chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While patient was receiving immunization, the syringe and safety needle separated while plunger was depressed.   immunizer states that patient received approximately 0.25mls of vaccine however do to syringe malfunction cannot confirm . per cdc  guideline revaccination was offered, mom refused. offer to call pediatrician mom also refused.  no side effects to child when they left the store.
Patient called the pharmacy at around 5:10 pm reporting that after she reached home 1 hour after receiving the vaccine at 11:44 am at the pharmacy she noticed she was bleeding  at injection site and she applied couple of bandages and the bleeding stopped and then she was tired so she went to sleep. After she woke up she noticed that it is swollen at the site of injection and has a little bump and looks bruised. Other then that she feels tired.
Swollen eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swollen eyes) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022b21a and 050c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EYE SWELLING (Swollen eyes). At the time of the report, EYE SWELLING (Swollen eyes) had not resolved.       Patient  had dermal filers Consent for follow up declined.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow Up received on 16-Jun-2021. Non-significant Follow up
This spontaneous report was received from a Veterinarian referring to his granddaughter a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. The veterinarian reported that his granddaughter received the first dose of ROTATEQ (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) in December 2018, and the second dose of ROTATEQ (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) on 09-MAR-2019. No adverse effect were reported.
Left lateral thigh shows erythema. 6x8 cm area. No induration. No bruising.
Worsening redness/swelling for 48 hours post injection; pain radiating from arm down to hip.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 51 year old female . Initial information was processed along with the additional information received on 08-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre diabetes, asthma, hypertension, hypothyroidism, penicillin allergy, and drug allergy (Advil, Leviquin, Zithromax, Metformin), and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 26-MAR-2021 for prophylactic vaccination. Age at time of vaccination 50 years old. The patient received second dose of non-company suspect vaccine elasomeran (Moderna vaccine) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 059H21A expiry: UNKNOWN) dose was not reported, administered to the left arm on 07-JAN-2022 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide, and levothyroxine sodium. On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2) which led to suspected clinical vaccination failure (Dose number in series 1). The patient was treated with non company suspect drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 09-JUN-2022 to 16-JUN-2022 for the treatment of covid-19. On 24-JUN-2022, 08:00, the patient experienced rebound covid (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000241596; Sender's Comments: V0. 20220715390-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related..
3/19/21 experienced nausea, headache and sore arm 3/20/21 to now (3/21/21) I just have the sore, swollen and warm arm at site of injection.  Ice and ibuprofen help.
Profuse sweating within 15 minutes of injection. Jitters, hands shaking, tremors. Upset stomach. Light headed. Dizziness. Extreme fatigue 6 hours immediately following injection. Facial itching and swelling on left side with onset within 6 hrs of injection. Pain and soreness at injection site. Shortness of breath.  Racing heartbeat. Headache.
Variation in monthly cycle after primary series of vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "recovered", described as "Variation in monthly cycle after primary series of vaccine".  Reporter consider event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
my first vaccine was on 1/22/2021, I woke up on 1/28/2021 with my arm swollen like a goose egg, very red and hot to touch and sore to touch.
pain and swelling at injection site by end of day, continued for 2-3 days with a rash developing on upper arm subsided then returned...itching, feverish arm,  pain at injection site this continued for another 5-7 days
Patient under age 18 was vaccinated with Johnson and Johnson, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age. Per data mining, this person made three attempts at appointment, finally declaring himself over 18 to get the appointment. His parent also validated the information that the son was over age 18 at the time of vaccine.
Fever, redness, swelling at site of injection, induration and tenderness. Area was 5 inches x 3 1/2 in, and purple!
Started with warm feeling moving up arm to neck, head and face on left side. Heart rate went from 68 to 95, with tight feeling in chest and throat. Stayed at clinic for over an hour. Took Tylenol and Benadryl that night and the next day. Feeling in shoulder, neck and face continued to feel like the site  of the injection ( felt aching and numb, but not to the touch). Today I am feeling better with slight discomfort in arm and neck.
Information has been received from a nurse concerning a male patient who on 29-APR-2011 was vaccinated with the first dose of GARDASIL, intramuscularly (lot number, expiration date and dose not reported). On 29-APR-2011, after receiving an injection of GARDASIL, the patient experienced dilated eyes, he fell backward and hit his head and was unconscious for 5 minutes. No treatment was given for the adverse event. The patient received unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Fever, Diarrhea, NauseaVomiting, Local Reaction: Pain-discomfort , General symptoms: chills, fever, headaches, joint pains, muscle pains, fatigue, nausea, diarrhea.  Narrative:
tingling and numbness on the left side of her body; tingling and numbness on the left side of her body; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on May2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling and numbness on the left side of her body. It was reported that, "The reason for calling that because my wife she have the shot since May but I called my primary doctor and he is not picking up the phone and I have the pamphlet with me and there is number so I find the number and I am calling you so basically my wife she is being about looking at side effects I guess with tingling and numbness on the left side of her body." The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
late second dose (37 day interval); arm was very sore; very bad headache; felt like nerves fired up throughout the body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like nerves fired up throughout the body), OFF LABEL USE (late second dose (37 day interval)), MYALGIA (arm was very sore) and HEADACHE (very bad headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 009D21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included MONTELUKAST, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE (FLOVENT), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced FEELING ABNORMAL (felt like nerves fired up throughout the body), MYALGIA (arm was very sore) and HEADACHE (very bad headache). On an unknown date, the patient experienced OFF LABEL USE (late second dose (37 day interval)). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form. On 19-May-2021, HEADACHE (very bad headache) had resolved. On 21-May-2021, MYALGIA (arm was very sore) had resolved. At the time of the report, FEELING ABNORMAL (felt like nerves fired up throughout the body) had resolved and OFF LABEL USE (late second dose (37 day interval)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-237277 (Patient Link).
CRAMPING - MENSTRUAL STARTED THURS, THEN SAT, 10/9 STARTED WITH  VAGINAL SPOTTING AND HOT FLASHES-- OCCURRED -- AND CONTINUED UNTIL 9/15/21.
Onset of muscle and joint aches that have persisted still now at 6 months post injection. MD appt in May with Dr to evaluate fatigue and joint aches- lab results with low neutrophils  (WBC'S)- Hematology f/u with Dr and she told me the neutropenia was due to the COVID 19 vaccine- labs returned to normal in August. Muscle aches and joint aches persisted worsening .  Appointments with several physicians. Apparently this vaccine has affected my immune system creating an auto-immune response. Hand pain severe. Hand surgeon states arthritis is her diagnosis after suggesting it is not carpal tunnel. Hand pain is hard to manage. Rheumatology appointment with Dr states diagnosis Rheumatoid Arthritis Sero Neg- I never had this before- only mild ostearthritis.
No adverse event; Dose administered after 12 hours post fist puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post fist puncture) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 30-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 30-Jun-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post fist puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post fist puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post fist puncture).    No concomitant medications were reported.  It was reported that, the patient received dose after 12 hours post fist puncture. Patient did not report any side effects.  No treatment medications were reported.
Pell's Palsy on the right side of my face.  It stated as what felt like an ear ache, but then progressed to a facial droop over a 3 day period after the second dose.  All observations of my ear were clear and no one saw anything to suggest I had an ear infection. I was put on prednisone 60 mg  for 7 days  and valacyclovir 1,000 mg 3 times a day  for 7 days.  I have slightly regained  some movement in the right side of my face starting about 4 or 5 months after the second dose.
Rather large rash extended from injection site in deltoid down the arm for a few days but eventually cleared up.
Developed Thrombotic thrombocytopenic purpura (TTP). Hospitalized for 8 days.  Suffered tonic-clonic (T-C) seizure which resulted in fractured T-12 vertebrae.
I had a fever to 102 that carried on to the next day. I had diarreha, chills, body aches, nausea, headache, and a bruise at the injection site.
initially had mild local react but 10 days later becme irritable, lost appetite & devel high pitched cry or cough; took ot ER MD made dx of lung congestion & bilateral ear infect;
PT WAS ANXIOUS AT TIME OF ENTERING FACILITY, COMPLAINS OF FEAR OF NEEDLES.  WAS CLAMMY INITIALLY AFTER INJECTION.  HAD PT LIE DOWN WITH FEET UP AND  GAVE HIM A  SUCKER. COOL WET COMPRESS TO FOREHEAD. AFTER QUESTIONING PT STATES NO BREAKFAST JUST A SMALL COOKIE. PT FEELING BETTER REPEATEDLY STATES I'M OK. OFFERED WATER, PT DECLINED.  AFTER APPROX 10 MINUTES ALLOWED PT TO LEAVE WITH PARENT STATING ALSO, SHE FELT OK LEAVING WITH HIM.  AFTER GETTING OUTSIDE ANOTHER PERSON CAME INTO CLINIC STATING PT WAS OUTSIDE HAVING A "SEIZURE". ANOTHER STAFF MEMBER CALLING 911. FOUND PT ON GROUND WITH JERKING MOVEMENTS TO EXTREMITIES, EYES ROLLED BACK, BITING LIP. AFTER COUPLE MINUTES ( APPROX) PT CAME AROUND IN VIOLENT MANNER. PT STATES HE COULD NOT OPEN HIS EYES, DID NOT HEAR WHAT WAS GOING ON AROUND HIM. STATES HE "COULD FEEL HIS HEART" AND ALL  HIS MEMORIES WERE FLASHING. NO APPARENT INJURIES NOTED, NO LOSS OF B&B AMBULANCE ARRIVED AND TRANSFERRED PT TO LOCAL HOSPITAL. PT REFUSED IV IN AMBULANCE. UPON ARRIVAL AT HOSPITAL PT REFUSED TO HAVE GLUCOSE FINGER STICK. LABS DONE AND WNL GLUCOSE NOTED TO BE 98. CT OF HEAD PERFORMED AND WAS NEGATIVE FOR ACUTE ABNORMALITIES. EKG DONE IN SINUS BRADYCARDIA.
Pt stated blurred vison, white areas peripheral vision; stated feeling dizzy pt became pale, clammy & lost consciousness; did not respond to verbal or physical stimuli BP 120/80; approx 2-3 mins color returned; pt became verbal & oriented;
Client received 1st Pfizer vaccine and received 2nd Moderna vaccine. Monitored client and educated client on possible side effects after vaccine.
15 minutes after getting the vaccine injection had onset of symptoms of whole body itching, nausea, throat itching and tightness.  Next day (less than 24 hours after vaccination) had hives that lasted 3 days.  Afterwards, patient developed prominent fatigue and joint pain, stiffness, that is more pronounce on the right upper extremity and lower extremity.  Hives and itching improved with Benadryl.  No improvement of joint pain or fatigue, 2 weeks after vaccination.
No adverse event; A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In February 2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent).    No concomitant medication were reported. Patient had no symptoms. No treatment information was provided by the reporter.
Monday 6 m WCC, shots at clinic. Tuesday fever (101.5) vomiting, fever improved and stopped vomiting back to daycare this morning (Wednesday) but now has white spots on mouth and rash around mouth. Eating/drinking okay. Mood is good. Strep going around daycare. Family members healthy. Not giving any medication at this time for symptoms. Is it related to vaccines? Only new one was influenza otherwise normal 6 month shots, which he had already at 4 mo check up. I am not sure whether his vomiting/fever the day after immunizations was related, so I am sending this along. Then 2 days after immunizations was seen in my facility for separate issues. **Note, I am at a different health care facility than where he gets well child care so I do not have access to that information. Today, Wednesday 2/6/19 I diagnosed him with oral thrush and impetigo on his chin/cheeks and started him on medications.
Injection site warmth to touch; arm where I recived the shot broke out with a rash; Injection site itch; hives; red swelling; red swelling; severe bout of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe bout of diarrhea), URTICARIA (hives), ERYTHEMA (red swelling), SWELLING (red swelling) and VACCINATION SITE WARMTH (Injection site warmth to touch) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Prone to having hives occasionally but haven't had them in recent years). Concurrent medical conditions included Cholesterol since 15-Dec-2019. Concomitant products included ATORVASTATIN from 15-Dec-2019 to an unknown date for Cholesterol.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-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 DIARRHOEA (severe bout of diarrhea). On 12-Mar-2021, the patient experienced URTICARIA (hives), ERYTHEMA (red swelling) and SWELLING (red swelling). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warmth to touch), VACCINATION SITE RASH (arm where I recived the shot broke out with a rash) and VACCINATION SITE PRURITUS (Injection site itch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLALANINE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE;PHENYLALANINE]) for Itching, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe bout of diarrhea), URTICARIA (hives), ERYTHEMA (red swelling) and SWELLING (red swelling) had resolved and VACCINATION SITE WARMTH (Injection site warmth to touch), VACCINATION SITE RASH (arm where I recived the shot broke out with a rash) and VACCINATION SITE PRURITUS (Injection site itch) had not resolved.            The patient never been diagnosed with/ tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Followup information received on 09-May-2021 and contains following information: Patient Address, contact number, email address were added, vaccination information of  both doses of the vaccine were added, Patient demographics Age, height, weight, initials and race were added, concomitant medications and information about the events were updated.
This spontaneous report was received from a registered nurse referring to a 18 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 12-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1712USA010085: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514: