chrisvoncsefalvay/vaers-outcomes huggingface dataset:
balance issues; couldn't think straight,; dry heaves; red itchy rash in her upper tarsal; red itchy rash in her upper tarsal; Patient didn't have the second vaccine yet; dizziness; muscle aches; nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Artificial sweetener intolerance and Food allergy.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches), NAUSEA (nausea), BALANCE DISORDER (balance issues), THINKING ABNORMAL (couldn't think straight,), RETCHING (dry heaves), RASH ERYTHEMATOUS (red itchy rash in her upper tarsal), RASH PRURITIC (red itchy rash in her upper tarsal) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't have the second vaccine yet). At the time of the report, CHILLS (chills), PYREXIA (fever), DIZZINESS (dizziness), MYALGIA (muscle aches), NAUSEA (nausea), BALANCE DISORDER (balance issues), THINKING ABNORMAL (couldn't think straight,), RETCHING (dry heaves), RASH ERYTHEMATOUS (red itchy rash in her upper tarsal), RASH PRURITIC (red itchy rash in her upper tarsal) and INTENTIONAL PRODUCT USE ISSUE (Patient didn't have the second vaccine yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-May-2021: added new adverse events, suspect vaccine details (batch number).
Influenza vaccine given 9/23/11 10:45AM. Febrile seizure midnight that day.
After vaccination pt went to sit by Mom in waiting room. After about 10 min, pt reports dizziness and nausea. On physician exam, pt was orientated, weakness, cranial nerve deficits, slurred speech, and pupil dilation. Pt was transferred to the ER.
Left upper anterior thigh with Redness, warmth, swelling 19 cm x 12 cm.
A report has been received from a Health Professional concerning a 20 year old , male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that the patient inadvertently administered expired FLUMIST Quadrivalent to a patient. The outcome of the event of inadvertently administered expired FLUMIST Quadrivalent to a patient is unknown. The report was considered to be non-serious.
12/7:  Patient presents with URI symptoms for 2 weeks.  He has continual congestion, back and body aches, chills, affected appetite with no improvement, and maybe reports some recent worsening with regard to coughing up 'gross' sputum, and chills.  Original symptoms started on 11/24.  He is vaccinated for covid in Feb/march 2021, but no booster shot.  He is eating and drinking still but has not been eating much.  He does smoke cigarettes daily.  He denies nausea/vomiting, but does have diarrhea since yesterday, which is a new symptom.
Entire body is sore. Fever of 102.3. Intense headache. Dizziness.
It was verbalized that students needed to be of the age of 18 and younger to be eligible for this stock of vaccine.  It was not realized until after administration that patient is 19 years old.  No adverse reaction occurred; patient not eligible and has no insurance.
I believe the vaccine was administered far to high up on my arm. It was at my acromion process at the top of my left shoulder when it should have been at least a few inches lower in my deltoid muscle.  Within an hour of administration I could not lift my arm at all.  My arm hurt all the time even when not moving or using the arm. There was severe pain swelling/inflammation that lasted for 3 days.  I took 800mg ibuprofen every 6 hours during this time and applied heat as often as I could.
Patient on crutches, had knee surgery a few months ago.  Patient reported a "faint feeling" shortly after receiving vaccine. Did state she had similar episodes in the past, last one was in Feb 2000. Had cardiac workup and undetermined cause.  Patient did eat this am, only med is Tylenol.  B/P was 118/82 P 76 and SPO2 was 99%  Applied ice pack behind neck, gave water. Watched for 45 min.  Symptoms resolved and patient discharged home.
Redness, tenderness, induration of rt.thigh, 24-48 hours after imm.
Patient reported experienced increasing pain at L shoulder which started on or around Tues 10/17/17 in the AM. He had a flu shot at on 10/16/17. Starting on 10/17/17 he experienced L shoulder pain. He was unsure if this was related to the flu shot initially or was due to a work related incident such as moving a wheelchair or applying a tie down on a service vehicle.
Runny nose/Congestion,  Cough (new onset or worsening of chronic cough),  Fatigue or tiredness, hospitalized
arm discomfort; sleepiness; spots on face/spots on breast area/spots on face arms (ongoing); itching; heaviness in arm; allergic reaction after doses 1 and 2, three days after the doses were administered; tenderness in arm; redness in the arm; pain in the arm; tiredness; swelling in the arm/ swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling) and VACCINATION SITE PAIN (tenderness in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling), VACCINATION SITE PAIN (tenderness in arm), LIMB DISCOMFORT (heaviness in arm), VACCINATION SITE ERYTHEMA (redness in the arm), PRURITUS (itching), RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, VACCINATION SITE DISCOMFORT (arm discomfort), VACCINATION SITE PAIN (pain in the arm), SOMNOLENCE (sleepiness), VACCINATION SITE SWELLING (swelling in the arm/ swelling), VACCINATION SITE PAIN (tenderness in arm), LIMB DISCOMFORT (heaviness in arm), VACCINATION SITE ERYTHEMA (redness in the arm), PRURITUS (itching), ALLERGY TO VACCINE (allergic reaction after doses 1 and 2, three days after the doses were administered), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown and RASH MACULAR (spots on face/spots on breast area/spots on face arms (ongoing)) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant use were reported.  No treatment were reported.   This case was linked to MOD-2021-378138 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received on 08-NOV-2021 contains new events added, dose administration date added.
Pain around the side and back of knee; Left elbow area pain. Believe its the lymph node.; Pain top of left foot.; Feels like bruised, but its not.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration in the left arm on 31Mar2021 at 12:45 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included cancer, amputation, cardiomyopathy and fibromyalgia. The patient had no allergies to medications, food or other products. Concomitant medications included heart and pain medication. 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 31Mar2021 at 16:00, the patient experienced left elbow area, much pain when bending it. The patient reported it was of the lymph node, most definitely not the joint. The patient feels like it was bruised but it was not. Pain around side and back of knee and top of left foot. Not as severe as elbow area. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for feeling abnormal, foot pain, lymph node pain and knee pain. The clinical outcomes of the events feeling abnormal, foot pain, lymph node pain and knee pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Red splotches  at injection site about 6-7 inches in size and warm to the touch. Called my doctor and was advised to go to urgent care (I am not near home). Urgent gave rx for Bactrim for possible cellulitis. 3 days later reaction was barely visible. Returned for follow up and asked about "covid arm". Doctor said it might be and to discontinue rx.
Left arm swelling, red, and warm biceps,(pain raising arm- no pain in tri/biceps). Pain on deltoid/ biceps- with cellulitis and no lymphadenopathy.
Runny nose; Fever; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), PYREXIA (Fever) and FATIGUE (exhaustion) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (Runny nose), PYREXIA (Fever) and FATIGUE (exhaustion). At the time of the report, RHINORRHOEA (Runny nose), PYREXIA (Fever) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
8 YO received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Gsk receipt date: 3-Feb-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received Kinrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Is feel head pressure a side effect; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Is feel head pressure a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Is feel head pressure a side effect). At the time of the report, HEAD DISCOMFORT (Is feel head pressure a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
From 2 days post vaccine, fever, fatigue, sore throat and headaches, lasting about a week. Persistent symptoms of headaches, dizziness, and blurring of vision still present at 19 day post vaccine.
L arm red and swollen all around back of arm approximately 5 1/2 inches long.  Pt. states site itches.
Pain radiated down arm. Patient came into pharmacy 1/1/15 to complain about not being able to move arm.
pt did not have a reaction to this. Pt was given the vaccine after beyond use of refrigeration time. But lot number was not expired.
Patient is 60 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
Arm had welts; Arm was red; arm was itchy; arm was blotchy; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). On 26-Jan-2021, the patient experienced URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy). At the time of the report, PAIN IN EXTREMITY (My arm was sore), URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The followup does not contain any new information.
Rash at site of injection, growing larger 3 in. by 1 1/2 inch, red, hard to touch on third day.
Vertigo/dizziness when walking; fatigue; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 08Jul2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included prior breast cancer and high triglycerides. The patient was allergic to lactose. Concomitant medications included fish oil (OMEGA 3) and monascus purpureus (RED YEAST RICE); about 2 days prior to vaccination, on an unknown date in Jul2021 for an unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jul2021, the patient experienced some pain in the injection site but nothing else for the first 2 days. On 10Jul2021, Saturday morning woke up with vertigo and recognized that turning her head to the left and down made it worse. Lots of fatigue and dizziness when walking. The day of reporting was day 3 (as reported) and still had some vertigo and dizziness while walking. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, vertigo/dizziness when walking and fatigue were not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Today it looks worse and redder than it ever did; Rash is not itchy but it is longer and redder up and down then side to side; Arm was red and rash like at the injection site; Arm was red and rash like at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of CONDITION AGGRAVATED (Today it looks worse and redder than it ever did), RASH ERYTHEMATOUS (Rash is not itchy but it is longer and redder up and down then side to side), VACCINATION SITE ERYTHEMA (Arm was red and rash like at the injection site) and VACCINATION SITE RASH (Arm was red and rash like at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Rash is not itchy but it is longer and redder up and down then side to side), VACCINATION SITE ERYTHEMA (Arm was red and rash like at the injection site) and VACCINATION SITE RASH (Arm was red and rash like at the injection site). On 02-Mar-2021, the patient experienced CONDITION AGGRAVATED (Today it looks worse and redder than it ever did). At the time of the report, CONDITION AGGRAVATED (Today it looks worse and redder than it ever did), RASH ERYTHEMATOUS (Rash is not itchy but it is longer and redder up and down then side to side), VACCINATION SITE ERYTHEMA (Arm was red and rash like at the injection site) and VACCINATION SITE RASH (Arm was red and rash like at the injection site) outcome was unknown.        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.   Concomitant medications were not provided Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30 April 2021 NNI
The patient is a 30 year old male who presented to the vaccine clinic. for the COVID vaccine. The patient was scheduled to receive his first Moderna dose. At registration, the patient did not have his COVID vaccine card. The vaccine survey from 05/06/2021 was missed by the person registering the client, so he received a second Moderna vaccine within 12 days of the first dose he received on 05/06/2021. The patient had neither allergic or adverse reactions from the first or second doses given within the 12 day timeframe. Follow up completed at the facility on 05/24/2021. The patient was no longer at the facillity but the nurse reports the patient reported fatigue but had no adverse events when he left the facility on 05/21/2021.
Grand mal seizure; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Dec2021, for COVID-19 immunization. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "Grand mal seizure". Clinical course: It was reported that 20 days after 2nd shot, she suffered a grand mal seizure. Later, she also received the booster and 19-20 days after receiving the booster she suffered another grand mal seizure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202201277773 same reporter/patient/event, different dose.;
Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 11 years old patient who sterile water as a diluent, ACT-HIB, instead of diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of medication error due to Inappropriate reconstitution technique. No ill effects have been reported. 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.
Pt developed circular colored area with bumps and massive itching. 12/11 - pt talked w/Doctor and Doctor told her to watch and wait.
slight burning sensation at time of injection , then no symptoms for 3-4 hours, then pain started  at site of injection and continued to worsen through the rest of the day.  Nest day woke up with severe pain in left arm from below the site of injection (upper triceps) region down to the elbow , got severe enough to not be able straighten my arm fully without major discomfort.  Took Advil 800 mg , that made it better but not completely. By evening time felt like i was tired and like what i feel like when i am about to get a cold.   Next day was not tired , feeling of getting sick was no longer there and pain got slightly better by midday.   Next day after that woke up with slight swelling in the site and the arm was red and was warm to touch.  That continued for 2 days and gradually got less red and swollen and started to itch.  Took almost a week for the itch to completely subside.
Had flu shot 1/5/2015. 2 days later noted sore lymph node same arm as shot. Node increased pain and size. Said fever 101.2 on 1/8/15. 1/9/15 saw doctor - was told "caused by shot". Given prednisone.