chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very ill; weakness; Headache; muscle pain; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (very ill), ASTHENIA (weakness), HEADACHE (Headache) and MYALGIA (muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced ILLNESS (very ill), ASTHENIA (weakness), HEADACHE (Headache) and MYALGIA (muscle pain). At the time of the report, ILLNESS (very ill), ASTHENIA (weakness), HEADACHE (Headache) and MYALGIA (muscle 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Heart racing from 9 AM all day, ranging from 110 to 148.  My normal is 65 at rest.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions, concomitant medication or known allergies provided. On 01-AUG-2018 (also reported as 01-AUG-2008), the patient was inadvertently administered a properly stored but expired dose of M-M-R II lot # M034856, expiry date 27-JUL-2018, for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported.
Patient came to our mobile vaccine clinic for her booster shot of the Covid-19 vaccine. She had received Moderna for her first two doses, but according to current CDC recommendations we offered her the pfizer vaccine for her booster. After administering her vaccine, we found that we had miscalculated how long ago she received her second dose. It had not yet been a full 6 months. Her second dose was on 6/18/21 and her booster was given 12/5/21. The patient was called today 12/6/21 and notified about the mistake. Current CDC recommendations do not require an additional booster to be given when the first booster is given before the recommended time.
ever since injection, left arm has been sore, then my left ear became very irriated, which extended down to my left arm and left leg, tingling, shocking sensations, now my left foot i am unable to walk normally, i trip easily, and unable to work, i am unable to use my left hand as i did in the past, no grip to hold on to, my mind mental status has changed, i can not concentrate on daily tasks without forgetting
Patient was seated in the passenger seat of the car. We talked for a few minutes prior to administration and I actually administered a vaccine to the person in the driver's seat first. I walked over to give his shot and he then tells me he "doesn't do well with vaccines." He later told me he felt sick to his stomach after getting the shot and had a metallic smell similar to a bloody nose. About 1 minute after administering his vaccine, the patient's head went back, his muscles went very stiff, and he appeared to convulse. We called 9-1-1. His mom was sitting in the back seat and placed an ice cube on the back of his neck which seems to have pulled him out of it. During the episode, he reports "blacking out" without orientation to time or place. After the episode, he was dizzy and lightheaded for a few minutes. Soon there after he was jovial. I took his BP and HR about 5 minutes later BP 100/62 and HR 48. Paramedics also took vitals which were a bit higher than these. He reported having a small cereal bar for breakfast and 2 cups of coffee.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vial was placed in refrigerator on 04-Nov-2021.No temperature excursion was reported. No adverse events were reported.  Treatment information was not provided.
Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 25-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports receive from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Pt recv vax on 2/22/99; on same day pt exp red/splotchy rash on arm, red whelps on back; tx=Benadryl & Triderm cream
Pt is 66 yo male s/p Pfizer vaccination: dose 1 on 2/16/2021 and dose 2 on 3/9/2021. Pt has a history of metastatic prostate cancer to the bone, HCV, alcohol abuse, chronic abdominal pain and lower back pain. During time of vaccination, cancer managed with Eligard every 3 months. Last treatment before vaccination on 1/11. He presents to the hospital with worsening abdominal pain and admitted on 8/12 for pain management. Upon admission, patient tested positive for COVID-19 and was asymptomatic. No therapy for COVID management needed.
Mom stated that infant had cried for more than 3 hours after administration of 2 mon IZ.(prevnar, HIB, pediarix and RV5 - unable to list all the IZ given at 2m visit #21.) Crying started 4 hours after shots given.  At 4 month visit split IZ at mom's request.  gave HIB and prevnar, 4 hours after IZ cried for 4 hours with redness at site that was knee to hip on side of injection. swell/redness gone after 24 hours.  not seen at clinic, verbal report from mom 5/8/07
Sore arm; Diarrhea; Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (Headache) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, PAIN (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (Headache) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Initial and follow up information has been received from a office medical assistant concerning her 12 year old daughter with no known drug allergies, neurocardio syncope since the 5th grade, Helicobacter pylori, irritable bowel syndrome and asthma who on 26-AUG-2008 (also reported 13-AUG-2010) was vaccinated with a dose of GARDASIL (Lot#657868/0523U) and VARIVAX (Oka/Merck) (Lot#660944/0512X) at a county health. Concomitant vaccination included MENACTRA and BOOSTRIX. Other concomitant therapy included FLORINEF, TOPAMAX and PREVACID. On 13-SEP-2008 the patient experienced chronic fatigue syndrome. Then the patient's neurocardio syncope was exacerbated leading to migraine headaches and was hospitalized twice in 2008, for an unspecified amount of time. On an unspecified date, the patient was seen by psych who said that the patient was depressed and brought on her own headaches. The reporter stated that this was not true. The patient had been followed by neurology for her neurocardio syncope. It was noted that the patient has been home schooled since 2009, since her conditions keep her from going to school. At the time of the report, the patient had not recovered. Therapy with GARDASIL was discontinued. Chronic fatigue syndrome, exacerbated neurocardio syncope, migraine headaches and depressed were considered to be disabling by the office medical assistant. Additional information has been requested.
localized reaction observed on varicella injection site on 6/4/08. The area was 68mm x 92mm red with 27mm x 41mm indurated. On 6/5/08, the measurements were 35mm x 37mm indurated and 40mm x 43mm reddness. Cool pack to area adviced.
had 4 times of breaking out in hives; acne all over the neck; bumps/rash on her neck; This case was reported by a consumer via call center representative and described the occurrence of hives in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2021, 1 week after receiving Shingrix, the patient experienced papular rash. On 24th October 2021, the patient experienced hives and acne. The patient was treated with antihistamine and clindamycin (Clindamycine). On 16th November 2021, the outcome of the hives was recovered/resolved. On an unknown date, the outcome of the acne and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the hives, acne and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient had the first dose of Shingrix and within a week patient had acne all over the neck. The patient also had 4 times of breaking out in hives (total of 4 episodes of hives outbreak with no reason). The patient treated with an OTC (over the counter) antihistamine for the hives and recovered from hives within 1 hour. The patient also treated with clindamycin for neck acne and had not cleared up yet. The patient also developed bumps/rash on her neck. The patient saw the doctor and the patient was treating with a prescription cream. This had not resolved. The lot number and expiration date of the vaccine were unknown. The reporter consented to follow.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238153:Same Patient
Pt. received vaccine injection in (R) deltoid and immediately after fainted and had spastic movement Pt placed in supine position and became responsive shortly after (1-2 mins). C/O feeling dizzy and seeing red light just prior to fainting.
parents describe bilateral leg swelling from thighs to feet on the on the day of HIB/DTP; seen 24 hrs later w/resolution of sx w/ exception of minimal lt thigh swelling; t100
NUMB HANDS WITH LOSS OF GRIP; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced numb hands with loss of grip.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numb hands with loss of grip was not reported. This report was non-serious. This case, from the same reporter is linked to 20221243340, 20221243356, 20221243261, 20221245816, 20221245969 and 20221243606.
Fever, chills, headache for 6 hours. Headache persisting through full day.
Balance disorder; Joint stiffness; Pain in joint; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance disorder), JOINT STIFFNESS (Joint stiffness), ARTHRALGIA (Pain in joint) and VACCINATION SITE PAIN (Vaccination site pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HYALURONATE SODIUM (HUMIA) for an unknown indication.    No Medical History information was reported.   On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started HYALURONATE SODIUM (HUMIA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder), JOINT STIFFNESS (Joint stiffness), ARTHRALGIA (Pain in joint) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, BALANCE DISORDER (Balance disorder), JOINT STIFFNESS (Joint stiffness) and ARTHRALGIA (Pain in joint) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported  The reporter's causality for the event(s) of BALANCE ISSUE, PAIN IN JOINT and JOINT STIFFNESS was not provided.   The reporter's causality for the event(s) of PAIN IN ARM AFTER COVID VACCINE WENT UP TO SHOULDER with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Reporter did not allow further contact
Approximately 3 months after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: scratchy throat, fatigue and body aches. I called my doctor and he did not pick up and I have been taking ibuprofen for now to help improve my symptoms and so far it has been working. As of today 07/12/2022 I am feeling fine and pretty much back to normal.
Within 2-3 hours Am a little fatigued, and a headache. Most days pain is 5-6/10 but with medication it can be as low as 4/10.  Sharp pains in legs cause falls.  About 4 falls, worse in the morning.  When standing after sitting for a prolonged period or in the morning getting out of bed is when pain is at its worst.    Finally sought Doctor's advice.  He ran a test showing elevated protein markers, T reactive and ESR elevated.  He referred to Rheumatologist.
This spontaneous case, initially received on 16-OCT-2018 from other non-health professional (consumer), concerns a 34-year-old, adult, female pregnant patient. The patient had 1 previous pregnancy. The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptive method. The patient had no birth defects and congenital anomalies were occurred in previous pregnancy. The patient had no medical history. It was reported that patient's husband did not use any medications prior to conception and the patient did not use any medications prior to the pregnancy and took prenatal vitamins. The patient's last menstrual period date (LMP) was 09-Sep-2018. On 16-Oct-2018, at gestational age of 05-weeks (first trimester of pregnancy) the patient was administered FLUCELVAX QIVc [dose: 0.5, ml, route of administration: intramuscular, anatomical location, deltoid, batch number and expiry date: not reported]. No treatment measures were taken. It was reported that, after vaccine administration, the patient did not experience any adverse event. There was no evidence of defect or adverse finding from a prenatal test and no birth defect or congenital anomalies were noted. The patient's estimated delivery date (EDD) was reported as 16-Jun-2019. The reporter assessed this case as non-serious.
4 days after the shot I started cramping very very badly. I do not get cramps regularly. I woke up out of a deep sleep and had my period so bad. My period is on time every month and is not normally this heavy. My period arrived 3 days early while sleeping.  I use soft discs to control my period. I am bleeding so much the disc is over filling and I have to change the cup 3 to 4 times per day. This has never happened. I am still on day 5 and still bleeding heavily and the blood is so dark it looks purple.
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
Local erythema-induration 7.5 inches and increase in limb circumference greater than 20% started 24 hours and 45 after vaccination. Infection at site could not be ruled out. Given 10 day course of Cephalexin. Cool compresses to site. No joint involvement or activity impairment. Mild pain at site. Temperature 99.9-100.4 degrees F x 1 day. Day 30  Erythema, induration and swelling over at day 7 after vaccination. Day 30 skin around injection site blotchy from stretching of skin due to swelling of limb.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient received first dose of COVID-19 vaccine. Afterwards he passed out to the gound. He came to, and was seated. 911 was called and emergency response came. Patient was evaluated and he said he was ok. EMT's left and patient remained for more observation. After some time, patient became ashen faced again and 911 was called again. This time patient left with emergency services. The EMT's said it was not an allergic reaction. Patient stated a severe fear of needles/previous reaction.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient passed out at the pharmacy 5 minutes after administration. She remained unconcious for approximately 30-45 seconds then regained conciousness. Patient remained at the pharmacy for 30 minutes more due to dizziness. Called patient 2 days later and she is doing well with no side effects.
My arm started itching severely/my arm is still itching; My arm was blush red; No appetite; high temperature of 101.8F; chills; body aches; severe headache/ Mild headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA, DECREASED APPETITE, PRURITUS, PYREXIA, and CHILLS in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced DECREASED APPETITE, PYREXIA, CHILLS, MYALGIA, HEADACHE, and NAUSEA. On 30-Nov-2021, the patient experienced ERYTHEMA and PRURITUS. The patient was treated with PARACETAMOL at a dose of 500 milligram, 3 in 24hrs. At the time of the report, ERYTHEMA, DECREASED APPETITE, PRURITUS, PYREXIA, CHILLS, MYALGIA, and NAUSEA outcome was unknown and HEADACHE was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 29-Nov-2021, Body temperature: 101.8F (High).         The concomitant medications were not reported.   This case was linked to MOD-2021-403057, MOD-2021-403058 (Patient Link).
This spontaneous report was received from a nurse concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On unknown dates, when the patient was 26 years old, she was vaccinated with first and second GARDASIL 9 doses for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, when the patient was 27 years old,  she received the third dose of GARDASIL 9 lot number M035486 and expiration date of 05-JUN-2019, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.            No concomitant medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  No treatment information was reported.