chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cardiac problems  after receiving either Pfizer or Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of CARDIAC DISORDER (Cardiac problems  after receiving either Pfizer or Moderna vaccine) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Cardiac problems  after receiving either Pfizer or Moderna vaccine) (seriousness criteria death and life threatening). The reported cause of death was cardiac disorder. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  It was reported that the reporter has seen that patients above 60 years of age who developed Cardiac problems after receiving either Pfizer or Moderna vaccine. Two patients even passed away post cardiac problems after vaccination.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  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.; 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.; Reported Cause(s) of Death: Cardiac disorder
Sore arm at injection site; severe nausea; runny nose; headache; body aches; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in left arm on 05Mar2021 at 18:00, (at the age of 53 years) as 1st single dose for COVID-19 immunization. The patient's medical history included epilepsy. Patient had no known allergies. The patient's concomitant medications included clonazepam (CLONOPIN) and Vitamin supplements taken in two weeks. Patient received no other vaccine in four weeks. Patient had no Covid prior vaccination. On 06Mar2021 at 15:00, the patient experienced sore arm at injection site, severe nausea, runny nose, headache and body aches. No treatment received as a result of adverse event. Patient was not tested for Covid post vaccination. The outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Day after vaccine patient woke up with fever & was incoherent. "I couldn't tell where I was, when I was on my bed. I was also dizzy" - had to crawl to bathroom. Next day patient was doing better.
Ingested all four doses of expired Vivotif; Spontaneous report received on 03FEB2021.  A pharmacist reported that a consumer "ingested all four doses of expired Vivotif" (PT: Expired product administered). The consumer was receiving oral Vivotif (expiry date: JUN2020) for immunisation. The consumer took all four doses of expired Vivotif on unknown dates. The pharmacist did not mention any adverse event experienced by the consumer. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown at the time of report.  Company Comment: It was reported that a consumer ingested all four doses of expired Vivotif (expired product administered) and then the consumer did not experience any adverse events. Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable with Vivotif.; Sender's Comments: It was reported that a consumer ingested all four doses of expired Vivotif (expired product administered) and then the consumer did not experience any adverse events. Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable with Vivotif.
Shot area turned red. Had a rash that was large as an apple. Itching. Pain in arm.
Redness at injection site at administration, swelling to 11 cm X 15 cm area seen on day 3, decreased ability to lift/move arm.
his shoulder was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Jan2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 21Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Nov2020 (unspecified if ongoing), notes: COVID as he tested positive for COVID-19 in Nov. The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "his shoulder was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received his first dose of the Pfizer COVID-19 vaccine last 21Dec2020 where "his shoulder was sore". Caller received his second dose of the vaccine last 08Jan2021 and mentioned that "the nurse injected it in his shoulder IM and that his shoulder was very sore and needed ice to relieve it". Caller received his booster dose of the Pfizer COVID-19 vaccine last 29Sep2021 "first thing in the morning and he felt good, but late night to early morning at around 1 or 3 or 4 am, his knuckles hurt, he had a fast heartbeat, had chills, had headache and it hit him harder than the actual COVID as he tested positive for COVID-19 in Nov where he got tested for work". Caller wanted to know why he sad such an effect with the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: 2 minutes post vaccine, pt complained of feeling hot and was unable to see. pt was feeling dizzy and faint. nurse had pt lay down at vaccination site, legs levated. bp 112/63, hr 67, regular and lungs clear and no difficulty breathing. @1449: 116/63, hr 67, 1453: gatorade and water intake, bp 111/69, hr 61. @1459 up in chair, no complaints from pt, sx has resolved. bp 116/72, hr 72. @1504 121/79, hr: 70. pt states feeling well and refused any er tx. pt wants to go home.
Pain when injected.    Sore, swollen, red arm approximately 3 1/2 inches by 3 inches.     This was second of the series.   I had sore arm with first but not swelling or redness.
No adverse event; 35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    Concomitant product use was not provided by the reporter.  Vaccination dates reported was between 22-Jul-2022 and 28-Jul-2022.  The patient was administered vaccine with a volume of 0.25 ml instead of 0.5 ml. Unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-615892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615892:Master Case
received Boostrix, DOB: 25-FEB-2015; Received Boostrix instead of Flu Vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN).   On 9th November 2021, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse reported that the 6-year-old patient received Boostrix vaccine in right deltoid instead of Flu vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This was 1 of 4 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021231229:SAME REPORTER US-GLAXOSMITHKLINE-US2021231231:SAME REPORTER US-GLAXOSMITHKLINE-US2021231232:SAME REPORTER
Dizziness, Myalgia, Arthralgia, Fever, Congestion, Injection site pain, Fatigue, Dyspnea Narrative:
(L) arm cellulitis 10/12/12. Tx with BACTRIM and KEFLEX and TYL #3.
Received flu shot 10/27/10. Pt. states that by Wed. PM developed large red hot knot at injection site. Pain progressed to L arm and developed numbness in fingers L & R hand. Pt. did not call office until 10-29-10. Seen OV same day 10-29-10 - Administered antihistamine XYZAL. Spoke with patient this AM 11-1-10 pain and swelling almost resolved, much better.
Patient received 1 year vaccines. Next day, started itching  severely, had fever of 101, and runny nose.  Fever continued to Sunday; alternated Tylenol and Ibuprofen to control it.   Rash started on face, then on elbow creases and then his legs.  Red dots like chickenpox now spread all over body from head to toes.  Patient went to the doctor today and doctor confirmed it was varicella and prescribed Prednisone. Clinic recommended a visit to Pediatrician and Allergist.  Patient doing well, with red bumps all over and itching a lot; looking out for scratching to avoid infection.
MULTIPLE STROKES; ANEURYSM; This spontaneous report received from a consumer via social media concerned a 42 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died from an aneurysm and multiple strokes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of aneurysm and multiple strokes on an unspecified date. This report was serious (Death).; Sender's Comments: V0:20211212714-COVID-19 VACCINE AD26.COV2.S-Multiple stroke, Aneurysm. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ANEURYSM; MULTIPLE STROKES
Incident:  09:30 Client given inaccurate dose of Pfizer, - LOT # EW0185-H  administered  Pfizer 0.3 cc of undiluted vaccine.  Client given usual monitoring of 15 mins without any s/s of adverse reaction.  Made aware of this incident upon arrival to next client's home which was an hour later. Notified Clinical Site Supervisor who reports that they will contact MD  and parents of client.
started with a sore arm, Tuesday pain radiated to chest. Pain pressure in chest come and go. Wednesday pain got worse. Thursday I felt dizzy and I felt short of breath. Chest area felt like bruised pain
Shoulder to elbow very warm to touch, headache, nausea, body aches x4 days
Diarrhea, fever, fussiness, decreased appetite, redness at inj site.
Feeling stiff jaw; Woke up with no smell or taste; Woke up with no smell or taste; Little headache; Feels metal taste in her mouth; Feeling very weird; Throat feel like Novocain is wearing off; A spontaneous report was received from a consumer who was a female patient, who experienced feels metal taste in her mouth, feeling stiff jaw, throat feel like novocaine is wearing off, little headache, woke up with no smell or taste and was feeling very weird.  The patient's medical history included seasonal allergies and penicillin allergy. No concomitant medications were provided.  On 23 Dec 2020 at 14:00, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced little headache.  On 23 Dec 2020, she had a little headache.    On an unspecified date in Dec 2020, she felt a metallic taste in her mouth and her throat felt like novocaine was wearing off, like she went to the dentist. She was feeling very weird  On 24 Dec 2020, the patient woke up with no smell or taste and had felt jaw stiffness for about two hours. Unspecified symptoms subsided. She stated that she believed her symptoms could be due to the fact that she could be anxious. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided  The outcome for the events, feels metal taste in her mouth, feeling stiff jaw, throat feel like novocaine is wearing off, little headache, woke up with no smell or taste and was feeling very weird, was not provided.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the listed event of Headache and the unlisted events of Dysgeusia, Joint stiffness, Oropharyngeal discomfort, Anosmia, Ageusia, and Feeling abnormal.  The events were considered possibly related to the vaccine due to the temporal relationship with the onset on the day of dosing, however the events might be explained by the patient's report of being anxious.
around two hours after taking the vaccine, my arm started to hurt a lot and at night I had a fever and for another day and another night.  the pain in the arm continued and the fever passed.  Today, March 21, my arm started to hurt more and swell the muscle.  And then it started to turn a little red.  The affected region is now redder and stiffer than the size of a steak.  I do not know what to do.
Pt came in with what looked like bug bites - Mom stated they appeared with VARCELLA shot + getting worse - Mom took child to hospital - trans. Pt to Hospital- Dr stated  that it was a reaction to Varicella shot - The rash was large - swelling area with pus tips > 0 2 1/2 CM
Initial report received on 03 December 2007 from a health care professional. An adult patient with no concurrent illness, who was traveling on a cruise ship as an entertainer, had received a subcutaneous dose of YF VAX vaccine (lot number UF197AA) on 26 November 2007. The site of administration was not reported. At an unspecified amount of time later, the patient developed big red spots and burning at the injection site, along with sweating, fever, and nausea. The patient did not seek medical attention. Treatment received was not reported. At the time of this report, the adverse events were resolving. The reporter for this case is the same as for cases 2007-0426, 2007-04170, 2007-04172, 2007-04173.
Woke up with large tennis ball sized knot on arm at injection site. Was hard, hot, and red for 9 days.
A week after I got my first injection of the moderna vaccine the injection site started to swell, become hot and itchy.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported. On 10-JAN-2019, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose, route and site of administration were not reported) lot # M025186, expiry date 18-MAY-2018, for prophylaxis. The vaccine was reconstituted with sterile diluent, lot number M034781, expiry date 11-APR-2019. No adverse effects were reported.
No adverse event; vaccine expired on 6-7-23 and was used to administer a vaccination on 6-29-23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 6-7-23 and was used to administer a vaccination on 6-29-23) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     There was no relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 29-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Jun-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 (vaccine expired on 6-7-23 and was used to administer a vaccination on 6-29-23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 6-7-23 and was used to administer a vaccination on 6-29-23) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine expired on 6-7-23 and was used to administer a vaccination on 6-29-23).    No concomitant medication was reported. It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The expiry date was reported as 07-JUN-2023. No treatment medication was reported.
Blood sugar was elevated. Was about 200-250 for the following two days. Elevation started at around 2am. Has only started to come down after two days. Even increased basal rates through my omnipod did not help lower it by much.
Migrating rash on trunk, limbs, neck. Rash with itch and redness persists for 10-15 minutes before recession. Occurs 3-20 times a day. OTC antihistamines appear effective. Triancinolone .1% topical initiated today.
headache, dizziness, severe fatigue, nausea, severely swollen lymph node above left clavicle--painful, onset of menstration after menopause for over a year.  Similar swollen lymph node that took over 6 weeks after second dose to go away
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a child male patient who received BEXSERO. In July 2017, the patient received the 1st dose of BEXSERO .5 ml. In July 2017, less than a month after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to BEXSERO. Additional information was provided as follows: The age at vaccination was not reported. The mother reported that the patient was a football player. The patient had 1st dose one month before the reporting date and he was due for his 2nd dose. However, the reporter wanted to wait for the 2nd injection because his initial dose made him sore at the area of injection and the area hurt for a few days. The area of soreness was approximately the size of an apple.
Chills, 102°, headache, body aches, extreme fatigue and  injection site pain  Symptoms began within 45 minutes lasted 48 hrs , treated with Tylenol.  Unable to get out of bed.
After the first / arm itched at the injection site; This case was reported by a other health professional and described the occurrence of injection site itching in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. After the first dose of Shingrix vaccine patient's arm itched at the injection site for several weeks, but that was all. For tolerance of 2nd dose refer case US2021AMR069511. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069511:Same patient. Same reporter., 2nd dose.
Mother states child had redness, hive-like rash, itching, fever, and vomiting.  Starting one hour after injections given.  Vomiting did not subside until 7-6-08.  Redness and abrasion to skin noted to lower left leg 7-7-08.  Mother states she gave MOTRIN, TYLENOL and applied NEOSPORIN to affected area.  Did not take child to PCP.  No Medicaid.  Child referred to clinic today 7-7-08.
Developed Tinnitus after 48 hours from receiving the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:30 (5:30 PM) (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, high blood pressure, obese all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no covid prior vaccination and not covid tested post vaccination. The patient was vaccinated at a Public Health Clinic/Veterans Administration facility. There were no other vaccine in four weeks and there are other medications in two weeks (unspecified). It was reported that the patient developed Tinnitus after (reported as 48 hours from) receiving the vaccine on 24Mar2021 at 5:00 pm. Continuing to have tinnitus. The event was considered serious due to disability. The outcome of the event was not recovered. There was no treatment for the reported event. The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage.