chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymph node painful/ it is pain, soreness, and some minor swelling that are the issues for this patient with respect to lymph node in his left shoulder; lymph node in his left arm pit swelled to the size of a golf ball/lymph node enlarged; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (lymph node in his left arm pit swelled to the size of a golf ball/lymph node enlarged) and LYMPH NODE PAIN (lymph node painful/ it is pain, soreness, and some minor swelling that are the issues for this patient with respect to lymph node in his left shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph node in his left arm pit swelled to the size of a golf ball/lymph node enlarged). On an unknown date, the patient experienced LYMPH NODE PAIN (lymph node painful/ it is pain, soreness, and some minor swelling that are the issues for this patient with respect to lymph node in his left shoulder). At the time of the report, LYMPHADENOPATHY (lymph node in his left arm pit swelled to the size of a golf ball/lymph node enlarged) and LYMPH NODE PAIN (lymph node painful/ it is pain, soreness, and some minor swelling that are the issues for this patient with respect to lymph node in his left shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-245583 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Half of her face drooped and was paralyzed, she went to the urgent care and was diagnosed with bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Half of her face drooped and was paralyzed, she went to the urgent care and was diagnosed with bell's palsy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FACIAL PARALYSIS (Half of her face drooped and was paralyzed, she went to the urgent care and was diagnosed with bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Half of her face drooped and was paralyzed, she went to the urgent care and was diagnosed with bell's palsy) had not 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.   Concomitant product use was not provided by the reporter.  As of 12-Apr-2021, the patient cannot move the left side of face.  Treatment for the event included acyclovir and prednisone.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient got the Pfizer booster along with a flu shot. After getting both shots, she sat down on the observation chair in front of the pharmacy. As soon as she noticed she couldn't, she told her grandpa. A technician was there at the time and immediately called the pharmacist for assistance. The patient was taken back to the consultation room where she leaned on the technician for support and fainted on the chair. Her blood pressure was 88/44 and O2 saturation was 98%. We called 911 paramedics. By the time paramedics came, she was stable. Paramedics confirmed she was fine. The last BP reading was 112/68. She declined to be taken to the hospital.
Approximately eight hours after receiving my second dose of Moderna, I began having a sore throat,  high fever, and general malaise. This lasted about 24 hours, after which I am experiencing low-grade fever and general malaise.
I had fever, chills, nausea, sweats, body aches, migraine, general fatigue. I couldn't eat for 24 hours. It passed after about 4 days. I also got hives and intense itching at the injection site.
redness, edema, diarrhea, tenderness, fever;ER visit-infect present;pt rx keflex;
Started getting restless even in father's arms. At 4:45 started SCREAMING hysterically for an hour and a half. Could not be comforted by mom or dad. Since then has had almost no appetite, will barely even drink. Repetitive head motions. Staring. Not responding to name. Cranky. Fever for two days. Seems depressed and listless.
trouble sleeping; tiny fever/fever; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), PYREXIA (tiny fever/fever), ARTHRALGIA (joint pain) and HEADACHE (headache) 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 08-Sep-2021, the patient received third 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) (Intramuscular) 1 dosage form. On an unknown date, 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 INSOMNIA (trouble sleeping), PYREXIA (tiny fever/fever), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (trouble sleeping), PYREXIA (tiny fever/fever), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.            Patient received third dose of COVID-19 vaccine Moderna on 08Sep2021. Patient experienced joint pain, a tiny fever, trouble sleeping and possibly headache. Patient stated it wasnot serious. Patient took aspirin and it was not clear if also took Excedrin to treat symptoms. No concomitant medications reported.
Intense swelling and injection site pain for 2 days that went away and then came back on day 8 with a hard hot 3-in swollen area below the skin slightly itchy painful to the touch at injection site consistent with what is being called covid arm
initial flu like symptoms that went away.  But then noticed increased heart rate, palpitations, shortness of breath, heart discomfort, inflammation in my throat, fatigue, exercise intolerance. swelling in toes and feet.  I am a runner and I can no longer run without my heart rate sky rocketing.  I have tried slowing down and cutting mileage.  I had seen some improvement but now as of 1/8/22 I have stopped running because symptoms were continuing and interfering with my daily life.
Couldn't move; fever; muscle ache; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Couldn't move), PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (Headache) and CHILLS (chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MOVEMENT DISORDER (Couldn't move), PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (Headache) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (Couldn't move), PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (Headache) and CHILLS (chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
She got her vaccine, nothing, had no reaction and has never had any problems with any vaccines.  About 9:00 PM she went to work and all at once she started to feel bad, shortness of breath.  She had 3 hours to go and kept going and went home and went straight to bed.  She was breathing heavy and got up about 5:00 AM and ate something as she had not eaten much the day before.  She was sitting at the table and could see her f\FITbit going up and up and going faster.  She looked up what to do for a fast heartbeat, and it said to lay down, which she went back to bed.  She did not know how high it got and was huffing and puffing.  She does not know how long it took for her heart to stop racing and was so short of breath.  The rest of the day she was wiped out and continued to huff and puff.  The next day it was a little better but felt like she was drug through the ringer and was still a little short of breath.  By Saturday she was back to normal.  She did see an ad about pericarditis and continued to take in fluids, and she is fine now.   She did also get her flu shot on the same day. She did not have any soreness in her arms from the vaccines.
Information has been received from the authors in a literature article concerning a 2 year old male patient who was vaccinated with PCV (23-valent) (manufacturer unknown) and had received 13-valent PCV 1 and 2 years earlier. Concomitant vaccines included meningococcal vaccine (manufacturer unknown). The 2 year old boy with sickle cell disease type hemoglobin SS SCD (Hgb-SS) was initially vaccinated with PCV (23-valent) (manufacturer unknown). Then, 6 weeks later received a second dose of PCV (23-valent) (manufacturer unknown). Subsequently, he was brought to the emergency department with acute onset of fever and swelling of the left thigh that occurred 6 hours after administration of the PCV (23-valent) (manufacturer unknown). A physical examination revealed mild erythema and generalized edema, with warmth and tenderness to palpation of the left thigh and knee. The patient was febrile (38.9 degrees C), and the fever resolved with one dose of ibuprofen. Laboratory tests revealed a white blood cell count of 39.8 x 1000/mm3 that showed leukocytosis (11.0 x 1000/mm3 before immunization). He was admitted and treated empirically with ceftriaxone, and vancomycin was added for suspected cellulitis. The patient continued to improve during his hospitalization, and he was discharged 3 days later receiving clindamycin. His symptoms had completeLY resolved by the time of his 3 day post discharge follow-up visit. This is one of several reports from the same literature (1506USA012954, 1506USA013115, 1506USA013114 and 1506USA013112). Additional information has been requested.
COVID; COVID; her husband also got the COVID-19 vaccines including three Moderna and two Pfizer, including bivalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "her husband also got the COVID-19 vaccines including three Moderna and two Pfizer, including bivalent". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19, interchange of vaccine products.  Clinical course: My Husband was positive for Covid, not recently" and did not have any symptoms. The patient was not the reporter. Reporter type: Consumer or other non health professional (wife). COVID-19 vaccine was a Pfizer product. Paxlovid was a Pfizer product, Reason for no lot number: of Prevnar and unspecified flu shot, Moderna COVID-19 vaccine, COVID-19 bivalent vaccine: Caller unwilling to complete the report. Caller mentioned her husband also got the COVID-19 vaccines including three Moderna and two Pfizer, including bivalent, and her husband also had COVID and had mild symptoms. Agent reports caller mentioned that her husband's doctor also gave the medication, which agent is not sure which but he believes it was Paxlovid. Agent reports caller would like to know contraindicated drugs with Paxlovid. Documented as consumer, unable to verify with caller. Caller provides no further details about this medication. They both tested positive, and her husband had no symptoms whatsoever, but she had some, but they didn't test her for the flu so those could have been the flu. Pfizer COVID-19 vaccine/Pfizer COVID bivalent vaccine, Moderna COVID-19 vaccine: She and her husband got the COVID-19 vaccines including three Moderna and one Pfizer, also including a bivalent, and she and her husband had COVID, which her husband had no symptoms and she had some.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot number, dose and route were unknown). No adverse experience were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Had a rapid rapid heart beat for 5 or 6 secs; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Had a rapid rapid heart beat for 5 or 6 secs) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced HEART RATE INCREASED (Had a rapid rapid heart beat for 5 or 6 secs). At the time of the report, HEART RATE INCREASED (Had a rapid rapid heart beat for 5 or 6 secs) had resolved. Not Provided          Concomitant medications included blood pressure medication x2, asthma medication x2, thyroid medication  Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: followup was received reporter contact information, email ID was added and second dose, start date was added and did not experience any side effects after second dose.
A report has been received from a Health Professional concerning a 52 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The nurse reported that they inadvertently gave FLUMIST to a 52 year old which started on 28-Oct-2013. The patient has not had any issues or symptoms since FLUMIST. The outcome of the event of inadvertently gave FLUMIST to a 52 year old is unknown. The report was considered to be non-serious.
2 days after the vaccine was given knot appeared on shoulder. after a week the knot moved to neck . went to doctor and was given antibiotics. a week later problem persist. was given steroids . Had no strength in left arm. problem has gotten better.
4 hours later I started to itch and scratch; Felt low for few days; My fingernail feels tender; Then after 2 hours later (6 hours later from shot) large hives appeared on upper torso, chest and on brain; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 4 hours later i started to itch and scratch/Pruritus, then after 2 hours later (6 hours later from shot) large hives appeared on upper torso, chest and on brain/Urticaria , felt low for few days/Asthenia, my fingernail feels tender/Tenderness.  The patient's medical history was not provided. Concomitant medications reported were Vitamin C for drug use for unknown indication.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) 4 hours later i started to itch and scratch, then after 2 hours later (6 hours later from shot) large hives appeared on upper torso, chest and on brain, felt low for few days, my fingernail feels tender.  Treatment details included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 4 hours later i started to itch and scratch, then after 2 hours later (6 hours later from shot) large hives appeared on upper torso, chest and on brain, felt low for few days, my fingernail feels tender was unknown.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No demographic information was available. On 29-SEP-2015, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # K008883, expiration date: 20-SEP-2015, route of administration was not provided. No adverse event was reported. Additional information has been requested.
The patient received her third Pfizer vaccination into her left deltoid at 9 AM on the day of admission.  At 1 PM on the day of admission she was at work at when she developed left-sided weakness, facial droop, left-sided numbness, left-sided headache, blurry vision, gait instability, slurred speech, word searching.  In the ED she was initially evaluated as a code stroke.  The CT scanner was down at the time so she proceeded to a brain MRI/A brain.  This was negative.  She was admitted to the hospitalist service for ongoing evaluation.  Neuro exam of the time of admission was inconsistent.  Differential included conversion disorder versus migraine.  She was eventually able to receive a CTA of the head neck which was negative.  Echo is still pending at the time of discharge, although anticipate this will be unremarkable.   On the day of discharge the patient has a residual headache but all of her other neurologic deficits have resolved.  Ultimately, her symptomatology may be psychosomatic, although it may represent a hyper immune response given the third Covid vaccine dose she received 5 months after her second dose.  She will discharge home with no new medications or changes.
Bleeding Patient reports off schedule menstruation, heavy flow with yeast infection Narrative:  Off schedule menstruation; heavier than usual flow followed by yeast infection. Self Resolved.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received paxlovid from 15Sep2022 to 19Sep2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information was received on 11-JUL-2017 from a medical assistant who reported that multiple unspecified patients received either VARIVAX or PROQUAD that were improperly stored (dates of vaccination, dose and lot#/expiration not reported). Temperature was 15 degrees F to 46 degrees F for a time frame of 24 hours. There had not been a previous temperature excursion. No adverse effects reported. No further information was provided. Additional information has been requested.
Information has been received from a company representative concerning her 8 week old bottle-fed son with no drug allergies who on 14-FEB-2008 was vaccinated PO with his first dose of ROTATEQ.  Concomitant vaccinations administered on that same day included a dose of PEDIARIX, a dose of ACTHIB and a dose of PREVNAR.  Within 2 hours of the vaccination, the patient experienced diarrhea which lasted 10 days and then there was a "continuous" diarrhea for the next 5 weeks.  The gastroenterologist indicated that her son had a problem breaking down proteins (due to damage to the gastrointestinal tract brush border) and was put on special formula.  Therapy with ROTATEQ was discontinued for further doses.  On 25-MAR-2008 the patient recovered.  No other information to report.  There was no product quality complaint.  Additional information has been requested.