chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWOLLEN ARM FROM MODERNA VACCINE; Fatigue; SORE ARM FROM MODERNA; MORE JOINT PAIN/FLARE UP OF JOINT PAIN; PAIN IN HAMSTRING FLARE UP; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (SWOLLEN ARM FROM MODERNA VACCINE), FATIGUE (Fatigue), VACCINATION SITE PAIN (SORE ARM FROM MODERNA), ARTHRALGIA (MORE JOINT PAIN/FLARE UP OF JOINT PAIN) and MYALGIA (PAIN IN HAMSTRING FLARE UP) 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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced VACCINATION SITE SWELLING (SWOLLEN ARM FROM MODERNA VACCINE), FATIGUE (Fatigue), VACCINATION SITE PAIN (SORE ARM FROM MODERNA), ARTHRALGIA (MORE JOINT PAIN/FLARE UP OF JOINT PAIN), MYALGIA (PAIN IN HAMSTRING FLARE UP) and HEADACHE (Headache). At the time of the report, VACCINATION SITE SWELLING (SWOLLEN ARM FROM MODERNA VACCINE), FATIGUE (Fatigue), VACCINATION SITE PAIN (SORE ARM FROM MODERNA), MYALGIA (PAIN IN HAMSTRING FLARE UP) and HEADACHE (Headache) outcome was unknown and ARTHRALGIA (MORE JOINT PAIN/FLARE UP OF JOINT PAIN) had not resolved.            No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SWOLLEN ARM FROM MODERNA VACCINE, FATIGUE, SORE ARM FROM MODERNA VACCINE and HEADACHE with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of PAIN IN HAMSTRING FLARE UP and MORE JOINT PAIN/FLARE UP OF JOINT PAIN with HUMIRA(ADALIMUMAB) was a reasonable possibility. No treatment details were reported. 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.
Chills, Hot Flashes, Nausea, Muscle Pain, Extreme Lethargy for 6 days.
This spontaneous report was received from a pharmacist refers to a child patient of aged 1-1.5 years old of unknown gender. On an unknown date the patient was vaccinated with M-M-R II injection (dosing regimen and lot # unspecified). No concomitant medications were reported. On an unknown date, 7-10 days after receipt of the M-M-R II, the child broke out in an unspecified rash. Pharmacist did not know any further data and could not provide any additional answers. No further information provided. The outcome of rash was unknown. Causality assessment was not reported. Additional information is not expected. No consent to follow up with the reporter.
eczema around my eyes; a period that lasted two weeks and then no evident menstrual cycles 2 months after; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 17Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications(in two weeks). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2593), for COVID-19 Immunization.  Patient has not received other vaccine in four weeks. The following information was reported: MENSTRUAL DISORDER (medically significant) with onset 27Nov2021, outcome "recovering", described as "a period that lasted two weeks and then no evident menstrual cycles 2 months after"; ECZEMA (medically significant) with onset 27Nov2021, outcome "recovering", described as "eczema around my eyes". The events "eczema around my eyes" and "a period that lasted two weeks and then no evident menstrual cycles 2 months after" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (25Dec2021) Positive. Therapeutic measures were taken as a result of eczema, menstrual disorder. AE treatment: corticosteroid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events eczema, menstrual disorder and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Severe swelling to armpit and lymph nodes in neck on left side, fever, fatigue, muscle and joint pain, chills, red hard lump at injection site the size of a baseball and nausea. I'm now going on day 3 of swollen lymph nodes and body pain.
Around 12:30pm on 4/24/2021, I noticed a small knot on my right arm, about 3 inches toward my hand from the injection site. The injection site was in my upper deltoid. The small knot measures about 1" (in the direction of elbow to shoulder) by 2" and the muscle in this area feels tight. The area is also slightly pink, slightly raised, midly itchy, and quite warm to the touch. I was advised that this is a typical event that may occur ~1 week after receiving Moderna vaccine. No medical intervention is planned, provided that the symptoms do not worsen.
This spontaneous report was received from a medical assistant and refers to a 14 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date in August 2016, the patient was vaccinated with a dose of PROQUAD (dose, route, lot# and expiry date were not reported). On an unknown date in October 2016, the patient was revaccinated with a second dose of PROQUAD (dose, route, lot# and expiry date were not reported). The revaccination occurred at the request of the patient's oncologist. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Extreme fatigue, fever, loss of appetite, headaches, sore arm, shoulder, neck and back.
Shortly after the vaccine, not possible to exactly name the date, I began noticing some visual processing problems while driving. I thought it was perhaps related to my cataracts. One day I realized it was more than just processing as I saw while using the Amsler test that all the lines were distorted when looking with my right eye. I have been monitored for more than 15 years for macular degeneration and each year there has been no change.  As a medical practitioner I keep up with current news and when I read that some doctors have been administering D-Dimler tests to check for blood clots after vaccination and that they have found evidence of small clots in a large percentage of people.  Since wet macular degeneration is caused by leaking capillaries I think that it is important to find out how these vaccinations are affecting the small capillaries not only in the eye but other organs as well. We need more complete information. This is a major health concern and the fact that we have no long term data on these shots is what?s keeping many people from getting them.
Left arm soreness, ~5pm Fatigue,8pm Chills, miss nausea ~10pm Fever (110.3') and headache, 12-4am Fever ended following 2 Tylenol tablets ~5am (98.1')  Fatigue, mild headache, slight nausea, moderate left arm soreness, and intermittent chills remain 12/27/20
5 - 10 minutes after receiving vaccine, I had difficulty swallowing.  I was fine 30 minutes later.  On day 12 after receiving the vaccine, the injection site began to itch and was sore.  I experienced some chills. The site was slightly red.  Itching and soreness is continuing along with additional mild itching occurring on the front of the calves and eyes.
Ever since I got the vaccination, my arm has hurt.  It still hurts, fairly bad.  It has not gotten better.  The farther I try to raise my arm over my head; and the farther I try to stretch my arm across my body to the right, it hurts more. It wakes me up every night. It hurts a lot if I roll over on it at ight.   I saw the PA again last week, and complained. He prescribed Celebrex.
Minutes after receiving it I had a metallic taste in my mouth with wasn't that big a deal it went away. For the last seven or eight days now though I've been sick and couldn't even need a full meal for the first week after receiving it and I've had diarrhea and nausea, and fatigue with restlessness when attempting to sleep.
Information has been received from a certified medical assistant concerning a 22 year old female who on 02-MAR-2007 was vaccinated with second dose of Gardasil, injection (Lot#655503/0012U). Concomitant therapy included Yaz. On 02-MAR-2007, after administration of Gardasil the patient experienced dizziness and was close to fainting. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from dizziness and close to fainting. The product quality complaint unit was not involved. Additional information has been requested. The same source also provided information concerning other patient's experiences (WAES# 0703USA04318 and WAES# 0703USA04319).
Moderna COVID-19 Vaccine  I had a rash show up 8 days after my vaccine right around the area of the site of injection. It continued to grow over the weekend and is now covering a large part of my arm. I looked it up and it matched the pictures of ?COVID arm?
1) small headache day after shot 2) pain in lymph node that started about 7 days after shot - pain continues 3 weeks after shot.  Exam at doctor noted no issues 3) unable to taste bitter tastes which started about 7 days after shot 4) periodic metallic taste in mouth 3-4 times within three weeks after shot.
Client was administered a pediatric dose of Hep A, error was recognized and second dose of Hep A pediatric given to remedy. Client was informed of error while still in clinic and consented to getting other "half" of dose. Client was monitored for 15 minutes post second vaccine with no adverse events reported or observed.
Breakthrough COVID infection, known exposure starting Aug 10 (grandma/caregiver), mom turned positive Aug 13-14, PT tested positive Aug 16, difficult to know exactly when symptoms started for him. Mild upper respiratory symptoms only for him. Mom (reporter) had rebound COVID and patient was still testing faintly positive at that time (Aug 25).
redness, swelling & then cyanosis of bilat legs w/baby crying inconsolably @ 255PM;305PM pt no longer crying w/color of legs only sl red & dec edema & no cyanosis;pt seen @ ER for observation;
Pt recv vax on 9/21/98; on same day pt exp fever (101.6), chills, muscle aches, headache
A report has been received from a Health Professional concerning a 13 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 06-Dec-2013. It was reported that patient was given an expired FLUMIST QUADRIVALENT which started on 06-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
sore headache; rush all over her body, is bad in her ankles; really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really sore arm), RASH (rush all over her body, is bad in her ankles) and HEADACHE (sore headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (really sore arm). On 11-Mar-2021, the patient experienced RASH (rush all over her body, is bad in her ankles). On an unknown date, the patient experienced HEADACHE (sore headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (really sore arm), RASH (rush all over her body, is bad in her ankles) and HEADACHE (sore headache) outcome was unknown.            Concomitant medications included blood thinner medications.
This case was reported by a consumer and described the occurrence of general body pain in a adult female patient who received SHINGRIX (batch number EH9Z7, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for tolerance to the 1st dose refer case US2018158666). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced general body pain, nausea and pain in arm. The patient was treated with CORICIDIN HBP (Nos). On an unknown date, the outcome of the general body pain, nausea and pain in arm were unknown. It was unknown if the reporter considered the general body pain, nausea and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. One hour before shot 2nd dose of SHINGRIX and 4 hours after shot, the patient received CORICIDIN HBP. Next morning, the patient experienced slight body aches, slight nausea and arm soreness. It was not really as bad as 1st shot of SHINGRIX. The reporter provided the details of the physician who was most familiar with the reported event and consent to contact the physician.
suspected vaccination failure/; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's brother's wife. The age at vaccination was not reported. The patient had the shingles shot and still got the shingles bad. The reporter stated that they would not ever get the shingles shot as Medicare would not pay for it anyway and even if they did, they still would not get that crazy shot. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case was linked with case US2021AMR231049, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR231049:same reporter
3/10/14 Developed urticarial rash at 9am. Diphenhydramine PO recommended.
About weeks later, I felt fatigued, had joint pain with SOB. Went to the doctor, ran Chest CT and diagnosis was inflammation in lungs. Doctor was not sure if diagnosis was vaccine related. Symptoms lasted about 2 months, now taking steroids.
1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; 1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 2, single (Lot number: N9581) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTTS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 12Jan2021, when the patient was 77-year-old, for Covid-19 Immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), HEADACHE (non-serious), COUGH (non-serious), FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Feb2021, outcome "unknown" and all described as "1st-5th doses mild flu like: HA, SLcough, fatigue sore arm 48hrs".  Additional information: Relevant past drug history: Name of Drug as Reported: Unk. Reaction: Allergy. Prior to vaccination, was the patient diagnosed with COVID-19:No. Since the vaccination, has the patient been tested for COVID-19:Yes. List of any other medications the patient received within 2 weeks of vaccination is MULTIVIT, LOSARTAN.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201380992 same patient and different drug dose/events.;
This patient was given an MMR vaccination to the left arm. As soon as he got the injection the patient had a red rash covering injection site and 1/2 the arm, plus red spots started to break out on his back. Went to get the doctor to look at the patient right away. The patient was given Benadryl, it helped control the rash and it started disappearing in some areas before the patient left. The mother was told to continue Benadryl.
Awakened at 1am with headache, chills which increased in intensity until 3:30am when I took three 200mg Advil. Awakened at 6am with stiffness in knees, back, slight diarrhea and severe headache. Took 3 more Advil at 9:45am, napped. Pretty much felt lethargic with joint/muscle stiffness and dull headache all day and to present at 6:38pm. I've never had a reaction to a vaccine like this. Even the first dose was only arm pain and nothing else.
I have a large red area that is hard and its also hot, kinda itchy; I have a large red area that is hard and its also hot, kinda itchy; I have a large red area that is hard and its also hot, kinda itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy) 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 ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy). At the time of the report, ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
Muscular weakness, fever, weak, back pain x 6 days; anorexia, loss of reflexes; conduction-block; Guillain-Barre-type inflammatory polyneuropathies;
Sore arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm for a day) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Sore arm for a day). At the time of the report, INJECTION SITE PAIN (Sore arm for a day) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable    No treatment drugs were reported   This case was linked to MOD-2021-014582 (Patient Link).
Developed hives on face and both arms.  Released after 30 minutes of monitoring with no further progression of symptoms.  Returned one hour later reporting scratchy throat and feeling of being swollen all over.  Also presented with increased redness on face (blushing). No difficulty with shortness of breath.  Escorted to ER for monitoring.
This case was reported by a nurse and described the occurrence of a swollen leg in a 4 year old male pt who received Infanrix. On 7/22/04, the pt received the 5th dose of Infanrix in the left thigh (lot DTPA614A9). Approximately 1 day after the 5th administration of Infanrix, on 7/23/04, the pt experienced a swollen leg. The pt was seen at a physician's office and was treated with steroids. The event resolved on 7/29/04. The nurse considered the swollen leg to possibly be related to vaccination with Infanrix.
pt recv vax 22JUN98 & sl fever & high pitched crying for 6hr;
This spontaneous report as received from a pharmacist via company representative refers to two patients of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 injection (dose number, route, lot number and expiry date unknown). On an unknown date the two patients experienced severe swelling at the injection site after administration of PNEUMOVAX23. Both patients sought medical attention. The outcome of severe swelling at the injection site was reported as recovered/resolved. No further information was provided. Additional information is not expected.