chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician by phone. This case is linked to cases 2019SA082205, 2019SA082208, 2019SA082209 and 2019SA082211 (same reporter). This case involves a 2 months old female patient who experienced red swollen thigh, painful to touch, site reaction, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 and ROTATEQ on an unknown date. On 15-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AA. On an unknown date, the patient developed a non-serious red swollen thigh, painful to touch, site reaction following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. No lab data was reported. Final diagnosis was red swollen thigh, painful to touch, site reaction. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by the sender: none.
Exhaustion; Very sore; Swollen arm; Foggy brain; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 04Mar2021 at 16:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included major depressive disorder, anxiety, high cholesterol and glaucoma. The patient previously received erythromycin (E-MYCIN), tetracycline hydrochloride (SUMYCIN), quinine sulfate (QUININE) and trazodone hydrochloride (DEPRAX) and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID -19.Concomitant medications included fluoxetine hydrochloride (PROZAC), simvastatin (MANUFACTURER UNKNOWN), calcium levomefolate (DEPLIN) and latanoprost (MANUFACTURER UNKNOWN); all for an unknown indication, from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. On 05Mar2021 at 12:00, the patient experienced exhaustion, very sore, swollen arm, and foggy brain. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events exhaustion, very sore, swollen arm and foggy brain was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother states pt developed small area of redness and warmth at site of varicella immunization at left thigh noted evening of 5/3/05. Area was dime sized. Pt was afebrile with cough, cold symptoms, no distress. On evening of 5/4/05 pt noted to have large area of redness, induration at site. Pt seen 5/5/05 in clinic with area of redness, some warmth and some erythema at Left leg injection site measuring 5cm x 6cm. Skin  within this region had five papular rash (faint). Pt was in no respiratory distress, remained febrile. And had not other lesions or rashes. At the time of the visit he continued on Omnicef for his otitis media.  Impression: local delayed hypersensitivity reaction at site of varicella vaccination site, suspect Gelatin or Neomycin as sensitizing agent. Mother to observe for worsening sxs. F/U by phone done 5/6/05. Clinic F/U of reassessment of exam in 2 wks to conicide with ear check.
Patient began to run fever and have chills on the evening 06/16/2018. Patient right arm began to swell and become red.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain  of adverse event.This is administrative error  without adverse event.
Severe bodyaches ,nausea vomiting, headache, left arm pain, chills fever
Some of the dose dripped on the arm; Some of the dose dripped on the arm; A spontaneous report was received from a consumer, concerning herself, a 68-year-old, female patient, who received Moderna's COVD-19 vaccine (mRNA-1273) and reported  that some of the dose dripped on her arm(underdose, device connection issue).  The patient's medical history included Allergic to lisinopril. Concomitant product use was not provided by the reporter.  On 24-Feb-2021, prior to the onset of events, the patient received her first of the two planned vaccine doses of mRNA-1273 (batch number unknown) for COVID-19 infection prophylaxis.  On 27-Mar-2021, patient received the second of the two planned vaccine doses of mRNA-1273 (batch number 003B21A) via unknown route on her right arm for COVID-19 infection prophylaxis.   On the same day, she reported that some of the dose dripped on her right arm while the dose was administered. No treatment medication was reported.  Action taken with mRNA 1273 in response to the event was not applicable.  The outcome of the event, some of the dose dripped on her arm, was considered resolved.; Reporter's Comments: This report refers to a case of Underdose and Device connection issue, for mRNA-1273, lot #: 003B21A,  with no associated AEs.
Information has been received from a nurse concerning a female patient who was vaccinated IM with Gardasil. Subsequently two to three days after the patient was vaccinated, she experienced a headache and sweating. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
This spontaneous report as received from a Registered Nurse to a patient of unknown age. The nurse reported that "the patient was administered the first dose of GARDASIL (0.5mL, intramuscular, lot# was unknown) on 23-NOV-2009. The second dose of GARDASIL (0.5mL, intramuscular, lot # was unknown) on 21-DEC-2009, and the third dose of GARDASIL (0.5mL, intramuscular, lot# was unknown)on 22-APR-2010". No adverse event was reported. Additional information is not expected.
Patient fainted and fell on the floor and hit his head approximately 3 minutes after he received his covid vaccine.  Patient stated he was feeling dizzy and nauseous.
arm pain on the side of the injection; tiredness; headache; muscle pain; chills; joint pain; fever; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Feb2021 (35-yeras age at the time of vaccination) as SECOND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 on an unknown date for COVID-19 immunisation. The patient experienced arm pain on the side of the injection, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell on an unspecified date in Jun2021. He asked if it was a severe risk if someone was afflicted by regular pain on the body after the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2nd dose not given in recommended time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant Medications were reported. No Treatment Information Provided.
Eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030m20a and 031a21a) for COVID-19 vaccination.     The patient's past medical history included Eczema (Patient had eczema in his childhood but it went away The eczema came back when the patient was given "several shots" 50 years ago.). Concomitant products included OMEPRAZOLE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ECZEMA (Eczema). At the time of the report, ECZEMA (Eczema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included a cream to help with the itchiness and a steroid shot 1 hour after the second dose.
Pityrasis rosea - appeared in June, diagnosed in August,  sun exposure recommended treatment, . left side only-thigh and groin, fading slowly Eczema- worsened, cortisone, eucrista, still worsening, debilitating at times Skin cancer- appeared in July, diagnosed in September, treated in September with surgery. scarred, will take 6 mos to year to fully heal, incapicitated during surgery. Permanent scarring probable on face.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received SHINGRIX. Concomitant products included magnesium. On 10th April 2018, the patient received SHINGRIX. On 10th April 2018, less than a day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving. The reporter considered the rash to be probably related to SHINGRIX. Additional information was received as follows: The patient reported that she started to feel the onset of the rash at bedtime the day of the vaccination. In the next morning, the rash was presented on the back of her legs, trunk and little on both shoulders. It was more pronounced on the trunk and legs than the shoulders. The patient took Multivitamins.
WOKE UP 2 DAYS AFTER 2ND VACCINE DOSE WITH VERY DRY MOUTH, SORE THROAT, FRONTAL H/A, BILATERAL FOREARM RASH AND SWOLLEN RED TONGUE WITH WHITE SPOTS - ABLE TO SWALLOW AND BREATH
Initial and follow-up information has been received from a licensed practical nurse concerning a 24 year old female with no known drug allergies, who was vaccinated with a second dose of Gardasil. On 01-AUG-2007, the patient's menstrual cycle was heavier and longer than normal. A urine pregnancy test was performed before the vaccination, and the patient was not pregnant. Unspecified medical attention was sought. The "patient refused follow-up appointment and/or testing." At the time of the report the patient's menstrual cycle returned to normal at the next cycle. Subsequently, the patient recovered. Additional information is not expected.
MIGRAINE HEADACHE; CHILLS; NOT FEELING GOOD; FEVER; BONES ACHE; DIFFICULTY SLEEPING; This spontaneous report received from a consumer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and gall bladder disorder, and concurrent conditions included migraine, and cigarette smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced bones ache. On 10-APR-2021, the subject experienced migraine headache. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced not feeling good. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 10-APR-2021 10:00, Laboratory data included: Body temperature (NR: not provided) 99.4 F. On an unspecified date, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, bones ache, migraine headache, and chills, and the outcome of not feeling good and difficulty sleeping was not reported. This report was non-serious.
Burning sensation throughout entire length of spine then severe lower back pain and neck pain, headache. Within 24 hours I had a fever of 102.8 degrees F and had chills, legs hurt and could hardly walk. Was unable to move left arm on its own. Reached out to primary doctor after a week and symptoms did not improve. Was prescribed Prednisone for treatment and told to seek consult from my Rheumatologist.  Called doctor office again on Tuesday, January 11, 2022 because symptoms spinal pain has not gone away. Started getting numbness and tingling feeling in left fingers and left leg. Went to Emergency Room on January 11, 2022 because I almost passed out.
Received FLUZONE vaccine at 1100 hours 10/18/11. When needle inserted by R.N. felt muscle twitch/jump. Patient stated "It felt like a pop, like when inserting an IV & you feel vein pop". 23 gauge 1" needle used. (No blood on aspiration noted). 2-3 pm on 10/18/11 started feeling "zingers", tingling into neck, shoulder, wrist, elbow (R) arm. Arm feels heavy. Saw M.D. Given Tramadol.
sore injection site right arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site right arm) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site right arm) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (sore injection site right arm) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. no treatment was reported.   This case was linked to MOD-2021-367384, MOD-2021-367385 (Patient Link).
mild headache 10 hrs after 2nd dose; malaise in the morning, the day after 2nd vaccine administration; took tylenol and felt normal within an hour
Experienced hives in arms, hands and legs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Experienced hives in arms, hands and legs) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and ADHD. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for Anxiety, LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced URTICARIA (Experienced hives in arms, hands and legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 01-Aug-2021 for Hives, at a dose of 1 dosage form. On 01-Aug-2021, URTICARIA (Experienced hives in arms, hands and legs) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.
headache, nausea, body aches, low grade temp.,congestion, graspy thorat, and cough. No treatment yet, waiting for my MD's office to open. Reported to my employee health nurse.
Redness, rash, itch on arm near injection site developed almost 2 weeks after vaccination
Had vaccine at 9 am 02/0821.  Today at 3:00 pm noted to have temp of 100.4 and generalized malaise.  Denies other complaints. Instructed to take  medication to reduce temp, take fluids, rest, retake temp in 4 hours notify MD if temp increases or symptoms worsen.
Can nausea be a side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Can nausea be a side effect) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (Can nausea be a side effect). At the time of the report, NAUSEA (Can nausea be a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Pain at site within 1/2 hour and then tingling down arm started an hour -2 later, extremely sore.
Pt recv vax on 2/16/99; on 2/25/99 pt exp fever (104.9F), rash resembling measles, conjunctivitis
Pain and swelling at injection site, temp of 102 degrees F, sweating, nausea and rigors day after vaccine administered.
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of GARDASIL 9 lot # L020015, exp. 16-AUG-2017 and L019297, exp. 18-AUG-2017 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
itchiness at the bottom of her feet, palms and it is spreading to ankle, and one finger; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness at the bottom of her feet, palms and it is spreading to ankle, and one finger) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided. .     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (itchiness at the bottom of her feet, palms and it is spreading to ankle, and one finger). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form and OATMEAL (topical) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PRURITUS (itchiness at the bottom of her feet, palms and it is spreading to ankle, and one finger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient is also using ice as treatment for the event.
Pain and change of menstrual. Received phyizer booster and had extreme debilitating pain and menstrual cycle began immediately...one week early.
PATIENT EXPERIENCE BLURRED VISION AND LIGHT HEADEDNESS IMMEDIATLEY AFTER VACCINATION.  A WEEK FOLLOWING DURING PATIENT MENSES SHE EXPERIENCED EXTREMELY HEAVY AND UNUSUAL BLEEDING.
rash all over body -arms, legs, back and scalp; dry skin; intense itching and redness; intense itching and redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash all over body -arms, legs, back and scalp), DRY SKIN (dry skin), PRURITUS (intense itching and redness) and ERYTHEMA (intense itching and redness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash all over body -arms, legs, back and scalp), DRY SKIN (dry skin), PRURITUS (intense itching and redness) and ERYTHEMA (intense itching and redness). At the time of the report, RASH (rash all over body -arms, legs, back and scalp), DRY SKIN (dry skin), PRURITUS (intense itching and redness) and ERYTHEMA (intense itching and redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   1st week in April saw dermatologist - said use dry skin cream for treatment
not getting high enough and requiring boosting as they get sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "not getting high enough and requiring boosting as they get sick".  Additional information: Some kids [5 over the last few years] not getting high enough and requiring boosting as they get sick.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300092588 same drug and event with different patient.;