chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccination at approx. 11:30 AM. At 2:00 AM the following morning, patient woke up very alert and anxious, with rapid heart beat. Patient reported to work at 6:45 AM and counted BPM at 120. Patient felt hands, feet, axilla to be sweaty. Patient discussed with colleagues and reported to vaccine clinic to report. Patient reports no other symptoms other than mild tenderness at injection site.
Fatigue the night of vaccine (Friday). Fever, body aches, and fatigue on Saturday.  Brain fog and fatigue Monday.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  No treatment information was provided.   This case was linked to MOD-2021-079301 (Patient Link).
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD. Total 42 dose was administered after 30-day Use By Date. The Bivalent 6m-5y vial of 0.4 mL (Lot number: 216K22A) was initially stored in the refrigerator on 23-Dec-2022. The vaccine was administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb2-023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 27th of 42 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298: patient no. 01 (Master case)
pt recv vax & felt as if was releasing a small ball into arm;arm became very sore to touch;feverish, sick on stomach, throwing up 29AUG98;muscle ache; h/a;swelling neck;leg & back began aching deep & then legs began do lock up;
After my second vaccine, May 8th 2021, I did not have a menstrual cycle in June or July.  In August I had a menstrual  cycle every day for a month leading into September.    My cycles are normal otherwise as I take the pill.
Pt said she was experiencing a temperature and her arm was red and swollen within hours of receiving vaccines. She went to urgt care to get on antibiotics.
Shortness of breath. Have been on 24 HR oxygen since! (2-3 liters/hr)
Leg pain in both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Jan2022 09:15 (Lot number: FKS127) at the age of 11 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Influenza A", start date: 10Dec2021 (unspecified if ongoing), notes: Influenza A. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FKS127 , Location of injection: Left Deltoid, Time: 09:45), administration date: 08Dec2021, when the patient was 11 years old, for Covid-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Jan2022 07:00, outcome "recovered" (16Jan2022), described as "Leg pain in both legs". The event "leg pain in both legs" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: Serious: No. Relevant tests: None. Specific relevant test for thromboembolic events with thrombocytopenia: None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.  No abnormalities found. Treatment: Motion pan, Ice pan, Pt felt better by 16Jan2022.  The patient provided information regarding the reported adverse event with the use of the product and considered the Pfizer product had a causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
After immunization, less than 5 minutes: light headed and dizzy, visual disturbance - bright, hearing muffled.
vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    Case contains the information regarding patient 16 of 100 reported.  Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the HCP.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (lot # L030162, expiry date 11-AUG-2017) (doses, route and site of administration were not reported). The doses of vaccine were stored under temperature of 53.1 F for 63 hours (total of 5 excursions). There was no previous excursion. No data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
I had been feeling tired and out of breath. I went to see my PCP in June and I told her about my symptoms. She did an EKG and found I had atrial fibrillation. It is possible that I might have this before the shot. They prescribed me Eliquis. I am now on Atorvastatin for hypolipidemia. I also had to go to the ER because I got faint and dizzy and I passed out. They did an EKG, chest x-ray, brain scan, ultrasound, and urinalysis. I had a slight UTI and Atrial fibrillation. Since then I have had stress tests, heart catherization, TEE, and cardio version.
Arm and shoulder pain starting at 3 hours through 36 hours,  body ache starting at 8 hours through 48 hours, intermittent headache starting at 8 hours through 72 hours with associated nausea, headache was intense enough to require acetaminophen on three occasions, chills starting at 15 hours that responded to acetaminophen, fatigue from 8 hours through 84 hours.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a military medical facility/clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical facility/clinic (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown.  Additional information has been requested.
Local reaction with inflammation near injection site at 3 days post, warmth, redness.  No associated allergic reaction.
Systemic: Chills-Mild, Systemic: Fainting-Medium, Systemic: clammy, dizzy, tingling in ears, O2 sat ok,temp ok; symptoms lasted 0 days
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information provided.  Date of refrigeration: 07-May-2021.   Reporter did not allow further contact
Patient reports Covid-like symptoms a day after vaccine was administered such as sore throat, cough, headaches, runny nose, shortness of breath, wheezing, fatigue and body .
Pt had about 4 1/2cm diameter of erythematous, indurated area on left thigh surrounding site of injection. No heat, tenderness, changes in gait or fever. Treated with Benadryl.
pt. recd. 3rd dose of hepatitis B vac. & exp. nausea,diarrhea,& chills.
Jan 17 blurriness in left eye... went for eye exam n the 21st, had emergency surgery Jan 22nd for a severely detached retina
CHIEF COMPLAINT:   pt comes in reporting redness, swelling, pain to left lower leg. also has been vomiting since friday. low O2 on arrival, wears home O2 24/7 that she has not had on PTA. SOB on arrival, cyanotic lips. diff speaking in full sentences.   HISTORY OF PRESENT ILLNESS:     57-year-old female with past medical history of COPD, HTN, Pulmonary HTN, and morbid obesity who presents with a chief complaint of right lower extremity pain, redness, and swelling.  Patient states that she began experiencing fever, chills, vomiting, and left ear pain on Friday, 2/11/2022.  She states that she then began to have right leg pain, redness, and swelling starting on Saturday, 2/12/2022.  She rates her pain as 8/10 in severity and throbbing/burning in quality.  She denies having the symptoms in the past.  She reports shortness of breath, which patient states is chronic and at her current baseline.  She reports being on 4 to 6 L of supplemental oxygen at home (pulmonologist).  Denies chest pain.  Patient states that she saw her PCP, 12 days ago at which time she was told to discontinue her furosemide.  Patient states that she has had slight increase in bilateral lower extremities over the past week, but not significantly changed from her baseline.  She states that her left ear pain and fever have improved, but is still experiencing chills.  Reports no other complaints at this time.
2.5 weeks after injection, I had chest tightness, burning pain in sterna area and back pain. Pain was persistent for 3 days and then I sought care in the local .
I inadvertently gave an 18 month old patient an unnecessary 5th dose of PREVNAR 13. An 18 month old patient came to my practice as a new patient on January 6, 2015. His old medical records had been scanned in and vaccines previously received were entered into his record. During transcription, a dose of PREVNAR 13 that the patient had received in September 2014 was inadvertently missed. In reviewing the patient's chart prior to seeing him, I determined he needed one more PREVNAR 13 along with HAV #2 and DTaP #4. I pulled up his original immunization record to check for transcription errors, but I too missed that he had already received his 4th PREVNAR shot. I's including screen shots of the scanned record I was checking. I believe the way the page cut off between the name of the vaccine and the dates given may have contributed to my error. Later that day, the patient's mother reviewed his records and called to discuss the error with an RN in my practice. The RN identified the PREVNAR dose that was missing from this transcribed record. She explained the error to the patient's mother, apologized for the error and reassured her that the additional dose of vaccine should not cause any harm. The patient's mother subsequently lodged a complaint with the Board of Medicine for my error in giving her child the additional dose of PREVNAR. I am consequently being investigated by the Board of Medicine and am required to respond to her allegations in writing within 7 days. The patient also received an unnecessary flu booster from his previous physician, in October 2014. Though I do not believe his mother is aware of this error.
demyelinating illness started 5 days after second vaccine started with numbness and tingling of legs, progressed to lower extremity weakness, developed facial numbness, hand incoordination mri showing enhancing lesions in brain, cervical, thoracic spine lp abnormal, lymphocytosis oligoclonal bands got high dose steroids for 5 days no  improvement getting plasmaphersis  hospitalized since 7/22 to present
Pt became SOB, had facial and eye swelling, vomiting, red eyes throat swelling. After recieving flu vaccine. Epi IM given, Benadryl 50 mg IV and Solumedrol 125mg IV.
2 days after vaccine (L) upper arm red, swollen, tender and hot. Improving but still painful.
Itchy rash on right arm, face, neck and chest. Took Benadryl 25mg.
This spontaneous report as received from a clinical manager refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with M-M-R II (HSA) lot # J002502, expiration date: 28-FEB-2015, dose and route not reported. No concomitant medication reported. The reporter reported that M-M-R II (HSA), reached temperatures that were outside the prescribing information (also reported as M-M-R II) was not stored at 11 degree Celsius it was stored at -11 degrees Celsius). Outcome and causality was not reported. This case has been linked to 1407USA006606, 1407USA008586, 1407USA008584, and 1407USA008585. Additional information has been requested.
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius (explicitly coded as incorrect product storage). On 15-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805477 was crossed linked to original cases 201804863 due to same reporter.
My left underarm was so painful I had to take off work on Monday the 29th.  I called doctor's  office and they got me in for a follow up.  Doctor made a referral for an ultrsound however, when I called the place I go to, she specifically said that I had to wait six weeks to get the ultrasound due to many people describing the same symptoms and for me to wait.    The entire arm pit was literally on fire.  I thought I was going through labor all over again in my underarm.  Even till this day, I sometimes feel a twinge of pain in the underarm.  Warm heat seems to help.
I contracted COVID-19 on 06/22/2022 with symptoms of cough, runny nose, congestion, and fatigue. I was prescribed molnupiravir, doxycycline, and guaifenesin with codeine on 06/24/2022. I was ill for 3 to 4 days before my symptoms began to resolve. I am fully recovered, but I have a lingering runny nose.
Fever 101, chills, nausea, fatigue for about 24 hours.  fatigue for a few days after.  It is now 12 days after my vaccine and at the site of the injection, my arm is itchy and a small area around it is bumpy but no discoloration.
Chills, body aches, chest conjestion/pain, fatigue, sore throat, headache, nausea ,short of breath  Sinusitis,  bronchitis  ,asthma shortness of breath. Now using nebulizer albuterolsul 2.5 mg/3 prn , wixela 2 x Da
New onset Afib time wise related to SPV. No other risk factor except Marfanoid appearance, and positive family history Marfan's. Treated diltiazem, NSR.
cold extremities; fever; chills; fatigue; rheumatoid arthritis; This is a spontaneous report from a non-contactable physician. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was none.  There were no concomitant medications. Historical Vaccine included received first dose of BNT162B2 intramuscular at the age of 39-year-old on 16Dec2020 at single dose for COVID-19 immunization and did fine. The patient did fine after first dose, after second dose had 36 hours of fever and chills. Covid test negative. Several weeks later she developed fatigue and cold extremities. She was found to have elevated CCP (Cyclic Citrullinated Peptide) antibodies, dx (diagnosis) rheumatoid arthritis. All events occurred on 04Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events included medication for pain, specialist referral. There was no other vaccine received in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. Covid test (Nasal Swab) post vaccination was Negative. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the time association and drug's safety profile, the events fever, chills, fatigue, and cold extremities are possibly related to suspect vaccine BNT162B2 administration. The event rheumatoid arthritis is more likely underlying/intercurrent condition, unrelated to suspect vaccine BNT162B2 injection given the product's safety profile and the pathophysiology of rheumatoid arthritis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.