chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on Right Hand; Initial Report Received on 11-Jul-2019 and 25-Jul-2019  A pharmacist from the US reported that a 37-year-old female patient (race unknown) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed a rash on her right hand.  Relevant medical history and concomitant medications were not provided.  On 10-Jul-2019, the patient received the first injection of HEPLISAV-B (unknown site) from a pre-filled syringe (lot # 933094, expiration date 17-Apr-2021, and NDC # unknown). The vaccine was administered by the supervisor of the reporting pharmacist at their pharmacy. The patient developed a rash on her right hand that resolved. The patient had no other adverse reactions and was "okay" at the time of this report.   On 11-Jul-2019, the patient called the pharmacy and reported the above adverse event. The pharmacist was advised to refer the patient to her doctor for any further determination of future injections. The pharmacist stated the patient has an appointment in 2 weeks already.   On 25-Jul-2019, the pharmacist reported that the patient has an appointment scheduled in 1-2 weeks with her physician to obtain a titer result. At the time of this report, a second dose of HEPLISAV-B had not been administered yet.   At the time of this report, the event of rash on right hand was considered resolved.    The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of rash as non-serious. The event of rash is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of rash as non-serious. The event of rash is unlisted per HEPLISAV-B USPI.
HYPOTENSION HYPOXIA 11/17/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Redness size 5 x 4, itching, swelling, no fever. Mother stated child's arm done the same thing last yr. after the flu shot that was given elsewhere.
local rxn wheal 1 1/2 x 3/4 cm @ inject site; rxn w/ice pack x 15mins; no inc in size in time frame; no systemic reactions apparent; local reaction to MMR inject;
Starting the day after the injection patient experienced extreme tenderness and 3 inch diameter red circle and swelling at the injection site. I advised her to see PCP, which she did the next day. PCP diagnosed a skin infection and prescribed SMZ-TMP DS, 1 tablet bid for 10 days. By 3 days after the injection there was some improvement.
rash at the injection site; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site rash (Verbatim: rash at the injection site).  The outcome of the injection site rash was not reported.   It was unknown if the reporter considered the injection site rash to be related to Arexvy.     It was unknown if the company considered the injection site rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-SEP-2023 The follow up would not possible as no contact details were available.
Lemon-size lump palpable and visible in left armpit; Although retained full range of motion in left arm/shoulder, area was tender and sore.; Although I retained full range of motion in left arm/shoulder, area was tender and sore.; Lemon-size lump palpable and visible in left armpit. Although lymphatic reactions know side effect, as a 2-yr breast cancer survivor, a lump was alarming; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine, gastroesophageal reflux disease, breast cancer, lymphedema (Stage 0), lumpectomy and radiation therapy on an unknown date in 2019, pituitary macroadenoma, herpes simplex type I/II. The patient had known allergies to shell fish (crustaceans), sulfonamide allergy, environmental allergy and fruit allergy (tomatoes). The patient receives unspecified medications in two weeks of vaccination. The patient previously took prednisone and codeine; both on unknown dates for unspecified indications and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 05Mar2021 at 15:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 19:00, approx. 36 hours following shot, the patient experienced lemon-size lump palpable and visible in left armpit, although lymphatic reactions know side effect, as a 2-year breast cancer survivor, a lump was alarming. Although the patient retained full range of motion in left arm/shoulder, area was tender and sore. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included physical therapy and lymphatic massage over a two-week period that eased the concern. On 01Apr2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab) and the result was negative. The clinical outcome of the events lemon-size lump palpable and visible in left armpit, although lymphatic reactions know side effect, as a 2-year breast cancer survivor, a lump was alarming, retained full range of motion in left arm/shoulder, area was tender and sore were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
woke up from sleep with stomachache, which spread and stayed inribs, both sides, front, in the middle ofthe rib cage.; woke up from sleep with stomachache, which spread and stayed in ribs, both sides, front, in the middle ofthe rib cage.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 11:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), atorvastatin (LIPITOR), acyclovir (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and aspirin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 04:00, the following night (36 hours post shot), the patient woke up from sleep with stomach ache, which spread and stayed in ribs. Ache in both sides, front, in the middle of the rib cage. It got better in the morning and started up in the next night, but less severe. The pain was diffuse and strong. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events woke up from sleep with stomach ache, which spread and stayed in ribs, both sides, front, in the middle of the rib cage was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
sore left arm shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-461858, MOD-2022-461877 (Patient Link).   Reporter did not allow further contact
Left arm pain continued following vaccine. Pt spoke with MD 7/5/16, instructed to use ASPERCREME and deep massage and expect resolution within a week. 10/18/16 message from pt stating pain is less but still aches all of the time. Pt will see primary care provided and may seek physical therapy.
On 6-11, 2022, I started having a tickle in my throat with slight cough. On 6-12, I started having head and chest congestion with the cough increasing in severity. I took a home Covid test on 6-13 with positive results. On 6-14, I called my pcp office and they suggested I take mucinex, nyquil and tylenol as needed, increase fluids and monitor for fever (i did not have any). I took the mucinex, nyquil, tylenol and occasionally took sudafed. On 6-17, I took another home Covid test with positive results. I am feeling alot better with some congestion but have no cough. I retested using a home Covid test on 6-20 still with positive results.  I am reporting a breakthru case of Covid.
Other vaccine same date vacine date 04Dec2021; Other vaccine same date vacine date 04Dec2021; Big red welt on the injection site; Big red welt on the injection site; arm pain; Swollen lymph node in the left armpit; redness; It is hot and itchy; It is hot and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 15:45 (Lot number: 331308A) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 04Dec2021 (Batch/Lot number: unknown) as dose 1, single. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: ER8736, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Dec2021, outcome "unknown" and all described as "Other vaccine same date vacine date 04Dec2021"; VACCINATION SITE REACTION (non-serious), URTICARIA (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "Big red welt on the injection site"; PAIN IN EXTREMITY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "arm pain"; LYMPHADENOPATHY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Swollen lymph node in the left armpit"; ERYTHEMA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "redness"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 04Dec2021, outcome "unknown" and all described as "It is hot and itchy". Therapeutic measures were not taken as a result of vaccination site reaction, urticaria, pain in extremity, lymphadenopathy, erythema.  Additional information: Big red welt on the injection site and arm pain. It was hot and itchy. Swollen lymph node in the left armpit. This redness had lasted for 3-4 days (and may continue). The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior and post vaccination.   Follow-up attempts are completed. No further information is expected.
Parents report onset of extremity tremors within seconds of administration of the IPV vaccine.  Tremors waxed and waned.  Patient was seen in Emergency Room the same night.  Discharged home, and followed up in Urgent Care today with increasing ataxia and cranial nerve 3, 6, 7 palsy on right. The discharge summary received on 3/23/04 states lethargy, opsoclonus-myoclonus-ataxia, first degree heart block and staring spells. The medical record received on 3/23/04 states facial droop, nystagmus and myoclonus.
flared up the rosacea; rash on my opposite arm of the shot; arm that received the vaccine is "alson red like a sunburn"; it is red like a sunburn did not itched/face is red like a sunburn and feels like heat like a sunburn; my face is red like a sunburn and feels like heat like a sunburn; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (it is red like a sunburn did not itched/face is red like a sunburn and feels like heat like a sunburn), FEELING HOT (my face is red like a sunburn and feels like heat like a sunburn), ROSACEA (flared up the rosacea), RASH (rash on my opposite arm of the shot) and VACCINATION SITE ERYTHEMA (arm that received the vaccine is "alson red like a sunburn") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Rosacea and Thyroid disorder.    On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced ERYTHEMA (it is red like a sunburn did not itched/face is red like a sunburn and feels like heat like a sunburn), FEELING HOT (my face is red like a sunburn and feels like heat like a sunburn), RASH (rash on my opposite arm of the shot) and VACCINATION SITE ERYTHEMA (arm that received the vaccine is "alson red like a sunburn"). On an unknown date, the patient experienced ROSACEA (flared up the rosacea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (it is red like a sunburn did not itched/face is red like a sunburn and feels like heat like a sunburn), FEELING HOT (my face is red like a sunburn and feels like heat like a sunburn), ROSACEA (flared up the rosacea), RASH (rash on my opposite arm of the shot) and VACCINATION SITE ERYTHEMA (arm that received the vaccine is "alson red like a sunburn") had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken Concomitant medication namely thyroid medication in two doses, Blood pressure medication , Lipid medication , Allergy medication and cream for the rosacea for unknown indication with an unspecified date.  Patient also reported that his Rosacea condition was present before vaccination but got flared up after first dose of vaccination.   This case was linked to MOD-2021-321080 (Patient Link).
I developed flu-like symptoms.  Coughing, achiness, headache, weakness.  Lost my sense of smell, some sense of taste.  Recovered after about 14 days; still cannot smell anything.
Pt received flu vaccination approximately 1 PM 10/25/12. Started developing sore throat that evening. Pt took NYQUIL before going to bed. In the AM when she awoke her eyes & lips were swollen. Throat was still sore. Her PCP advised her to take BENADRYL which she did.
Approximately 25-30 minutes following the vaccine injection I began to experience a scratchy throat, perfuse diaphoresis then red itchy skin. I alerted the nurse, BP was 215/95 then repeated 190's/90's. I treated with fluid and Benadryl. The symptoms progressed to mild cough, swollen lips, and swollen inner ears. I took the second Benadryl and awaited my sister to take me home. The nurse waited with me and I assured her that I would use the Epipen and seek medical attention if the symptoms did not subside. I called my allergist on-call service who ordered steriods and encouraged EpiPen use and an ED visit. I assured her that I would seek medical care if anything worsened. I contiuned to take Benadryl and drink water. The pharmacy was closed so I could not start the steriods right away.I felt much better by morning so continued, then rebounded, took the EpiPen, and went to Ed where I was treated and released. Two days later, Increased HR requiring hospitalization, may be related to steroids
Information has been received from a registered nurse (RN) concerning a 6 month old male who on 12-jul-2007 was vaccinated with the first dose of Rotateq. Unspecified medical attention was sought. No product quality complaint was reported. Additional information has been requested.
Local reaction with 2 bumps and redness to injection area x 2 wks. Treated with antibiotic ointment, oral BENADRYL, and oral ibuprofen.
Pt reports feeling faint, dizzy, lightheaded, & heart palpitations a few minutes after receiving 1st Moderna dose (no reported breathing issues). Paramedics were called; BP & HR were normal per paramedics. Pt drank Gatorade & felt better. Pt did not go to hospital.  Pt's MD was notified & stated vasovagal reflexes are possible w/ vaccines. MD was not concerned  Pt was advised to f/u w/ PCP.
After the chills and aches (headache and body) my blood sugar level has elevated to upwards of 400 consistently every day since 12/1/2021.
Patient received vaccine that had temperature excursion; Patient received vaccine that had temperature excursion; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: AA7116, expiration date: 31May2021), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient's medical history and concomitant medications were not reported. Patient received vaccine that had temperature excursion. Product details of other lot of Prevnar 13: LOT#: AL3577; Expiration date: 30Jun2021, LOT#: X93780; Expiration date: 31Jan2021; LOT#: X93806; Expiration date: 31Jan2021.  Information on the batch number has been requested.
As I sat at the pharmacy during the 15 minute wait after my vaccination, I immediately felt some vertigo.  I didn't report it to a pharmacist as I didn't feel like there was anything to be done about it.  A week later, I started treating a yeast infection.  I have so far taken 4 Fluconazole tablets.  The infection will not go away.
60 year old received Fluzone HD which is intended for 65+ age group - no side effects
My arm was sore, and I was fatigue. I slept for 20 hours the next day. Even after I slept, I was still tired for the next few weeks.  Three months later, I had congestive heart failure. I went to the ER. They pumped 7 liters of fluid off my heart. They did an EKG, stress test, and blood work.
Shortly after vaccine, I became extremely fatigued. Night of receiving vaccine I developed headache, chills and a fever (101F). The next day, along with fatigue, headache, chills, and fever, I was nauseous. Two days after, I developed a slightly painful swollen lymph node under my right arm (vaccine side) - but, my other symptoms have subsided except for a slight headache.   The injection site itself was slightly painful and swollen on the day of the vaccine but this is gradually going away.
feeling warm; lot of redness; where she got the shot, my mother is experiencing pain; almost feverish; little soreness in arm of the injection; hand of the arm where she got the shot feels cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in arm of the injection), FEELING HOT (feeling warm), ERYTHEMA (lot of redness), PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold) and VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (little soreness in arm of the injection). On 01-Apr-2021, the patient experienced FEELING HOT (feeling warm), ERYTHEMA (lot of redness), VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) and PYREXIA (almost feverish). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (little soreness in arm of the injection), FEELING HOT (feeling warm), ERYTHEMA (lot of redness), PERIPHERAL COLDNESS (hand of the arm where she got the shot feels cold), VACCINATION SITE PAIN (where she got the shot, my mother is experiencing pain) and PYREXIA (almost feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter, she had ice on the injection site.
Administration of a dose after 12 hours the vial was first puncture; administration of a dose after 12 hours the vial was first puncture and was exposed at RT for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration of a dose after 12 hours the vial was first puncture and was exposed at RT for more than 12 hours) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration of a dose after 12 hours the vial was first puncture and was exposed at RT for more than 12 hours). On 23-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration of a dose after 12 hours the vial was first puncture and was exposed at RT for more than 12 hours) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.