Intensive Care Unit with four chest tubes and a breathing vent. Action taken of FLUMIST QUADRIVALENT was unknown. The patient recovered from the event on an unspecified date. Reported seriousness of event patient had 4 chest tubes, was on a breathing vent and had influenza is given by the reporter as hospitalized. The company physician considered patient had 4 chest tubes and was on a breathing vent as no adverse events. Sender's Comments: Influenza is not listed in the company core data sheet for FLUMIST QUADRIVALENT. Due to limited information on the patient's age, start date, indication and dosing of the suspect drug, exact onset date of the event, relevant medical history, underlying comorbidities, concomitant medications, risk factors for the event present and diagnostic workup it is not possible to make a conclusive assessment of the causal relationship of influenza and FLUMIST QUADRIVALENT.
Ache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache) and FATIGUE (Tiredness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced PAIN (Ache) and FATIGUE (Tiredness). In 2021, PAIN (Ache) and FATIGUE (Tiredness) had resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient received 2 different mRNA vaccines. Pts first dose was Moderna, second dose was Pfizer. Patient was notified of the error. patient had no adverse symptoms. Advised patient that they do not need another dose of vaccine at this time.
I felt lightheaded and everything went dark. My husband caught me after I passed out and he reported it to the pharmacy tech on duty and she did not do anything.
Diarrhea; hot flashes; body aches; nausea; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Aug2021 at 12:00 (at the age of 18-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Aug2021 at 00:00, the patient experienced diarrhea, hot flashes, body aches and nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events diarrhea, hot flashes, body aches and nausea was not recovered at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom reports pt devel widespread, pink body rash w/pruritis 3 days p/vax; seen by MD who felt rash may be hypersensitivity to some component of vax or diluent;
36 yo healthy nurse with a h/o egg allergy (as child -> vomiting. does not eat any eggs cooked or baked) who was admitted to ED observation with swelling and erythema of her LUE after injection with flu vaccine. She was in her usual state of health when she had a flu vaccine by occ health at hospital (10:30 AM on 10/1). Within 1 hour, she experienced pain and throbbing in her LUE and within 2 hours, there was erythema and warmth. She notes that the warmth, erythema and swelling originated several inches below the injection site (in her L delt). She felt systemically well with no F/C, no trouble breathing. She was seen at occ health 3 hours after the injection who gave her Claritin and Motrin, but an hour later, she had further swelling and erythema, as well as tingling in her fingers. THat evening, she took Benadryl. She was unable to work the next day (10/2) bc of too much swelling in the arm - she saw her PCP who prescribed Keflex and prednisone but she did not take either bc the swelling and erythema were worsening so she went to the ED. Throughout, she felt systemically well without F/C, N/V, shortness of breath. In the ED, she was afebrile and hemodynamically stable. She had a CT of the arm that showed edema without gas or a collection. She was started on Vanc/Clinda/Cefepime and kept the arm elevated. Over the course of the evening, the arm finally began to improve with less swelling, less erythema, less pain. Abx were stopped in the next AM (10/3) and she had ongoing improvement with elevation, Motrin. Of note, she has never had a flu vaccine till last year (fall 2014) when she was offered FluBlok, which is recommended for people with egg allergy. She had no ill effects from that vaccine. She specifically asked for the FluBlok vaccine again this year.
In September, began experiencing thinning hair, a bald patch on scalp, irritability/mood swings, and weight loss which led to blood work that revealed low TSH. I was seen my an endocrinologist who confirmed hyperthyroidism/thyroiditis.
Mom reported patient had vague sense of not feeling well, said heart rate increased to 186 bpm and she vomited. She was taken into ED and given IV fluids with HR 150 which then normalized and sent home from ED. She awoke the next morning at home and was back to normal.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.; No adverse event; had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.).    Concomitant medication use information was not provided by reporter.  Vial size was reported as 10 dose vial. Date the vial was initially stored in the refrigerator was reported as 14-Mar-2023. The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Pt. fainted and nausea, and light-headed. < 1 min. Gave orange juice.
BP 180/90 reports feeling numbness Ana tingling of upper body. Refused transport to ER . Grips equal Perrla
Tenderness in neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Tenderness in neck) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Tenderness in neck). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Tenderness in neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MODERNATX, INC.-MOD-2021-086393 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporter's information was added. On 29-Apr-2021: Email, NNI on husband event.; Sender's Comments:  MODERNATX, INC.-MOD-2021-086393:Crosslink
Hives, skin writing  No treatment, thought it might be reaction to antidepressant taken 4 days before adverse reaction, stopped the antidepressant on day of symptoms showing, still have symptoms approximately 2 weeks later. Scheduled a doctor visit that will happen in three days.
Mother states child woke up at 10:30 AM left arm swollen, very red, hot and firm across entire arm from shoulder to 2-3 inches above elbow. Called ER was told warm compress and Tylenol. Swelling increased and arm became bluish. Took child to ER. States that ER MD told her this was the worst infection to immunizations he had ever seen. Child given antibiotic (augmentin) and advised to use Motrin for discomfort.
Shot Monday morning; middle of Monday night had one episode of vertigo. Tuesday went to work but starting feeling ill as day progressed. End of day had 101 fever, fatigue and nausea throughout evening. Vertigo all night Tuesday night and all day Wednesday w/severe nausea (missed work Wednesday). Went to primary doctor Wednesday who prescribed medication for vertigo.
Vaccinator administered vaccine using a vanish point needle. Needle malfunctioned and some vaccine came out around needle. Vaccinator estimates that more than 1/2 of vaccine was administered to patient. No additional vaccine was given.
Feeling very weak; slightly nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling very weak) and NAUSEA (slightly nauseous) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feeling very weak) and NAUSEA (slightly nauseous). At the time of the report, ASTHENIA (Feeling very weak) and NAUSEA (slightly nauseous) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Fevers up to 103.7 for 4 days, chills and rigors Pt took all 4 doses, after each dose, he experienced mild side effects which subsided in a day or 2.  After the 4 dose, fevers began 2 days later and have persisted since (peaking and wanning).  We are continuing to treat for the fevers.
Patient contracted COVID after being fully vaccinated.  No booster. Shortness of breath, dyspnea, hypoxic, congestion, anorexia, weakness, cough.
Swelling of injection site, red and hot to touch, later that evening throat "felt swollen itchy" went to ER prednisolone 10 mg x 5 days.
C-Reactive protein blood test went up 30 points; She experienced a flare of her Crohn's Disease she never had in her life; She can't eat or hold anything down; She can't eat or hold anything down; it has gotten worse/ Event: Overactive flare was reported as worsened; overactive flare like she has never experienced in her immune system; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162b2 (COVID-19 vaccine, Solution for injection, Lot No: EW0271), via an unspecified route of administration, administered in Arm Left on 06Jun2021 as 1stdose, single for covid-19 immunisation (age at vaccination is 49 years). Medical history included crohn's disease from 2006 and ongoing. The patient's concomitant medications were not reported. The patient experienced a flare of her crohn's disease she never had in her in 2021, she can't eat or hold anything down in 2021, it has gotten worse/ event: overactive flare was reported as worsened on 2021, c-reactive protein blood test went up 30 points on 11Jun2021. The patient underwent lab tests and procedures which included c-reactive protein went up 30 points on 11Jun2021, C-Reactive Protein went back down the 30 points two weeks later. Patient received one dose of the Pfizer Covid-19 Vaccine. On unspecified date in 2021 she experienced a flare of her Crohn's Disease she never had in her life. She can't eat or hold anything down and it has gotten worse since she received the vaccine. She has had no relief, and no one knows what to do. She has held off receiving the second dose of the vaccine. She was advised to get a spike protein qualitative antibody test. She is asking what do the results mean. Her doctor and the lab could not help reviewing the results with her. She thinks she is going to end up in the hospital if this continues. Patient is asking should I take the second vaccine, having Crohn's Disease is there any information or trials other than immunocompromised people were not involved in the clinical trials and that people immune compromised may have a lower response. History and Investigations about the patient was C-Reactive Protein went back down the 30 points two weeks later. Upon follow-up16Jul2021 spontaneous report; contactable consumer (patient) reported about patient characteristics (Age at time of onset of reaction/event, sex, medical history and concurrent conditions, Patient medical start date, Reactions and events details, drug information, History and Investigations details). Outcome of the events were recovered/not resolved except C-Reactive protein blood test went up 30 points was recovered/resolved on unspecified date.  Follow-up (16Jul2021): This is a follow-up spontaneous report. A contactable consumer (patient) reported about patient characteristics (Age at time of onset of reaction/event, sex, medical history and concurrent conditions, Patient medical start date, Reactions and events details, drug information, History and Investigations details.
Patient received the first covid19 Pfizer biontech immunization and 15 minutes later reported to the pharmacist that they felt nauseous and dizzy.  Pharmacist instructed patient to sit down on the ground and as they crouched down to do so, he passed out and his wife caught him and eased him to the ground. Patient then regained consciousness in less than 30 seconds and remained on the ground for 15 minutes with legs propped up.  911 was contacted and fire dept came to check patient's vitals.  Patient reported feeling a lot better after the wait period and vital signs were reported normal.  Consultation was provided and patient instructed to follow up with primary MD, and patient went home.
Approximately one week after receiving one dose of varicella virus vaccine live the pt experienced a rash. About one month the pt experienced a second rash that was reported to look like little mosquito bites.
This spontaneous report was received from a registered nurse regarding a 12 month old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 13-MAR-2018, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N013393 and expiration date: 11-DEC-2018), (strength and dose were not reported) orally for prophylaxis (product storage error). It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1809USA008676: US-009507513-1803USA009994: US-009507513-1809USA008677: US-009507513-1809USA008679: US-009507513-1809USA008677: