chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GJ6665), 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "borderline high blood pressure" (unspecified if ongoing); "Allergy to sulfonamide " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: tested positive for COVID on home test; (2023) Negative, notes: initiating Paxlovid I tested negative on an at home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Jun2023 to 07Jun2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300285157 same reporter/patient, different drug/AE;
Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Vomiting-Severe, Additional Details: patient had severe vomiting and diarrhea and exhaustion after the vaccine.  continued for 3 days after (still ongoing).  cannot keep anything down.
Enlarge breast (gynecomastia); This spontaneous case was reported by a health care professional and describes the occurrence of GYNAECOMASTIA (Enlarge breast (gynecomastia)) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 22-Mar-2021, the patient experienced GYNAECOMASTIA (Enlarge breast (gynecomastia)). At the time of the report, GYNAECOMASTIA (Enlarge breast (gynecomastia)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Shortness of breath and leg pain times 3 days. Diagnosed with Pulmonary Embolus on April 8,2021
Patient had severe rash on the arm which he got the shot for about 1 week. It is getting better now.
1/4/2021: RECEIVED FIRST DOSE OF COVID-19 VACCINE. WAS OBSERVED BY HOSPITAL STAFF FOR THE REQUIRED 15 MINS WITHOUT INCIDENT. 1/6/2021: C/O CHILLS AND TEMP OF 99.6F 1/12/2021: C/O FATIGUE & DIZZINESS. PT DAUGHTER WAS ILL. SO, BOTH SWABBED FOR COVID, WHICH RETURNED NEGATIVE. 1/13/2021: INJECTION SITE BECAME RED, HARD & ITCHY. PT ADVISED BY EMPLOYEE HEALTH TO TAKE BENADRYL, WHICH RELIEVED ONLY THE ITCHING. 1/14/2021: ARM PAIN THAT WAS WARM TO TOUCH AND TEMP OF 99.9F.  1/16/2021: PT SEEN AT URGENT CARE FACILITY AND DIAGNOSED WITH CELLULITIS OF UPPER LEFT ARM, GIVEN DOXYCYCLINE TO TREAT.
Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked; Nose completely blocked/congestion; Coughing; Severe headache; Tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19), SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion), COUGH (Coughing) and HEADACHE (Severe headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 038A21A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Interval of a couple of weeks with the COVID-19 Vaccine) in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Soy allergy (Soy intolerance), Drug allergy (keflex), Sulfonamide allergy (Sulfa drugs) and Type 2 diabetes mellitus. Concomitant products included METFORMIN for Type 2 diabetes mellitus.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2022, the patient experienced COVID-19 (Tested positive for Covid-19). On an unknown date, the patient experienced SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion), COUGH (Coughing) and HEADACHE (Severe headache). The patient was treated with CEFPROZIL at an unspecified dose and frequency and IVERMECTIN at an unspecified dose and frequency. On 21-Oct-2022, HEADACHE (Severe headache) had resolved. At the time of the report, COVID-19 (Tested positive for Covid-19), SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion) and COUGH (Coughing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2022, SARS-CoV-2 test: Positive. In October 2022, X-ray: Sinuses were totally blocked.  She was prescribed with another nasal spray. She had a teledoc on 24Aug2022. Patient had not experienced similar events in the past.
1. June 24th (24 hours): Mouth lesions. Headache. Vaginal bleeding 2. Sunday June 27th (96 hours): Severe oral blistering and cheilitis. Odynophyagia. White plaques on tonsils.  Painful lymphadenopathy in the neck. T max: > 38 degrees. Reduced to liquid diet.  ER Visit Sunday June 27th. Provisional dx of HSV. But HSV swap negative.  Sent home with supportive care.  3. Tuesday June 29th (134 hours): Virtual consult. Rx Magic mouth. Oral Rx for Valacyclovir. 2000 mg PO x 2 doses. 4. July 2nd: Lesion on lips still present. Some improvement in pain.  5. July 7th: Oral lesions gone. One crack/fissure in the lower lip remained.
Guillain Barre syndrome. Admitted for myalgia & progressive weakness to intensive care.
Woke up the morning after his 2nd vaccine with severe chest pain so bad that we rushed him to the ER. The Dr didn't seem that interested in knowing that he had just had his 2nd vaccine. She ordered x-rays that showed his lungs were normal, Did an EKG that was normal. His blood pressure was 159/110 however they didn't think that was a worry (I did.) They provide him Tordall for inflammation and sent him home for the day. I don't believe Dr took it very serious.
Employee received the dose on her unit.  She came up to employee health 2 hours after vaccination and reported chest pain, upset stomach, and itchy face.  This nurse instructed her to go to ED and is the one reporting to VAERS.
SP02 99% heart rate 102  Feeling flushed and warm  b/p 128/90   Hx of asthma, no shortness of breath.   4:20 pm still feels flushed, no shortness of breath.  Only allergy is Keflex, no dizziness.  Offered to go the the ER but, declined. Told to monitor and call 911 if worsens. Daughter is with her.
On the evening of the 12th around 5:30 or so i developed a really sever headache. After going to bed at 9:30 felt weak and achy still had the headache. Felt just like the flu. Got a night of restless sleep. Got up around 7:30 took 1 Aleve and very hot shower felt better 1 hour later. Shoulder still smarts at the injection site but that's to be expected. My wife had the same series of vaccinations with no side effects.
Excessive nose bleed for an hour. My son woke from his sleep with a nose bleed at 2 a.m. on 1/9/22. No other symptoms.
intense sweating before syncope for 1 minute, chills, fatigue for 3 days after receiving Moderna booster. Had Pfizer vaccines administered.
Vaccinated Saturday at 4:15pm. General fatigue and injection site soreness through Sunday and Monday. Woke up at 4 am Tuesday morning with shortness of breath, sweating, headache, dizziness and nausea. Waited it out until I felt I could breathe normally and went back to sleep. Felt a little better after a few hours of rest but some chills continued throughout the day.  Currently experiencing a sore throat as well. I have also developed 3 ulcers in my mouth since getting the vaccine.
Trouble lifting arm (left). Could not lift arm over head. Pain in shoulder and middle arm. Seems to be resolving. Leave to high with shot pt felt.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 14-MAY-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced confirmed immunological vaccine failure.  On MAY-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative with a level of 5.87 when <12 is considered negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179590.; Sender's Comments: V0: 20210523786-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Stroke.  11/05/09 Medical records and ICD9 Codes received for DOS 10/30. Final DX: Clumsiness of upper extremity, hypertension, speech disturbance, hepatitis C, TIA.  Patient developed R sided numbness and weakness. Diff walking and talking.  Progressed to slurred speech and R facial droop. Unequal hand grip. R side weaker.  H/O Hep C. Jaundice. Hypertensive and bradycardic. Acute CVA w/R sided weakness/numbness and slurred speech. L hemispheric cerebrovascular accident with secondary carotid occlusion.  ICD9 Codes: 070.51, 250.01, 435.9, 437.2, 781.3, 784.5, 070.51, 250.00, 250.01, 272.4, 401.1, 401.9, 427.89, 437.2, 696.1, 781.3, 784.5, 787.6, V12.59, V13.8, V45.99
Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On 17-OCT-2016 and 01-NOV-2016, the patients were vaccinated with improperly stored VAQTA (lot # M030598, expiration date: 13-OCT-2017; lot # M032492, expiration date: 02-MAR-2018) (dose and route not reported). The nurse reported no adverse effects noted. The temperature for the vaccine stored was 10.1 Celsius degree with 2 hours time frame. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Admitted into hospital on 11/8. Expired 11/11. Admitted with acute flash pulmonary edema, pneumonia and COVID. Experienced multisystem organ failure. Needed increase of oxygen.
Fainted  at doorway. Got her into a chair and a few minutes later fainted again. Never lost consciousness.
*Atrial fibrillation .  No prior instances.*    Vaccine 1/20/2021.   On 1/21, 25 hours after vaccine  felt slight pressure in chest and rapid heat beat.  Heart rate 150.  EKG in Cardiologist's office.  Admitted to hospital  On 1/22/2021 -- DC (Direct Current) Cardioversion Procedure  Prior to the procedure, a transesophageal echocardiogram was performed which showed no evidence of left atrial appendage thrombus.  The patient was successfully cardioverted on the 1st attempt after administration of 150 joules using a bi-phasic defibrillator.  A post cardioversion EKG was obtained and reviewed.  The patient tolerated the procedure well with no complications. Post-procedure vitals: HR 65 BP 119/71 O2 sat 99%
Dizziness Flushed, sweaty, heart racing Narrative:  outpatient RRT called at0904 to the auditorium. pt stated ~15min after vaccine administration she felt a tingle in her throat for a few seconds that quickly resolved, dizzy, and felt her heart was racing. observing RN inauditorium gave 25mg benedryl IM shortly after, she then felt tired and like she was 'drunk'. no alcohol on board per pt. vaccine was second dose and administered in left deltoid. denies f/c/n/v/d/CP/SOB, is able to breathe clearly and swallow secretions.  Other Relevant History:
11JUL95 mom calls in stating pt looked like was going to sneeze;last PM then shuttered whole body;not a convuls like a missed sneeze;no fever, nl appearance & nl acting;AM either foot/head jerks;appeared to choke & have problems breathing
Arm started hurting a little that night.  Arm got worse and couldn't sleep well.  Next day, had flu-like symptoms, was tired, and arm was very sore.   Patient couldn't do much all day. Patient took Tylenol which helped to cut level of pain. On Sunday felt a little better; still tired but was able to move around. Today,  arm still very tender, swollen, hot area 2 inches below injection site.  Called doctor this morning; and was told to keep eye on it to see if worsens.   Recovery at 95%, it is mainly the sore arm that is not back to normal.
12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.
Patient complained of dizziness following vaccination. Patient was placed in a supine position with legs elevated. Patient also complained of some numbness in left arm and feeling a little hot. Patient's blood pressure was checked several times and reported initially at 89/79 and finally 100/66. Wife reports patient usually have blood pressure readings in the lower range. Patient also reports having a vasovagal event following vaccinations. Patient was observed for about 20 minutes. Reported feeling fine and left pharmacy.
acute onset of bilat ophthalmoplegia occurred on 9/5/99;60 day follow-up received on 10/19/00 provided no additional data.
6/25/07 3 X 2.5CM raised itchy hot induration at injection site few hours later redness over entire triceps area. 6/25/07 Today with raised clear blisters, no pus - blisters appear dry and flat - cool compresses and watch.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 08-AUG-2016, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number L025207, expiry:27-JUL-2017). No adverse events were reported. Administered dose of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 40 hours. Data logger was involved. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
total cholesterol and LDL were both elevated; The total cholesterol and LDL were both elevated; This is a spontaneous report from a contactable pharmacist reporting for patient. A patient of unspecified age and gender received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and expiration Date were Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation on Jan2021. The patient medical history and concomitant medications were not reported. The patient had a routine lipid panel drawn. The total cholesterol and LDL were both elevated on an unspecified date. The patient is otherwise healthy without any other underlying medical problems. The outcome of the events were unknown. The reporter was wondering if there is a correlation or if you have had any other reports of similar effects.  Information about lot/batch number has been requested.
Case number PHEH2014US019656, is an initial spontaneous report from a nurse received on 29 SEP 2014. This report refers to a 10-year-old male patient. Past medical history and concomitant medication was not reported. The patient was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch number 160984) intramuscularly on 29 SEP 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Approximately  6 hrs. after shot , left arm became very sore but in addition my left. Jaw became  painful and the following morning an earache started on left side. Taking Tylenol
COVID-19 resulting in inpatient hospitalization of a vaccinated patient.  Pt was also boosted with Moderna on 11/11/2021, unknown lot number
Fever 99.4-100.8 for 4 days, severe joint and muscle pain, exhaustion.  On Day 5 developed Bronchitis-like symptoms, but fever was gone.  Have a slightly wet cough, but not able to raise any mucus.  This is day 7 and the bronchitis symptoms continue.
This spontaneous report was received from a pharmacist concerning a male patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # and dose unknown). Concomitant medications were not provided. On an unknown date the patient developed a "lump" at the injection site. The outcome of injection site mass was unknown at the time of the report. Additional information is not expected as the reporter details were not provided.
The first reaction was to the site of injection, which I understand is common to be red, but 3 or 4 days my under arm was swollen almost to my elbow. The pharmacist said it should subside usually around 5 days. The reaction to my arm did subside around 10-19-13. On 10-20, 10-21-13 I started having problems with numbness of my tongue, mouth, upper and lower lips, and facial numbness around my chin. I saw my PCP on 10-24-13, the only thing he could see was a few patches on the back of my tongue which resembled thrush, so he gave me a prescription for lozengers. I went back to him on 11-1-13, the patches were gone, but I still had all of the numbness, plus he noticed I was having an issue with my eye focusing looking to the left. So he ordered an MRI of the brain to rule out a stroke, and also an ultrasound of my carotid arteries on 11-06-13. MRI showed no strokes and ultrasound was good. So he recommended seeing a neurologist for a second opinion. I saw a neurologist on 11-18-13, she ordered a LP to rule out MS, but before the procedure could be done all my symptoms subsided, and I have not had any more symptoms. I had a follow up visit with my neurologist on 12-11-13, and in her medical opinion she believes that I had an adverse reaction to the ZOSTAVAX vaccine.
hotness; sore; red; tiny bumps like a rash; joints were hurting; bad headache; felt fatigue; fever was 99.7 degrees F; arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), FEELING HOT (hotness), PAIN (sore), ERYTHEMA (red) and RASH (tiny bumps like a rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen), PAIN (sore), ERYTHEMA (red), RASH (tiny bumps like a rash), ARTHRALGIA (joints were hurting), HEADACHE (bad headache), FATIGUE (felt fatigue) and PYREXIA (fever was 99.7 degrees F). On 25-Mar-2021, the patient experienced FEELING HOT (hotness). On 25-Mar-2021, PAIN (sore), RASH (tiny bumps like a rash), ARTHRALGIA (joints were hurting) and PYREXIA (fever was 99.7 degrees F) had resolved. At the time of the report, PERIPHERAL SWELLING (arm is swollen), FEELING HOT (hotness), ERYTHEMA (red), HEADACHE (bad headache) and FATIGUE (felt fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99.7 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided Treatment information includes Tylenol and Excedrin.
Large red whelp to (L) deltoid with body aches and fever that started after receiving tdap shot on 11/07/16.
Rash/hives sudden onset after vaccination----Issues with Teeth has had several pulled has no gum disease ----itchy rash sudden onset
DIZZINESS/LIGHTHEADNESS FOR ABOUT 5 MINUTES, FAINTED FOR 5 SECONDS
Severe chest pain and difficulty breathing resulted in a rush to ER. High fever for 12 hours, chills, headache, and heavy period flow.
Information has been received from a physician concerning a 17 year old female who was vaccinated with Gardasil. Subsequently the patient passed out 4 days after vaccination. Patient outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Runny nose, coughing, 9-8-18, rash starting on her chest and back 9-9-18 (at least that's when I noticed the rash), ear infection 9-11,18, over the course of the next 2 weeks her rash spread to her face, legs and arms, including her bottom.
I had the typical fever, body aches, chills, fatigue on Thursday, the day after the vaccine. Felt better on Friday. Went to work but still a little tired. Woke up Saturday feeling exhausted. All my limbs felt heavy.  About 8 am I was having trouble moving my fingers and hands.  I laid down and started drinking water. After about 30 minutes I was able to move my fingers again but I still felt really tired and rested the whole day.  Sunday and Monday I had a headache but have now made a full recovery.  I didn't go to the doctor.  Figured it must have been a vaccine side effect.