chrisvoncsefalvay/vaers-outcomes huggingface dataset:
J&J Dose 4/7/21 (1808980) COVID Positive 1/11/22 COVID Positive 1/16/22  1/16/22: Patient is a 61 year old male who presented to ED with complaints of shortness of breath. Patient has been experiencing generalized weakness and fatigue.  He was tested at Health Center for COVID-19 last Tuesday and was informed today that his results were positive.  He is vaccinated against COVID-19 but has not received his booster. He has shortness of breath, especially on exertion. No chest pain. Has developed a productive cough. Decreased appetite and oral intake. Nausea without vomiting. He endorses diarrhea for the past several days. He has a past medical history significant for paroxysmal atrial fibrillation anticoagulated on Xarelto, hypertension, COPD, hyperlipidemia alcohol and tobacco use.   On arrival to ED the patient was hypertensive 153/94. Laboratory findings were significant for hyponatremia 114. Leukocytosis 16.28.  Chest x-ray significant for minimal bibasilar airspace disease which may represent atypical infiltrates or atelectasis.  Patient received DuoNeb treatment, Solu-Medrol and Toradol in ED.  IV fluid resuscitation was given with NS 0.9% 1 L bolus.  1/21/22: 61-year-old male with a history of PAF, HTN, HLD, COPD not on home O2 and chronic ETOH abuse.  He presented with complaint of generalized weakness and fatigue of a week duration and a routine COVID 19 PCR came back positive.  He is fully vaccinated including receiving a booster dose in October 2021. The main reason for admission is severe hyponatremia with Na of 114 mEq/L, no respiratory symptoms with O2 saturation of 95% on room air.  She was admitted to hospital for severe hyponatremia.  The nephrologist was consulted for management.  She was managed with the water restriction and later oral sodium chloride salt with some improvement.  On re-evaluation this morning the sodium level was 126 milliequivalent/liter.  Patient feels much better and will want to go home.  Patient is discharged on the medication listed below.  More importantly patient was counseled to quit drinking as it is the primary reason why he has severe hyponatremia.  He promised to quit.  He will follow-up with the PCP with repeat BMP in a week.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of incorrecct storage VARIVAX (Merck) (lot # J003539, expiration date 25-MAR-2015), (dose, location and route unspecified). The outcome of the event was not provided. Follow up information has been received from the registered nurse who called and stated all patients (who received VARIVAX (Merck) exposed to unknown temperatures for 5 hours during interoffice transport) have been revaccinated. No symptoms reported. This is one of several reports received from the same source (Linked MARRS#: 1309USA011086, 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897, 1401USA000205). Additional information is not expected.
Stomach virus; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (Stomach virus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced GASTROENTERITIS VIRAL (Stomach virus). At the time of the report, GASTROENTERITIS VIRAL (Stomach virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had stomach virus and was scheduled for second shot on the day of reporting.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
A 40 year old female with past medical history of complex unspecified pulmonary problems and thyroid cancer, received RabAvert for pre-exposure. After the second dose of RabAvert, the pt experienced chest pressure and asthma-like symptoms. When the pt received her first dose of RabAvert, she was also on a steroid inhaler. Her treating physician had approved the administration of RabAvert knowing there was a drug interaction. When the second dose of RabAvert was given, the pt was NOT on the steroid inhaler. The event occurred within one hour after the second dose, and resolved within 8 hrs.
SWELLING, HOTNESS, REDNESS/PURPLE, NAUSEOUSNESS, PAIN, SORENESS ON ARM AND UNDER PITS.
Attending Physician: DO;     Date of Admission: 2/1/2022   Chief Complaint:  Bilateral lower extremity edema   Source of Information:  Patient and Available medical record   History of Present Illness:  Patient is a 61y.o. male with PMH significant for Recently diagnosed sarcoidosis, CHF, HTN, Afib, CKD III and gout presents to ED with c/o edema. Pt states symptoms began 3 weeks ago with progressive worsening. Symptoms include lower extremity edema that extends into the abdomen, SOB on exertion or when lying flat, cough with scant sputum production that is blood tinged at times, N&V 2/2 abdominal fullness and fatigue. Pt states he tried to call his nephrologist and cardiologist however was unable to be seen in office. Pt states he was told to increase his diuretic without increased urination or relief of symptoms. He then ran out of lasix about a week ago and has made attempts to get his medications refilled. Pt states he is compliant on low sodium diet and mindful of fluid restriction. Pt denies any known sick contacts and was surprised he is positive for covid-19. He is vaccinated x 2 and has an appointment for his booster. Pt denies fever, chills, chest pain, palpitations, SOB at rest, purulent sputum, abdominal pain, diarrhea, constipation or dysuria.  In the ED, pt was afebrile and normotensive. BUN 48, creatinine 2.65, GFR 29. BNP 3,195. Troponin 0.04, 0.04. Hgb 8.4. Covid-19 detected. Chest xray - Cardiomegaly with mild pulmonary vascular congestion. UA negative for infection. In the ED, pt was given lasix 80mg IV. Pt will be admit for further treatment.
Patient was given his second covid dose (Moderna) 21 days from his first dose (Pfizer).
Broken out into a terrible itching rash over my entire body.  It is still present approximately 6 weeks later.  Due to the severity of the rash, I did not receive the second vaccine.
Chemotherapy fatigue/DIFFERENT FATIGUE THAN JUST TIREDNESS; Neck pain; Neck injury; Joint range of motion decreased/LACK OF MOBILITY; This spontaneous case was reported by a consumer and describes the occurrence of CANCER FATIGUE (Chemotherapy fatigue/DIFFERENT FATIGUE THAN JUST TIREDNESS) in a 64-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.     Concurrent medical conditions included Rheumatoid arthritis and Breast cancer female since 1992.    On 15-Nov-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CANCER FATIGUE (Chemotherapy fatigue/DIFFERENT FATIGUE THAN JUST TIREDNESS) (seriousness criterion medically significant), NECK PAIN (Neck pain), NECK INJURY (Neck injury) and JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/LACK OF MOBILITY). At the time of the report, CANCER FATIGUE (Chemotherapy fatigue/DIFFERENT FATIGUE THAN JUST TIREDNESS), NECK PAIN (Neck pain), NECK INJURY (Neck injury) and JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/LACK OF MOBILITY) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 64 year old female patient with concurrent condition of breast cancer, who experienced the unexpected serious (medically significant) event of Cancer fatigue  (reported as Chemotherapy fatigue/different fatigue than just tiredness), unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations and treatment of the event was available in the report.  Concurrent condition of breast cancer could be contributory to the event.  The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-628644 (Patient Link).; Sender's Comments: This spontaneous case concerns a 64 year old female patient with concurrent condition of breast cancer, who experienced the unexpected serious (medically significant) event of Cancer fatigue  (reported as Chemotherapy fatigue/different fatigue than just tiredness), unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations and treatment of the event was available in the report.  Concurrent condition of breast cancer could be contributory to the event.  The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
patient called to report she had chest pain on left side about 4:30pm on 10/2/21 after receiving the vaccine at  11:32am,  and on 10/3/21 she woke in the morning with red swollen cheeks
Broke out with fever Saturday 6/3/06. Now has rash all over her body, itching on her head.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients received an unspecified number of improperly stored doses of ROTATEQ oral (dosage and lot # not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
chills; nausea; tiredness; soreness in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness in arm), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in arm). On 17-Jan-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness). On 19-Jan-2021, VACCINATION SITE PAIN (soreness in arm), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-014510 (Patient Link).
Swollen, sore lymph node in left axillary region - believed to be axillary adenopathy
My body ached everywhere. This was similar to the onset of a cold. The injection site on my left shoulder started to get stiff and aching according  to #5 above. This spread throughout my body. The discomfort subsided by 9:00 a. m. on 03/12/2021. The duration seems to have been 36 or so hours. I feel good as of 11:30 a. m. 03/12/2021. I am providing this information if it is useful for any CDC purposes statistical or otherwise.
Patient reported dizziness, nausea, chills and malaise for 2 days after the immunization. Slightly better on day 3.
Pt called stating rash was occurring on lower extremities. Pt informed to take BENADRYL to decrease itching and go to urgent care or emergency room if needed.
reports panic attack while driving.  C/O SOB, dizziness, and chest tightness.  Has remote history of panic attacks.
Immeditely after my first shot on March 7  I felt fine (except some mild soreness at injection site).  A full week later, on March 14, I had some mild chills, fatigue, headache, and a red itchy rash. The rash was located on my right inner forearm, my left inner thigh, my lower back and hip area, and my ears. No rash on injextion site arm. I took benadryl and used a topical 1% hydrocortisone cream, and the rash eventually subsided after 5 days.
(03/04/2021)Rash on left wrist with bumps, progressed to fluid filled blisters. Went to urgent care where it was determined as Dermatitis. Was given Triamcinolone to treat. It helped with the itchiness but the rash and blisters stayed around a month. It left some scarring but otherwise recovered.
At time of vaccine administration, a small hard red bump formed and was approximately 2 cm across as well as minor bleeding that stopped after 1 min of direct pressure.  The patient did not report any pain nor did they report any symptoms of anaphylaxis type symptoms (itching/swelling of the face/neck/throat). No treatments were provided for the bump that formed. I monitored the patient for 15 minutes and patient did not complain of any further issues surrounding the swelling/bump formation. I advised the patient to monitor and seek medical care if swelling increased, new pain develops or if any other concerning symptoms developed. Patient did not need any assistance to their vehicle and seemed in well when leaving the clinic.
Within the 15 minute wait period, tingling and itching occurred in left eye, back and side of tongue and lips. Also, sweating and flush feeling.
Patient is a 89 y.o. male who presents with 4-5 days of weakness, cough, diarrhea and decreased oral intake.  Has had chills but no fever.  Tested positive for covid 05/14.   Patient presents with respiratory distress COVID-19.  Able to maintain oxygen saturations but given level of dyspnea and tachypnea patient is not stable for discharge home.
pt recvd vax 14MAY93 1230PM & devel redness, soreness, warmness of thigh; temp 101-102 ax; 630PM limping & refusing to walk on leg; apparently temp 100-102; WBC 24.1, leg still red, swollen, tender; referred to hosp for r/o cellulitis;
Dizziness, cold respiration and nausea episodes began Nov 28. H1N1 vaccine cause. Both my wife and I are experiencing this since Nov 28 and were vaccinated together.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and NO ADVERSE EVENT (No adverse reaction) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Aug-2022 at 9:18 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022 at 9:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture).  No concomitant medications were reported. Number of doses/vials includes 2 doses from 1 vial. Date the vial was initially stored in the refrigerator was reported as 04-Aug-2022. Date and time vial was first punctured was reported as 18-Aug-2022 at 10:30 AM. Vial was stored in fridge post puncture. Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8degree to 25 degree Celsius which was 46degree to 77degree Fahrenheit) was total of 30 minutes. Vial was not exposed to room temperature for more than 24 hours. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2022: Live follow up received contains significant information: Added patient demographics, suspect product dose details and narrative updated.
24 hours after 2nd dose left arm near injection site became swollen and is still swollen to this date. The swelling is a little hard and sometimes warm to touch
Mother called to report vomiting x1 episode, headache and tiredness. Fever 100.7F, occurring 1 day after injection. Mom to monitor at this time.
Patient lost consciousness and had seizure activity. Upon regaining consciousness, patient became somewhat alert and reported loss of vision, which returned after a few minutes. He then reported hallucinations, numbness over whole body, and chest tightness.  Could not find a radial pulse, but patient was breathing and fingernails remained pink. Patient was sweating through his shirt.  911 was called, responding within 10 minutes. Patient was transferred to a stretcher and taken to the hospital.
p/vax pt felt dizzy; has chronic fatigue; & frequent h/a; seen own MD, no tests done; told to not take 3rd shot;
Received Pfizer vaccine for Booster shot on 1/7/2021. She had a vaccine allergy/reaction or scratchy and itchy throat and she felt some "slight swelling starting".  She initially received J&J vaccine and had a similar reaction of scratchy throat. She stated MD okayed her to received Pfizer Booster and she premedicated herself with Claritin prior to Booster. Pt stated that she has a history of vaccine allergies (again MD cleared her to receive Booster).  Benadryl 25mg IM given at 15:06, she was reevaluated at 15:35 (30 minutes later) VSS, a/o x4,  talking in complete sentences. Pt stated symptoms resolved and that she felt safe to go home and drive.
Information has been received from a registered nurse concerning a female who was vaccinated with varicella vaccine. Subsequently, a varicella virus antibody test revealed a positive titer. On 08/19/1998, the pt underwent a renal transplantation. Subsequently on approximately 04/24/2001 a varicella virus antibody test revealed that the titer that was not negative. The pt sought medical attention. In follow-up, the nurse reported that the loss of effect was not do t lack of serocenversion and was not regarding her. No further info is expected.
p/vax pt devel a cough that persisted for a few days then became whooping like cough 5 days later;pt parents also reported reddish blotches on pt lt knee & ankle;
Patient fainted 30-60 seconds after administration of the vaccine.  Did not fall, was lowered to the floor and came to quickly. Sat on the floor for a few minutes, then moved to a chair. Left 15 minutes later with his spouse stating he was fine.
I developed a red, raised rash that was itchy and painful within a few weeks of receiving the first dose of the Pfizer vaccine. It was later diagnosed as shingles. I also experiences frequent surges of heat in my feet throughout the day. The sensation quickly fades within a few seconds.  *Note, I recently was diagnosed with with a molar pregnancy and my immune response was likely lowered as a result. I have also been very stressed as I have dealt with multiple miscarriages (5) within a span of  a year and a half.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 62-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 24-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:same reporter
Patient received the MMR, DT, Hib, and influenza vaccinations on 01/12/05.  The patient returned on 01/13/05 with the left side of her face swollen - diagnosed as parotitis.  No treatment was given.  Patient was also diagnosed with Bronchiolitis that same visit and was treated with xopenex nebs at home via a home nebulizer.
Fever 3.1.13 & red spots on left arm 3/3/13.
This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 53-year-old female patient who received FLULAVAL quadrivalent (batch number C92E7, expiry date June 2016). Concomitant products included FLONASE. ALLEGRA, SINGULAIR, lisinopril, omeprazole, SYMBICORT and SYNTHROID. On 5th October 2015, the patient received FLULAVAL quadrivalent .5 ml. On 6th October 2015, 1 days after receiving FLULAVAL quadrivalent, the patient experienced injection site bruising, tiredness and injection site pain. On an unknown date, the outcome of the injection site bruising, tiredness and injection site pain were not recovered/not resolved. The reporter considered the injection site bruising, tiredness and injection site pain to be related to FLULAVAL quadrivalent. Additional details were received as follows: This case was previously reported to doctor. The reporter stated that, she received the prepackaged FLULAVAL quadrivalent, in her left shoulder area. The patient experienced bruise the size of a tennis ball, soreness and feeling tired. The reporter reported the adverse event back to the staff of the employee health where she received the vaccine.
Joint and Muscle pain; BUMPS/RASH ON BODY, HANDS, LEGS; MOUTH SORES - FOR N 7 days post flu injection (No FEVER)
Day 1 after 2nd shot - soreness at injection site. Day 2 - headache/fatigue and soreness around the injection site. Day 3 - red, swollen and hot around injection site. Day 4 - larger red area, swollen and hot below the injection site.
Patient called and stated that left side of her face turned red and had a small rash. She has some sort of difficulty breathing and felt her tongue somewhat swell up. I informed her to take benadryl 50mg right away and seek medical emergency at urgent care or ER.
5 minutes post immunization client return to clinic with redness to L lower forearm. No itchy. Called MD, vital signs within normal limits. No resp distress. Benadryl 12.5mg 15ml, 7.5ml PO given as ordered. Monitored for 30 minutes.