chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had some redness, swelling and pain initially after injection but it was gone in two days.   However, Day 8 following injection I woke up with a bright red, itchy rash on my arm surrounding injection site.   It was about 3 inches.  It spread to my chest although not as red there.    If it hasn?t improved by Monday I will go see my dr
Itching and wheezing, which resolved with Benadryl.  Neurological effects after first shot:  unusual thought processes, weird sensation in head/brain, being jittery, difficulty concentrating (which may also have been related to Benadryl).  Neurological side effects abated a couple days after the first shot. Second shot caused milder wheezing and itching due to pre-treatment with Benadryl.  It is unknown at this time whether more neurological side effects will result from the second shot, which was only given 15 hours ago.
Patient stopped in a few days after vaccine given,  injection site had 3 reddish dots near injection site (dots appears horizontally to each other).  Also some other subdermal redness in area
Information has been received from a medical assistant concerning a 20 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 17-MAR-2009 was vaccinated with the first 0.5ml dose of GARDASIL IM. On 28-MAY-2009 the patient was vaccinated with the second 0.5ml dose of GARDASIL (lot# 0162Y) IM. Concomitant therapy included DIFLUCAN which was taken when the first dose of GARDASIL was given. On 07-JUN-2009, 10 days after the second vaccination, the patient developed a rash. The patient called the physician. There were no laboratory diagnostic studies performed. On an unspecified date, the patient recovered. Additional information has been requested.
11-year-old patient given adult dose of 0.3mL instead of 0.2mL. No signs or symptoms noted.
This spontaneous report as received from a nurse practitioner refers to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). On an unknown date the patient experienced swelling, redness and pain at the injection site and also experienced vomiting. It was not reported whether the patient  was sought medical attention. The outcome of the adverse events was reported as recovered/resolved on an unspecified date. Additional information has been requested.
she has covid is 70years old good health both covid shots and booster.; she has covid is 70years old good health both covid shots and booster.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program (005570).  A 70-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome unknown; IMMUNISATION (medically significant), outcome unknown, described as booster. The patient was informed she has covid, she was 70years old good health both covid shots and booster, with cold like symptoms and would to know if any treatment available to help recover and availability at this time.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial and follow-up information has been received from a pharmacist and a certified medical assistant, concerning a 70 year old male with hypertension, hypercholesterolaemia and not known drug allergy and a history of gastrooesophageal reflux disease and chickenpox in his childhood, who on 27-OCT-2008 at 9:00 a.m., was vaccinated with ZOSTAVAX, Lot number 662970/1207X, 0.65 mL, subcutaneously in back of the left arm. The certified medical assistant reported that concomitant therapy included ezetimibe (+) simvastatin (MSD), aspirin (ASA), AVAPRO and LOPRESSOR. The patient on unspecified dates, was also vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscularly into the deltoid and influenza virus vaccine (unspecified) (manufacturer unknown), 0.5 ml, intramuscularly into the deltoid. The pharmacist reported that the patient was diagnosed with zoster after receiving ZOSTAVAX. The patient was being treated with VALTREX 1 gram three times a day for 7 days. The certified medical assistant reported that the physician was interested in collecting and sending isolates for a VZVID analysis. The office scheduled a call on 05-NOV-2008. At the time of the report the patient had not recovered. The patient sought medical attention at office visit. In follow-up received on 05-Nov-2008, the physician reported he planned on asking the patient to return to the office and obtain a specimen. The physician did not further describe the status of the patient other than to report that the patient's rash which he felt was herpes zoster was on his forehead. In follow-up information, received from a questionnaire, the certified medical assistant reported that the event begun on 04-NOV-2008 and the rash did not occur at the site of injection post-vaccination. The pharmacist was not sure of a rash occurred at the site of injection post-vaccination. The patient had a dermatome C2 and the rash was located on his forehead into scalp. It was reported that the maximum patient's temperature was 98.6 degrees and the patient felt pain quantified as 4 (between 0 (least) and 10 (most)). The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 10-NOV-2008. The sample was taken from a vesicular lesion on the C2 dermatome. The results were: Inadequate specimen, negative for B-globin, no strain ID. In information received from the pharmacist on 20-NOV-2008, he considered the event to be an other important medical event. No further information is available.
pt presents to ED in respiratory failure; positive COVID test in ED; bilateral pulmonary infiltrates, toxic metabolic encephalopathy, UTI, sepsis; given convalescent plasma and Decadron; pt's condition worsened, needing intubation, pt and family refused intubation; pt's condition deteriorated, poor prognosis and he passed away in the hospital
On the late afternoon/evening of 6/08, father of this 2 yo female patient noticed a rash on her abdomen, chest and back, and small amount on arms. Rash was mildly pruritic. Patient had decreased appetite and vomited once. Father reports she may have had a low-grade temperature yesterday (not measured). No changes in stool. Father noted patient was not as playful and energetic as usual. He treated rash with diphenhydramine 2% topical cream which gave patient some relief. Appetite somewhat improved today. No further N/V. Rash has started to diminish. No swelling or difficulty breathing. Father is unaware of any recent exposure to new animals/household chemicals/fragrances/soaps or other new potential allergens. On Exam this morning (6/09), patient appears happy, playful, communicative, without itching. Skin: mild generalized rash on abdomen/chest and back - colorless slightly raised papules s/o erythema, barely visible. Face and extremities clear. Oral cavity/lips clear. No urticaria/hives. Lungs: CTA Heart: RRR Temp: NL.
2 days after FLUMIST, woke up with headache and left side face numbness, lasted 3-5 days. Went to Urgent Care & PCP, who treated for migraine with EXCEDRIN with relief.
severe idiosyncratic multi-symptom; rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair; Elevated liver enzymes; Scalp is itchy; long term delayed reaction; Lymph Nodes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair) and HEPATIC ENZYME INCREASED (Elevated liver enzymes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and BETAMETHASONE for an unknown indication.    On 11-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 IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom) (seriousness criterion medically significant), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair) (seriousness criterion medically significant), HEPATIC ENZYME INCREASED (Elevated liver enzymes) (seriousness criterion medically significant), PRURITUS (Scalp is itchy), SKIN REACTION (long term delayed reaction) and LYMPHADENOPATHY (Lymph Nodes are swollen). At the time of the report, IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair), HEPATIC ENZYME INCREASED (Elevated liver enzymes), PRURITUS (Scalp is itchy), SKIN REACTION (long term delayed reaction) and LYMPHADENOPATHY (Lymph Nodes are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   .Very limited information regarding these events have  been provided at this time.  Further information has been requested.
Dizziness, like vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness, like vertigo) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (Dizziness, like vertigo). At the time of the report, DIZZINESS (Dizziness, like vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used were Blood pressure medications. Treatment information includes Antibiotic.
Erythema, warmth, swelling at lower half of right upper arm appearing  around 24 hours after administration. ? if delivered into deltoid. Swelling 14x12cm.
Ear, neck was hurting; Ear, neck was hurting; Couldn't get face, neck comfortable; Swelling in left side of face from behind ear into jaw; Swelling into the mouth; Throat hurts little bit on left side; Little bump under left ear; Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Little bump under left ear), SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth), OROPHARYNGEAL PAIN (Throat hurts little bit on left side) and EAR PAIN (Ear, neck was hurting) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE/BENAZEPRIL) for Blood pressure.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the arm). On 19-Mar-2021, the patient experienced MASS (Little bump under left ear). On 20-Mar-2021, the patient experienced SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth) and OROPHARYNGEAL PAIN (Throat hurts little bit on left side). On 21-Mar-2021, the patient experienced EAR PAIN (Ear, neck was hurting), NECK PAIN (Ear, neck was hurting) and DISCOMFORT (Couldn't get face, neck comfortable). At the time of the report, MASS (Little bump under left ear), SWELLING FACE (Swelling in left side of face from behind ear into jaw), MOUTH SWELLING (Swelling into the mouth), OROPHARYNGEAL PAIN (Throat hurts little bit on left side), EAR PAIN (Ear, neck was hurting), NECK PAIN (Ear, neck was hurting), DISCOMFORT (Couldn't get face, neck comfortable) and VACCINATION SITE PAIN (Soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
SEVERAL SIDE EFFECTS; This spontaneous report received from a vaccine facility concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On 2021, the subject experienced several side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from several side effects. This report was non-serious.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was inadvertently administered a dose of VARIVAX (Merck) (injection) (strength, dose, route and lot number or batch number unspecified) instead of the intended ZOSTAVAX. No concomitant medication was reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Pt was stuck with an empty syringe and a slight bubble was injected.  Then the pharmacist realized that the syringe hadn't been filled yet and the volume she saw was air and not the clear vaccine.  The patient then received the vaccine.
Left sided facial paralysis, most notable when pt laughed, cried. Noticed 1/2 days to vaccine Rec'd. Lasted 2 weeks and resolved slowly was seen by DR and was given herbs for Immune support (per parent).
This spontaneous report as received from a registered nurse via the company representative refers to a 12 month old female patient, the child of the reporter. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route, lot number and expiration date were not reported). Other suspect therapies included M-M-R II (dose, route, lot number and expiration date was not reported) and unspecified hepatitis A vaccine. No concomitant medications or patient's medical history were reported. On an unknown date the child developed a chickenpox, consisting of varying patches on the body overall. No symptoms other than pustules were reported. The patient sought medical attention and was seen by the pediatrician. On an unknown date the patient recovered. The relatedness between the vaccination with VARIVAX (Merck), M-M-R II and the events of chickenpox and pustules was not reported. Additional information has been requested.
nausea; diarrhea; body aches; achiness all over; headache; chills; achiness all over, especially in joints; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (achiness all over), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Bacrtrim), Food allergy (filet of sole) and Latex allergy (slight latex sensitivity). Concomitant products included CALCIUM for Osteopenia, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), MONASCUS PURPUREUS (RED YEAST RICE), FISH OIL and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.   On 20-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 24-Mar-2021, the patient experienced PAIN (achiness all over), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (achiness all over, especially in joints). On 25-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nausea) and MYALGIA (body aches). On 26-Mar-2021, DIARRHOEA (diarrhea), NAUSEA (nausea) and MYALGIA (body aches) had resolved. At the time of the report, PAIN (achiness all over), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (achiness all over, especially in joints) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product also include allergy medication,Vitamins and Supplements.  Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information include paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May 2021 Reporter details, patient demographics, medical history, product details, concomitant products, events were updated.
pt recv vax; 9 days later, exp elev LDH, malaise and fatigue
Nurse apparently administered pfizer bivalent for kids instead of the regular pfizer for kids 5-11 yo. Initial series for the patient was 2 red. Notified Clinical MD Dr. regarding event per Dr. "no repeat dose but they need to be informed of the error, its not ideal since it was supposed to be a non-bivalent dose but its actually probably medically optimal since it has better coverage against the current variants. You still need to alert the parents but there is nothing at all they need to worry about. and the kid can still get a bivalent booster in 2 months if they desire him to. ".    Relayed Drs. message to parents, verbalized understanding.
Patient was in the hospital for pneumonia and developed Covid pneumonia and was transferred to the ICU where she went into cardiac arrest and passed.
At the injection sight located on the back of the upper L arm, there is a red lump the size of a small lime. It is tender, itchy & burns.
My sugar started running a little bit lower but not dangerous; I got the first shot it further gone down into the 110 which is where the warning and I kept going okay taking medicine working better; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 52-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 52 years) in Left Arm on 03Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history included ongoing stage 4 non-alcoholic cirrhosis of the liver, the patient was diagnosed with a stage 4 non-alcoholic cirrhosis of the liver and they were just about they put me on a transplant now that all sudden was now the stage 2 and ongoing brittle diabetic, the patient had from a last 3 years I became very brittle diabetic they have been trying all the medication. Concomitant medications included dapagliflozin propanediol monohydrate 10mg (FARXIGA) and semaglutide 1 mg (OZEMPIC) taken for an unspecified indication. It was reported that prior to taking the first vaccine the patient had been stable and was on to medication. The patient knew their sugar started running a little bit lower but not dangerous, so something they don't know if anyone else have had experiences with blood sugars with taking this vaccine or not, you know sometimes they say unintended things affects you to medication, so they figured was this worth calling let me know about this in case is having in people and maybe whatever if getting again. Before the patient had the vaccine their sugars were very out of control, they were 200 and they had the patient on medications and was maintaining like 150 all the time. So, the patient got the first shot it further gone down into the 110 which is where the warning and they kept going okay taking medicine working better. The patient underwent lab tests and procedures which included blood glucose decreased: hypoglycemia on an unspecified date. The seriousness of the event was reported as non-serious. The outcome of the events was unknown.   Follow up attempts are needed. Further information has been requested.
Information regarding PREVENAR 13 was received from a healthcare professional regarding a 24-month-old female patient who experienced a 3 inch red swollen circle at the injection site 30 minutes after injection and PREVENAR 13 not shaken immediately prior to administration. The patient received the first dose on 06-May-2010. On 06-May-2010 the patient experienced a 3 inch red swollen circle at the injection site 30 minutes after injection and PREVENAR 13 not shaken immediately prior to administration. The PREVENAR 13 was shaken when removed from the refrigerator but not immediately prior to administration. Following vaccination the mother took her child to have blood drawn in the same medical building and returned within 30 minutes to have the nurse check the injection site reaction. The area was marked and instructions were given for the mother to contact the office if fever or other problems developed. The mother had not contacted the office therefore, the outcome of these events is unknown and no additional information was available at the time of this report.
Redness, swelling, and soreness at injection site, also experienced chills night before.
Approx 30 hrs after receiving 2nd hep B vaccine, diarrhea, stomach cramp, took Gas x at home, 2 hrs later for vomiting, back pain. Approx 4 hrs after receiving injection went to outpt clinic, received an EKG and Maalox, belladana and lidocaine which helped decrease symptoms immediately. 20 hrs later denies pain or rx at injection site, no nausea, vomiting, diarrhea.
Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.
Began with fever of 101.8; Following day had large area of redness and swelling covering most of the outer aspect of my upper arm.