chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My Atrial Fibulation (AFIB) had stopped after an ablation in April. The ablation came after dose #2 and my AFIB becoming near constant. After this dose, my AFIB returned and my heart rate became mush lower (27 at night). It is to the point I will be having a pacemaker implanted on 3/18/2022.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to another hospital with sudden onset left leg pain, numbness, and weakness during athletic activity. No Doppler pedal pulse detected and transferred to this facility. Found to have occlusions on left CFA, right profunda, and right popliteal as well as a left atrial mass (myxoma),  left atrial thrombus, and mitral insufficiency.  Admitted, anticoagulated, and underwent balloon embolectomies, mechanical valve replacement, right heart catheterizations, and thrombectomies. Discharged to home stable on anticoagulation with cardiology follow-up in place.
Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM; No adverse event; Patient administered dose of the bivalent booster which were beyond the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023 at 2:22 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Feb-2023 at 2:22 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose of the bivalent booster which were beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered dose of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered dose of the bivalent booster which were beyond the 30 day BUD) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 02:22 PM).    No concomitant medications were reported.  Pharmacist reports that they inadvertently administered 4 doses of the bivalent booster which were beyond the 30-day BUD. 2 doses were administered on 06Feb2023 and 2 doses on 07Feb2023.  It was reported the patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  It was reported the patient had any acute illness at the time of vaccination and up to 1 month before and chronic long -Standing health conditions were unknown.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-709192, US-MODERNATX, INC.-MOD-2023-710235, US-MODERNATX, INC.-MOD-2023-710239 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710235:Patient   US-MODERNATX, INC.-MOD-2023-709192:Patient - Female US-MODERNATX, INC.-MOD-2023-710239:Patient
pt recv vax;c/o inject site soreness,pain, redness & edema;dph,pred,inhaler,rephalecin,naprosyn prescribed;MD felt adverse rxn to vax;swelling, arm feels heavy;arm swollen from shoulder to fingertips;
Heart Palpitations (appear to be premature ventricular contractions), foggy head.  on and off for two weeks.  Anxious feelings and foggy brain accompany palpitations.  Feel normal part of the time.
Information has been received from a physician concerning a 21 year old female who was vaccinated with intramuscularly in the arm with the first dose of GARDASIL (Lot # not reported). In approximately October 2007, the patient experienced menorrhagia. No other symptoms were reported. Patient outcome was not reported. Additional information has been requested.
bled after Fluarix administration; This case was reported by a nurse via call center representative and described the occurrence of hemorrhage in a 36-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number M3R5B, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 14th October 2022, 39 sec after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the hemorrhage was unknown.   It was unknown if the reporter considered the hemorrhage to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-OCT-2022. Reporter's Comments: The reporter stated that a patient experienced a hematoma about 39 seconds following administration of Fluarix.  The reporter mentioned that the hematoma was resolved by end of the day when patient follow-up was done.  The reporter stated that a patient was very muscular and bled after Fluarix administration and developed a hematoma. The registered nurse states she was very good about her IM technique for administration.
fever, lethargic, admitted to hosp to r/o sepsis & viremia;
Atrial fibrillation; Heart Condition; This is a solicited report received from contactable reporter(s) (Consumer). The reporter is the patient. Other Case identifier(s): 22K-163-4458666-00 (AbbVie). Solicited report from the USA by a consumer of an elderly male with an event of non-serious In and out of Atrial fibrillation with Heart Condition with HUMIRA (ADALIMUMAB). There was no reported medical history.  On unknown dates, the patient experienced In and out of Atrial fibrillation with Heart Condition and In and out of Atrial fibrillation with Heart Condition. In 2022, the In and out of Atrial fibrillation with Heart Condition resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Clinical information: A 76-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9241), on 25Jan2021 as dose 2, single (Lot number: EK9231) and on 02Nov2021 as dose 3 (booster), single (Lot number: FE3590), all intramuscular for COVID-19 immunization; adalimumab (HUMIRA), (Lot number: 1162590) till 17Jun2022, subcutaneous for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The action taken for adalimumab was dosage permanently withdrawn on 17Jun2022.  The reporter considered "atrial fibrillation" and "heart condition " related to BNT162b2. The reporter's causality for the event(s) of Heart Condition with HUMIRA (ADALIMUMAB) was not provided while for the event of In and out of Atrial fibrillation was a reasonable possibility.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on provided information and temporal association reported events atrial fibrillation and heart disorder causal relationship with the suspect drugBNT162B2 cannot be excluded. However there is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history and diagnostics workup. This case will be reassessed upon receipt of follow-up information.    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 RAs, Ethics Committees, and Investigators, as appropriate.
A 78-year-old female, primary care patient of Dr., came to the emergency room today at the behest of her son and daughter because she was confused and very weak. She was diagnosed with COVID by home testing on May 17.  She has been fully vaccinated  with both boosters.  She had symptoms that started about May 15 that consisted of mainly allergy-type symptoms: sneezing, coughing, congestion.  Dr. called in Paxlovid for her  and she has taken half of that treatment.  Her daughter spoke with her yesterday and she did  not feel good, but she seemed normal when she talked to her through the patient's screen door.  She had been up and around the house.  The patient lives alone and is generally very independent and ambulatory.  Then today about 1 p.m., the daughter talked to her on the phone, and this time she was clearly confused, not herself, and that is when they recommend she come to the emergency room.  Of note, last weekend, she visited her son's rural farm area.  She was outside quite a bit, riding around on an ATV, and the son says they have a lot of ticks.  It is not known for certain she actually had ticks and she is not able to tell me that tonight.  She was evaluated in the emergency room and referred for admission because of some abnormal labs and confusion. PT REMAIN INPATIENT AT THIS TIME.
Pt stated "I received the Pfizer vaccine on last Friday and I have had increased weakness and it's been harder to breath since the Saturday after I got the vaccine"
Pain and soreness at & around the injection site up to 3-4 days after the injection; painful swollen lymph nodes in the left axilla starting one day after the injection, lasted 3-4 days after the injection.
pain, discomfort at injection site starting 3 hours after shot.  Tired, exhausted after 9 hours.  Awakened multiple times during night with intestinal pain and discomfort; chills - could not get warm; feet and lower legs cold and some cramps several times; feeling of diarrhea and nausea - but never manifested; muscle pain in trunk of body.  Failure to sleep,
Depression; Diarrhea; Eczema flair up last was 30+ years ago; Increased joint problems; Fatigue continues today; Headache; Fever (102F); This spontaneous case was reported by a nurse and describes the occurrence of DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems) and FATIGUE (Fatigue continues today) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema (eczema flair up last was 30+ years ago). Concurrent medical conditions included Asthma.    On 23-Feb-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 DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems), FATIGUE (Fatigue continues today), HEADACHE (Headache) and PYREXIA (Fever (102F)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DEPRESSION (Depression), DIARRHOEA (Diarrhea), ECZEMA (Eczema flair up last was 30+ years ago), MUSCULOSKELETAL DISCOMFORT (Increased joint problems), HEADACHE (Headache) and PYREXIA (Fever (102F)) outcome was unknown and FATIGUE (Fatigue continues today) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever (102F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.   This case was linked to MOD-2021-270806 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received includes additional events (Significant follow-up).
NOW BREATH OUT OF BOTH NOSTRILS FREELY; GREY HAIR; This spontaneous report received from a patient concerned a 44 year old female. 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 admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced now breath out of both nostrils freely, and grey hair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the now breath out of both nostrils freely and grey hair was not reported. This report was non-serious.
Nausea; Vomiting; Diarrhea; A spontaneous report was received from a nurse on 18JAN2023. On an unknown date, a patient (age and gender unknown) started taking Vivotif capsule (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. The patient subsequently had "nausea" (Nausea), "vomiting" (Vomiting) and "diarrhea" (Diarrhoea).  The patient's medical history, concomitant medications, or known allergies were not reported.   It was reported that on an unknown date, the patient experienced adverse reactions from Vivotif such as nausea, vomiting and diarrhea.  The outcome of the reported events was unknown. The action was taken with Vivotif with respect to the reported events was unknown.  The reporter did not provide a consent to follow up for additional information.  Company comment: It was reported that a consumer developed nausea, vomiting, and diarrhoea following the administration of Vivotif. Further information regarding the events, medical history or concomitant medication is limited. Considering the case information, the causality of the events nausea, vomiting, and diarrhoea is assessed as possible with Vivotif (its role cannot be ruled out). The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer developed nausea, vomiting, and diarrhoea following the administration of Vivotif. Further information regarding the events, medical history or concomitant medication is limited. Considering the case information, the causality of the events nausea, vomiting, and diarrhoea is assessed as possible with Vivotif (its role cannot be ruled out). The case is considered non-serious as per medical assessment.
I broke out in a rush like red, they described it like muzzel rush on my chest stomach and down your back and I also had lymph nodes on my right side under my armpit and it was very noticeable and I also had a headache for a couple days but it was gone by Saturday afternoon. I contacted NP on Saturday morning when I woke up with a rash and she said it was something normal with the vaccination and if I would get very itchy to take Benadryl but if it got any worse to contact her which it didn't.
a short time p/vax became weak & was assisted to the floor;dec BP, dec LOC, 02 given, epi administered; EMT called & pt transported to ER
Pfizer vaccine was diluted with sterile water and not sodium chloride. No adverse reaction occured.
High fever, nausea, cough. She was hospitalized (emergency room visit) due to severe dehydration as a result of her reaction. A cough persisted for months after. Pneumonia was discovered several months after the shot after a chest x-ray was taken.
Sore throat, tingling on left top of scalp (usual site).  Presented as another flare-up of Shingles, but Zoster sine herpete (ZSH).  Two days later, I visited my PA, and she immediately started  me on Valtrex (1g/3x daily) and gabapentin.
Pt recvd HIB/OPV/DTP on 18FEB92 & 3 hrs later pt died; pt just recently recvd well care check-up which was nl; probable SIDS; autopsy being performed;
2nd Pfizer shot was inadvertently administered early at 15 days after the first.
This spontaneous report was received from a company representative who was reporting on her daughter, a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patient started series of human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot#, expiration date, dose, route of administration and anatomical location were not reported). The reporter was not sure which vaccine the patient received. It was reported that the patient finished her series late in 2020 (reported as late last year). On an unknown date in 2021, the patient was diagnosed with an abnormal pap smear, high risk non 16/18 human papillomavirus (HPV). The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided.
1wk p/vax temp inc to 104 & child had febrile sz x 2;seen in ER, CBC done (nl);was active & alert p/released home;followed up next AM in office doing well;on antipyretics around clock x 2 days then as needed;
By the time I came back and saw my mother on Thursday she was short of breath and her lungs were filling with fluid. She was coughing up pink frothy fluid. She called ambulance they gave her shot of oxygen. We took her to hospital because she needed oxygen. They put her on 3 liters of oxygen and 3 days later sent her home on hospice with 3.5 liters of oxygen and round clock care and totally bed bound. She started to get confused, I was requesting for her to get more Lasix, she stopped swallowing. It was a long decline she got weaker and weaker. I think the vaccine was too much for her frail system.
Next day, patient reports redness, swelling and itching on vaccination site. Patient did not take any medication, did not call pharmacist or doctor.   Patient experienced similar problems after the first dose.
16JUN crabby & felt warm;17JUN fever early AM-sl rash seen by MD;rash inc & fever in in PM, sz & seen in ER;blood drawn tx w/Ibuprofen & APAP;18JUN rt OM & rash-varicella like rash;
Tingling; Get more nerve sensitive afterwards / Tingling than normal since I had the shingles; Nerve sensitive; This case was reported by a consumer and described the occurrence of tingling in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced at end of February on on the left side of head and face) and post herpetic neuralgia (shortly after that shingles). Previously administered products included Shingrix (1st dose received 2.5 to 3 months before the 2nd dose).   On 25th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced tingling, condition aggravated and post herpetic neuralgia. On an unknown date, the outcome of the tingling and condition aggravated were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the tingling, condition aggravated and post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient asked could get more nerve sensitive after the vaccination. The patient did not experienced pain just more tingling than normal since he had the shingles. The patient was told that after he got shingles it could take up to a year for the nerves to settle down. The reporter did not have the lo tnumber and expiry date since he was driving. The reporter asked asked him for MD contact information and he did not want to provide it at this time without first speaking to his MD. The patient's symptoms of postherpetic neuralgia had not resolved. The reporter referred him to his MD and referred offered that his MD could call medical information.
1 day history of itching rash to face and upper back. Small 2mm maculopapular area noted c/w Varicella. OTC Benadryl.
nausea, SOB, tachycardia, gave epi injection and oxygen with non-rebreather, EMS took pt to ER
Extreme vertigo. I was suffering from it slightly before the shots, but I was still quite functional and it did not really affect my daily life. After the second shot, it became quite severe where I could not even walk without becoming nauseated. The severity of the vertigo has decreased, however it still affects daily functions such as  leaning over, turning my head too fast, watching tv where the camera is not completely steady.  Each will cause a reaction which can take hours to subside. I still have days where it can be quite severe leaving me bed bound for the day.
31 y/o male received YF and primary SPV on 6/17/2009; pt was well day of and prior to vaccination. He developed new onset daily headaches onset 1-2 days later, "5/10" and self-treated with prn TYLENOL; no visual disturbance or any other neurologic, systemic or constitutional symptoms, except single isolated brief episode of mental lapse described as "forgetting to make planned left turn" at a usual familiar intersection. Had normal take at SPV site. Pt received AVA#1 and MGC vaccines on 6/11/2009; no known allergies to drugs, foods, latex, insects. On night of 6/23/2009, at about 23:15, pt had motorcycle accident (helmeted) while driving on familiar route w/good visibility and no other vehicle or pedestrian involvement; he sustained a serious closed head injury and was hospitalized for 8 days, requiring short term intubation. He was noted to have waxing/waning consciousness and seizure activity on arrival to ED. Toxicology screen was negative. Head CT 6/24 revealed small left occipital condyle fracture w/subarachnoid hemorrhage and small falx subdural hematoma; also had right clavicular comminuted fracture. Brain MRI 6/26 revealed grade II diffuse axonal injury involving splenium of corpus callosum and white lobar matter; FLAIR sequences demonstrated residual blood by-products in falx; EEG 6/28 was normal. He was discharged on 7/1/2009 in stable condition with GCS 15, ambulating well and tolerating a regular diet. Pain was controlled with oral pain medications. He was transferred to rehab facility for about 2 weeks of therapy. On 7/16/2009 pt had an ORIF repair of his right clavicle fracture. He had vertigo post-hospitalization, resolved with Epley maneuver ; residual mild recurrent headaches, continued neck and right shoulder pain, and insomnia. In Aug 2009 N/P evaluation (per pt) indicated some deficits in processing speed, short term memory loss, and executive decision-making. He has had gradual continuous improvement but continues follow-up with speech and OT as well as neurology. He remains on a physical profile as of Nov 2009. 11/30 and 12/8/2009 MR for 6/24-7/1/2009, Dx closed head injury, seizures post MVA, headaches  patient with c/o's headaches post vaccine and on 6/24 was involved in a motor cycle accident which resulted in a closed-head injury and fractured rt clavicle. Seizure activity noted post MVA, to SICU, intubated and given IV Ativan and Keppra. DC'd to Rehab x 2 weeks Still with problems involving short term memory loss and decision making.