chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was itchy; injection site reaction/area swelled; sore arm; low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (was itchy), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 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 started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE PRURITUS (was itchy) and INJECTION SITE SWELLING (injection site reaction/area swelled). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (was itchy) was resolving, PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and INJECTION SITE SWELLING (injection site reaction/area swelled) had resolved.            Concomitant medication was not reported.   The patient had injection site reaction area swelled to around 3 cm and was itchy. She did take Benedryl and that helped some with the itchiness and it was no longer swollen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Day 1-3 - Fatigue, pain on back and shoulder. 4 - Nausea and vomiting.
Patient hospitalized for induction of labor within 6 weeks of receiving covid vaccination. No information regarding baby's size.
No adverse event occurred. Patient previously received the first dose of Moderna Vaccine on 4/22/21. Upon consultation with their doctor, they wanted to continue with the second dose.
BACKACHE FROM LAYING DOWN FOR TOO LONG; ODD SMELLING SNOT; ARM TOO SORE TO LIFT; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-JUL-2021, the patient experienced backache from laying down for too long. On 30-JUL-2021, the patient experienced odd smelling snot. On 30-JUL-2021, the patient experienced arm too sore to lift. On 30-JUL-2021, the patient experienced headache. On 30-JUL-2021, the patient experienced nausea. On 30-JUL-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, fatigue, backache from laying down for too long, odd smelling snot, and arm too sore to lift. This report was non-serious. This case, from the same reporter is linked to 20210826549.
Dizziness, loss of sight/hearing for brief time.  She exhibited slight jerking movement, fell to concrete floor w/sm. scrape on her side. I gave her 25 mg. She felt better in 15 min.
Fainted on day 3 of second dose. Have been experiencing short bouts of dizziness.  Had nose bleeds and dizziness after first dose on March 23rd. Nose bleed was on day 3 after first shot. Went to urgent care to get it checked.
Fever, temp 100; Body aches; This is a spontaneous report from a non-contactable consumer. This consumer reported for a patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 07Feb2021 as dose 1, single for covid-19 immunisation at Pharmacy. The patient medical history and concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. On 08Feb2021, the reporter stated that a coworker of hers was experiencing symptoms after receiving a first dose of the covid vaccine, administered 07Feb2021. The patient had a fever, Temp 100, and body aches. The patient underwent lab tests and procedures which included body temperature: 100 on 08Feb2021. The outcome of the events was unknown.  No follow up attempts are possible. Information on the lot/batch number could not be requested. No further information is expected.
got them in the eye after vaccine/Suspected Vaccination Failure; got them in the eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got them in the eye after vaccine/Suspected Vaccination Failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: got them in the eye) (serious criteria GSK medically significant). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and unknown steroid eyedrops (Steroid Eye Drops). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient got shingles in his/her eye after shingles vaccine. The patient was on an antiviral and steroid eye drops for life. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
My arm became sore at the site of injection. Rather than going away in a day or two, my arm remained sore. It hurt to the point that I couldn't pull a sweater off over my head or reach behind my back with my left arm.The pain has gradually become less, but on the date I submit this report (February 8), almost 4 months later, it still hurts. I have been treating it with physical therapy, exercises, and small doses of ibuprofen. I did see my doctor in November. He thought it was not worth reporting. I have decided to report it since the problem has persisted for so long.
Pain, swelling and tenderness of left arm approximately 3 inches below injection site began on 11/16/21 approximately 3 hours after injection. Fever, body aches and cough began approximately 18 hours after injection. Fever and body aches resolved in 24 hours. Pain, swelling and tenderness of left arm worsened and on 11/19/21 I went to urgent care to check for a blood clot. After a venous Doppler it confirmed superficial thrombosis of the left basilic vein.
18 days after receiving vaccine, patient developed typical varicella rash on back, chest and legs.  No fever was reported.
Left eyelid ptosis, left facial sensory deficit, possible left sided vision changes started morning of 5/7/2021.  .  Remote 2mm cerebellar stroke found on imaging.
Pt received shot on 6-22-11 - has a history of leukemia. We called oncology & family doctor - they okayed her to get the shot. Two days later she appeared with a reaction on her arm. It was blistered area around inj. Went to doctor & got antibiotics and told to keep it bandaged. Reported to Merck.
10:30AM I started hiking and half way through had heart palpitations.  Eventually it became harder and pounding and continued for 45 minutes.  Was told by oncologist that it could be SBT.  It happened again on 1/26/22.  As a result, I went to see a cardiologist.
I got a rash that the skin looks like its burning and peeling. At times itches, spots on side, legs, chest, back, and breast. .
on my second shot the student nurse misapplied the needle.  She consulted the supervisor who brushed off the incident.  My arm hurt on that day and continues to hurt...getting worse.  The pain is in the exact location of the second shot
dizziness; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dizziness.  The patient's medical history was not provided.  Concomitant medications like IVABRADINE HYDROCHLORIDE once daily, OMEPRAZOLE once daily, FLUDROCORTISONE ACETATE once daily and DESVENLAFAXINE SUCCINATE once daily were reported.    On 12th Jan 2021, prior to the onset of the event, the patient received their first dose of mRNA-1273 (batch/ lot # 0113l20A.) for prophylaxis of COVID-19 infection.  Within over 24 hours after at 11:30 pm on Wednesday 13Jan2021 the patient experienced the event Dizziness.  Laboratory details was not provided.  Treatment was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was considered as Unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
p/1-2hr from vax appeared stiff, fists clenched then inconsolable for several hr;refused feeding;lt thigh tender @ inj site;alert, interactive;given APAP;
Non itchy pink bumps all over body; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 18Feb2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and acid reflux. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021, the patient experienced small non itchy pink bumps all over body, the patient started noticing them on legs two days post vaccination and didn't think anything of it. On 26Feb2021, eight days post vaccination, the patient noticed more bumps on arms and stomach. The bumps were not painful, itchy, or threatening in any way, just slightly alarming that they were there. It was also reported that the reporter was unsure if it was a side effect of the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event small non itchy pink bumps all over body was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 07-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
At 2 am started with chills, headache, aches and pains.  Progressed to 100 temp and severe headache, chills and aches.  Spent 2 days  in bed.
The next day my whole body was hurting for 3 days, then then I started getting swelling in my ankle the left first then the right. the back bone of the foot turned really red, then my eyes are swollen up, my right eye turned blood red, my neck swelled and it's still swollen, I had swelling in my hands and two days ago my legs started swelling and the right is worse than then left. Yesterday and day before my groin had a lump and the doctor said it's my lymph node. I went to the ER and they said it was the lymph node, I'm getting worse instead of better. After the first injection I got a rash and a nodule came up and now I have a bunch of nodules, I also have Panniculitis Mesentery. I also have pictures of my eyes, my swollen feet, and ankles.
Vaccination site warm; Vaccination site itching 2-3 inches in diameter; Vaccination site swollen 2-3 inches in diameter; Injection site redness 4-5 inches in diameter /Injection site Bright pink/ red in color; Injection site swelling 4-5 inches in diameter; Vaccination site raised 4-5 inches in diameter; Vaccination site hot to the touch; Vaccination site tenderness; Product administration error; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site hot to the touch), VACCINATION SITE PAIN (Vaccination site tenderness), PRODUCT ADMINISTRATION ERROR (Product administration error), VACCINATION SITE WARMTH (Vaccination site warm) and VACCINATION SITE REACTION (Vaccination site raised 4-5 inches in diameter) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot to the touch), VACCINATION SITE PAIN (Vaccination site tenderness), PRODUCT ADMINISTRATION ERROR (Product administration error), VACCINATION SITE REACTION (Vaccination site raised 4-5 inches in diameter), INJECTION SITE ERYTHEMA (Injection site redness 4-5 inches in diameter /Injection site Bright pink/ red in color) and INJECTION SITE SWELLING (Injection site swelling 4-5 inches in diameter). On 04-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warm), VACCINATION SITE PRURITUS (Vaccination site itching 2-3 inches in diameter) and VACCINATION SITE SWELLING (Vaccination site swollen 2-3 inches in diameter). At the time of the report, VACCINATION SITE WARMTH (Vaccination site hot to the touch), VACCINATION SITE PAIN (Vaccination site tenderness), PRODUCT ADMINISTRATION ERROR (Product administration error), VACCINATION SITE WARMTH (Vaccination site warm), VACCINATION SITE REACTION (Vaccination site raised 4-5 inches in diameter), VACCINATION SITE PRURITUS (Vaccination site itching 2-3 inches in diameter), INJECTION SITE ERYTHEMA (Injection site redness 4-5 inches in diameter /Injection site Bright pink/ red in color), INJECTION SITE SWELLING (Injection site swelling 4-5 inches in diameter) and VACCINATION SITE SWELLING (Vaccination site swollen 2-3 inches in diameter) outcome was unknown.            Action taken with mRNA-1273 in response to the event were not applicable. Treatment information was not provided Concomitant medication were not provided.
Pt noted chest/asthma like Sx. increase PND, slight cough and itchy throat. Pt takes q o wk allergy injections.
swollen lymph nodes, 8cm by 5cm; This is a spontaneous report from contactable healthcare professional. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of vaccine on 23Dec2020 and displayed swollen lymph nodes on 24Dec2020, 8cm by 5cm. The patient was scheduled to receive second dose of vaccine on 13Jan2021 and asking for recommendations. The outcome of the event was unknown.  The information on the batch/lot number has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis (lot number M023169, expiration date 13-JUN-2018; dose and route of administration were not reported). Reporter was unsure whether GARDASIL 9 or GARDASIL (captured in case MARRS # 1701USA005206) was administrated. Administered doses of vaccines experienced the following temperature excursions: on 15-DEC-2016 of 11 degrees Celsius for 4 hours 13 minutes, on 16-DEC-2016 of 11 degrees Celsius for 9 hours 20 minutes, on 29-DEC-2016 of 11 degrees Celsius for 3 hours 37 minutes, a total  temperature excursion was 17 hours 10 minutes cumulative hours in more than 8 degrees Celsius and less than 25 degrees Celsius. Data logger was involved. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005206: US-009507513-1701USA005207: US-009507513-1701USA001537.
Tingly on her face; Could not eat.; Every part of her body hurt; Chills; Headache; Nauseous; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly on her face), EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PARAESTHESIA (Tingly on her face), EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nauseous). On 03-Feb-2021, PARAESTHESIA (Tingly on her face) had resolved. On 05-Feb-2021, EATING DISORDER (Could not eat.), PAIN (Every part of her body hurt), CHILLS (Chills) and NAUSEA (Nauseous) had resolved. At the time of the report, HEADACHE (Headache) had not resolved. Not Provided      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 concomitant medications were provided.  Treatment details included Tylenol and  Motrin.
I ASKED ADMINISTRATOR TO ADMINISTER A VACCINE FOR ME TO PATIENT, I GRABBED THE VACCINE AND PLACED IT ON THE TRAY AND TOLD ADMINISTRATOR WHERE TO ADMINISTER THE VACCINE, AFTER SHE ADMINISTERED THE VACCINE I REALIZED THAT I HAD PLACED THE ADULT DOSE VACCINE ON THE TRAY INSTEAD OF THE PEDIATRIC DOSE, BUT THE VACCINE HAD ALREADY BEEN ADMINISTERED.
PFIZER BIONTECH COVID 19 VACCINE:  ADMINISTRATION ERROR  Vaccine vial was not diluted prior to giving dose resulting in error.  Individual received 0.3ml of undiluted vaccine.  No adverse effects reported.
Shots were given around 9:50AM. Mom called around 12:10PM and said pt had red splotches on abdomen and now moving to face. Reported no difficulty breathing. Was at store and bought Benadryl, gave 1 tsp. Dr instructed to go to ER, went to ER, spoke with mom at ER at 2:48PM. Rash was fading after just one dose of Benadryl and no other treatment. Discharged home to take Benadryl 2x day. Called mom 10/25 no answer, 10/27 dad said he was fine.
36hr after first Covid vaccine, developed urticaria multiforme; diffuse head to toe pruritic rash with welt, wheals, hives, some swelling around hands and feet. Also with cough and headache, no fever.
Vomiting and diarrhea occurred leading to dehydration. Had to be hospitalized.
itching and "knot" in throat; superficial red bumps to upper right arm near vaccination site; itching and "knot" in throat; superficial red bumps to upper right arm near vaccination site; This is a spontaneous report from a contactable pharmacist. A 30-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via intramuscular route of administration in the right arm on 29Apr2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization, rubella vaccine (RUBELLA), via an unspecified route of administration on 29Apr2021, (Batch/Lot number was not reported), for immunization. Medical history included known allergies, HPV vaccine, penicillin, walnuts, amoxicillin, avocado, azithromycin, banana, ciprofloxacin, grapes and asthma, crohns disease, ulcerative colitis, migraines, allergies from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via intramuscular route of administration in the left arm on 08Apr2021 as dose 1, single for COVID-19 immunization. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, patient developed mild itching and knot in throat, superficial red bumps to upper right arm near vaccination site. Patient was given 2 cups of water and symptoms resolved soon after. The patient did not receive any treatment for the events. The clinical outcome for the events was recovered on an unspecified date in 2021.  No follow-up attempts are required. No further information is expected