chrisvoncsefalvay/vaers-outcomes huggingface dataset:
couldn't walk at times; shooting paint in both legs, just above the knee, more around inner area,Intense pain,sore arm; injection arm sore; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (couldn't walk at times), FATIGUE (Fatigue), MYALGIA (shooting paint in both legs, just above the knee, more around inner area,Intense pain,sore arm) and VACCINATION SITE PAIN (injection arm sore) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (injection arm sore). On 11-Apr-2021, the patient experienced GAIT INABILITY (couldn't walk at times) and MYALGIA (shooting paint in both legs, just above the knee, more around inner area,Intense pain,sore arm). On 11-Apr-2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (injection arm sore) had resolved. At the time of the report, GAIT INABILITY (couldn't walk at times) and MYALGIA (shooting paint in both legs, just above the knee, more around inner area,Intense pain,sore arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
inconsolable crying;erythema & swelling of thigh inj site; parents described SOB;fever @ ER (parent report) 104;
Bells Palsy; Sore arm; A spontaneous report was received from a consumer concerning her husband a 68-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy / facial paralysis and sore arm / pain in extremity.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient experienced had a sore arm. On 13 Mar 2021, the patient developed medically significant event of Bell's Pplsy.  Treatment for the event included prednisone, 'doxixclavir', and eye drops.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events Bell's palsy and sore arm was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Extreme all over body itching with urticaria and dermagraphia started 14 days after I got my Moderna booster.
Entire body got swollen; Weird dizziness; Felt warm; Llittle bit of a headache; Achy body; Shallow breathing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOPNOEA (Shallow breathing), SWELLING (Entire body got swollen), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm) and PAIN IN EXTREMITY (Sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergies to food additives and preservatives) and Vitamin D deficiency.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 03-Apr-2021, the patient experienced HYPOPNOEA (Shallow breathing), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm), HEADACHE (Llittle bit of a headache) and MYALGIA (Achy body). On 08-Apr-2021, the patient experienced SWELLING (Entire body got swollen). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and Manual therapy (Rubbed all the lymph areas and that calmed the swelling down) for Swelling. On 16-Apr-2021, HYPOPNOEA (Shallow breathing), SWELLING (Entire body got swollen), DIZZINESS (Weird dizziness), FEELING HOT (Felt warm), PAIN IN EXTREMITY (Sore arm), HEADACHE (Llittle bit of a headache) and MYALGIA (Achy body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.
Fever nights sweats, nausea, fatigue Narrative: employee states; she experienced night sweats, low grade fever (101.2), fatigue and nausea
mom states recd shot for school this yr; observed swelling to rt arm which extends from elbow rt arm to shoulder rt arm; T 99.3 Fri afternoon;
Had two adverse events: first was 4/2/21 while we were on spring break (teacher) started as cold, freezing, shaking then led to dizziness, triceps (both) stinging, both butt cheeks feeling like they were burning (blisters), could not sleep, shaking as if I were having withdrawal symptoms, could not sit down or lay down without pain. Went to Hospital on holiday morning. They ran an EKG, CT Scan, took 11-12 vials of blood and did cultures which came back negative.  We left early to return back home where I went to Family Practice to see my personal physician where he took eight more vials of blood and it all came back negative.  The second episode occurred in October 2021, where I had a fever for a week and broke out in a rash over my whole body.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-MAR-2013 at 4:20 pm, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 130.50 hours (also reported "17 hours-1, 412 2 admin"). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
myalgia; migraine; first dose vaccine content in the syringe up to the plunger appeared "red"; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), MIGRAINE (migraine) and PRODUCT ADMINISTRATION ERROR (first dose vaccine content in the syringe up to the plunger appeared "red") in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 048C21A) for COVID-19 vaccination.     Medical history was not provided. .    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-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 MYALGIA (myalgia), MIGRAINE (migraine) and PRODUCT ADMINISTRATION ERROR (first dose vaccine content in the syringe up to the plunger appeared "red"). The patient was treated with CANNABIS SATIVA (CBD COMPLEX) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (myalgia), MIGRAINE (migraine) and PRODUCT ADMINISTRATION ERROR (first dose vaccine content in the syringe up to the plunger appeared "red") outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medication information was not provided.
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, lot # and route of administration were not reported). On an unknown date the patient had positive Pap Smear exam for HPV included the type 18 in high risk range. It was reported that before having this exam on unknown date, the patient had completed the three dose series of GARDASIL. It was also reported that the HPV cleared on its own without the need of treatment. The patient did not seek medical attention. The outcome of the event was reported as recovered/resolved on unknown date. Additional information is not expected due to the reporter did not want to be contacted again.
Two After first dose started having pain in my surgically repaired shoulder start having a nasty pain . Before second shot I begged the Dr at the Pharmacy  not to inject my left arm. He did,  within an hour the pain got much worse. The pain lasted 3 months before it stopped. I?ve since has another shoulder surgery on other arm. I?m reluctant to get booster shot for fear of a reoccurrence. At my rehabilitation facility I mentioned the severe pain had to stop therapy for weeks until the pain subsided. Once I returned to therapy my Therapist told me there were a couple others experiencing shoulder pain after COVID 19
Pt called and reported her arm is very red and swollen and it hurts to move. We referred her to a doctor to have her arm evaluated.
A few days after receiving the second shot, and ongoing, such severe pain in right leg that no weight can be comfortable placed on it and must walk with a very severe limp. Standing or placing any amount of weight on the leg is excruciatingly painful.
HIVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021, the patient experienced hives. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives. This report was non-serious.
Severe headache; Fatigue; Loss of appetite; Body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: Er8732) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE; PRISTIQ; ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF. The following information was reported: HEADACHE (non-serious) with onset 03Apr2021, outcome "recovered" (2021), described as "Severe headache"; FATIGUE (non-serious) with onset 03Apr2021, outcome "recovered" (2021), described as "Fatigue"; DECREASED APPETITE (non-serious) with onset 03Apr2021, outcome "recovered" (2021), described as "Loss of appetite"; PAIN (non-serious) with onset 03Apr2021, outcome "recovered" (2021), described as "Body ache". Therapeutic measures were not taken as a result of headache, fatigue, decreased appetite, pain.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 19Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 23Aug2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 19Mar2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens autoimmune condition" (unspecified if ongoing); "Known allergies: Orange oil" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 09Jun2022, stop date: 14Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: Pyrexia: (20Jun2022) 100 Centigrade, notes: 100c; SARS-CoV-2 test: (10Jun2022) positive; (Jun2022) Negative; (20Jun2022) positive. Clinical course: On 10Jun I got a positive Covid test. I have cough and shortness of breath, muscle pains, brain fog, headaches took paxlovid since I have an autoimmune condition for 5 days. The symptoms were decreased and got a negative Covid test on day 6. 10 days after getting the positive test I got another positive test on 20Jun. Today I got experienced a fever of 100c cough, shortness of breath, runny nose and started a second 5 day cycle of paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client incorrectly reported their year of birth one year earlier so clinic staff believe client was 12 when in fact they were 11. Pfizer 12+ dose given to 11 year old client on 8/4 and 8/25 of 2021.
Upset stomach; Abdominal pain; Vomiting; Nausea; A spontaneous report was received from a nurse on 31JUL2023 regarding a 26-year-old male patient who had "upset stomach" (PT: Abdominal discomfort), "nausea" (PT: Nausea), "vomiting" (PT: Vomiting) and "abdominal pain" (PT: Abdominal pain) following the administration of oral Vivotif capsule (typhoid vaccine live oral Ty21A; lot number: 3003830, expiry date: FEB2024) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On an unknown date, the patient took the first dose of Vivotif. Reportedly, after 7 hours of administration of the first dose the patient had an upset stomach and nausea and after 8 hours of administration the patient experienced abdominal pain and vomiting. No fever was reported. Subsequently, the patient decided to discontinue the vaccine and was given a typhoid injection before leaving for the trip.  The outcome of the reported events was unknown at the time of this report.  The action taken with Vivotif with respect to the reported events was withdrawn.  No additional information was reported.  Company comment: It was reported that a patient received Vivotif and after 7 hours of administration of the first dose the patient had an upset stomach (abdominal discomfort) and nausea. Then at 8 hours after administration the patient experienced abdominal pain and vomiting. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal discomfort, nausea, abdominal pain, and vomiting is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient received Vivotif and after 7 hours of administration of the first dose the patient had an upset stomach (abdominal discomfort) and nausea. Then at 8 hours after administration the patient experienced abdominal pain and vomiting. Considering the case information, the role of Vivotif cannot be ruled out and the causality of abdominal discomfort, nausea, abdominal pain, and vomiting is assessed as possible. The case is considered non serious as per medical assessment.
pt recvd MMR vax 25JUN91 & immed following inject pt felt faint, vomited & exp a tingling feeling all over body; felt dizzy & was given ammonia to inhale;
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 78-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
I was lethargic and had chills, fever, a runny nose, no appetite. That probably lasted about a week. Those symptoms went away but then I was put back on Glipizide and had an allergic reaction. I had never had a problem with it before. I was having stomach issues. I saw my primary Dr. and my GI doctor. Neither of them could identify why I was having these stomach problems. Then I started getting infections in my skin. I also had an infection that they couldn't seem to identify the cause. I think it was around that same time that I started getting ulcers on my right ankle and left foot. I was given several different antibiotics and my body was rejecting them. It had become resistant to two or 3 antibiotics that I was given. Nothing was getting rid of these infections. I was told I needed to see an infectious disease doctor. I was still waiting to see the infectious disease doctor when I got my second dose. From the time of the first vaccine I have been under constant medical care.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) Inconclusive.         No Concomitant medications were reported.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Followup document received on 22-JUL-2021 contains updated event outcome
Patient started experiencing periods of sweating and cold/hot sweats with visible beads of sweat on his face.
Difficulty breathing, numbness in arm, and mild seizure working 5 minutes of receiving vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Apr2023 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pertussis (Dose number unknown, single), for Pertussis immunisation, reaction(s): "known allergies: Pertussis immunization". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Sep2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment taken from 20Sep2023 to 25Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315090 same patient, different drug and different AE.;
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-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 medical history reported.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 02-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34ear-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pt developed redness, pain, and swelling at injection site on L upper extremity the night of the vaccine being administered. Symptoms progressed over his entire upper arm with warmth present. No fever. Patient seen in emergency room 10/24/23, given Benadryl, ice pack, Motrin, and Tylenol. Pt seen back at clinic on 10/26/23. PCP discussed symptoms of reaction to Infectious Disease physician and that MD recommended to start clindamycin for cellulitis.
Flushing and arm stiff and painful. Progressed to stiffness in neck, severe headache and nausea, faint.
This spontaneous report was received from an advanced registered nurse practitioner via a company representative concerning a 14 year old female patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose, route unspecified). No concomitant medications were reported. Her parents called the nurse practitioner office on an unknown date and stated that the patient went into menopause (date unspecified) and unspecified type of symptoms were reported. The outcomes of the events were unknown. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.