chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Legs were shining like they were moisturized and when I pressed down I can tell they were swollen.; It did go down a lot but when I shake my leg I can feel the water on top of my foot.; I had a little headache; Swelling of Breast area and Lymph Nodes; blood pressure went up to 167/102; Swelling of Breast area and Lymph Nodes; Tenderness of Breast Area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure went up to 167/102), BREAST SWELLING (Swelling of Breast area and Lymph Nodes), BREAST TENDERNESS (Tenderness of Breast Area), PERIPHERAL SWELLING (Legs were shining like they were moisturized and when I pressed down I can tell they were swollen.) and OEDEMA PERIPHERAL (It did go down a lot but when I shake my leg I can feel the water on top of my foot.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Mastectomy.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HYPERTENSION (blood pressure went up to 167/102), BREAST SWELLING (Swelling of Breast area and Lymph Nodes), BREAST TENDERNESS (Tenderness of Breast Area) and LYMPHADENOPATHY (Swelling of Breast area and Lymph Nodes). On an unknown date, the patient experienced PERIPHERAL SWELLING (Legs were shining like they were moisturized and when I pressed down I can tell they were swollen.), OEDEMA PERIPHERAL (It did go down a lot but when I shake my leg I can feel the water on top of my foot.) and HEADACHE (I had a little headache). On 27-Mar-2021, HYPERTENSION (blood pressure went up to 167/102) had resolved. At the time of the report, BREAST SWELLING (Swelling of Breast area and Lymph Nodes), BREAST TENDERNESS (Tenderness of Breast Area), LYMPHADENOPATHY (Swelling of Breast area and Lymph Nodes) and HEADACHE (I had a little headache) outcome was unknown and PERIPHERAL SWELLING (Legs were shining like they were moisturized and when I pressed down I can tell they were swollen.) and OEDEMA PERIPHERAL (It did go down a lot but when I shake my leg I can feel the water on top of my foot.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: 167/102 (Inconclusive) 167/102. On 27-Mar-2021, Blood pressure measurement: 128/82 (Inconclusive) 128/82.     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 relevant concomitant medication was reported.  Treatment details included, pain medication.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 12-May-2021 and New events (Peripheral Swelling, oedema Peripheral, Blood Pressure increased, headache) were added.  Contact information updated.
Received 2 Hepatitis A/B vaccines.  Developed myalgia-were prolonged after 2nd shot.
3/9/08 told by client that after school he was having a lot of pain in his left arm, it swelled up, he got nauseated and vomited, and his throat felt itchy.  His parents took him to the ER.  Parents Spanish speaking only.  Client reported no treatment.
The pt's left upper arm was red, warm to the touch on 6/5/01, gave Benadryl and was worse the following day. There was a 5 x 8 area of erythema and warmth. No discomfort with movement.
feverish; ached all over; GI Issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021, outcome "recovered" (2021), described as "feverish"; PAIN (non-serious) with onset 13Nov2021, outcome "not recovered", described as "ached all over"; GASTROINTESTINAL PAIN (non-serious) with onset 13Nov2021, outcome "not recovered", described as "GI Issues".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I first time experienced hoarseness and that progressed into congestion. I had a low-grade fever at 100.5 degrees. I also had fatigue. The second time was more significant, I felt much worse It started with sore throat congestion and low-grade fever at 100.4 degrees. The fever the lasted over several days. I also had significant fatigue. I also had a UTI type of symptoms, diarrhea. I was prescribed Paxlovid.
Myalgia, NauseaVomiting, fatigue missed work following second dose due to symptoms
102 F fever for 24 hours. Broke with tylenol and came back. Overall sick feeling.
On 5/20 patient started experiencing right arm and leg weakness, accompanied by right sided facial numbness and facial droop.   She was taken to the ER and admitted to the hospital for right sided hemiplegia and left sided frontal lobe stroke per MRI.  No signs of atrial fibrillation.  Hospital notes indicate that etiology of stroke is unclear.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received HAV (Havrix) (batch number U016222, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 01-MAR-2023 Reporter's Comments: The reporter consented to follow-up via email. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Almost 12 hours after receiving the injection I woke up from sleep with chills and a fever. This didn't last long - maybe a couple hours. I fell asleep without an issue and woke up in the morning with SEVERE arm pain as well as fatigue and like generalized weakness - I essentially felt like I was getting sick with a cold or something. This lasted a couple days but the arm pain was terrible. It felt like someone had taken a baseball bat to my upper arm - I had very limited range of motion and felt severe pain in the region of my joint capsule. This eventually went away, but I still feel like my arm is a little stiffer than it was previously - it cracks and pops when I do yoga and such and it never did this before.
Dose was inadvertently administered to the patient after excursion due to power outage .Patient was notified same day. Patient did not report  any side effects.
COVID 19 Treatment/ tested positive for COVID on 24Jun2022; COVID 19 Treatment/ tested positive for COVID on 24Jun2022; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastric reflux" (unspecified if ongoing); "frequent headaches" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Tylenol, reaction(s): "Known allergies: Tylenol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "unknown" and all described as "COVID 19 Treatment/ tested positive for COVID on 24Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (30Jun2022) Negative; (01Jul2022) Negative; (07Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was exposed to COVID ON 20Jun2022 and tested positive for COVID on 24Jun2022 - rapid home test. Began treatment with Paxlovid later that day and completed treatment on 29Jun2022. Patient took all doses roughly 12 hours apart. Symptoms of body aches. Low grade fever, chest congestion and headache resolved before treatment ended and patient felt good. Some mild pluritic chest pain with non productive cough continued 1-2 more days and mild sinus drainage continued throughout 10 day quarantine. Patient tested negative on 30Jun and on 01Jul2022. On 03Jul2022 sinus drainage increased and on 05July I felt unwell with much more sinus congestion and pressure. She repeated home test and it was immediately positive. Restarted quarantine. Patient was still positive on 7Jul2022 but sinus congestion was improving. She was feeling better but she had a headache. Additional issue was she developed a macular hole with blurred vision in her right eye around 28Jun2023 physician said this was unrelated. Other medications included omeprazole, multivitamin, D-3 2000iu, ibuprofen, Docusate na100 mgx2 all started on 01May2022.  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, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
The pain woke me up at 6:30AM on 5/22. It was very intense, and I called out of work. I spent the next two days in bed. I didn't go to the doctor for the same reason I didn't go for the 1st vaccine and health event. There wasn't any specific health treatment that was necessary. I would say it was worse for two days and the third it was getting better and after that I was better. I also had a period that started the 1st of June and lasted through June 28th. Because I have the Mirena, I haven't really had periods for several years but spotting here and there. Maybe 2 days of spotting every two months so this was a radical difference. I had a period for a whole month. I also had a period from July 15-23rd. I have had since then, 1 on August 1 in September, and 2 in October for periods. And each lasted about 8 days. It's definitely irregular as far as what's been happening with my body for the last 5 years. None of the periods are heavy, they just go on forever. September 22-October 8 for one of the periods. then started again on 10/27 and I'm still having a period currently. I did go to the doctor after the cysts at the end of June and I talked to my doctor about it, and we decided to just wait on the periods to even out.
PATIENT IS UNABLE TO LIFT THE ARM IN WHICH THE VACCINE WAS GIVEN DUE TO GREAT PAIN. SHE STATES THAT IT IS NOT GETTING ANY BETTER DESPITE WAITING SEVERAL DAYS.
Severe pain at the injection site for several days. Watery eyes, hot/cold chills and nasal drainage.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR. Provider d/c note: "Patient is a 79-year-old male past medical history of CHF, CKD, hypertension, prostate cancer.  He presents for chief complaint of progressive weakness resulting in a fall this morning.  Patient states he normally walks with a cane or walker.  He is found himself to be progressively weak off the past several months related to right hip pain.  He notes several mechanical falls over the past few days.  Patient is able to recall an episode of falling this morning landing on his right hip.  He denies lightheadedness dizziness presyncope or syncope.  Denies any injuries hitting head or abrasions.    Trauma workup negative in ER. Pt was found to be covid positive, he initially didn't require O2 although soon after admission was found to be desaturating into 70s requiring 100% HFNC.  He was started on steroids and O2 was weaneed down daily to point of not needing at all.  He did receive a few days of empiric abx as difficult to tell if complicated by bacterial pneumonia. He was evaluated by PT/OT  who recommended therapy on DC although wife was adamantly against this and wanted him him.  Patient did have episode of delirium while inpatient. Unsure if 2/2 steroids or sundowning although this resolved in morning. He was subsequently discharged in stable condition."
This case was reported by a physician via sales rep and described the occurrence of delirium in a 90-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced delirium (serious criteria GSK medically significant). On an unknown date, the outcome of the delirium was recovered/resolved. It was unknown if the reporter considered the delirium to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician spoke with GlaxoSmithKline Medical Science Liaison (GSK MSL) employee that one of his patients experienced delirium 2 to 3 days after a dose of SHINGRIX. The symptoms were resolved however, the physician asked MSL whether the symptoms were associated with the vaccine. The MSL was asked if the sales representative called GSK to report adverse event. The MSL said that she did not think so because she spoke with the physician directly. The MSL did not have contact information for this physician. The MSL was not sure how the last name was spelled either. The MSL would get all those details in a couple of days. The MSL provided reference number and requested a callback so GSK could send follow up to this case.
Headache, Myalgia, HEADACHE, BODY ACHES, WEAKNESS, FATIGUE, VERY SORE LEFT ARM Narrative:
(+) redness, swelling tenderness in L thigh measuring about 9.5 x 14cm.
Fever of 100-101, chills, headache, body aches, nausea starting in the middle of the night after receiving vaccine earlier that day and lasting for about 24 hours.
Pt. C/O thick tongue and throat scratchiness same as when she took Penicillin.  Pt give Benedryl, IM and within 5 min stated feeling better, no more sx reported
Lightheaded about 15 minutes after vaccine. The next day I  was tired, light headed,  headache, fever. The day after that I had horrible headache, very dizzy and had bad chest pains.
pt recv vax 28OCT98 & 29OCT98 high fever 104;pt w/congestion, cough, whelps (red, raised areas);
Today pt reported that she had swelling of the left arm, redness, experienced fever and chills starting the night of vaccination and lasting for one to one and one half days. She states that she is fine now with no lingering issues.
she is extremely sick; abdominal pain/sharp pain; has severe headaches; nausea; got chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she is extremely sick), ABDOMINAL PAIN (abdominal pain/sharp pain), HEADACHE (has severe headaches), NAUSEA (nausea) and CHILLS (got chills) in a female patient of an unknown age 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 ILLNESS (she is extremely sick), ABDOMINAL PAIN (abdominal pain/sharp pain), HEADACHE (has severe headaches), NAUSEA (nausea) and CHILLS (got chills). At the time of the report, ILLNESS (she is extremely sick), ABDOMINAL PAIN (abdominal pain/sharp pain), HEADACHE (has severe headaches), NAUSEA (nausea) and CHILLS (got chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On the 24th, I noticed the same  itchy, painful bumps on my hand. It spread to my whole body.  They are still there.
Sore throat; Chest congestion; Immense muscle pain; Debilitation back pain; Over tiredness; Sleeping over 18 hours per day; Severe congestion; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 09Apr2021 at 15:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to just nickel metal. 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. Concomitant medications were not reported. On 10Apr2021 at 16:00, the patient experienced severe congestion, sore throat, chest congestion, immense muscle pain, debilitation back pain, over tiredness and sleeping over 18 hours per day. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe congestion, sore throat, chest congestion, immense muscle pain, debilitation back pain, over tiredness and sleeping over 18 hours per day were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sinus problems; Stomach pain; Sick feeling; Fast heart beat; Muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat) and MYALGIA (Muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat), MYALGIA (Muscle pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SINUS DISORDER (Sinus problems), ABDOMINAL PAIN UPPER (Stomach pain), MALAISE (Sick feeling), HEART RATE INCREASED (Fast heart beat), MYALGIA (Muscle pain) and FATIGUE (Fatigue) outcome was unknown.            This case was linked to MOD-2021-325764 (Patient Link).
This spontaneous report was received from a nurse via company representative and refers to a female patient in her 20's. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-MAR-2018, the patient was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II lot number M011666 with expiration date on 08-MAR-2018, it was stated that the dose dose was expired by 9 days (strength , dose, route of administration and anatomical location were not reported) for prophylaxis. Additionally, it was reported that on 19-MAR-2018, the patient received a tuberculin skin test, no results were provided and no adverse effects were reported.
My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (age at the time of vaccination 54-years-old), as a single dose for covid-19 immunization. Medical history included glaucoma, allergy to Sulfa drugs, and COVID-19. There were no concomitant medications. The patient previously took historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 703-288), via an unspecified route of administration, administrated in Left arm on 06Jun2021 12:00 PM (age at the time of vaccination 54-years-old), as a single dose for covid-19 immunization and on 06Jun2021 06:00 PM patient experienced Weird Stinging sensation behind my right knee, high fever, and chills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On an unspecified date, the patient experienced my second shot also had fever and chills, and greatly inflamed tendonitis in my elbow which also has yet to go away. On 28Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative, Nasal Swab. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
EXACERBATION OF CHRONIC FATIGUE SYNDROME/ACTIVITY INTOLERANCE/BRAIN FOG/GENERALIZED WEAKNESS/MALAISE; FEELING VERY POOR; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: on and off anaemia, chronic fatigue syndrome, pollen allergy, iodine allergy, and latex allergy, and other pre-existing medical conditions included: The patient was on blood thinner. The patient had lot of health problems. The patient denied ever having active COVID infection/diagnosis. The patient experienced drug allergy when treated with lisinopril for drug used for unknown indication.  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 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 11-MAY-2021, the patient experienced exacerbation of chronic fatigue syndrome/activity intolerance/brain fog/generalized weakness/malaise. On 11-MAY-2021, the patient experienced feeling very poor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from exacerbation of chronic fatigue syndrome/activity intolerance/brain fog/generalized weakness/malaise, and feeling very poor. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.