chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme swelling at injection site; Redness; Pain / Leg pain; This case was reported by a consumer via patient support programs and described the occurrence of injection site swelling in a 3-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Previously administered products included Flulaval Quadrivalent with an associated reaction of injection site swelling (received last year and had more swelling, refer case US2019AMR184239).   On 5th October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient's grandmother reported for the patient. The patient received dose of FluLaval Tetra 2019-2020 season in unknown thigh. The reporter stated that, after vaccination with dose of Flulaval quadrivalent, the patient experienced extreme swelling at injection site, redness, and pain. This case has been linked with case US2019AMR184239, reported by same reporter.
Information has been received from a medical assistant referring to a 23 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 02-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007540: US-009507513-1902USA007537: US-009507513-1902USA007536: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1901USA008772: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550: US-009507513-1902USA007541:
The day after my vaccine, 11/27/2021 at 03:30AM-my bones, I could hardly stand. In the shower I felt like I had fiberglass shards from my ear lobe to the bottom of my chin to the other ear lobe. It was itchy and it hurt to itch. The itchiness is only on my face. The itchiness stayed. But the feeling of not being able to stand lasted a day 1/2. It was overwhelming body aches and pain. The body aches felt like I had COVID all over again. That lasted 1 1/2 days. I was out of work for one day and I have been back ever since. My left lymph node swelled in my neck. The lymph node went away. Note: I had COVID-19 last year 2020, I was out for a month. I had a doctor appointment on 12/05/2021 I  started getting blisters on my lips. They were numb and they were swelling. And it felt like I had a severe burn. The doctor told me to keep a close eye on it. I was basically told to put a topical lotion on my lips.  12/01/2021 I had my blood work done. 12/05/2021 I found out I was diabetic. I went to a dermatologist on 12/02/2021- because my lips are peeling and cracking. She prescribed Eucrisa. They are still peeling. There is nothing else on my face. I have rosacea. It is nothing they have seen before. The doctor said if this is an adverse effect, they have not seen it before.  I go back on 01/06/2021 for a follow up. My bottom lip is numb and it looks like I have Botox on my lips. I do take a Benadryl in the morning because it still itches under my skin. They asked me, did I change makeup or soaps, and the answer is no.
swelling spread to half of right breast and down to middle of rib cage; swelling in underarm area; right shoulder & half of right breast is red and itches; pain and redness in right arm; pain and redness in right arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot Number: lot ER8736) via an unspecified route of administration, administered in right arm (upper right arm) on 25May2021 11:15 AM (at the age of 68-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol and had known allergies from an unknown date and unknown if ongoing. The patient's concomitant medications included estrogens conjugated (PREMARIN), ezetimibe (ZETIA), both taken for an unspecified indication, start and stop date were not reported. Patient was non pregnant at the time of vaccination. Patient took no other vaccine within four weeks of covid vaccine. Patient did not have COVID prior to vaccination. Patient did not tested for covid post vaccination. On 25May2021 11:45 AM the patient experienced pain and redness right arm, and right shoulder & half of right breast is red and itches, on 26May2021 on Wednesday or next morning experienced swelling in underarm area, on 27May2021 on thursday patient experienced swelling spread to half of right breast and down to middle of rib cage and on friday or every is still swollen today. No treatment received for the events. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Pt initially called on 9/21/10 and stated after receiving ZOSTAVAX she still has redness after 6 days at injection site; no pain slight swelling redness approximately 1 1/2" width; spoke with pt again on 9/23/10 pt still has redness same size - no pain or swelling now, little itch.
right optic neuritis; multiple sclerosis; intermittent numbness; weakness in her lower extremities; This spontaneous report was received from an unspecified reporter (reported as researchers) via an online article referring to a 17 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. Two weeks after that (date unknown), the patient experienced blurred vision in the right eye. A right frontal enhancing lesion was seen on brain magnetic resonance imaging (MRI). She was diagnosed with right optic neuritis and did not receive further doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). One week after discharge, she experienced intermittent numbness and weakness in her lower extremities in addition to blurred vision in her right eye. A repeat brain MRI revealed a new left parieto-occipital enhancing lesion. The outcome of the events was unknown. The causality assessment was not provided.  Upon internal review, left optic neuritis and optic neuritis were determined to be medically significant.  This is one of several reports received from the same source.; Sender's Comments:  AU-MERCK-0908USA04367: US-009507513-1803USA006311: US-009507513-1803USA005270:
This case was reported by a physician via sales rep and described the occurrent of injection site pain in a 18-year-old female patient who received BEXSERO (batch number 151401A, expiry date unknown). On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: This case was reported by a doctor of medicine. The age at vaccination was not reported. The patient received BEXSERO on an unknown arm. The reporter stated that following the first dose of BEXSERO the patient could not lift her arm for a few weeks and had pain in the vaccinated arm that lasted for a few weeks. The events resolved and did not required doctor visits. The reporter did not have vaccination date or expiration of vaccine. I was reported that this was made in error. however, there was no duplicate case was identified and no further clarification could be obtained.
After 2 hours I took nap around 12:30p. Woke up 1:45p and headache still present. Took Tylenol around 2:15p. Upon driving to work noticed headache worsened and left eye turned red as well as both eyes watering. That was 2:25p. Around 3p nausea began to set in. Called work and told then I could not work shift because of migraine headache, throbbing behind eyes, left being red and both eyes watering.  Side effects beginning to lessen now at 6:20p. Headache starting to go away but left eye is still red but both eyes are not watering currently.
Headache, local swelling and redness at glut, neuralgia 3 weeks. Antihistamine, ice, elevation, cold laser treatment.
Within a 12 hours of injection I was running a fever of 101 which lasted 24 hours. Approximately the same time as the onset of fever my gums became severely inflamed  and sensitive along with my lips being numb. Although the pain has moderated the symptoms of inflammation and numbness persist to this day approximately  10 days after injection. I was seen by dentist 6 days after injection and he has shared with colleagues the situation.
9th day post inject site red and itchy then are was slightly sore. Redness was 4 inches by 2 inches and lasted for 4 days
On 06/08/2021 My ears started ringing and felt like I had an ear ache.  On 06/09/2021 I had fever, convulsing chills, headache, earache, tired, sore, nauseous  and hurt  all over.  On 06/10/2021, same symptoms at lessor degree of intensity but now I have mouth sores.  On 06/11/2012, I felt better.  On 06/12/2021, nausea, fever, chills, earache, headache and severe tiredness hit full force again.  On 06/13/2021, overwhelming tiredness and nausea.  06/14/2021 same as day before.
5x4cm erythema, warmth, swollen, tender area w/fine rash @ inj site which resolved in 2-3 days;
Migraine; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In March 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant products were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.   No treatment information was reported by the reporter.  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.  Company Comment:  This spontaneous case concerns a 65-year-old female patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant ) adverse event of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and event onset date were not disclosed. Patient received a 2-dose primary series of mRNA-1273 vaccine given on unknown dates, at an unknown interval.  The relevant medical history of Rheumatoid arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant ) adverse event of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and event onset date were not disclosed. Patient received a 2-dose primary series of mRNA-1273 vaccine given on unknown dates, at an unknown interval.  The relevant medical history of Rheumatoid arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Received flu vaccine at 12:00 noon on Saturday Sept 5.  Became ill at 1:00 pm on Sept 5.  Fever, headache, cough, nose congestion and chest congestion, vomiting, fatigue, sore body joints.  Some symptoms lasted 9 days.
No adverse reaction to vaccine.  Using system to report onset of Covid19 symptoms and positive antigen tests confirming that the patient had a Covid19 breakthrough case following travel.  Symptoms were mild: throat irritation, cough, nasal congestion and sneezing, tiredness.  Low fever, did not exceed 101 degrees F.  O2 levels as measured by pulse oximeter were consistently 96-99%.  Patient's doctor was notified of the positive test and the doctor's office called to consult with the patient on May 3.  Status of symptoms did not warrant further medical attention.  Last positive antigen test May 8.  Tested negative on May 11.
Immediate headache. I was in a fog for several hours after vaccine. My left side of my face has felt weird ever since getting the vaccine 4 days ago. I felt pain and pressure on the let side of my face starting the same day I received the vaccine.
pt recvd vax 18MAR93 & was dx w/lt OM & rt external ear canal trauma; 15MAY94 was dx w/H. flu bacteremia confirmed by blood culture;
Information has been received from a physician concerning a 16 year old male who on 10-JAN-1995 was vaccinated with a first dose of MMR II (HSA). On 23-FEB-1997, the patient was vaccinated with a second dose of MMR II (HSA) (route, sites and lot numbers were not reported). On 14-NOV-2009 the patient experienced mumps. On 16-NOV-2009 the patient was diagnosed with mumps. The patient was afebrile. Parotitis count was 39. Laboratory tests on 16-NOV-2009 showed serum immunoglobulin M test - negative, serum immunoglobulin G test -6.3 and serum amylase - 459. The patient had left parotitis. At the time of report, the patient's status was unknown. The outcome of mumps was not reported. Follow-up information was received from a physician who reported that the patient experienced mumps on 30-NOV-2009 (previously reported as 14-NOV-2009). The patient had right parotitis. The first blood work was not done. This is one of several reports from the same source. No further information is available.
Patient received 0.5ml imtramuscular of Flulaval to the Left Deltoid.  Mom stated and patient's records documented that patient received flu vaccine in 8/2022.  Mom and Dad informed.  Post vac instructions provided and they were able to repeat them and stated they understood
This is a spontaneous report from a contactable consumer (patient).  This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route in the right arm, on 23Feb2021 12:45 (at the age of 47-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Dec2020. The patient did not have concomitant medications. On 01Mar2021, the patient developed runny nose, congestion, a little bit of weakness and tired. He said he felt like he did when he had the COVID-19 virus in Dec2020. He said when he had the COVID-19 Virus in Dec2020, he had the virus for a few days, and the virus was not bad. He clarified he had the COVID-19 Virus for like 10 days total. He clarified he had a runny nose, congestion, a little bit of weakness, and was tired. He said today (on 02Mar2021) his symptoms were not as strong as yesterday, clarifying his symptoms were down by maybe 20% from yesterday. He took some liquid dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) for his symptoms. The events did not require emergency room visit/physician office visit. The patient was recovering from the events.  No follow-up attempts are possible; information about Lot/Batch number cannot be requested.
Pt developed "head rush" then tingling feeling in legs after vaccination, also felt like he wanted to cry. Denies chest pain, SOB, trouble breathing or swallowing. Pt discharged home in stable condition.  SpO2 98% RA  BP 132/81 HR 84 Respirations 18, unlabored.
abdominal pain and skin rashes ---ED x2 eventually determined it was Chronic Spontaneous Urticaria -----controlled, NOT cured, by daily antihistamines
Chest pain centered at the heart. Pain was both consistent (at a level 3/10) and would at times spike in pain level (to 7/10). No chest pain has ever been felt as severe as this before.  The pain started earlier the day after the vaccine and became worse at night. Throughout the rest of that week it took at least 4-5 days before I felt comfortable enough to run and continue my usual physical activities.
Patient's mom states patient developed hives on neck and face.  Her face began to swell and she ran a low grade fever.  She gave the patient Claritin 10mg and Tylenol.  Patient also used Benadryl and Hydrocortisone Cream for the itch.  Mom states patient also had some wheezing on Saturday 10/09/10 during a soccer game that resolved with rest.  Patient did not seek medical attention at any point.
tested positive for COVID on Thursday 05May; tested positive for COVID on Thursday 05May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gilbert's syndrome" (unspecified if ongoing). Concomitant medication(s) included: MIRENA, start date: 15Oct2015, also reported as other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "not recovered" and all described as "tested positive for COVID on Thursday 05May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive; (11May2022) Positive; (12May2022) Negative; (13May2022) Negative; (18May2022) Positive, notes: felt sick again and tested positive; (19May2022) Positive; (20May2022) Positive, notes: have tested positive the last three days. On Thursday(19May2022) and Friday(20May2022) felt only mild symptoms. Friday's antigen test line was almost non-visible. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (start date: 05May2022, stop date: 10May2022). Clinical course was reported as, Patient tested positive for COVID on Thursday 05May2022 and Belgian Paxlovid that evening. She felt better but still mildly symptomatic by day 3. Patient again tested positive through Wednesday 11May2022 but negative on Thursday 12May2022 and Friday 5:13. Then on 17May2022 at 13:00 patient felt sick again and on Wednesday 18May2022 she tested positive. Patient have tested positive the last three days, though Thursday and Friday. She felt only mild symptoms. Patient expect she will test negative today (at the time of report) because Friday's antigen test line was almost non-visible. No therapeutic measures were taken as result of symptoms and patient was recovering from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On the 01/06/2021  I noticed that I had a fever of 100.9 I was really fatigued . I Thinking I was okay . I went to visit the nail shop and fainted.. I was rushed to the hospital . My heart was fluttering and racing . My blood pressure was also low .
Right arm pain to hand with shooting pain two days after. Some numbness in right palm and fingers. Severe bone pain. Joint pain but this seemed like bone pain. Worse pain I've ever had even compared to child birth. The bone pain was like nothing I have ever experienced. Shortness of breath and some chest pain with gasping for air twice while trying to fall asleep, which has never happened to me. I'm very healthy.
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three-years old patient who was vaccinated with a dose of PENTACEL (lot number: C5552AA and expiry date: 10-Oct-2019) in the right deltoid instead of DAPTACEL on 12-Oct-2018. On 12-Dec-2018, the patient also received a dose of suspect HIB (PRP/T) VACCINE lot C5552AA in the right deltoid and PNEUMO VACCINE (lot number not reported) concomitantly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered as patient was supposed to get a DAPTACEL vaccine, but was given PENTACEL instead. No adverse events 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 and Module VI of the 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. List of documents held by sender: none.