chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Both doses were expired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Both doses were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Both doses were expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received the 2 doses with less than 25 days apart, and both of them were expired.  No concomitant medications were reported.  No treatment information was reported   This case was linked to MOD-2021-342394 (Patient Link).
Couldn't eat or taste; Excruciating pain in feet and hands; Couldn't eat or taste; Arm swollen the size of a cantaloupe; Felt like she had covid; Out of breathe; Couldn't walk; Fever; Chills; Muscle pain in right shoulder; Shoulder feels heavy; Shoulder feels like bumblebees are inside; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe) and FEELING ABNORMAL (Felt like she had covid) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, VITAMIN D [VITAMIN D NOS] and BIOTIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe), FEELING ABNORMAL (Felt like she had covid), DYSPNEA (Out of breathe), GAIT DISTURBANCE (Couldn't walk), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain in right shoulder), ARTHRALGIA (Shoulder feels heavy) and ARTHRALGIA (Shoulder feels like bumblebees are inside). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg three times a day. On 05-May-2021, DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe), FEELING ABNORMAL (Felt like she had covid), DYSPNEA (Out of breathe), GAIT DISTURBANCE (Couldn't walk), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. At the time of the report, MYALGIA (Muscle pain in right shoulder), ARTHRALGIA (Shoulder feels heavy) and ARTHRALGIA (Shoulder feels like bumblebees are inside) outcome was unknown.            This case was linked to MOD-2021-201239 (Patient Link).
27jul90 pt vax hepta B. 2 hrs aft vax pt legs ached. 5 hrs aft vax pt could not hold head upright, generalized myalgia, h/a, temp of 101.2 degF, and throbbing at inject site.  pt reported feeling nausea but no vomiting or diarrhea.  pt tx .
Have not gotten her monthly menstrual cycle; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 14May2021 at 16:00 (at the age of 32 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination and prior to vaccination the patient was not diagnosed with COVID-19.  The patient did not receive other vaccine in four weeks. On 14May2021, the patient reported that she have not gotten her monthly menstrual cycle. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the event. The patient underwent lab tests/ COVID test after vaccination which included nasal swab with a negative result on an unspecified date. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
passed out; severe reaction/Idiosyncratic Vaccine Reaction; severe right thigh and buttock pain; developed sweats; severe right thigh and buttock pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PHENTERMINE (ADIPEX [PHENTERMINE]) and PIROXICAM (PAXIL [PIROXICAM]) for an unknown indication.    On 31-Aug-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 LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), VACCINATION COMPLICATION (severe reaction/Idiosyncratic Vaccine Reaction), PAIN IN EXTREMITY (severe right thigh and buttock pain), HYPERHIDROSIS (developed sweats) and MUSCULOSKELETAL PAIN (severe right thigh and buttock pain). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), VACCINATION COMPLICATION (severe reaction/Idiosyncratic Vaccine Reaction), PAIN IN EXTREMITY (severe right thigh and buttock pain), HYPERHIDROSIS (developed sweats) and MUSCULOSKELETAL PAIN (severe right thigh and buttock pain) outcome was unknown.        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.   No treatment medication information was mentioned by reporter.  Company comment: This case concerns a 39-year-old, female patient with no relevant medical history who experienced the unexpected event of Loss of consciousness. The event occurred twelve hours after receiving the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273is not affected by this report.; Sender's Comments: This case concerns a 39-year-old, female patient with no relevant medical history who experienced the unexpected event of Loss of consciousness. The event occurred twelve hours after receiving the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273is not affected by this report.
ACHY; SENSITIVE TO TOUCH; COLD SWEATS; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced achy. On MAR-2021, the subject experienced sensitive to touch. On MAR-2021, the subject experienced cold sweats. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the chills, sensitive to touch, cold sweats, fever and achy was not reported. This report was non-serious.
1st vaccine:  arm, shoulder, neck pain pain post 3 days fever, chills, rigors, myalgia, arthralgia continued for 7 days HA, fatigue continued for 10 days Medication Treatment: Meloxicam 7.5 mg daily for 6 days Imitrex 25-75 mg daily for 10 days  Caffeine 100 mg daily for 10 days  2nd Vaccine:  arm pain, swelling, redness, itching post 3 days fever, myalgia, arthralgia, fatigue 48 hrs  Medication Treatment: Meloxicam 7.5 mg 1 dose at bedtime
About 5 minutes after the injection, my throat began to feel tight like it was swelling. When it did not improve in about 5 more minutes, I took a benedryl, which l carry with me in my purse. When the time was up that l was supposed to wait (15 min.), l pulled out of line but did not leave the parking lot. I parked behind the EMS  on duty to wait a while longer to be sure the symptom improved rather than getting worse. EMS talked with me to be sure l was ok, and to check for a rash, which l did not have. After about 10 more minutes my throat had improved to the point where l felt like l was going to be ok & could drive home. I did experience tingling around my mouth, tooth pain, & a metallic taste in my mouth . My drs. Office suggested l report these symptoms to you.
Approx two days after the 2nd vaccine, I developed bilateral, very high frequency tinnitus. It has remained persistent and seems to be getting louder over time. It is even audible in the presence of background noise. I?m considering the use of a steroid dose pack to try and reduce this auditory side effect.
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2013 the patient was inoculated with ZOSTAVAX vaccine at a public health department for routine adult health maintenance and the prevention of shingles.  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014 the patient was treated by a physician for onset of a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Approximately 20-24 hours after vaccines given, mother noted swelling, redness, and warmth at site of immunization.  Child also complains of itching.  Symptoms have persisted 48 hours later, but not worsened.  Right deltoid/arm
sweating; labored breathing, could not catch his breath; chills; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling well), HYPERHIDROSIS (sweating), DYSPNOEA (labored breathing, could not catch his breath) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015C21A, 030M21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION COMPLICATION (not feeling well) and CHILLS (chills). On 19-Aug-2021, the patient experienced HYPERHIDROSIS (sweating) and DYSPNOEA (labored breathing, could not catch his breath). At the time of the report, VACCINATION COMPLICATION (not feeling well), HYPERHIDROSIS (sweating), DYSPNOEA (labored breathing, could not catch his breath) and CHILLS (chills) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-294237 (Patient Link).
Pt reports redness, swelling, pain, and a firm lump the size of a quarter on her right deltoid that began 2/27/21. Pt received first dose of Moderna COVID vaccine in right deltoid on 1/14/21 at clinic. Pt then received HPV vaccine with her OBGYN (outside clinic) in right deltoid on 2/4/21. Received second dose of Moderna COVID vaccine on 2/17/21 in left deltoid at clinic. Had a telephone visit with her healthcare provider on 3/1/21 who advised symptom management and to seek a higher level of care if systemic symptoms occur. Currently taking ibuprofen for comfort, no other interventions recommended by patient's primary care provider. Denies lymphedema or systemic signs and symptoms. Advised patient to follow-up with her primary care provider if symptoms do not improve or worsen.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:168 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine 10-Nov-2021 and 11-Nov-2021. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
The following persisted greater than 3 months following vaccination: Muscle soreness in the arm of injection; Numbness and tingling at the tip of the tongue.
Pt vaccinated w/1st dose of Hep B vax, 2 days p/vax developed a fever of 101F which persisted for 3 days & remitted spontaneously;
Began with pain in the bicep. Arm began to weaken. Have not been able to lift my arm since.
Client presented to the vaccination site on 11/14/2021, accompanied by his parent for his first dose Pfizer COVID vaccine. Today, the client received the first dose Pfizer COVID vaccine for 5 through 11 years of age (Lot# FK5618 exp: 01.19.22) at 1303) noted the client was 13 years old after administration of the Pfizer COVID vaccine for 5 through 11 years of age. With  translating, provided education stating the client received the incorrect formulation of the Pfizer COVID vaccine. educated client on possible adverse reactions and when to seek medical care. The client denied any chronic conditions, current medications, or known allergies. verbally consulted with Clinical Project Coordinator requesting for guidance on how to proceed. While the client was at the observation area, Clinical Project Coordinator, received a recommendation from the doctor via text. The doctor recommended against repeat vaccination today but stated in 21 days the client may receive a dose of COVID vaccine Pfizer for 12 years of age and older at the parent's request. talked to the client's father at the EMT station. provided education regarding administration of the incorrect formulation of the Pfizer COVID vaccine and the recommendation from the doctor stating the client may receive a Pfizer COVID vaccine for 12 years of age and older in 21 days. provided education again to the client's father regarding possible adverse reactions, and when to seek medical care. The client did not report any symptoms during the 30-minute observation period. The client left the vaccination site at 1333 ambulating unassisted with a steady gait with his parent.
Elevated temperature 99.9 - 101.9 for 10 days, left tonsil abscess x 30 days, right hip pain continuing
have a knot in the injection site  and it has redness in that area. Also have a knot in the arm pit that is as big as fist. no redness to it.
Rash on neck, chest, forearms and armpits, looks like hives, not itchy.
itchy; rash is going down in her arm; headache; tiredness; little fever; sore; hardness; warm to touch; covid arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (covid arm), PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch) and PRURITUS (itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm). On 08-Mar-2021, the patient experienced PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch), RASH (rash is going down in her arm), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (little fever). On 11-Mar-2021, the patient experienced PRURITUS (itchy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (covid arm), PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch), PRURITUS (itchy), RASH (rash is going down in her arm), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (little fever) outcome was unknown.            Reporter did not allow further contact
PATIENT BECAME VERY SLEEP AND LETHAGIC-12;10 B/P 160/113 PULSE 89-GIVEN WATER TO DRINK-CONTINUE TO BE VERY SLEEPY-12;12-175/97 87-O2 SAT-88-CLIENT TOLD TO TAKE DEEP BREATHS-12;15-181/102-P.88-BLOOD SUGAR-268-PTIENT HAS HISTORY OF DIABETES-DID NOT EAT THIS MORNING AND DID NOT TAKE INSULIN-12;22-185/105 P. 86--DR CAME AND ASSESSED PATIENT AND ENCORAGED HER TOCONTINUED TO DRINK FLUIDS. ABLE TALK AND FOLLOW CAMMAND-BUT UNABLE TO STAY AWAKE-12;181/103 P. 83-EMT CALLED BECAUSE CLIENT UNABLE TO STAY AWAKE-B/P 178/101 P. 84-DEPLOYED T0 EMERGENCY ROOM -BP-178/102-86
SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM). At the time of the report, VACCINATION SITE PAIN (SORE ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever of 102.5 for 2 days then 1 day at 101, chills, fatigue and swelling and red at injection site for 3 weeks
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 4 years old female patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 21-Feb-2019, the patient received a 0.25ml dose of prefilled syringe of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported via intramuscular route in unknown administration site. It was an actual medication error due to Vaccine underdose. It was reported that 4 years Child received an injection for 0.25 instead of the 0.5ml of vaccine FLUZONE QUADRIVALENT. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender- none.
severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had Flare a week after first vaccine; Had flare a week after first vaccine with mild foot swelling; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ej1685), via an unspecified route of administration on 17Dec2020 at 08:00 AM on Right arm at single dose for COVID-19 immunization in hospital. Medical history included possible asthma, left foot post traumatic arthritis with multiple surgeries including precious allograft, meralgia paresthetica left side otherwise healthy (History of mild arthritis foot and ankle surgery). Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had history of mild arthritis foot and ankle surgery, she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain in Dec2020, severe arm pain about 2 hours after vaccine with difficulty lifting arm for 24 hours after vaccine on 17Dec2020. Took mefenamic acid (ADVIL) for pain. Elevated feet for swelling. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of event 'severe leg and foot pain/severe arm pain' included mefenamic acid (ADVIL), for event 'foot swelling' included Elevated feet; no treatment was received for the other events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Seen for 6 month physical 10/8/11. Developed fever, vomiting, fussiness and decreased appetite 10/11/11. On 10/13/11 episodes of (L) sided weakness, lethargy. Weakness resolved by the time seen in office. Also noted to have viral exanthem. Sent to ER but will be observed for developmental sequelae. Currently some residual weakness.