chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 19 year old daughter with an allergy to Zithromax who on 17-JAN-2007 was vaccinated IM with a 0.5 mL of the first dose of Gardasil. Concomitant therapy included acetaminophen/codeine phosphate (TYLENOL WITH CODEINE) and albuterol. On 24-MAR-2007 the patient was vaccinated with the second dose of Gardasil and is now pregnant. Her LMP is 13-APR-2007. On 18-JUN-2007 the patient experienced light spotting and stomach cramps. The patient's outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.
Narrative:  COVID infection following COVID vaccine series 02/25, Pfizer, dose #1 03/18, Pfizer, dose #2 08/01 pt cc: cough, dyspnea, malaise, wheezing, chest congestion, low backache unknown exposure: unknown 08/09 COVID swab, result: detected 08/12 SARS-COV-2 TOTAL AB SPIKE SEMI QN>2500.00 08/09 ekg sr 84, qtc 441, no acute changes 08/09 ABG i-pH 7.40, i-PCO2 30.6, i-PO2 50, i-HCO3 19.1, SpO2 84 08/09 Admit to medicine dx: Acute Hypoxic Respiratory Failure due to Covid 19 Pneumonia LOS: 8 days 08/09 BNP 12.1 08/09 LIPASE 28 08/09 CRP 10.970 08/09 PROCALCITONIN <0.05 08/09 CXR impression: The exam is limited by poor timing of the contrast bolus and respiratory motion artifact. Given these limitations, no central pulmonary embolism is visualized. -Patchy and groundglass opacities in the mid/lower lungs, most compatible with multifocal infection. Imaging features of Covid-19 pneumonia are present. Other processes such as influenza pneumonia and organizing pneumonia, as can be seen with drug toxicity and connective tissue disease, can cause a similar imaging pattern. 08/09 CXR impression: Support devices: None identified Mediastinum: Normal cardiac size. No central pulmonary vascular enlargement. Lungs and pleura: Left lower lobe infiltrate is identified. Small infiltrate versus atelectasis in the right lower lobe is seen. Clinical correlation is recommended. Bones: Unchanged 08/10 SARS-COV-2-IgG 0.07 08/10 FIBRINOGEN 491 08/10 ESR 81 08/10 DDIMER 0.24 08/18 FIBRINOGEN 212 08/18 DDIMER <0.22 08/18 ESR 44 08/31 CXR impression: No acute cardiopulmonary abnormality. Interval resolution of LEFT lower lobe pneumonia identified earlier this month.
Woke up cold chills and shivering, full body aches, shooting pains in legs, headache, unable to move both arms without excruciating pain,  redness and swollen injection site.  Wet cold washcloth on injection site,  600 mg ibuprofen, icepack on head for throb, added covering to bed for chills.  Multiple hours later, chills and shooting pains subsided. Still have headache and swollen injection site, body aches continue but are minor.
Inflammation and very painful at the injection site.  Told to take Benadryl by physician on 7/14.  On 7/15 patient reports still there but feeling better around injection area.
fever; tiredness; arm pain, redness, swelling at injection site starting 12 hours after injection and lasting for 36 hours.
COVID Vaccine Breakthrough Case   Moderna Dose 1 2/6/21 (032L20A) Moderna Dose 2 3/6/21 (024M20A) COVID Positive 12/11/2021  12/15/21: Patient is an 82yo male with medical history of DMT2, cardiac dysrhythmia , CKD, COPD on 3 L home oxygen, HLD, BPH, s/p Nephrectomy,. Patient is being admitted for worsening COVID symptoms and worsening respiratory failure. Patient tested positive for COVID Dec 11 . He was at the infusion center today when he acutely decompensated 5mins into his infusion with two syncopal episodes. On arrival to ER he was initially saturating 89% on 5L but progressed to require vapotherm at 20L 65%. CT angio chest and CT abdomen ordered for abdominal pain is likely to be suboptimal because patient's IV line infiltrated and not enough contrast was administered. CT head ordered because of patient endorsing a fall was negative. Pulmonology was consulted by ER provider.  12/20/21: Patient is a 86-year-old male history of chronic COPD home oxygen dependent 3 L at baseline admitted to the hospital for acute on chronic hypoxic respiratory failure due to COVID-19 pneumonia, patient was treated with supplemental oxygen, remdesivir and Decadron, as time progressed patient clinically improved, oxygen was wean down to home oxygen.  Patient was evaluated by therapy recommended skilled nursing facility, however patient declined but he was agreeable with Agency.  Patient will be discharged home with Agency, recommended follow-up with PCP within 1 week.
Pt. had received last postexposure rabies shot Left deltoid on 08/19/11 @ 9AM. While pt. was in facility's driveway she felt some tingling/numbness over Left upper arm. Escorted her back to the clinic- vitals checked BP 160/78, pt. anxious observed for 15 mins. Numbness still present but not worse-she went home. 3:45pm- Called pt. @ home she stated numbness/tingling is gone and arm just feels sore.
13APR99 720AM mom reports hearing pt grunting in bed;reports pt was moaning, groaning, stiff, hands jerking, lips;7:50 in ER T104.4, opened eyes, responsive;14APR99 mom reports pt is weak;
Angina-like chest pain and frontal headaches off and on for three weeks from date of 1st injection.  I believed it to be vaccine side effects and continued normal daily exercise routine, which is quite rigorous in some instances.  Exercise seemed to alleviate problem temporarily.  I never considered angina or heart issues as a  problem since I've had great exam stats, including low cholesterol, low triglycerids, normal EKG, not overweight, never smoke, exercise regularly, maintain healthy diet.  Day of second dose, chest pain and headaches increased significantly.  EKG performed by PCP and Emergency Room confirmed abnormal.  Diagnosed with acute myocardial infarction, emergency angiosplasty performed on right coronary artery.  I felt this all to coincidental given timing and duration of side effect with 1st and 2nd shot.  All EKGs in past, including one in August 2020, normal, and then abnormal six months later.
after approximately 10 minutes of receiving Covid-19 vaccine, the patient fell out of chair in which he was seate. patient was unconscious for approximately 1 minute while I rolled him over and checked for pulse. his eyes were wide open and he seemed to have had an absensence seizure lasting upto a minute before regaining consciousness. he was quickly cognizant and I asked if he had any history of seizures or if he might be hypoglycemic.  He did say that he had not eaten and it was 3:00pm. paramedics soon arrived and removed the patient from the scene.  I did text patient the next day and he said only that he had a sore arm and symptoms consistent with having a vaccine administered.
Patient was supposed to get Polio however, the provider ordered Pedvax HIB and patient was given an extra dose of that vaccine. Patient had no adverse affects.
Ten minutes after vaccination pt reports feeling dizzy, lightheaded, and chest tightness. Nurse observed increased HR, decreased BP, thready pulse, pt looks pale, feels cool and clammy. Pt recovered 1 hour after onset of symptoms mentioned above.
During administration of vaccine, client complained of feeling dizzy. Immediately after, she complained of increased dizziness, ear-ringing, and "feeling sick." She appeared pale and diaphoretic. Nurse instructed client to remain seated and stayed next to client. About 1 minute after the vaccine had been given, client slumped over in chair and fainted. Episode of syncope lasted about 20-30 seconds. Client recovered fully after 5 minutes, and was given water and crackers.
Left thigh injection site for DTaP IM, MMR SQ. Per pt's dad, pruritis, erythema, urticaria for 2 days. Pt here today, minor erythema at site.
Knee joints, great pain/discomfort when sitting down/getting up, made it extremely difficult to even sit on a toilet
Information has been received from a licensed practical nurse concerning a 22 year old female patient with no pertinent medical history and no allergies who on 02-AUG-2010, "yesterday", was vaccinated with the second 0.5 ml dose of GARDASIL IM into her left arm (lot # 666929/0331Z). There was no concomitant medication. On 03-AUG-2010, the patient called the doctor office to state that she experienced fever, headache, chest pain, dizziness and felt weak. Treatment was oral BENADRYL. No lab diagnostics studies were performed. At the time of reporting, the patient's fever, headache, chest pain, dizziness and felt weak persisted. The patient sought unspecified medical attention. Follow up information was received from the licensed practical nurse who reported that on 02-AUG-2010, the patient with no known drug allergies and no illness in for routine exam at time of vaccination experienced headache, "temperature", chest pain, dizziness and weakness. On 04-AUG-2010, the patient recovered from these adverse events. The patient did not seek medical attention. Additional information is not expected.
Lymph nodes red; Lymph nodes swollen; Right underarm was little swollen at injection site; Right underarm sore at injection site; Right underarm warm at injection site; Right arm hurt; Right arm was heavy (getting worse) and whole right arm also felt more heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy), SKIN WARM (Right underarm warm at injection site), PAIN IN EXTREMITY (Right arm hurt), ERYTHEMA (Lymph nodes red) and LYMPHADENOPATHY (Lymph nodes swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy) and PAIN IN EXTREMITY (Right arm hurt). On 11-Jan-2021, the patient experienced SKIN WARM (Right underarm warm at injection site), ERYTHEMA (Lymph nodes red), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Right underarm was little swollen at injection site) and AXILLARY PAIN (Right underarm sore at injection site). On 07-Jan-2021, PAIN IN EXTREMITY (Right arm hurt) had resolved. At the time of the report, LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy), SKIN WARM (Right underarm warm at injection site), ERYTHEMA (Lymph nodes red), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Right underarm was little swollen at injection site) and AXILLARY PAIN (Right underarm sore at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PATIENT RECEIVED 1 ST DOSE OF COVID-19 VACCINE AT 1417, POST VACCINE ADMINISTRATION PATIENT HAD AN EPISODE OF FAINTING/SYNCOPE. PATIENT WAS PLACED ON THE FLOOR WITH LEGS ELEVATION. PATIENT GAINED CONSCIOUS RIGHT AWAY AFTER 2-3 SECONDS. PATIENT WAS ALERT AND ORIENTED X4 VERBALIZED THAT HE FELT LIKE HE WAS SLEEPING. VITALS CHECKED RIGHT AWAY WITH BP 104/50, SAT. 99 %, RESP. 18, HR 53. DENIES ANY PAIN OR DISCOMOFRT AND STATED THAT HE HAS HISTORY OF FAINTING DURING BLOOD WORK, PATIENT HAS NOT KNOWN ALLERGY. PATIENT CAME WITH WIFE WHO WITNESSED THE EPISODE AND ACTIVATED 911 RIGHT AWAY. PATIENT STATED FEELING BETTER WITH VITALS TEMP. 99.6, SPo2 98.7, BP 102/68, HR 67, RESP 18. EMS STAFF ARRIVED AT 1432, REPORT GIVEN TO EMS STAFF, TAKEN TO HOSPTAL AT 1447.
Myalgia, Arthralgia, Pain at the injection site, chills Narrative:
This spontaneous report as received from a nurse prescriber via a company representative and refers to an 1-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in the middle of December 2017, the patient was vaccinated with a dose of M-M-R II subcutaneously (dose, frequency, lot# and expiration date were note reported) for Vaccination against measles, mumps and rubella. On an unknown date, after the M-M-R II administration, the patient experienced a fever, fatigue and a poor appetite. It could not be confirmed when the fever, fatigue and poor appetite resolved. On an unknown date, 10 days after the M-M-R II administration, the patient experienced a suspicious rash. The rash started at the patient's head and neck and progressed to the trunk. There was "no peeling" associated with the rash. The rash disappeared within 24 hours. The patient did not seek medical attention. At the time of this report, the patient was totally fine, healthy with no concerns. The relatedness between the fever, fatigue, poor appetite and rash and M-M-R II was not reported.
A week after vaccine, I felt heart pain in the center left part of my chest. It was strong, sharp, chest tightness, and stabbing pains. I had a reaction to the second dose of Moderna, but this was different. The pain came on strong and was persistent. The chest pain lasted for approximately 3 hours strongly. I went the next day to the urgent care and they performed an EKG and they could not rule out with the test they performed so I was sent to the ER. While at the ER, I had a chest x-ray, CT study for PE, lab work, and hooked up to a heart monitor and IV. The outcome was unknown causes of chest pain. The ER did not know what was wrong. I think I was checked for PE, CAD, Pleurisies. I was discharged. Was checked for PE, CAD, Pleurisies. I am at a healthy weight and active so having heart issues is out of the normal.
PATIENT REACTED TO FLUZONE HD - ARM (RIGHT) SWOLLEN AND DARK COLURATION. SHE HAD CHILLS AND FEVER. SYMPTOM SUBSIDED BUT AREA STILL HAD SEVERE DICOLURATION AT INJECTION SITE AND STILL PAINFUL. PATIENT DID NOT NOTIFY HER DOCTOR AND DID NOT WANT US NOTIFYING DOCTOR.
Localized severe bruising, swelling, redness, heat and drainage from injection site in left deltoid.
Narrative: Patient with one covid vaccine. Patient passed from respiratory failure before second dose due. unclear the underlying cause from respiratory failure. No other death details recorded. reporting with Regulatory Authority instructions.
The patient is a 73 y.o. male with a history below admitted for Paroxysmal atrial fibrillation with RVR. Pt came in with complaints of sob, chest pressure, palpitations. Started yesterday. Associated weakness. Consistent with afib he has had in past. Did not improve overnight. Also still feels sob from covid diagnosed on recent admission 1/30 - 2/2. Had received remdesivir x3 days at that time. Using baseline O2
8 hours after receiving  Moderna injection I spiked a fever. Highest temp was 102.6 - fever lasted for approx. 12  hours
0855: Pt reported to have itchiness and weakness to the left arm (injection site). Pt received Moderna (069f21A) 3rd dose at 0850. Pt was brought back to the observation unit for monitoring.   0900 Vitals:   Temp: 98.8 HR 61 BP 155/89 RR 18 O2 99% RA   Lungs sounds clear, and no stridor noted. Equal grip strength to bilateral arms.    0905: MD made aware, order for cetirizine 10 mg PO and monitor for another 20 mins.   0906: Cetirizine 10 mg PO given   0915:   HR 61 BP 153/86 RR 18 O2 99% RA   Pt denies worsening symptoms. Continue to monitor. Lungs sounds clear, and no stridor noted.    0930:   HR 56 BP 147/84 RR 18 O2 99% RA   Pt reports itchiness is getting better.  Pt denies other symptoms. Continue to monitor. Lungs sounds clear, and no stridor noted.   0945:   HR 56 BP 146/82 RR 18 O2 97% RA   Pt reports itchiness is gone. No other symptoms.   1000:   HR 56 BP 156/82 RR 18 O2 97% RA   1003:Pt passed walking test and clear to go home.
Information has been received from a RN concerning an 8 yr old female with no medical history or allergies who in Jan 2000, at three years of age, was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The RN reported that on 24Oct05, the pt presented to the school nurse with chickenpox characterized by three lesions on her stomach and a couple of lesions on her back. The pt was sent home from school and was followed up by her physician. No lab/diagnostic tests were performed. At the time of this report, the outcome was unk. Follow up information indicated that the pt had transferred to an unk location. Additional information is not expected.
The patient started with "bumps" and burning on the left side of he head and reports mild headache with it. No fevers. Reports feeling warm inside. Appears to have shingles in the C3 dermatome on the left.
A non-serious spontaneous report of "administered H1N1 to 57 year old" was received from a pharmacist concerning a 57-year-old patient. The patient was diabetic. On 16-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Site became hot and reddened.  Patient contacted me and I referred her to physician to ascertain if it was local reaction or cellulitis. Patient was prescribed cephalexin whereupon the reaction was resolved
patient recieved moderna 0.25ml as a booster dose for covid-19. Previous series completed with pfizer. Within   approximately 5 min of vaccine patients wife gets the pharmacist pt complains of chest and back pain. Ems is called but pt leaves in his own vehicle and goes to the ER.  Pt returns later and states that er cleared him and that it wasnt his heart. He says it felt like muscle pain but that it had completely resolved by the time he came back to the pharmacy a few hours later.
Syncopal episode 10 minutes post vaccination (when leaving office) - writer arrived to assist pt within 1 minute post event - pt states "I don't know what happened - I just felt dizzy and must of went down". Pt oriented x 3, BP = 110/76; P = 68; R = 16. After 10 minutes, pt reports ok to leave. Denies any adverse effects. Boyfriend here and will drive pt home.
12/17/21 ID physician's note: "Patient is a 67 year old female with PMH significant for diabetes type 2 and ESRD on HD, CAD, HTN, CHF, and emphysema with home o2, who presented to the hospital with c/o coughing and shortness of breath and was found to be positive for COVID-19 via rapid testing.  Daughter at bedside, assisting with HPI and ROS, although patient is AOx3, and also responds appropriately.  She first had symptoms of malaise and fatigue on 12/14 evening, and then developed a cough on 12/15. She had some nausea the day before yesterday, but otherwise denies n/v/d.  Shortness of breath has occurred only with coughing, but otherwise denies any problems breathing, but has been using home O2 since Wednesday.  Patient reportedly uses home O2 up to 4 LPM intermittently, but for example, last week only used O2 twice, whereas with the onset of cough she has been using it consistently.   She went to dialysis this morning before coming to the hospital.  In the ED, her chest xray showed pulmonary edema/pleural effusions, and she was given lasix.  Her hs troponin was 55, and BNP 1,813, ekg showing inferior infarct, repeat trop and ekg pending.  Denies chest pain/pressure.  No other concerns identified. She's been started on remdesivir and decadron.  Of note, she has received two vaccinations for covid, the second being in July 2021" .
This spontaneous report as received from a doctor of pharmacy concerning an approximately 79 year old female patient. Current conditions of the patient included Altace allergy, Oxycodone allergy, Percocet allergy, Codeine allergy, Iodinated contrast media allergy and shellfish derived products allergy. On 15-OCT-2013 (also reported as 15-OCT-2015), the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were report as J004269 and 12-JUL-2014 respectively), subcutaneously in the right arm. No concomitant therapy was reported. Since 15-OCT-2013, after the vaccination, the patient experienced an increasing soreness around shoulder and neck, red hard bump and itchy rash the size of a half dollar. The patient did not seek any medical attention. No treatment was given. It was unspecified if any lab tests were performed. The patient was not recovered from the events. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
The day after the 2nd Hep-B, the pt was very listless; decreased interaction; decreased strength and tone. No fever. NOTE: See twin brother below.
hoarseness, coughing,immediately followed by significant constriction in throat and chest, with watering eyes.  Took 2 benadryl within 30 minutes of onset of symptoms and within another 30 minutes 2 puffs from inhaler ordered by PA friend.   Severe symptoms subsided, and rest of evening and following 2 days (so far) still having watery eyes and some itching / small hives.
Rash At Injection Site And Below Site; Elbow Area; Around Neck. Took CIPROFLOXACIN HCL 500 MG For 7 days. Applied Betamethasone VA 0.1% Cream. 5/21/19 Had Penumonia Shot at Pharmacy. Prevnar 13. Reaction was a rash on arm Viisited Dr. on May 29, 2019, prescribed Ciprofloxacin for seven days and betamethasone Cream for rash. (5/29/19) 6/26/19 Saw Dr. Rash continues and spreading. Continue using cream. Dr. suggested I see a Dermatology Doctor.
Rash, swelling (2 to 3 inches in diameter), itching at injection site about one week after vaccine administration.  Symptoms lasted two days.
Left arm became red and swollen, tender to touch.  Examined today.  Instructed to take Ibuprofen 600 mg Q 6 hours and ice.  RTC tomorrow for further evaluation.
Patient reports having severe pain while urinating and notices blood clots in urine.  First noticed this adverse reaction on 3/7/21
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after expiry) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. Patient did not had any allergies to medications, food and other products. It was unknown patient neither diagnosed with COVID-19 nor tested positive. On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. It was reported patient did not had any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek for medical care and it was unknown whether patient experienced a similar event in the past. It was reported that the vial was initially stored in the refrigerator on 20-Apr-2022 06:44PM. The vial did not undergo any temperature excursion. Treatment medications were not reported.