chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Sep2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single. Family history included: "COVID-19", start date: 2021 (unspecified if ongoing), notes: I was not formally diagnosed with COVID but certain I contracted the virus as two members of my household were formally diagnosed. I lost my sense of taste and smell for greater than six months. I had the virus likely around Feb-Mar2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number FC3180,, dose number 1, vaccine location Right arm), administration date: 08Aug2021, when the patient was 48 years old, for COVID-19 Immunisation, reaction(s): "Submandibular glands swelled to size of plums", "Malaise", "fatigue", "nausea", "body aches", "persistent mild to moderate headache". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "Submandibular glands swelled to size of plums"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "mild headache"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset Sep2021, outcome "recovering" and all described as "hurt with injection and bruised at site.". Therapeutic measures were not taken as a result of lymphadenopathy, pain, headache, vaccination site pain, vaccination site bruising. Additional information: Submandibular glands swelled to size of plums within two days, slowly resolving over the course of 30 days. This occurred again with dose two, but not as severe. Malaise, fatigue, nausea, body aches, persistent mild to moderate headache for one week for dose one; mild headache, body aches, and swollen glands dose two. Dose two (20Sep2021), hurt with injection and bruised at site. If treatment AE: No, Since the vaccination, patient not been tested for COVID-19, Patient was receive any other vaccines within 4 weeks prior to the COVID vaccine. Known Allergies: No. No follow-up attempts are possible. No further information is expected.
41yo male with history of HLD, LBP, and tobacco use who presented to care initially at the with chest pain. He received the second dose of the Moderna vaccine on 18MAR21 at clinic and within 14 hours developed chills and myalgias. He denies any immediate onset of symptoms after receiving the vaccine. The following day he reports experiencing chest pain 24 hours after the vaccine was administered that progressively worsened over the subsequent 36 hours that finally prompted him to seek care. He describes the pain as a central non-radiating squeezing pain that worsened with movement and breathing. He waited to seek care because he reports several of the soldiers in his unit have experienced similar chest pain that eventually resolved.   He reports being at his baseline health prior to receiving the vaccine and denies any fever, cough, rhinorrhea, congestion, malaise, vomiting, diarrhea, or rash.   Upon initial presentation to care at clinic he was noted to have a Tropnon I of 0.9, WBC of 14, elevated CRP (7.3), and temp to 101.4. Patient was given ASA, Plavix, Lovenox, Tylenol, and Ceftriaxone.    Since arriving to clinic and EKG was obtained showing ST elevation in lead 1 and avF concerning for ischemia and underwent a left heart catheterization which was clear of obstruction. Serial high sensitivity Tropnonin levels have been trended to peak of 465. Respiratory viral panel to include SARS COV-2 was negative. Cardiac MRI was consistent with myopericarditis, and show mildly reduced EF for 46%. Blood cultures have not grown any organism. His chest pain has resolved since starting Aspirin and Colchicine.
DEVELOPED CHEST PAIN ON THE NEXT DAY FOLLOWED BY FEVER, COUGH LOSS OF TASTE AND SMELL
First shot on 15-Apr-2021, second shot not yet administered; 15yr old recived vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (First shot on 15-Apr-2021, second shot not yet administered) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15yr old recived vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2012, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15yr old recived vaccine). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (First shot on 15-Apr-2021, second shot not yet administered). On 15-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15yr old recived vaccine) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (First shot on 15-Apr-2021, second shot not yet administered) outcome was unknown.       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 medication was reported. No treatment information was provided.  The patient was doing fine.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up contains updated patient details and updated narrative.
Chest area is sore when lifting up arm.  Feels as though she tore a muscle on the entire left side.
I've had irregular bowel movements. They've been normal BM's, but just more frequent; my arm was sore where I got the shot; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (I've had irregular bowel movements. They've been normal BM's, but just more frequent), VACCINATION SITE PAIN (my arm was sore where I got the shot) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (my arm was sore where I got the shot) and FATIGUE (Tired). On 17-Mar-2021, the patient experienced BOWEL MOVEMENT IRREGULARITY (I've had irregular bowel movements. They've been normal BM's, but just more frequent). At the time of the report, BOWEL MOVEMENT IRREGULARITY (I've had irregular bowel movements. They've been normal BM's, but just more frequent), VACCINATION SITE PAIN (my arm was sore where I got the shot) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt seen urgent care 9/6/14 had PNEUMOVAX 2d prior c/o right arm redness, temp 99.9 first day and body aches. On 9/6/14 right arm swelling gone up into right shoulder and upper arm. Pt has rash on right arm also. TX with methylprednisone 4 mg tid x 3 days and BENADRYL.
This spontaneous report as received from a pharmacist refers to her father, 62 year old male patient with hypertension. In summer 2013 the patient was vaccinated with PPV (manufacturer unknown) (lot # not reported) dose and frequency not reported. No concomitant therapy was reported. The pharmacist stated that her father received an unspecified PPV (manufacturer unknown) and after receiving the PPV (manufacturer unknown) in 2013, her father experienced severe chills and was taken to an unspecified emergency room. Her father was not admitted to the hospital and after an unspecified treatment, her father was discharged from the emergency room on an unspecified date. The outcome of her father experienced severe chills was reported as recovered/resolved. Additional information has been requested.
Due to recent onset of Polymyalgia, on the day of my first Covid-19 vaccination I was taking PredniSONE.  Four weeks later for the second dose of the Covid-19 vaccination I was taking PredniSONE . I have tapered off the PredniSONE and now am taking  per day. The nurse at the  vaccination facility told me that because I was taking PredniSONE my immune system was suppressed and the vaccine would not be as effective. If you are studying this matter I may be a candidate for the study.
Raised, hard, oval shaped, hot, itchy, redness on skin (2-3 inches), no fever, 40 hours after injection
Patient states she experienced extreme SOB. She took BENADRYL orally and was better w/in one hour of BENADRYL.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient nodded off into a faint when I went to get him a snack, he remained in his chair but dropped his water.  Patient said he was feeling sweaty and seeing black. He rested with head down & on the floor.  Had some water and a snack.  Side effects lasted 5-6 min, patient remained in pharmacy for an additional 15 min without any further events.
Case previously recorded as MA2009-4797. Initial case report received from a pharmacist on 09 NOV 2009. Patient 6 month to 3 years were inadvertently vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) 0.25 mL IM in 2009. When patients returned a month later, they received the remaining 0.25 mL dose IM from a saved syringe labeled with the patient's name. No adverse effect was reported. Seriousness criterion: not serious. Causality: no applicable. Off label use (child under 4 years old) and wrong storage (half-used syringe stored 1 month) are unexpected regarding vaccination with FLUVIRIN 2009/2010. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Reference no.: NA09-007832.
PATIENT RECEIVED 2ND Covid-19 vaccine on 2/22/21 and started developing a Rash on her neck later that day.  She came into our office (pcp) on 3/1/21 and advised us of this,  by 3/1/21 the pt stated it was much better since the start of sx on 2/22/21.
Day after my arm was very sore, muscle aches in both thighs, fatigue, and headache.
Fever BODY ACHES, CHILLS, INJECTION SITE PAIN,  SLEEPING DIFFICULTY
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received BEXSERO for prophylaxis. Co-suspect products included BEXSERO for prophylaxis, MENVEO for prophylaxis and MENVEO for prophylaxis. On 6th July 2016, the patient received the 1st dose of BEXSERO. On 6th September 2016, the patient received the 2nd dose of BEXSERO. On an unknown date, the patient received the 1st dose of MENVEO. On 6th July 2016, the patient received the 2nd dose of MENVEO. On 19th November 2018, 2 years and 136 days after receiving BEXSERO and MENVEO, 2 years and 74 days after receiving BEXSERO and unknown after receiving MENVEO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal meningitis were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal meningitis to be related to BEXSERO, BEXSERO, MENVEO and MENVEO. Additional details were received as follows: The age at vaccination was not reported. On 19 November 2018, the patient was hospitalized for bacterial meningococcal meningitis. At the time of reporting patient was in the hospitalized. The reporter did not consent to follow up. No further details were provided. Field representative would follow up with the primary reporter. This case was advised by medical affairs lead to report this event.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter.  No treatment medications provided by the reporter.
Got shot, got shingles anyway/Suspected vaccination failure; Got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 01-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The doctor told him that 51 percent who get shingles vaccine get it anyway. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case had been linked with US2023AMR034658 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR034658:Same reporter
Went to bed @ 0400. Woke up shaking. 11/08/14 She was observed to be shaking/jerking in her sleep. Was making throaty/gasping sounds, unable to wake her up while this was happening. Looked like a seizure.
Patient was administered the immunization and within 30 seconds of giving the administration, the site of injection became swollen (around the size of a quarter). There was minimal bleeding at the site of injection. Patient sat the full 15 minutes at the pharmacy to ensure no other reaction occurred. The swelling at the site of injection went down during that time and patient did not have any other complaints or other adverse reactions. Followed up with the patient 3 hours after receiving the immunization via phone call, and was told by caregiver that the swelling had gone down and patient did not have any other complaints or side effects.
(L) arm had red circle on deltoid approx. 2 1/2 in. in diameter & patient just started to feel warmth within the red circle, no pain. Advised to take BENADRYL & apply warm compresses.
Congestive heart failure, in AFIB; Congestive heart failure, in AFIB; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 21Apr2021 (at the age of 59-years-old) as 1 st dose, single for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The reported Events were congestive heart failure, in AFib on 03May2021, hospitalization not prolonged. The events resulted to emergency room/department or urgent care. Received unspecified treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to a 1 month old patient. On 31-JUL-2013 the patient was vaccinated with a dose of VAQTA (Lot # J000366, exp. 22-AUG-2015, also reported as "22-AUG-2105") intramuscularly. No adverse effects were reported. It was not known if the patient sought medical attention. Additional information has been requested.
pt recvd vax & devel redness, soreness & warmth @ the inj site; pt was also nauseated;
Patient required immediate intubation on arrival to the ED due to pulse ox in the 40?s.
Started having irregular heart beat.  Went to ER and monitored for 3hours PVC's dissipated and employee went home.  Follow up with PCP on the 18th.
Multiple myeloma; Cardiac amyloidosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6200) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Vaccination history included: Bnt162b2 (First dose, Lot. EN6208, in the left arm), for COVID-19 immunisation. The following information was reported: PLASMA CELL MYELOMA (disability, life threatening) with onset Apr2021, outcome "not recovered", described as "Multiple myeloma"; CARDIAC AMYLOIDOSIS (disability, life threatening) with onset Apr2021, outcome "not recovered", described as "Cardiac amyloidosis". The events "multiple myeloma" and "cardiac amyloidosis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. Therapeutic measures were taken as a result of plasma cell myeloma, cardiac amyloidosis (chemotherapy and medications).  Follow-up attempts are completed. No further information is expected.
Extreme muscle aches and joint pain to the point of barely being able to move  Chills Sweats  Burning/Irritated Skin  Nausea  Thirst
within 25 minutes of shot, his throat was tightening up; swelling along jawline on both side of his face; salivary gland was swollen and very sensitive; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (within 25 minutes of shot, his throat was tightening up), SWELLING FACE (swelling along jawline on both side of his face) and SALIVARY GLAND ENLARGEMENT (salivary gland was swollen and very sensitive) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced THROAT TIGHTNESS (within 25 minutes of shot, his throat was tightening up), SWELLING FACE (swelling along jawline on both side of his face) and SALIVARY GLAND ENLARGEMENT (salivary gland was swollen and very sensitive). On 03-Feb-2021, THROAT TIGHTNESS (within 25 minutes of shot, his throat was tightening up), SWELLING FACE (swelling along jawline on both side of his face) and SALIVARY GLAND ENLARGEMENT (salivary gland was swollen and very sensitive) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Pt received both Pneumovax 23 and Fluzone per pt request on 10/11/05 in the right deltoid. On 10/12/05 her arm began swelling and started turning red. She had no fever except locally in the arm and felt mild flu-like symptoms.
Administered incorrect vaccine, patient's parent was informed and advised to wait in case of reaction. Patient did not have any reaction and left clinic.
NauseaVomiting chest tightness, throat tightness Narrative:  This is a 20 year old who had a sensation of throat tightness immediately after his covid vaccine. He was transported to the ED. Treated with epi pen, solumedrol, benadryl, and pepcid. Also reports nausea which was treated with ondansetron 4m IV. Symptoms have not reoccurred. Prescription also given for epi pen. Discharged to home.
SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Extreme, bilious emesis approx 4-5 hours after receiving ROTARIX. Evaluated in ER. No intussusception.
Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023; No adverse event; Dose were administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Aug-2023, the patient received first 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-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) 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 (Dose were administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 10-JUL-2023. Vial did not undergo any temperature excursion. Vial size was reported as 2.5 milliliter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-737984 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737984: