chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reb blotch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Reb blotch at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE RASH (Reb blotch at the injection site). At the time of the report, VACCINATION SITE RASH (Reb blotch at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.
Parent states the child had "vomiting, slight fever, and alot of bleeding". Grandmother called in on 8/11/09 to report.  Grandmother not sure if she will be taking the grandaughter to the hospital.
Information has been received from a licensed practical nurse concerning a female patient who was expose to GARDASIL (Lot not reported) on 02-JUN-2009 in utero. Concomitant therapy included WELLBUTRIN. It was reported that on 04-JAN-2010 at 34 weeks and 2 days of gestation, the patient born with an Apgar score of 9/9. The mother of the patient had a premature rupture of membrane and this forced a premature labor (WAES 0906USA01485). An ultrasound performed during pregnancy revealed a possible benign heart echogenic focus. No infections or illnesses were reported during pregnancy. No other medications were used during pregnancy. No further information is available.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 20-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 108 and 336 hours respectively. The lowest recorded  temperature -3 (-3 Celsius degrees). The highest recorded temperature was 59 (15 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
I had my first vaccine on 1/29/2021 without any reaction.  I had my second vaccine on 2/22/2021.  12 hours hours later I started having body aches and decreased urine output
asthma flare up; migraine (12 days); muscle pain; swollen forearms (also reported as "both arms woke up looking like popeye"); fatigue; heart palpitations; heavy feeling in chest; severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"); severe muscle spasms; entire body felt like been run over by a truck very painful to touch anywhere on my body; blood pressure kept spiking ("I have hypotension my normal blood pressure was 90/60"); This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot: EW0170), via an unspecified route of administration on the left arm on 14May2021 10:00 (at the age of 37-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included asthma, migraines, hypotension/ low blood pressure (patient's normal blood pressure was 90/60), allergy to sulfa drugs and latex allergy. The patient's concomitant medications were not reported. The patient previously took azithromycin and was allergic to it. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 14May2021 11:15, the patient had asthma flare up, migraine (12 days), muscle pain, swollen forearms (also reported as "both arms woke up looking like popeye"), fatigue, heart palpitations, heavy feeling in chest, severe overheating ("not able to control my body temperature went from feeling normal to sweating and really red and overheated even when at rest"), severe muscle spasms, entire body felt like been run over by a truck very painful to touch anywhere on my body, and blood pressure kept spiking ("I have hypotension my normal blood pressure was 90/60"). The adverse events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The patient was put on steroids which made the reactions worse. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
tingling in L arm radiating to  finger. Became lightheaded and felt BP rise. Symptoms began N 10 minutes after vaccination. ___BP 126/96 P=86 R=18
having sore arm at injection site after both Pfizer BioNTech Covid-19 vaccine doses; having sore arm at injection site after both Pfizer BioNTech Covid-19 vaccine doses; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "having sore arm at injection site after both Pfizer BioNTech Covid-19 vaccine doses". 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 certified medical assistant (C.M.A.) referring to a patient of unknown age. No relevant medical history or concurrent conditions were reported. On 23-NOV-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K005402, expiration date 07-NOV-2015; dose and route not reported). No adverse effects were reported. Additional information has been requested.
Red and swollen around injection site. Formed blister that popped and scabbed over. Patient applying Melaluca oil.
swelling, redness & pain on local area assoc to limp; (area affected-4" x 3");
bitter taste; dry mouth; lost my sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost my sense of taste), DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028W2W and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to benedryl), Penicillin allergy, Hypertension since 2004, Depression (mild) since 1996, Macular degeneration since 2018, Restless leg syndrome since 2002, Arthritis since 2017, Insomnia since 2008, Prediabetes since 2004 and Allergic reaction to analgesics (Allergic to codeine). Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) from 2019 to an unknown date for Age-related macular degeneration, CELECOXIB (CELEBREX) from 2020 to an unknown date for Arthritis, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 2004 to an unknown date for Depression, BENAZEPRIL from 2004 to an unknown date for Hypertension, ROPINIROLE HYDROCHLORIDE (ROPINOL) from 2019 to an unknown date for Restless leg syndrome.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AGEUSIA (lost my sense of taste). On an unknown date, the patient experienced DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth). At the time of the report, AGEUSIA (lost my sense of taste), DYSGEUSIA (bitter taste) and DRY MOUTH (dry mouth) had not resolved.            No treatment information was reported. Patient started chewing a lot of gum and keeping mints.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: significant follow-up. Medical history added and start dates updated.Start dates of concomitant medications updated. Ageusis, event start date and causality were updated. Dry mouth was added as an event.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "degenerative disc disease of cervical and lumbar spine" (unspecified if ongoing), notes: degenerative disc disease of cervical and lumbar spine; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid from 24Dec2022 to 28Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
her is that she reported right away the reaction to the first shot to her provider; then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things; couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain; couldn't even use it; crying; Caller states that what she got was nausea; she states she was throwing up; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it) and CRYING (crying) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it), CRYING (crying), NAUSEA (Caller states that what she got was nausea) and VOMITING (she states she was throwing up). At the time of the report, VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it) and CRYING (crying) outcome was unknown and NAUSEA (Caller states that what she got was nausea) and VOMITING (she states she was throwing up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  Patient received some muscle relaxer pills, nausea and vomiting medications.   This case was linked to MOD-2021-425442 (Patient Link).
Patient brought into office. Father concerned about arm. States red around shot area and slight fever. Patient states no pain.
Portal hypertension; Inappropriate schedule of product administration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PORTAL HYPERTENSION (Portal hypertension) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Liver cirrhosis (Patient had liver cirrhosis since 8 years.), Diabetes mellitus, Portal hypertension, BPH, Hyperlipidemia and Kidney disorder. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for BPH, INSULIN for Diabetes mellitus, SIMVASTATIN for Hyperlipidemia, FUROSEMIDE (LASILIX [FUROSEMIDE]) for Portal hypertension, POTASSIUM for Renal disorder.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 08-Apr-2021, the patient experienced PORTAL HYPERTENSION (Portal hypertension) (seriousness criterion hospitalization). The patient was hospitalized from 08-Apr-2021 to 24-Apr-2021 due to PORTAL HYPERTENSION. On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, PORTAL HYPERTENSION (Portal hypertension) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient missed his second dose of Moderna Covid -19 vaccine, which was scheduled on 15-April-2021. It had been 42 days passed since his first dose of vaccine. No treatment information was provided by the reporter.  Company comment: This report refers to a case of  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 027A21A  with associated interval hospitalization for portal hypertension. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The portal hypertension is a cofounder; Sender's Comments: This report refers to a case of  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 027A21A  with associated interval hospitalization for portal hypertension. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The portal hypertension is a cofounder
09Jun89 pt given L-tryptophan a+ ex muscle aches.  04Aug89 pt vax w/ 3rd hepta B; sx worsened + was hospitalized w/ hypersensitivity reaction.  Eosinophils high + IgE high. Dx eosinophilia-myalgia synd secondary to tryptophan.
Rash at injection site; Reddish at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Reddish at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 041l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Reddish at injection site). At the time of the report, VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Reddish at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-369040, MOD-2021-010081 (Patient Link).
Rt arm had a 3" X 5" size reaction, red, warm to touch and raised to area Tetanus shot given in. Started nickel size and Saturday increased. Took Benadryl Saturday and Sunday one tablet q 6 hrs for 8 doses. Today 5/31, has orange side slightly red area with dime size bumps at injection site. Temp 99.6 Sat 5/27.
pt recv vax 18AUG97 & w/in 1hr p/vax pt exp warmth & flushing over neck & trunk both front & back, followed by itching approx 2hr later;seen by MD in ER tx w/med;
SEVERE HEADACHE; TOES STARTED TO TURN PURPLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: granulomatosis with polyangiitis, and other pre-existing medical conditions included: The patient had not tested positive for Covid and had no Covid symptoms. The patient experienced leukocytoclastic vasculitis and petechia all over lower half of body when treated with influenza vaccine.  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 17-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-OCT-2021, the patient experienced toes started to turn purple. On an unspecified date, the patient experienced severe headache. Laboratory data (dates unspecified) included: SARS-CoV-2 IgG antibody test (NR: not provided) 492.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, and the outcome of toes started to turn purple was not reported. This report was non-serious.
Day 1 (evening): soreness in arm radiating to back and neck, accompanied by waves of light nausea, resolved itself after about two hours. Low-grade headache continued to bedtime w/no appetite. Day 2: Low grade headache and lightheadedness. Light nausea only after eating. Resolved by dinner. Day 3: Some lingering fatigue, but symptoms mostly resolved.
Left arm red 3 inches diameters warm to touch. Noted this am sterile abscess per doctors. Seen 9/28/06
Patient has rt  lower lobe Pulmonary emboli and rt popliteal dvt
Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old male patient who experienced rash from head to toe diagnosed as contact dermatitis. The patient received the second dose on 05-Sep-2008. The patient also received the second dose of DAPTACEL (Aventis-Pasteur), the second dose of Polio-Vaccine (Not Specified), the second dose of Hib (manufacturer unknown) and the second dose of ROTATEQ (Merck & Co Inc) on 05-Sep-2008. The patient experienced rash from head to toe on 10-Sep-2008. On 15-Sep-2008, the patient was seen by the physician who diagnosed as contact dermatitis. Treatment included ORAPRED. The patient is recovering. Se related case(s): US-WYE-H06036008 (adverse event, non-expedited). No additional information was available at the time of this report.
joint pain; headache; dizziness; Patient is weak; lost appetite; A spontaneous report was received from a consumer concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events joint pain, headache, dizziness, patient is weak and lost appetite.  The patient's medical history was not provided. Concomitant medications reported were Tylenol for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced joint pain (Arthralgia), headache, dizziness, patient is weak (Asthenia), lost appetite (decreased appetite).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  was unknown.
I started feeling a stiff/sore neck around 1:30am after receiving my second shot. When I woke up in the morning around 8:00am my neck continued to be stiff and sore throughout the day. Also, it felt like the lymph node in my right armpit was inflamed. I was taking Tylenol about every 4-6 hours. When I woke up the following day (Sunday, May 23rd) the stiffness had gone away, my neck was still a little sore but definitely better.
no adverse event; administerd vaccines experienced temperature excursion; This spontaneous report was received from a registered nurse referring to a 33 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-OCT-2019, the patient was vaccinated with an improperly stored dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot R036582 expiring on 02-JAN-2021, for prophylaxis  (dose, route of administration, lot number and expiration date were not reported).   The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) experienced temperature excursion of unknown degrees Celsius for a total of 96hours, as recorded by a data logger, on several days between 28-SEP-2019-19-OCT-2019.   On 06-NOV-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # S000132 expiring on 17-DEC-2020, for prophylaxis  (dose, route of administration, lot number and expiration date were not reported).   The administered dose of varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursion of unknown degrees Celsius for a total of 192hours, as recorded by a data logger, on several days between 28-SEP-2019-03-NOV-2019.   The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
1. severe local reaction at injection site including induration, erythema, pain, edema 2. DVT