chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bee sting like sensation in the right arm; Red rash; Swelling; This spontaneous case was reported by a nurse and describes the occurrence of SENSORY DISTURBANCE (bee sting like sensation in the right arm), RASH ERYTHEMATOUS (Red rash) and SWELLING (Swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SENSORY DISTURBANCE (bee sting like sensation in the right arm), RASH ERYTHEMATOUS (Red rash) and SWELLING (Swelling). At the time of the report, SENSORY DISTURBANCE (bee sting like sensation in the right arm), RASH ERYTHEMATOUS (Red rash) and SWELLING (Swelling) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported Treatment included cold compress. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-037423 (Patient Link).
Nasal congestion and loss of taste several days after having lunch with a friend who later tested positive for COVID. She tested positive for COVID on 4/7/21
Information had been received on 29-JUN-2016 from a field representative who called for a licensed practical nurse. The nurse advised the primary reporter that after giving ROTATEQ (dose, lot number and date of use not reported) oral, the patient (age and gender unknown) almost immediately started projectile vomiting (date not reported). The outcome of event was unknown by reporter. No further information provided. Additional information has been requested.
Administered a dose from a vial that had expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose from a vial that had expired) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose from a vial that had expired). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered a dose from a vial that had expired) had resolved.        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.   No concomitant medications were reported No treatment medications were reported.  It was reported that that there was no expiration date on vial but reporter assumed that it was 15-Oct-2021.
Elevated heart rate; General fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated heart rate) and FATIGUE (General fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HEART RATE INCREASED (Elevated heart rate) and FATIGUE (General fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, HEART RATE INCREASED (Elevated heart rate) and FATIGUE (General fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medicines (names were not specified).
Shortly after vaccination, client felt slight tightness in the chest and shortness of breath. Approximately 5 minutes after vaccination, client began having tingling in the right arm (same arm as vaccination). Tingling spread to head and neck area and client began to feel warm. O2 saturations were 100%. Pulse was normal. Client had a general feeling of "unwell". Client was monitored for 30 minutes after vaccination.  Symptoms were stable, and client was sent home with husband. Instructions given to client to watch for worsening symptoms and call their healthcare provider if symptoms worsen.
Information has been received from a registered nurse referring to unspecified patients of unknown ages and genders. Since October 2014 the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (route, lot#, dose and frequency were unknown). No adverse effects were noted. It was unspecified if the patients sought medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing.  The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
Chills developed 5-6 hours after injection 101 F fever 24-36 hours after injection
Patient was given Fluzone HD by mistake today and she is only 64 yrs old with no AE; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 64 years old female patient who received a 0.7 ml dose of an INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ512AB, expiry date: 30-Jun-2021) via intramuscular route in the left arm on 23-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Pain in chest beginning April 9, 2021. Entered the emergency room with blood clot in the lungs on April 11. Last dose Moderna vaccine received March 25, 2021. No known prior blood clot issues or causative health issues. Suspected prior infection with Covid 19 due to symptoms of illness approximately June 2020, but not confirmed with testing or afterward or with antibodies. Blood clot confirmed with CT Scan in hospital
injected into a blood vessel; Her arm started to have a reaction/Her arm was swollen above the bandage; Big whelp and a rash that went up her upper arm/Rash was gone; "hard chills" which were chills with shaking; Nauseated; felt dizzy; Tachycardia; High blood pressure of 150/90; "jabbed her in the arm and there was blood running down the arm."; Hard, big knot; quarter size bruise on her arm; Experiencing soreness but today she can lift her arm much better; "hard chills" which were chills with shaking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), HYPERTENSION (High blood pressure of 150/90) and VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (felt dizzy), VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), HYPERTENSION (High blood pressure of 150/90), VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm), CHILLS ("hard chills" which were chills with shaking), TREMOR ("hard chills" which were chills with shaking), NAUSEA (Nauseated), INJECTION SITE HAEMORRHAGE ("jabbed her in the arm and there was blood running down the arm."), VACCINATION SITE MASS (Hard, big knot), VACCINATION SITE BRUISING (quarter size bruise on her arm) and PAIN IN EXTREMITY (Experiencing soreness but today she can lift her arm much better). On 08-Feb-2021, HYPERTENSION (High blood pressure of 150/90) had resolved. On 10-Feb-2021, VACCINATION SITE RASH (Big whelp and a rash that went up her upper arm) had resolved. At the time of the report, DIZZINESS (felt dizzy) and CHILLS ("hard chills" which were chills with shaking) had not resolved, VACCINATION SITE SWELLING (Her arm started to have a reaction/Her arm was swollen above the bandage), TACHYCARDIA (Tachycardia), NAUSEA (Nauseated), INJECTION SITE HAEMORRHAGE ("jabbed her in the arm and there was blood running down the arm."), VACCINATION SITE MASS (Hard, big knot), VACCINATION SITE BRUISING (quarter size bruise on her arm) and PAIN IN EXTREMITY (Experiencing soreness but today she can lift her arm much better) outcome was unknown and TREMOR ("hard chills" which were chills with shaking) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product use was reported. The treatment details included diphenhydramine shot.   Reporter did not allow further contact
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot # M022531, expiration date: 23-FEB-2018) (dose and route of administration were not reported). There was no adverse effect reported. This is one of two reports from the same reporter. Additional information has been requested.
pt recvd vax 26MAR92 & same day of vax exp nasal congestion, watery discharge from eyes & nose, swollen right eye & swollen upper & lower eyelids; also had difficulty breathing;
No adverse effects have been reported; she had received the M-M-R II on 20-SEP-2019/ administered PROQUAD on 23-SEP-2019; she had received the M-M-R II on 20-SEP-2019/ administered PROQUAD on 23-SEP-2019; Information has been received from a nurse referring to a 5 years old female patient. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The nurse reported that she received correspondence on 24-SEP-2019 that on 20-SEP-2019, the patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot S005248, expiration date 20-FEB-2021; strength, dose and route were not reported) for prophylaxis at an unspecified clinic. There was no information available on the sterile diluent (Merck manufactured) (strength, dose, route, lot#, expiration date were not reported) for prophylaxis used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or if both products were properly stored. On 23-SEP-2019, the female patient was seen for a well visit and was administered properly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot S005880, expiration date 25-AUG-2020; strength, dose and route were not reported) for prophylaxis as the parent did not let the nurse know that the patient had received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 20-SEP-2019 (Overdose; Inappropriate schedule of product administration). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was reconstituted with properly stored sterile diluent (Merck manufactured) (lot S025290, expiration date 20-MAR-2022; strength, dose and route were not reported) for prophylaxis. No adverse effects had been reported.
The nurse described her child as being "wild" but other than that her child is healthy.; feotal exposure during pregnancy; This spontaneous report was received from a registered nurse referring to her child, a patient of unknown age and gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The reporter was pregnant about 7 years before the reporting time. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The reporter's concomitant medications included cromolyn sodium (NASALCROM), loratadine and budesonide. The reporter had no pertinent medical history or drug reactions or allergies. On 07-MAR-2014, the reporter was inadvertently administered a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (intramuscular; strength, dose, lot # and expiration date were not provided) for prophylaxis, instead of the intended "diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (tdap)" vaccine, no adverse effect was reported (Wrong product administered; Exposure during pregnancy, No adverse effect; captured into 1403USA004380) (Foetal exposure during pregnancy; captured into 2105USA002713). It was also reported that the company representative could not confirm if the patient had received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The pregnancy outcome was live birth. The fetal outcome was normal. The reporter described the patient was being "wild" (ill-defined disorder) but other than that the patient was healthy. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown.  The outcome of the event ill-defined disorder was unknown. The causality between the event ill-defined disorder and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.; Sender's Comments:  US-009507513-1403USA004380:
Right after getting the vaccine, patient had fluid accumulation/ swelling/redness  from left shoulder through the left elbow. It lasted for 5 days after treating with ice and benadryl. About a week after receiving the shot, patient felt beyond fatigued and her "perception changed eg, objects were moving. This lasted about 2 hours (1st episode). Neurologist called it a possible small seizure. Then she also felt numbness in top left back area of her head for about 10 hours on and off. This was on thursday (2nd episode 11/30/17) A third episode happened similar to 1st episode happened on saturday (dec 2).
Since recieving her second dose of Moderna client reports severe ringing in her ears and extreme loud ringing to the point of a panic attack and needed to take xanax to get some relief.  Client reports not being able to get warm at all, has not reported having chills though.  She also has experienced headache, has pressure and pain in eyes reports no blurred vision but will stare and get fixated on certain items so is being very cautious with driving.  Reports a fogginess feeling and brain zaps that are terrible occuring several times a day.  Left arm pain at injection site and up around bicep, and left hand stinging/numbness, and fatigue yet has trouble sleeping.
This spontaneous report as received from a pharmacist refers to a 78 year old female patient. Medical history and concomitant conditions were not reported. On 05-AUG-2014, the patient was vaccinated with VARIVAX (Merck). Dose, route, lot number and expiration date were not reported. The pharmacist reported that the patient received VARIVAX (Merck) instead of ZOSTAVAX (Merck) (on 05-AUG-2014). No adverse effects were noted. This is one of two reports from the same source (other case # 1408USA011578). Additional information has been requested.
Mild flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Mild flu) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AC1A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA (Mild flu). On 20-Mar-2021, INFLUENZA (Mild flu) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was not on any concomitant medication. No treatment medication was reported. It was reported that the patient drank a lot of water.   This case was linked to MOD-2022-447163, MOD-2022-447164 (Patient Link).
After one week of getting the vaccine my left arm, right around where I got the injection, formed a rash and became very red, swollen, and hot. After taking Benadryl and putting on hydrocortisone there has been no changes. It itches only if something rubs against it or if i touch it. It is about 3inches in length and about 3inches in width.
Patient received a Varicella immunization and a Hepatitis B immunization in her left upper arm on 9-20-07. She developed a 5.5cm by 2.5cm area of induration 21 hours after administration of immunizations on left upper arm that resolved within 72 hours with Benadryl.
The pt's parent describes 1/2 dollar coin size of redness, hardness with 5-6 bumps that started two days ago with 2-3 bumps with itching. On 04/25/2002, pt still compained but the area is decreasing in size.
I had sudden sensorineural hearing loss first in my left ear and then in my right. I still have distorted hearing in my left ear and my right ear is still muffled. It happened a little under 3 weeks after the vaccine. The doctor performed a hearing test in my left ear and it showed moderate sensorineural hearing loss compared to the hearing test I had last August. 2 weeks later my right ear showed decreased hearing. I was put on 60 mg of steroids for 2 weeks and given doxycycline for 2 weeks. The dr also had me do a CT scan. I also had an elevated D-dimer test for clots.
Meningococcal B vaccine was inadvertently administered to age under 16 in a healthy child.
Missing menstrual period as well as lighter than usual menstrual period 60 days into my cycle
Developed rash on stomach, back, legs, butt, arms that was raised bumps.
sore arm 1 day, 102 degree fever for 2 days, fatigue 2 days, dizziness 2 days, headache 2 days, diarrhea 2 days, nausea 2 days
Patient complains of sore arm that remains stiff and painful several weeks after receiving a flu vaccine. She stated that it was sore for a few days after receiving the vaccine and she thought it would get better but it has not. She also states that she has trouble lifting the arm past shoulder height due to pain. When asked, patient has not tried any over the counter treatments for the pain. Advised to try ibuprofen 200-400mg every 8 hours for a few days to see if the pain improves. Also recommended that patient see her primary care provider for further evaluation. I asked patient to point to where she received her vaccination and she pointed fairly high up on the arm, closer to the shoulder above the muscle.
Was very sore. By the next day my entire body hurt. I had a severe headache. I was barely able to walk on Thursday evening. My knee and elbow joints were swelled. On Saturday my left arm was very swelled where I received the shot. My lymph nodes under my left arm were swelled and very sore. Today is the 18th and the site of my shot is still hot and red also it has a knot still. I. Never went back to the Dr because I don't have health insurance.
Headache; fatigue; palpitations; elevated heart rate; fever; chills; This is a spontaneous report from a non-contactable physician reporting for a patient.  A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot # EH9899, intramuscularly on 22Dec2020, as a single dose in right arm (age at vaccination: 28 years old) for COVID-19 immunization (dose 1). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced headache, fatigue, palpitations/elevated heart rate, fever, and chills. The events were reported as non-serious. The patient received treated for the events with acetaminophen (TYLENOL). She recovered from the events headache, fatigue, palpitations/elevated heart rate, fever, and chills on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.