chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 16yo girl admitted on 5/19 with sepsis secondary to myocarditis and pneumonia, s/p IVIG, after presenting with fever, myalgia, sore throat, hypotension, elevated troponin, elevated CRP, and leukocytosis with left shift. Sore throat has been present for about a week and fevers began on 5/17 with a Tmax of 103. On 5/18, she began developing shortness of breath and upon evaluation by the PCP on 5/19, she was admitted. During initial workup on 5/19 upon admission, hospitalist was high concerned as she developed hypotension of 91/48 on 5/20 at 08:35am. CT of chest on 5/20 showed patchy consolidation of the posterior lower lobes bilaterally. At that point, I was contacted and recommended broadening regimen to clindamycin , ceftriaxone, and azithromycin. Upon transfer to Hospital, further serologies were collected which showed leukocytosis with left shift, highly elevated CRP, elevated troponin, elevated IL-6, elevated ferritin, negative Covid abs test, negative RVP, and negative Covid PCR. IVIG (2grams/kg) started on 5/20 at 22:57. Cardio and ID on board and all regular myocarditis infectious workup has been collected. ID consulted for workup and management.     Of note, patient received the Covid vaccine on 5/1/21
PT is a 17 y/o previously healthy boy who presents with 3 days of moderate-severe, substernal chest pain, dyspnea, and nausea 2 days after receiving the 2nd dose of the Pfizer COVID-19 vaccine. On Tuesday (7/6), PT received the second Pfizer COVID-19 vaccine. The following day (Wednesday 7/7) PT had "flu-like symptoms" with chills, subjective fever, and a sore arm that resolved by Thursday (7/8). He was back to his baseline state of health on Thursday (7/8) and felt fine that whole day. On Friday afternoon (7/9) when he was at work washing dishes where he had some physical exertion he began to notice at 16:30-17:00 that he developed substernal, sharp, 7/10 chest pain that did not radiate, improve/worsen with deep breaths, sitting up, laying down or with movement of his upper extremities. It worsened towards the end of the night and peaked at 8/10 by 22:00-23:00 that same evening. His sister picked him up from work per his regular routine and he went home and took a shower which improved the pain to a 5-6/10 when he went to sleep. He woke up at 3 AM on Saturday (7/10) AM and had one episode of NBNB emesis associated with the chest pain. When he woke up later that morning he felt improved until 10-12 AM he developed mild chest pain again which he took Tums for. He also tried Motrin which did not help his pain at all. On the morning of admission (7/11), he woke up at 6-7 AM with upper right back pain, dyspnea, and nausea along with the persistent chest pain which prompted him to present to MFSH. He does endorse mild sore throat but denies any fevers, recent sick contacts, known COVID-19 exposure or previous history of COVID-19. There is a family history of cardiac disease including a fatal MI in his father. His mother's family also has a history of heart disease and both sides have a history of high cholesterol. He did add Whey Protein recently to his diet to for muscle building, but he DENIES any drug, alcohol, tobacco, vaping, marijuana, THC use. He does not play any sports regularly. He also denies any recent bug/tick bites or rashes.
Patient was vaccinated at 1455, while waiting for her husband to get vaccinated patient took a step and fell at 1506 on her left buttock, patient denies hitting her head, upon visualization of her head no bumps, lumps or bruises.  Patient is AxOx4 speaking in full complete sentences with unlabored breathing. Husband states "She hasn't ate much all day that can be why"   Vitals:  BP: 135/63  o2- 97% HR - 68  RR - 18    Patient denies dizziness and states " I don't know why I fell" patient was observed ambulating with steady gait after fall and denies pain. ED was called and report was given to charge nurse. Patient was transported to the ED via wheel chair at 1534,  report was given to triage nurse. Patient was in stable condition VSS with unlabored breathing upon transport.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Hydroxychloroquine, reaction(s): "Known allergies: hydroxychloroquine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: When asked if this was a report about covid treatment, stated as Yes. The patient was not pregnant at the time of vaccination. Other medication in 2 weeks: Unknow. Anti-viral details included COVID-19 Treatment, Brand: Paxlovid, start date 05Aug2023 and stop date 08Aug2023. Developed rebound of Covid 4 days after finishing Paxlovid from 17Aug2023 09:00 PM, received no treatment and was recovering at the time of this report.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Student had received a dose of Vaxelis for their 11 year old vaccines instead of TDAP; Student had received a dose of Vaxelis for their 11 year old vaccines instead of TDAP; This non-serious spontaneous safety report, with reference number 2023SA105580 (and inquiry number 01560211), was received by the partner on 03-APR-2023 and forwarded to agency on 04-APR-2023, from a health care professional.   Due to the nature of the event, the causality between the event "Student had received a dose of Vaxelis for their 11 year old vaccines instead of TDAP" and Vaxelis was not applicable.   Further information is expected.  Non-Significant Follow-up information was received by the partner on 03-APR-2023 and forwarded to agency on 05-APR-2023, from a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Student had received a dose of Vaxelis for their 11 year old vaccines instead of TDAP" and Vaxelis was not applicable.  Further information is expected.
Rash; Couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and GAIT DISTURBANCE (Couldn't walk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and GAIT DISTURBANCE (Couldn't walk). At the time of the report, RASH (Rash) and GAIT DISTURBANCE (Couldn't walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
severe inj site rxn including swelling, erythema & induration; MD (husband of pt) tx w/DPH & hydrocortisone;exp myalgias & arthralgias;diff urinating & must strain to pass urine;urine has a foul odor;
Bronchial tubes began to close up; Low oxygen levels to 83%; Swelling of face; hard time catching breath; terrible body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHOSPASM (Bronchial tubes began to close up) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pulmonary disorder (Reported consulting pulmonologist ). Concomitant products included METOPROLOL, OXYCODONE and Nebulizer for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced BRONCHOSPASM (Bronchial tubes began to close up) (seriousness criterion medically significant), OXYGEN SATURATION DECREASED (Low oxygen levels to 83%), SWELLING FACE (Swelling of face), DYSPNOEA (hard time catching breath) and PAIN (terrible body ache). At the time of the report, BRONCHOSPASM (Bronchial tubes began to close up), OXYGEN SATURATION DECREASED (Low oxygen levels to 83%), SWELLING FACE (Swelling of face), DYSPNOEA (hard time catching breath) and PAIN (terrible body ache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Oxygen saturation: 83 % (Low) Low.     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.   Treatment medications included prednisone and other medications.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Soreness at injection site.  Substantial soreness and aching all over.  Mild headache.
3:45pm - black spot in center vision 1 min after vaccine given. States felt coming on when putting medication (vaccine) in arm. Laid pt down on examining table vitals taken, cool cloth over eyes. Vitals normal, patient declined 911, called 911, after taking her into hallway, pt. black spot gone but right eye loss of peripheral vision, right side, right fingers tingling. Smile normal equal, hand grasps equal, ambulance came took patient to hospital. Pt. able to walk to cart. Called 11/29/12 vision return to normal did stay at ER - went home.
Information has been received from a consumer concerning her 8 week old granddaughter who on 05-NOV-2007 received her first dose orally of Rotateq. It was reported that one day after administration of the dose (06-NOV-2007), she was examined by her physician after she developed blood in her stool. It was reported that on 06-NOV-2007 a stool culture was taken (results not reported). It was reported that the patient was referred to an unspecified specialist for evaluation. As of this report it was reported that the patient had not recovered. No product quality complaint was involved. Additional information was not available. Upon internal review, the patient's blood in stool was considered to be an other important medical event. Additional information has been requested.
Chest and throat tightness, nausea, dizziness, clammy, BP 160/100.
Narrative: Patient presented to covid vaccine clinic today for Janssen vaccine, Fifteen minutes after vaccine patient reported a mild lump in his throat. He denied respiratory, cardiovascular or neurological symptoms. He did not experience any type of rash or puritis. BP was 132/85, pulse 58 and ox sat 97%. He remained oriented x3 without distress. He was kept and monitored for a total of 40 minutes with improvement in symptoms. He was given bottled water with reported improvement. He has a follow up appointment that was pre-scheduled with primary care today. He will follow up with them in the next hour. He was discharged in good condition with his wife.
Heart palpitations, pericarditis, shingles, couldn?t breathe, spleen pain, diarrhea, period for 40 days
Pain at site of injection; fatigue; chills; This is a spontaneous report from a non-contactable pharmacist. An adult female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for covid-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced pain at site of injection, fatigue, chills on an unspecified date in Jan2021. The outcome of the event was recovered in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Inflammation and redness at injection site.  3 inch by 2 inch swatch below injection site that is bright red, swollen, hot, itchy, bumpy.  5 days later it is starting to get better.
Severe swelling of entire inside of upper arm; severe redness; itching; very hardened area at injection site; very sore, painful and burning. Redness and itching keeps spreading; now past elbow on inside of arm 3 days later.  Still able to function but painful even to use arm and especially if anything, even clothing, comes in contact with it.
Baseball sized red, hot rash. Pain and itching at site. Also chills that seem to extend from the site.
hair loss; aches; fatigue; joint pain; This is a spontaneous report from a contactable consumer (the patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), dose 2 via an unspecified route of administration on 12Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for covid-19 immunization. On 14Mar2021, the patient developed aches, joint pain, and fatigue (slept for 4 hours during a nap which was unusual for her). 7-10 days after the vaccine dose, on an unspecified date, she started to have some hair loss. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dizziness; Upset stomach; Bad diarrhea; Sweatiness; Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else; Difficulty sleeping; Dull headache; Nauseous; Chills; Fatigue/stayed in bed and couldn't do much; Nauseous/felt like vomitting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Bad diarrhea), HYPERHIDROSIS (Sweatiness) and FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Bad diarrhea), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else), INSOMNIA (Difficulty sleeping), HEADACHE (Dull headache), NAUSEA (Nauseous), CHILLS (Chills), FATIGUE (Fatigue/stayed in bed and couldn't do much) and VOMITING (Nauseous/felt like vomitting). On 07-Mar-2021, DIARRHOEA (Bad diarrhea) had resolved. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweatiness), FEELING ABNORMAL (Experiencing her voice echoing in her head/she felt seasick in bed/stayed in bed and couldn't do much else), INSOMNIA (Difficulty sleeping), HEADACHE (Dull headache), NAUSEA (Nauseous), CHILLS (Chills), FATIGUE (Fatigue/stayed in bed and couldn't do much) and VOMITING (Nauseous/felt like vomitting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-049818 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Initial and FU information processed together and in this FU case became serious upon addition of new event. However we have not marked this FU as Significant as it leads to change in regulatory clock start date. On 13-Mar-2021: Consumer reported that her own symptoms resolved in about a week.; Sender's Comments:  MOD21-049818:
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
That night of receiving my vaccination, I had a headache and woke up with a migraine the next morning. I went to my cardiologist on 12/16/2021 who took my blood pressure and saw it was peaking at 160/100. So the doctor (cardiologist) ran an EKG on me which came back normal and added to my prescription from just taking Amlodipine to Metoprolol as well as Amlodipine together to try help regulating my blood pressure. Currently, the medicine has helped regulate my blood pressure and lessen the intensity of my migraine, but still have them. I have monthly follow-up appointments with my cardiologist until May to monitor my condition.
Two days post vax pt experienced an immune response/allergic reaction to DT booster characterized by a reddened, tender area that felt hot to touch. Pt was treated with Claritin, Benadryl and Keflex.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I would like to make a formal complaint about the shots I received while in the military. I received several shots including the anthrax vaccination without having a choice. This has lead to many health problems that I now suffer from and will until I die. I'm only 27 and have some major health problems such as heart disease.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 02-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575:
This spontaneous report was received from a 56 year old male patient (field representative) regarding himself. The patient did not have any pertinent medical history or drug allergies. On 29-JUL-2015 the patient was vaccinated with ZOSTAVAX, (1 vial, route unspecified, batch number-L00049, Expiry date-08-MAR-2016). The pharmacist is the one who was administered the ZOSTAVAX. Other suspect therapies included FLUARIX. The patient was on some unspecified concomitant medications. On 27-SEP-2015, 61 days after onset of therapy the patient developed fever, headache, swollen glands and a creepy crawly sensation. No laboratory tests were performed. On 01-OCT-2015 he was diagnosed with shingles and was treated with Famdiclvir, Prednisolone, TYLENOL and NAPROXEN (dosing regimens and manufacturers unspecified). It was also reported that the field representative was under duress because he was the patient. No product Quality Complaint (PQC) was involved. Cancer and overdose were not reported. The outcome of the event was reported as recovered/resolving. The causality assessment was not provided. Additional information has been requested.
This spontaneous report as received from a physician refers to an 18 year old female patient. The patient's current conditions and medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL injection 3 dose series (unknown strength and route). On an unknown date, the patient "had an abnormal pap smear after receiving the 3 dose GARDASIL series". The patient sought medical attention and made a office visit. The outcome of the event was reported as recovered. The causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Tongue swelling, numbness, treatment with Benadryl and steroid injection and antibiotics improved symptoms
Pain in the right shoulder, difficult to lift the arm, and fever reported at home of 102 degrees F.
Complaining of abnormal heart rhythm, AF, no other symptoms. No dizziness, no chest pain.
Patient received influenza vaccine 10/26/11. 2 hours after patient received vaccine, hives developed generalized to body and swelling to periorbital area relieved within 36 hours.
headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 25-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot on 28-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included CETIRIZINE HCL for an unknown indication.    On 28-Sep-2023 at 1:00 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 29-Sep-2023, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 30-Sep-2023, HEADACHE (headache) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
Pt reports that 2 to 3 yrs ago recvd a series of 3 doses of unk Hep B vax & JAN92 titer was checked result was neg; pt did not respond, unk in protected;
Patient reports swelling at the injection site. there is a small bump noted. Reports pain in the left arm and it is difficult to raise arm due to pain level.