chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Asthma has gotten increasing worse than it has been in years. Still using double daily dose of Arnuity 100mcg but now using rescue inhaler 2-3 times a day. My lower legs, below the knees have been experience pain in the area where I have had varicose vein procedures, phlebectomies and perforators. Cramping and pressure pains. Hard to sleep through the night.
Foggy feeling in head; syncopal episode; brain fog; fell down on the side walk hitting her hand; right hand bruising; fatigue/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (syncopal episode) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue/tiredness). On 11-Apr-2021, the patient experienced SYNCOPE (syncopal episode) (seriousness criterion medically significant) and CONTUSION (right hand bruising). 11-Apr-2021, the patient experienced ASTHENIA (brain fog) and FALL (fell down on the side walk hitting her hand). On an unknown date, the patient experienced FEELING ABNORMAL (Foggy feeling in head). At the time of the report, SYNCOPE (syncopal episode), ASTHENIA (brain fog), FALL (fell down on the side walk hitting her hand), CONTUSION (right hand bruising), FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (fatigue/tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 153/91 (High) 153/91.         The action taken with mRNA-1273 with the events was considered as not applicable. Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 15-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012708 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Nausea; Short of breath; weird sensation in head; racing heart; headache; slight tremor in head, arms and hands; extreme fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of admin-istration (at the age of 64-years), administered in arm left on 11Feb2021 at 12:00 as dose 1, single for COVID-19 immunization. Medical history included allergies to medications, food, or other products from an unknown date and unknown if ongoing. The patient concomitant medications were not re-ported. The patient did not take any other vaccine in four weeks. Patient does not have covid prior vaccination and had not been tested for covid post vaccination. On 11Feb2021 within 15 minutes after dose administration at 12:15, the patient experienced short of breath, weird sensation in head, racing heart, headache, slight tremor in head, arms and hands. Next day on 12Feb2021, experienced nausea. On an unknown date in Feb2021, experienced extreme fatigue. The treatment was not received for the all the events. The vaccination facility type was reported as school. The clinical outcome for all the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Left SQ vaccine area hived, redness, warm to touch. Dr gave SEPTRA DS 800 - 160 mg tab for 10 days for cellulitis.
23 year-old M, primary SPV vaccinee who received his SPV on 4 June, with no other vaccines, reported intermittent episodes of shortness of breath during the period between 12 and 14 June (8-10 days post-vaccine receipt). Patient denies any chest pain or pressure. Denies palpitations. He describes the shortness of breath like "being at 7,000 feet altitude". No other accompanying symptoms except felt "crumby" - tired, achy. Symptoms not severe enough to seek medical evaluation at the time and also said "he was too busy with work". Patient noted dyspnea when walking, but reports there were times during this period when he exerted himself and did not experience dyspnea. He was unable to identify factors making symptoms worse or that made them better. Symptoms have not recurred since 14 June. Patient did not self treat. He denies any recent infections or exposures. He denies any chronic illnesses, especially DM, HTN and hyperlipidemia. He reports asthma during elementary school, but not since then. He takes no medications on a routine basis. Patient smokes about 1/4 ppd x 3 years. He has not family history of premature CAD, but mother had CVA around age 57. Patient routinely runs and lifts weights. Reports running 2 miles this morning without experiencing any symptoms. No hx of any previous vaccine adverse events.
It was swollen at injection site; By next morning, she had swelling on both side of her neck that lasted 3 weeks; She had sore throat that started next morning and is still there; She had tightness on the neck that started next morning and it is still there; She had lump in right arm at injection site on same day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (She had lump in right arm at injection site on same day), SWELLING (By next morning, she had swelling on both side of her neck that lasted 3 weeks), OROPHARYNGEAL PAIN (She had sore throat that started next morning and is still there), MUSCLE TIGHTNESS (She had tightness on the neck that started next morning and it is still there) and VACCINATION SITE SWELLING (It was swollen at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022A21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced VACCINATION SITE MASS (She had lump in right arm at injection site on same day). On 17-May-2021, the patient experienced SWELLING (By next morning, she had swelling on both side of her neck that lasted 3 weeks), OROPHARYNGEAL PAIN (She had sore throat that started next morning and is still there) and MUSCLE TIGHTNESS (She had tightness on the neck that started next morning and it is still there). On an unknown date, the patient experienced VACCINATION SITE SWELLING (It was swollen at injection site). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 08-Jun-2021, SWELLING (By next morning, she had swelling on both side of her neck that lasted 3 weeks) had resolved. At the time of the report, VACCINATION SITE MASS (She had lump in right arm at injection site on same day), OROPHARYNGEAL PAIN (She had sore throat that started next morning and is still there), MUSCLE TIGHTNESS (She had tightness on the neck that started next morning and it is still there) and VACCINATION SITE SWELLING (It was swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Salt water gargle.
Tested positive for Covid 19.  Symptoms included congestion, body aches and feeling "run down"
fever  , right ankle swollen to the point I couldnt put a sock on , then foot hurt , its been two weeks and foot / ankle still hurts
Pt's arm swollen to 6cm X 6cm, with redness and tenderness.
administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose administered after manufacturer date of expiry[11October2021Number of doses/vials:1 vial, 4 doses for 4 patients Date the vial was initially stored in the refrigerator: 17October2021 Date(s) of administration of vaccine: 17October2021  No concomitant medications were reported   No treatment information was provided
she presented palpitations in the heart/her heart was thumping so hard; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Aug2021, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient stated she had the first dose and her heart was thumping so hard (reported as " palpitations in the heart") and she was in the hospital in 2021.The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT) performed on 7/17/21, most likely done at a . Test came back positive. Case investigation interview conducted and based on case manager documentation on July 19th at 11:15, "Advised of test results.  Client stated that symptoms (runny nose, congestion, productive cough) began 7/14 and continue today.
Caller reports multiple doses of VAXELIS administered since temperature excursion; This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded to agency on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.
Patient called and reported that he had nearly constant body fatigue, unsteadiness on his feet, throbbing headache and hard to raise his left leg at times. He stated that the symptoms have persisted but have started to decrease as of 3/19/21
Pain in left arm where injection was administered. Pain radiates down entire arm from the underarm to the hand when arm is extended or twisted.  Linear bumps appeared visible to the naked eye from the underarm to the elbow.
I hear ringing in my ears that won?t stop. Sometimes it gets dimmer if i sit up, but it?s really bad when I lay down and when I?ve been trying to go to sleep. It?s like a whirring sound, the kind you?d hear from a machine whirring (like when you stand next to an ice cream machine?) There?s also this, like, chugging noise in the background.
Around 7:30 pm, started feeling nauseous and really tired. Around 11:00 pm, woke up with chills, fever, dry heaving, muscle aches. Was up all night throwing up and having muscle aches. Continues the next day- low fever, body aches, chills
This spontaneous report as received from a physician via company representative refers to a patient of unknown age. On an unknown date in August 2013 the patient was vaccinated with the first dose of RECOMBIVAX HB 1 ml, intramuscular. The physician reported the patient was inadvertently administered the third dose of RECOMBIVAX HB on 08-NOV-2013, 2 months after (approximately in September 2013) the second dose of RECOMBIVAX HB. No adverse effects reported. Additional information has been requested.
Nurse wanted this rxn reported. The patient had severe chills. The nurse said this is not normal for this patient.
Patient came in wondering if due for tdap. floater rph working didn't carefully check and gave pt another shot on 10/5/23 thinking pt didn't receive yet. found out later pt did receive already 3/16/23. pt having no adverse reaction so far.
Shingles; This is a spontaneous report from a non-contactable consumer(patient) or other non hcp. A 60-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number:FC3180) via an unspecified route of administration, administered in Arm Left on 20Aug2021(at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Darvon (dextropropoxyphene hydrochloride) and experienced allergy. The historical vaccine included bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: FA6780) via an unspecified route of administration, administered in Arm Left in Jul2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination has not been tested for COVID-19. The patient experienced shingles on 03Sep2021. Adverse event result in emergency room/department or urgent care. Therapeutic measures included Valacyclovir. Treatment received for the adverse event: prescription for Valacyclovir. The event outcome was reported as recovering  No follow -up attempts are possible. No further information is expected.
Patient experienced burning sensation to eyes bilateral 5 min after administration. After 25 min had passed, patient began to experience a sharp/stabbing pain to the right side of her head that traveled down to her Rt eye and Rt side of her face.
Some blurred vision after the 2nd dose; Upset stomach after the 2nd dose; Fever after the 2nd dose; Chills after the 2nd dose; Muscle pain after the 2nd dose; Headache after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Some blurred vision after the 2nd dose), ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose) and MYALGIA (Muscle pain after the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jun-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 05-Jun-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose), MYALGIA (Muscle pain after the 2nd dose) and HEADACHE (Headache after the 2nd dose). On 06-Jun-2021, the patient experienced VISION BLURRED (Some blurred vision after the 2nd dose). On 06-Jun-2021, ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose), MYALGIA (Muscle pain after the 2nd dose) and HEADACHE (Headache after the 2nd dose) had resolved. At the time of the report, VISION BLURRED (Some blurred vision after the 2nd dose) outcome was unknown.            Concomitants and treatments were not reported.   Reporter did not allow further contact
Information has been received from a physician concerning a pt who was vaccinated with varicella virus vaccine live. Subsequently, 30 seconds after receiving the vaccination the pt developed a seizure. The pt had been up all night prior and had drunk large quantities of coffee. the pt was taken by ambulance to an ER but it was unknown if the pt was admitted to the hospital. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Patient was given 0.2cc of adult Pfizer purple top Covid vaccine instead of pediatric Pfizer (PEDS) orange top Covid vaccine. Patient is 11 years old, will be 12 on 09/14/2022.
expired QUADRACEL given to a patient with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection,(dose and strength not reported) (lot C5755AB; expiry date: 10-Jul-2022) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (unknown latency).  It was asked  if revaccination is necessary after giving expired QUADRACEL to a patient.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event expired quadracel given to a patient with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
patient received undiltued vial of covid 19 pfizer vaccine, so 6 undiluted doses at one time
soreness; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and ARTHRALGIA (joint pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included MS (Multiple sclerosis).    On 27-Mar-2021, 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 (soreness) and ARTHRALGIA (joint pain). At the time of the report, PAIN (soreness) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided    This case was linked to MODERNATX, INC.-MOD-2021-090483 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-090483:crosslinked dose 2
Fever up to 102.7, tachycardia, joint pain, fatigue, and chills started approximately 20 hours after vaccine administration.  Fever responded to 400 mg of ibuprofen. All other symptoms are persisting at this time.
Rash, itching, swelling and firmness surrounding injection site, not circular but more on the right side of the injection site when looking down towards it. Area is warm to the touch. This is the first day of the symptom and no treatment by a doctor has been recommended; however, I take AllerClear in consistently and didn't take any this morning -- I took one this evening around 10:30pm.
red lines going from his hand up to elbowon right arm; palm and wrist swelled up can hardly move; issues in knees and difficulty in walking ,had to walk very slow; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE, PERIPHERAL SWELLING and ERYTHEMA (red lines going from his hand up to elbow on right arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, WARFARIN, WARFARIN, VITAMINS, and MINERALS for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced GAIT DISTURBANCE. On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (palm and wrist swelled up can hardly move). On 13-Apr-2021, the patient experienced ERYTHEMA (red lines going from his hand up to elbow on right arm). At the time of the report, GAIT DISTURBANCE and PERIPHERAL SWELLING (palm and wrist swelled up can hardly move) outcome was unknown and ERYTHEMA (red lines going from his hand up to elbow on right arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  The patient denied consent for further follow-up.  No treatment of events was reported.
Redness and itching and burning sensation at site of injection within 10 minutes of administration of Varicella vaccine. Went to ER - got Decadron 8 mgm by mouth in ER and took Benadryl at home 8/12/13. Fully recovered.
The arm was swollen for 2 full days, rapid heartbeat during the first night, body temperature up to 37.4 for 2 days, fatigue for 7 days, allergic reaction on the second day, headache for 3 days, a red rash appeared on the face on the second day (probably vasculitis), getting tired quickly.