chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Interchange of vaccine products; Little soreness in upper arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Feb2023 as dose 4 (booster), single (Lot number: GJ3274) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing), notes: Takes blood pressure medicine, takes a statin, has been taking now for a year, or 9 months. The patient took concomitant medications. Vaccination history included: janssen covid-19 vaccine (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 12May2021, for COVID-19 immunisation; janssen covid-19 vaccine (DOSE 2, SINGLE, Anatomical location: Left arm), administration date: 22Dec2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FP7138, Anatomical location: Left arm), administration date: 24Aug2022, for COVID-19 immunisation, reaction(s): "Interchange of vaccine products", "On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "recovered" (2023), described as "Little soreness in upper arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "recovered". Additional information: This report was not related to a study or programme. Previously had one of the boosters, did not have much as much reaction, had a little soreness, nothing to speak of. Just had a little soreness in upper arm, which was fine. Had that before, did not think much of it. All COVID vaccines given in left arm. Is right-handed, would have likely had in left arm. Nothing changed before she took this, was all same stuff she had always been taking and supplements, stuff like that. Never had COVID, thank God. There was no Family Medical History Relevant to Adverse Events (AEs).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312069 same patient/vaccine, different dose and event;US-PFIZER INC-202300312075 different patient/vaccine, different dose and event;US-PFIZER INC-202300024576 same patient/vaccine, different dose and event;
Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 6/12/2022 Discharge Date:  06/13/2022  PRESENTING PROBLEM: Hypoxia [R09.02] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: 78-year-old male with multiple medical problems including atrial fibrillation and history of chronic obstructive pulmonary disease.  He presented actually with complaints of some left chest discomfort that resolved spontaneously.  And no significant EKG or laboratories findings suggestive of ischemia.  He was tested for COVID and found to be COVID positive and hypoxemic.  He is admitted for further treatment of his hypoxia and presumed COVID pneumonia.  The patient was started on remdesivir as well as dexamethasone.  Surprisingly the patient had very dramatic and rapid improvement in oxygenation.  By the day of discharge his oxygen levels return acceptable without supplemental oxygen.  He was continued on dexamethasone post discharge.  He was also encouraged to get a COVID booster in the future once he recovers from his current COVID infection.  His other routine medications were left unchanged.
This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a Registered Nurse concerning a 26 year old female who on 02-OCT-2008 was vaccinated with the first dose of GARDASIL (660393/0067X). Concomitant therapy included TRI-SPRINTEC. Subsequently the patient developed tenderness at the injection site, as well as swelling and soreness. The patient returned to the office on 23-OCT-2009. There was bruising 4 inches below and anterior of the injection site. There was no masses, no redness and no induration. Tenderness was present. The patient was told to use hot compresses three times a day for 1 week and to call the office if her symptoms persisted. Follow up information received from the physician indicated that the female patient with no known allergies/drug reactions complained of persistent pain at the site of injection and bruising just below injection site which started on 02-OCT-2008 and lasted for six weeks. On approximately 16-NOV-2008, the patient recovered. Additional information is not expected.
@ 450PM mom called clinic to report swelling to rt eye, nose, lips & lt wrist w/itching;advised to take to ER;given DPh & vomited;
Pt complains of pain/inflammation in injection site, and she also started running fever on Thursday 3/21/19 at about 11:30 AM of about 101 degrees all day, and again on Friday 3/22/19 (fever slightly lower).
No adverse event; patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023).    Concomitant product information was not provided by the reporter.   Patient didn't had any information about previous COVID-19 vaccination doses and it was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient received the vaccine on 14-Apr-2023.  Treatment medication was not provided.
- Received shot Tues afternoon; minor discomfort at injection site.  - Started to feel extreme fatigue Weds. afternoon (approx 1300hrs) quickly followed by increasing muscle cramps and joint pain/joint aches.  - Finished workshift (1630hrs), drove home, took TheraFlu and went to sleep (approx. 1730).  Woke (approx 2330hrs, Weds night) in profuse sweat and dizzy/disoriented.  Got some water; went back to sleep; joints still hurt; still extremely tired.   Woke Thurs. morning (approx 0400) still sweating and itchy; upon waking noted large distinct hives on torso, chest and arms; very itchy.  Joints still ached/hurt to move; had extremely painful migrane/headache (very sensitive to light/sound, "pain in the center of skull" which varied between different quadrants of head; eventually migrane nausea).  - Called in to work sick, took Tylenol went back to bed.  Could not sleep due to migrane.  - Migrane and muscle/joint pain began to ease approx. Thurs evening (approx 1700hrs) followed by deep sleep Thurs. night.  Woke Friday morning with 'residual' headache; reported for duty.
Numbness, tingling down left arm after injection, followed by numbness and pain (5/10) elbow to wrist, the next day.
Patient developed chest pain the same day of the vaccine.  This pain was substernal and radiated to arm.  He observed this for a week and then contacted clinic after one week.  He was directed to the ER and was admitted for t wave changes on his EKG.  He had a normal cardiac cath and echo was diagnosed with likely pericarditis secondary to COVID vaccine.  Symptoms have resolved on clinic visit follow up today.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient has history of fainting with IVs but never to vaccinations. He said he gets stomach aches with sugar derivatives. First BP taken was 107/93 with a low pulse. 5 minutes later it was 165/93 pulse 99. We called the paramedics and they came within 5 to 10 minutes. Patient stabilized after.
Pt recvd vax 26APR94 & w/in 30 mins p/vax pt had a high pitched cry cont for 4 1/2 hrs & a stiff neck; afebrile; no inject site react; rx'd w/APAP fam h/o sibling who had fever, irritability & sz p/DTP;
COVID breakthrough case. I received my 2nd booster shot on 05/25/2022 and my COVID symptoms started on 06/16/2022 runny nose, cough, ears clogged. I did a telehealth with my doctor on 06/20/2022. She prescribed me medication for 5 days (antiviral) PAXLOVID.I tested negative on 06/23/2022.
The day after the booster I had fever, headache, chills and vomiting. I then had blood in my urine. I went to the doctor several days later. I have had several blood tests and a kidney biopsy. I had high protein levels in my blood and learned that I have IGA nephropathy. My symptoms have gotten better but I am fatigued. There is no treatment. My flare up seems to have gotten better.
half-inch long bump below the injection site; red below the injection site; warm below the injection site; headache; fever; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 18th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 19th July 2022, the patient experienced local swelling, localized erythema, skin warm, headache and fever. On an unknown date, the outcome of the injection site pain, local swelling, localized erythema, skin warm, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, local swelling, localized erythema, skin warm, headache and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comment: The reporter was patient. The patient had allergy to ultrasound gel. The patient received second Shingrix dose on arm. That day patient had pain at the injection site. 1 day after receiving Shingrix, the patient noticed a half-inch long, red, warm, bump about 2 inches below the injection site. The patient had a fever and headache on next day after vaccination. On the day of reporting the bump was greater than 1 inch and redness, swelling, warm skin were not recovered. The patient had nothing else to report. Reporter consented to follow up and might follow up with physician.
Headache, soreness of arm, high fever, exhaustion, heavy chest pain, tired.
1/10/2023 I started feeling unwell with an upset stomach and a bad headache. The next morning, 1/11/203, I was sick all over with dizziness and fatigue. I went to the clinic. I was tested for Flu, COVID, Strep. COVID was positive, Flu and Strep were negative. The doctor did not want me to take PAXLOVID due to the medications I was on. She told me to call my doctor. I called my doctor when I got home. I was prescribed methylprednisolone and azithromycin. On 1/11/23 I began taking the medications. I continued to have fatigue and dizziness.
Patient states she started to experience  severe anxiety that lasted for days after the vaccination. She also states that she has been experiencing tachycardia and a loss of appetite. Patient states that all these symptoms started about a week after the shot and is still having these symptoms persist. The patient is currently being accessed by her physician.
Patient received PNEUMOVAX 23 on 2/20/17, she woke up 2/21/17 with sore arm - got worse throughout the day. 2/22/17 started with red spots to arm, and arm pits. Tx w/steroid ointment on 2/22/17 from Dr. dermatologist.
Had difficulty focusing and concentrating; had shaking in my hands; chills; Hot flashes; eventually leading to muscle aches; swelling of my left arm.; swelling of left leg; heaviness in my left arm; lethargy; easily fatigued; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 13May2021 at 10:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 10:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. 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 13May2021 at 12:45, within two hours of receiving the second dose, the patient experienced difficulty in focusing and concentrating, had shaking in hands that could not be stopped, chills, hot flashes which eventually led to muscle aches on the left side of the body, swelling of left arm and left leg, heaviness in left arm and lethargy/easily fatigued. The worst pain was between 23:00 and 06:00 of next day, which was about 12 hours after the shot. The patient also reported that he did not have symptoms after the first dose. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events difficulty in focusing and concentrating, shaking in hands, chills, hot flashes, muscle aches on the left side of the body, swelling of left arm and left leg, heaviness in left arm and lethargy/easily fatigued were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient was administered Moderna Covid-19 3rd dose on 10.25.21. Vial had an expiration date of 10.21.21, which was extended by Moderna to expire on 12.21.21 on 10.22.21 (via e-mail from management). This morning (2 hours after pt received vaccine) new guidance was received stating only vials that were frozen are to be used with new expiration date. The vial used for patient was previously thawed-out.
Patient reports fever of 3 day duration following vaccine. Higher on days 1 and 2, but not recorded.
fever, sore throat cont onset 2 days prior to vax;h/a, fever, chills, vomit 2 days p/vax; sz, tonic/clonic 4th day p/vax;
temperature 101.2-101.8; chills; increased blood pressure (144/75) HR 95
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 036L21A and 036L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Reporter stated that patient had no reaction for first two doses.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jan-2022: Contains no new information.
I developed severe back pain from an old injury. The back pain was far more painful this time and I had a 25 minute long shivering attack (rigors?). I was admitted to Piedmont for observation (I had an intermittent fever) and tested for everything. All results; MRI, CT, Echocardiogram, showed normal for my age. The pain is better and improving but it?s still been significantly longer lasting than any previous time. My PCP suggested I post this info to the CDC website but I wanted to let you know in case you were compiling any info related to symptoms/side effects.
Kidney pain in left kidney.  (1st shot done in lf arm).  Lasted about 2 days.  Very painful when trying to bend over, or when trying to get up from a sitting position, and when trying to sit down.  No pain when standing straight up.   Did not seek treatment.
A report has been received from a Pharmacist concerning a 13 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The Pharmacist reported that the patient received only a half dose FLUMIST in one nostril at one of the facilities mobile clinics. No adverse reactions reported. The outcome of the event of administration of only a half dose of FLUMIST in one is unknown. The report was considered to be non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer history - breast" (unspecified if ongoing), notes: Cancer history - breast and ocular melanoma, but not undergoing treatment now. In remission; "Cancer history - ocular melanoma" (unspecified if ongoing), notes: Cancer history - breast and ocular melanoma, but not undergoing treatment now. In remission. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS], start date: 01Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2022) Negative; (08Sep2022) Negative; (10Sep2022) Positive; (15Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19; paxlovid was taken as treatment medication from 02Sep2022 to 06Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
L arm neuro changes; Left arm severe pain; Weakness; Unable to move; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3302) at the age of 68 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "RA" (ongoing), notes: Route: Per Oral; "Lymphoma", start date: 1994, stop date: Jun1995, notes: Chemo + Radiation.; "Chemo" (unspecified if ongoing), notes: Chemo + Radiation.; "Radiation" (unspecified if ongoing), notes: Chemo + Radiation.; "Weakened immune system" (unspecified if ongoing), notes: Weakened immune system; "immune compromise" (unspecified if ongoing), notes: immune compromise. Concomitant medication(s) included: METHOTREXATE oral taken for rheumatoid arthritis (ongoing). The following information was reported: PERIPHERAL NERVE INJURY (medically significant), outcome "recovered", described as "L arm neuro changes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm severe pain"; ASTHENIA (non-serious), outcome "recovering", described as "Weakness"; MOVEMENT DISORDER (non-serious), outcome "recovering", described as "Unable to move". Therapeutic measures were not taken as a result of peripheral nerve injury.  Clinical course: Left arm with severe pain for 2-4 weeks p 1st injection into L deltoid. Weakness, unable to move X 2wks improved by 1 month later.  Vaccination Facility Type: Hospital. Vaccine Administered at Facility? No. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Family Medical History Relevant To AE(s): None. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia: None; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  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.
Narrative: 79yo male with the following problem list: PROBLEM LAST MOD PROVIDER Seen by palliative care medicine service (ICD-10 Z51.5), Onset 04/13/2021 Low vision left eye, normal vision right eye 02/05/2020 (ICD-10 H54.52A1) Iron deficiency anemia) (ICD-10 11/20/2019 D50.9) Obstructive sleep apnea of adult (ICD-10 G47.33) Chronic kidney disease stage 4 11/11/2016 GDS level 3 - mild cognitive decline (ICD-10 R41.9) Adjustment disorder with mixed emotional features 02/09/2016 (ICD-10 F43.23) Secondary and unspecified malignant neoplasm of 11/19/2016 intra-abdominal lymph nodes (ICD-10 C77.2) Diastolic heart failure 07/05/20106 (ICD-10 I50.32), Onset 00/00/2015 Clostridium difficile infection 09/29/2014 (ICD-9 041.84), Onset 09/22/2014 Aldosterone deficiency (ICD-9 09/29/2014 255.5), Onset 09/22/2014 Renal tubular acidosis (ICD-9 588.89), Onset 09/22/2014 POLYNEUROPATHY IN DIABETES (ICD-9 357.2); 08/26/2010 Polyneuropathy in diabetes (ICD-9 357.2/250.60) Type 2 diabetes mellitus without complication Hyperlipidemia, unspecified 11/20/2015 (ICD-10 E78.5); Hyperlipidemia Essential Hypertension (ICD-10 11/20/2015 I10.) died at home on 11/19/2021. Pt had received covid vaccines on 3/17/21 & 4/15/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and lenth of time from vaccine administration.