chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 013A21A and 010M20A) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. No concomitant drug information was provided. It was reported that patient had headache with all the previous Moderna doses. No treatment drug information was provided. This case was linked to MOD-2022-662834 (Patient Link).
Pt had an incidental finding of COVID positivity on 10/1 prior to a procedure on 10/8.  He came to the hospital on 10/7 with cough and mild sputum production, but developed sepsis secondary to COVID pneumonia with superimposed bacterial infection.
This spontaneous report as received from a medical assistant refers to a 10 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 13-JUN-2014 the patient was vaccinated with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # H020002, expiry date: 08-AUG-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Some pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some pain in the arm) 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 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Some pain in the arm). At the time of the report, PAIN IN EXTREMITY (Some pain in the arm) outcome was unknown.            No treatment information was provided.     No relevant concomitant medications were reported. Action taken with mRNA -123 is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 13 month old female with an amoxicillin allergy (drug rash) who on approx. 10/20/00 was vaccinated with a 1st dose of MMRII, in the left leg. The pt's mother reported on 11/3/00 that "recently", the child's left leg was red and had an abscess formation. The pt sought unspecified medical attention. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008347.
Large rash at shot site - over a week after first shot given.  Major itching of torso, head, feet.  Hair on head is falling out at a rapid pace.  I am at almost 3 weeks after the first shot and still itching and still losing my hair.
Site: Swelling at Injection Site-Mild, Systemic: Nodule-Mild, Additional Details: got nodule right after administation, put ice at it at the phramacy, talked to patient same day at 5:30, all good, no worse or better but feeling fine
This spontaneous report was received from the patient's wife referring to her husband, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 03-MAR-2017, the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2017, after receiving PNEUMOVAX23, the patient had unspecified adverse effects (adverse event). The outcome of the adverse events was unknown. The causality between the adverse events and PNEUMOVAX23 was not provided. Additional information is not expected because no consent for follow up was provided.
HEART ISSUES; This spontaneous report received from a patient via a company representative concerned a female 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 prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced heart issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issues was not reported. This report was non-serious. This case, from the same reporter .
Information has been recevied from a health professional concerning a 42 month old amish male with no medical HX and no allergies who on 07/23/2004 was vaccinated SQ in the LL with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. there were no concomitant medication. It was reported that the family was exposed to varicella on  11/25/2004. The pt broke out with about 8 vesicles in mid december there were no lab tests or relevant diagnostic date. Subsequently the pt recovered. Additional infomation is not expected.
Pt at 1014 called RN observer over and stated that she felt like she was going to have a seizure. Pt explained that she has Focal Aware seizures and only has L arm tremors. Pt's L arm was tremoring Pt had seizure from 1015-1016. Pt was moved to triage and VS @1019 were 98.6, Hr 93, RR 20, BP 110/76, and sao2 of 98%. Pt was feeling nauseated at 1023 and self medicated with Zofran 8mg po. Pt called FM to come pick her up. Pt C/O headache and felt another seizure starting and took Ativan 1mg po @ 1039. VS at 1043 were 99.6, Hr 92, RR 20, BP 134/92, and sao2 99%. Pt had another seizure @1044 with L arm tremors lasting 1 min. Rapid response team called. Pt transported to ER at 1053
Patient stated that 3 days after receiving her vaccine, she developed a rash that started on her hands and has since spread to her arms, shoulder, neck, and now back. Patient reports that the rash "looks similar to hives" and is extremely itchy. Patient is unable to get Benadryl to take due to not having transportation.  Advised patient to see her PCP for rash, patient is to try to get a ride for a doctor's appointment.
COVID Arm (rash and lump at injection site) started on Day 8 after injection  Swollen & Painful Lymph Nodes on left side of body. Most effected are the nodes in arm out and collar bone. This started 4 days after injection.
She didn't get the second shot; Viral Syndrome; Cough; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral Syndrome), COUGH (Cough) and PRODUCT DOSE OMISSION ISSUE (She didn't get the second shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The medical history was not reported by the reporter.  Concomitant products included ZIPRASIDONE, RISPERIDONE, ARIPIPRAZOLE (ABILIFY) and METOPROLOL for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VIRAL INFECTION (Viral Syndrome) and COUGH (Cough). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She didn't get the second shot). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (ROBITUSSIN DM COUGH CONTROL) for Cough, at a dose of 1 dosage form. At the time of the report, VIRAL INFECTION (Viral Syndrome), COUGH (Cough) and PRODUCT DOSE OMISSION ISSUE (She didn't get the second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Initial additional significant Follow-up received on 28 July 2021 included Adverse Event  out come updated and patient didn't get the second shot.
Inappropriate schedule of product administration; Generalized aching; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) in a 54-year-old female patient 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.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (Generalized aching) and PYREXIA (Fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). At the time of the report, PAIN (Generalized aching), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna were missed to be booked-in.
Felt hot, like a hot flash, lasting about 3 or 4 minutes on 4 different occasions before midnight.  No treatment, but did take 2 Ibuprofen 200mg with supper after getting the shot. I have had no ill effects since the vaccine.
No adverse effect reported yet.  I had intended to administer varicella vaccine, but gave IPV instead. Polio was not due yet:  recommended 4th dose 3/19/24, but minimum valid date is 4/6/21, so unlikely that this will significantly interfere with child's immunization schedule. We are working to obtain varicella vaccine as child is overdue (has not had any varicella vaccine). Challenge in this remote location is the short shelf life of the vaccine.
Baby was noted to have temperature in the AM after vaccination.  Temp at that time was around 103.  Temp spiked to 105F on Wednesday, 2/16/11 and baby was seen in ER.  CXR and urinalyisis were negative.  Mom is alternating acetaminophen and ibuprofen every 3 hours and reports that fever remains at 103 or above at 9AM on 2/18/11.
It was reported that a 72 year old female received the Fluzone WV '99-'00 vaccination. Reportedly, several hours, post vax, the pt developed a rash over her entire body and extremities. She also had itching.
Pt describes immediate pain down to bone at injection site. Pain continued, "difficult to lift arm". Yesterday woke with continuous sheet of erythema, edema, heat extending 2/3 of upper left arm. Pt denies fever. No additional portals of entry noted on left arm. Pt to see her private MD today and will report back Tx to health dept.
Around midnight my arm started itching at the injection site.  I looked and it was red and warm like on the first day or two of the injection.  I looked on-line and it said it was COVID-arm.  So far no other symptoms.  It has been 9 days since I had the first dose.
Information was received from a physician concerning a 42 year old female with asthma and no allergies who in 2004 was vaccinated with two doses of Varicella virus vaccines live.  There was no concomitant medication, the patient was not on any medications for her asthma.  Subsequently the patient failed to seroconvert.  Two antibody tests were taklen; one test one month after the second dose in 2004 and one month ago in approximately FEB 2005.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to reort (s) previously submitted on 5/16/2005. Information has been received from a physician concerning a 42 year old female with asthma and no allergies who in 2004 was vaccinated with two doses of ZOSTAVAX (Merck). There was no concomitant medication; the patient was not on any medication for her asthma. Subsequently the patient failed to seroconvert. Two antibody tests were taken; one test one month after the second dose in 2004 and one month ago in approximately February 2005. Unspecified medical attention was sought. There was no product quality complaint involved. Follow-up information from the physician indicated tht the patient was not vaccinated at her office and she did not have the lot numer or any other specifics. The physician reported that she followed up with the patient and offered to revaccinate them with VARIVAX (Merck), but the patient declined. No further information is available.
(R) upper deltoid erythematous arm with swelling and tenderness assessed cellulitis (R) deltoid. KEFLEX 250mg p.o. q 6 hr x 10 day / 3 day after shot.
severe diarrhea; could not eat and that lasted 2 days; dizziness; stomach issues; second dose was nasty; temperature of 101.6; queasy; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), EATING DISORDER (could not eat and that lasted 2 days), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (stomach issues) and FEELING ABNORMAL (second dose was nasty) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), cetrizine hydrochloride, BUSPIRONE HYDROCHLORIDE (BUSPAR), VALPROATE SEMISODIUM (DEPAKOTE ER), ESCITALOPRAM, EZETIMIBE, IRON, ISOSORBIDE, METFORMIN, Montelukest sodium, NALTREXONE, ROSUVASTATIN, TRAZODONE, TOPIRAMATE (TOPAMAX), PANTOPRAZOLE, ALUMINIUM HYDROXIDE, BISMUTH HYDROXIDE, MAGNESIUM HYDROXIDE, SILICA GEL, SODIUM HYDROXIDE (TRISIBAM), INSULIN LISPRO (HUMALOG) and ALIROCUMAB (PRALUENT) for an unknown indication, MULTIVITAMIN & MINERAL.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced DIARRHOEA (severe diarrhea), EATING DISORDER (could not eat and that lasted 2 days), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (stomach issues), FEELING ABNORMAL (second dose was nasty), PYREXIA (temperature of 101.6), NAUSEA (queasy) and VOMITING (vomiting). At the time of the report, DIARRHOEA (severe diarrhea), PYREXIA (temperature of 101.6) and VOMITING (vomiting) had resolved, EATING DISORDER (could not eat and that lasted 2 days), FEELING ABNORMAL (second dose was nasty) and NAUSEA (queasy) outcome was unknown and DIZZINESS (dizziness) and ABDOMINAL DISCOMFORT (stomach issues) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication include Zofran and Tylenol.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
SOB AND FELT LIKE THROAT WAS CLOSING-REDNESS AND PAIN AT INJECTION SITE.
Around dinner time patient started feeling soreness in his arm that was sensitive to temp and touch (day of vaccination). Next day patient's arm get worse with pain radiating all the way down hi arm. Also experienced nausea and terrible muscle pains. No treatment needed. Patient recovered after 1-2 days.
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA223710, 2018SA223733, 2018SA220766, 2018SA220773, 2018SA220774 and 2018SA218532 (same reporter). This case involves 5 year old (5 year 8 months) patient of an unknown demographics who received a dose of DAPTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. 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. Documents held by sender: none.
10:20am- patient c/o itching,burning sensation on bilateral upper arms.  Pt severely allergic as above, including dogs.  Service dog entered OBS tent after patient reported above, decision made to move her outside to fresh air.  I administered 25 mg Benadryl PO liquid for symptoms as described.  Patient traveled today with mother driving.  Patient left area with mother feeling well, denied worsening complaints.  cold packs applied to right ear (redness noted, c/o itching) Patient denied SOB, chest pain, difficulty with gait.  Discussed consult with allergist prior to second dose for medication and management recommendations.  Patient left with mother at 10:45am feeling well, ambulating normally. NP
pt recvd 1st dose of Hep B vax 03DEC90 or 04DEC90 & devel swelling of lips & urticaria.
Extreme fatigue; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the left arm on 14Jan2021 (14:00) at a single dose for COVID-19 immunization at the urgent care center. Medical history included sulfa allergy. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 15Jan2021, the morning after the vaccination, the patient had extreme fatigue. The patient did not receive any treatment for the reported event. The outcome of the event, extreme fatigue, was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
reddened fifty cent piece sized hard area noted @ site of inject w/in 2 days of vax;
This spontaneous report was received from a back office lead and refers to a 18 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # and expiration date was not reported) 1 ml, intramuscularly, into a left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.