chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Light in the chest; Lump in the throat; Tachycardia; Dizziness; Her doctor recommended her to delay the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness) and OFF LABEL USE (Her doctor recommended her to delay the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient had cancer 10 year ago.). Concomitant products included METOPROLOL SUCCINATE for Blood pressure, MELATONIN for Sleep disorder, THYROID (ARMOUR THYROID) for Thyroid disorder.    On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced OFF LABEL USE (Her doctor recommended her to delay the vaccine). On 18-Sep-2021, the patient experienced CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia) and DIZZINESS (Dizziness). On 15-Sep-2021, OFF LABEL USE (Her doctor recommended her to delay the vaccine) had resolved. At the time of the report, CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia) and DIZZINESS (Dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On the night of  the 17sep2021 Patient took wells sleep tea for Sleeping aid. No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-323073 (Patient Link).
I have had persistent diarrhea since I got the injection, and also i smell cigarettes 24/7 now.
Redness, itching, soreness at injection site, Redness progressed during night of vaccination to cover most of upper arm. I was contacted 2 days later with rash still present but soreness had decreased. The patient thought that her reaction may have been made worst because of "Norovirus" symptoms that she had experienced 2 days before injection even though she did not indicate illness on consent form. I told her to take BENADRYL at bedtime and to mark edges of rash to gauge any change overnight. When contacted the next morning, she said the rash was moving down the arm but soreness was gone except when area was rubbed. There still appeared to be some heat at the injection site. The patient did not go to the doctor or seek any treatment for her rash as far as I know.
Patients lips swelled and became so numb he was unable to move them. This was his first flu shot ever.
Airway restriction, shortness of breath resolved after several hours . Headache,ringing in the ears,muscle aches, dizziness and weakness for several days. Fever around 10 hours after injection. Redness at injection site
9/26 Painful swollen arm reported to PH. 9/27 Painful 4"x5.5" reddened and indurated arm reported to private MD who treated with analgesic.
Patient complained of severe itching localized to injection site and heat around the injection site about 20 minutes after her 2nd Pfizer dose was administered.  Denies shortness of breath, denies lip/tongue/face swelling. Vital signs stable. 10 mg sublingual Zyrtec administered and patient transferred to doctor's office for observation. Symptoms resolved and patient was discharged.
Patient complained of "tightness in chest" starting a few hours after vaccination. He called again, same complaint on 11/27, 11/28, 12/3, 12/12 and 12/13/01, but refused to come in for evaluation. he finally saw his PCP who found no physical basis for his complaint.
Pt started at 6:30pm with temp of 100 degrees F & swelling (L) deltoid. At 10:30pm temp of 103.2 with emesis x 3 during the noc. Swelling (L) deltoid increased. Applied ice pk to site & given MOTRIN. Seen by physician 8-20-10 who felt normal localized Rx & had GI virus.
Moderna COVID-19 Vaccine EUA  I had no side effects after the vaccine until 8 days after on March 8, 2021 - when I woke up the site of the vaccine is now red and raised and about the size of a half dollar coin and itches.
Was seen in our emergency room, and complained of one side of her face not working. She was diagnosed with Bells Palsy.
Subsequent to receiving two doses of varicella virus vaccine live, titers revealed that the pt had not seroconverted. The pt sought unspecified medical attention.
Initial unsolicited report received from a pharmaciston 23 September 2016. This case involves a 69-year-old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI663AB, expiration date, dose, dose in series were not reported) intramuscularly in the right deltoid on 22 September 2016. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were hypertension (HTN), arthritis, and hypothyroidism. Illness at the time of vaccination was also reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 22-Sep-2016, same day following the vaccination, the patient developed itchy palms which were red and swollen due to her scratching them. The patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Reaction to ZOSTAVAX arm. Swelling, given erythromycin from ER and prednisone.
Pt woke next morning with body shaking uncontrollably for more than 1 hr. Pt sent to ER.
Caused a flare up of rosacea on both sides of my face and nose. I had bumps and redness. I noticed it the day after the injection. Today is day 3 and it is slowly getting better but still there.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 04-JAN-2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Upon internal review, varicella pneumonia was determined significant medical event. Additional information has been requested.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case is linked to case 2019SA024680 (same reporter). This case involves a 10 years old male patient who received a 0.5 ml dose of FLUBLOK QIV batch number: QFAA1833, expiration date: 30-Jun-2019 via unknown route in the left deltoid on 26-Dec-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were given. It was an actual medication error due to inappropriate age at vaccine administration. A 10 year old patient received FLUBLOK QUADRIVALENT. No symptoms reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
fever; aches in joint; aches in muscle; loss of appetite; extreme exhaustion; soreness at injection site; This is a spontaneous report from a non contactable consumer, the patient. A 44-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207), via an unspecified route of administration in the left arm on 17Mar2021 at 15:45 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included thalassemia minor. The patient had egg allergy. The concomitant medications included Liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and zoloft (MANUFACTURER UNKNOWN) for unknown indication from unspecified date. 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 18Mar2021 at 01:00 AM, the patient experienced fever, aches in joints and muscles, loss of appetite, extreme exhaustion, soreness at injection site. After vaccination patient was unable to get out of bed. On second day after vaccination patient still felt sick to go to work even though severity of symptoms had been decreased. The clinical outcomes of events fever, aches in joints and muscles, loss of appetite, extreme exhaustion and soreness at injection site were recovering. No follow-up attempts are needed. No further information is expected
Muscle weakness; Headache; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness and headache. On an unknown date, the outcome of the muscle weakness and headache were unknown.   It was unknown if the reporter considered the muscle weakness and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know that how long did the muscle weakness and headache last after the dose of Shingrix.
No additional AE reported; a consumer was inadvertently administered the PNEUMOVAX 23 vaccine/The consumer was not scheduled to receive this vaccine; This spontaneous report as received from an unspecified reporter, reported as other refers to a 53-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-JUN-2021, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, lot # T031820, expiration date: 10-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis. The patient was not scheduled to receive this vaccine and had not previously been vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient C/O flushed and feeling hot.  vital signs at 1350 were BP= 130/81; P=83 ; R=16 ; T= 98.9.  patient was observed for 20 minutes. At 1410, the patient was stable and stated that the symptoms have resolved.
excruciating pain that was sharp pain in her chest and rib cage; Excruciating pain that was sharp pain in her chest and rib cage; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (excruciating pain that was sharp pain in her chest and rib cage) and MUSCULOSKELETAL CHEST PAIN (Excruciating pain that was sharp pain in her chest and rib cage) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia and Arthritis.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 CHEST PAIN (excruciating pain that was sharp pain in her chest and rib cage) and MUSCULOSKELETAL CHEST PAIN (Excruciating pain that was sharp pain in her chest and rib cage). At the time of the report, CHEST PAIN (excruciating pain that was sharp pain in her chest and rib cage) and MUSCULOSKELETAL CHEST PAIN (Excruciating pain that was sharp pain in her chest and rib cage) had resolved.            Concomitant medications included medicines for cholesterol and arthritis.  Treatment information were not reported.
No Adverse Reactions Reported. In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State).
Pain in arm at at site of injection c/o hot & cold & numbness in area VS. & O2 sat WNL.
Patient complained of Left arm tingling and numbness. BP taken and was 150/80 P 78. Patient given to EMS on scene for follow up.
~2002 noted to have a PE, placed on coumadin While on coumadin, she was subtherapeutic (not taking as she was told) and had a RLE DVT Resumed coumadin at full dose, later tried to wean and developed a 2nd RLE DVT while subtherapeutic on coumadin Resumed coumadin and on 3/9/2015, w/ INR of 3.0, noted to have a 3rd RLE DVT, w/ ext iliac stent from IR placed due to vascular compression, thought 2/2 fibroid, given lupron q3 mos x about a year, she believes the fibroid shrunk, hysterectomy was contemplated but not done, stayed on coumadin until  9/24/18 pain and swelling RLE, post flight to vegas 18-22 Sep, RLE u/s showed (new calf vein DVT) Persistent chronic appearing nonocclusive thrombus and/or scarring within the low right popliteal vein. Interval visualization of acute appearing thrombus within both upper post tibial veins, peroneal veins and a single ant tibial vein. INR was 2.7 -- > switched to Xarelto, 20 mg daily  Received her Covid vaccinations with her second on 6 February 2021  13 April 2021 nonocclusive DVT extending from the right popliteal vein into proximal right posterior tibial and peroneal veins. There was thrombus in this location on the September 2019 comparison, however, significant portions of the DVT on the current study have acute appearance, likely reflecting recurrent acute or acute on chronic DVT.   15 April 2021 CT angiogram No acute pulmonary thromboembolic disease. Multiple similar linear webs and areas of concentric narrowing/occlusion in bilateral pulmonary arteries compatible with old or chronic pulmonary embolism. Advise correlation with signs of pulmonary hypertension to exclude the possibility of chronic thromboembolic  pulmonary hypertension (CTEPH). Similar scattered linear scarring which may be sequelae of old pulmonary infarcts. Diffuse bronchial wall thickening with extensive mosaic lung attenuation which may relate to chronic thromboembolic pulmonary disease. (with acute on chronic right lower extremity DVT, significantly improved on Lovenox at diagnosis, she has clotted with an INR of 3.0 on Coumadin, she has clotted on rivaroxaban 20 mg daily, she did not want Lovenox injections, her Covid vaccination may have contributed to her thrombosis, as well as IVIG, we plan to minimize IVIG and transitioned to Eliquis and ASA 81)  IR angioplasty 5 May 2021 Pelvic venography demonstrating a long segment of moderate to severe narrowing of the previously placed iliac vein stents secondary to extrinsic compression. This area was angioplastied with an excellent angiographic result.   5 May 2021 VQ scan high probability for PE, likely related to clot noted on 15 April CT pulmonary angiogram
Significant swelling occurred on the underside of her arm - below armpit. Instructed patient to take BENADRYL if possible allergic reaction.
Stroke following administration; A spontaneous report was received from a consumer concerning a 78 year old ,female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a stroke/cerebrovascular accident.  The patient's medical history was reported as previous stroke two years ago. Concomitant medications taken by the patient included losartan, glipizide, lintas, metformin, blood thinners, hydrochlorothiazide.   On 26 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced a stroke which needed emergency treatment. She received treatment for this condition and was back at home at the time of reporting and at that point she had no other side effects.  Treatment activities for event was received but not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event, stroke  was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age along with prior history of stroke are considered significant risk factors.
CHF; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 104 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE CHRONIC (death) with onset 2022, outcome "fatal", described as "CHF". It was reported that the patient received two Pfizer COVID-19 vaccines at the age of 102 and died this year (as reported) at the age of 104 due to chronic heart failure (CHF), not due to COVID-19.  The patient date of death was 2022. The reported cause of death was cardiac failure chronic.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: CHF
pt recvd vax JUL95 & SEP95 pt had herpes zoster; No further details were provided;
in 12 hours began to feel headache, nausea fever of 100 to 101.8 for 2 days straight.  Chills so bad my hands were shaking and muscle aches so bad it woke me from sleep.  Slept almost 40+ hours in 2 days.  on 2nd day got COVID Arm the red rash about 2 inches from the injection site - was 3inches by 4inhes in size and that was hot and tender to the touch. 3 day only had the headache and nausea and all symptons gone by 4th day.
Received H1N1 vaccine, while waiting developed a cough, then progressed to shortness of breath. EMS evaluated. Parent refused transport, EMS escorted out building.
Subjective complaint of increasing confusion, stiff neck, and "funny taste in mouth" States 90% recovered was sent to a clinic and was referred elsewhere.
05222021 ? sharp aching headaches waking me from sleep prompted me to schedule annual eye appointment  06142021 ? Optometry appointment ? New reading glasses, red vision diminished, asked me to track  headaches waking me from sleep and to come back for additional tests. Last visual migraine was 01222021.  06172021 ? 07:03am Visual Migraine, Aura only 07032021 ? 08:46am Visual Migraine, Aura only 07082021 ? 06:00am to 3pm, Headache returned - sharp aching behind both eyes 07122021 ? Optometry follow up tests ? Found edema in right retinal nerve, ~25 micron difference from last scan. Left eye is relatively stable. Referral to Ophthalmologist for papilledema. 07152021 ? 04:30am to 10:54am, Headache - sharp aching behind left eye 07212021 ? 04:34am to 08:55am, Headache - sharp aching behind both eyes  07212021 ? Dr. Appointment: Ophthalmology Retina ? follow up from Optometry, confirmed small cupping present and recommended MRI, MRA, MRV to see if there was a tumor or growth causing the sudden change in intracranial pressure (I think I was checking out at this appointment when I received the V-Safe check-in text asking if anything new / unusual was going on... in my head, it clicked that "wait, this started right after the series of covid shots")  07282021 ? 04:05am to 08:06am, Headache - sharp aching behind left eye  07302021 ?  Radiology MRI, MRA, MRV of brain w/ & w/o contrast  08092021 ? Visual Migraine, Aura only 08112021 ? 06:30am to ?, Headache - sharp aching behind left eye 09032021 ? Visual Migraine, Aura only 09182021 ? Visual Migraine, Aura only 09192021 ? Visual Migraine, Aura only 09202021 ? 04:00am to 07:00am Headache - sharp aching behind left eye  09202021 -- Dr Appointment with PCP for various issues and where I told her that I was having headaches and visual migraine auras.  I do not recall mentioning/discussing anything or any correlation between the auras/headaches and the COVID-19 Vaccine. She referred me to  neurology, based on new symptoms  10032021 ? Visual Migraine, Aura only 11142021 ? Visual Migraine, Aura only 11152021 ? Visual Migraine, Aura only  03102022 -- Future Neurology Appointment
the area became red, swollen, and painful; the area became red, swollen, and painful; the area became red, swollen, and painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), in Jun2023 as dose number unknown, single (Lot number: GN1897) at the age of 79 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Jun2023, outcome "recovering" and all described as "the area became red, swollen, and painful".  Additional information: Around 7 days after the shot, the area became red, swollen, and painful. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.