chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient has severe pain on the back of the arm under her breast to her neck; The patient has severe pain on the back of the arm under her breast to her neck; The patient has severe pain on the back of the arm under her breast to her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZOA) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck). The patient was treated with KETOROLAC for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck) outcome was unknown.        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 by investigator.  Patient used ketorolac 1 tablet by mouth every 6 hours as needed for pain for 5 days.
Gangrene of foot - hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient possibly inadvertently received 1cc of COVID vaccine instead of 0.5cc. Patient was notified. State was notified
09/14/22 presents to ED for "rapid heart rate". PMHx of "cerebral palsy, quadriparesis, status post TBI now trach and PEG tube dependent"
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/25/2023 ATHEROSCLEROSIS OF AORTA ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 ATHEROSCLEROSIS OF AORTA
Neurological Symptoms; This spontaneous case was reported by a non-health professional and describes the occurrence of NEUROLOGICAL SYMPTOM (Neurological Symptoms) in a male patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     Medical history and concomitant medication was not provided.     On an unknown date, the patient received second dose of mRNA-1273 (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (Neurological Symptoms). At the time of the report, NEUROLOGICAL SYMPTOM (Neurological Symptoms) outcome was unknown.            The action taken with the drug in response to the event(s) was not applicable.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 68 years 1 month.  No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code 80777-0273-99. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication were provided.
death Narrative:  Patient, that is a facility resident, received his Moderna covid vaccine #1 on 12/28/20. On 1/14/21 due a continued decline in status, he was changed to hospice care. On 1/25/21, he received covid #2. He was noted to have a decline in oral intake and increase in somnolence over a few weeks prior to his date of death on 2/9/21. No autopsy results available. 15 days from date of second vaccine to date of death.
Woke up with both arms sore, no redness or swelling noted, no fever. Muscle aches still persist in both arms where vaccine administered.  Not worse, but no improvement.  Describes as "heavy" feeling.
About 10 hours after getting vaccination woke up with chest pain that I had never experienced before. On a scale of 0-10 the intensity varied between a 2 & 4. Went to urgent care on Sunday and they performed chest x-ray, blood work, and EKG with everything returning within normal limits. They referred me to a cardiologist. Went to cardiologist on 10/24. 10/25 Echocardiogram prolapsed mitral valve which doctor said was common. 11/14 CT scan with contrast of heart, awaiting results. Chest pain was always present the first two weeks. Ever since then it has been intermittent varying between 0 and 2 in intensity. Before adverse event I rode bicycle 3-6 days a week and since 10/15 I have ridden my bike 3 times. The shot produced the most tolerable side effects outside of the chest pain. Had no fever; chills; or fatigue with this dose.
Patient requested vaccine in pharmacy setting prompted by an injury. Was not caught in time and vaccine was administered to patient. Patient has been followed up with and does not have a primary care provider or other provider for us to follow up with. Patient was recommended to seek additional care since he has obtained an injury.
pt recvd vax;went for nap;4pm,mom noted pt starting to arouse;noticed pt completely white;lips white,limp & eyes in stare;later,became fussy;would not eat;approx 6pm recovered;
Gravida 2 Para 1     Estimated due date  11/1/2021    Received Pfizer dose # 1 on 3/26/2021 .  Relates she started spotting 4/14/21.  Was seen by OB 4/15/21 and no heartbeat detected.  Patient relates OB advised her to complete covid vaccination as scheduled   Pfizer dose # 2 was given 4/16/21  Relates she miscarried on 4/17/21 and was seen in ER.
Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Adult female patient who experienced pink/red patch (discoloration) and soreness, while she received vaccine IMOVAX RABIES. The patient's past vaccination(s) included IMOVAX rabies with Patient received her 1st injection in her left arm but did not give the date she received the injection. The patient's other past medical history, medical treatment(s) and family history were not provided. On 10-Aug-2018, the patient received a second dose of suspect IMOVAX RABIES lot N16401M, expiry date 29 July 2019 via intramuscular route in the right arm. On an unspecified date, post vaccination patient developed a non-serious pink/red patch at the site and vaccination site erythema and pink/red patch at the site and soreness. It was reported that, patient got injection at the emergency department. Lab data not reported. Final diagnosis was pink/red patch at the site and soreness. No corrective treatment was received (States it was not treated because she doesn't go back until tomorrow.). The patient outcome is reported as Unknown for pink/red patch at the site and soreness and as Unknown for pink/red patch at the site and soreness.
2 day history of fever, headache, nausea, redness and slight edema to vaccination site measuring at 16cm x 10cm.  Seen by ER MD.  Diagnosis cellulitis.  Treatment: Keflex x7 days.  Benadryl as occasion requires.  Symptoms started 5 days post vaccination.  Based on photographic analysis forwarded to OCHO adverse event could just be robust take but ER MD diagnosed client with cellulitis.
This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored PROQUAD (Merck) injection, lot# L007229, exp. date 03-SEP-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reprots received from the same reporter. Additional information has been requested.
1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sensation of tightness in chest and throat but no dyspnea, able to talk, no change in MS.  Evaluated by PA - Code Green called. VS stable, transferred to ICU>  In ICU labs completed, monitoring continued - all stable.  Ate sandwich without difficulty or N/V.   discharged to home  1/13:   Had continued sensation of numbness and tingling in tongue that night and metallic taste in mouth with fatigue and headache.  Aprox 11am 1/13 developed racing heart , increased numbness and tingling in tongue and metallic taste in mouth.  Called 911 - transferred to different hospital.  Evaluation including EKG completed without finding. Symptoms gradually resolved - discharged how with instruction to f/u with PCP.  1/14 - Home/stable, mild change in sensation in mouth and tongue persist otherwise tolerating all activity, working from home without difficulty.
Shortness of breath; nose bleed; Headache; tremors; Migraines; Tinnitus; Hearing loss; joint pain; memory loss; depression; All events in box 7 are the same for box 14.
1st shot reactions Extreme Nausea; Extreme Fatigue --8 days later extreme itching on arms and welts--may have had an eye bleed; high eye pressure   Based on the extreme nausea and highly restricted diet--cut my basaglar units in half.  While i have returned to a diet at almost 80-85 percent; my insulin units remain  33% lower.  I wanted to report this finding bc I have not found any information to guide me on any diabetic effects.
This spontaneous prospective pregnancy report as received from a nurse refers to a 18 year old female patient. There were no pertinent medical history or drug allergies. On 18-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # and route not provided); and subsequently, in approximately July 2013, the patient found out she was pregnant. The patient LMP was on 03-JUN-2013 and EDD is 10-MAR-2014. Initial exposure to GARDASIL was at 6 week(s). On an unknown date, a pregnancy test was performed. There was no treatment given. The patient sought medical attention, on an unspecified date, she contacted the nurse. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
Arm sore; Arm redness; Fatigue; Joints hurt; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 10Dec2021, outcome "unknown", described as "Fatigue"; ARTHRALGIA (non-serious) with onset 10Dec2021, outcome "unknown", described as "Joints hurt"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021, outcome "unknown", described as "Arm sore"; ERYTHEMA (non-serious) with onset 13Dec2021, outcome "unknown", described as "Arm redness". The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The reporter got booster on Thursday, 09Dec2021. On Friday the patient had fatigue and her joints hurt. She was unsure of the exact date. The patient's arm was sore and it hurt to lift her arm and it was red. Patient's medical history was unknown. Family Medical History Relevant to AE was not provided. History of all previous immunization with the Pfizer vaccine considered as suspect was unknown. Additional Vaccines Administered on Same Date of the Pfizer Suspect was unknown. Prior Vaccinations (within 4 weeks) was unknown. Investigation Assessment was unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
6 days post vax, pt experienced Petit mal seizures, 2 one at 8:45 pm; 45 mins after waking up and one at 2:00 pm;45 mins after waking up. Pt was hospitalized overnight for seizures.  Pt developed a fever of 102-103 and lasting from 2/11/00 through 2/13/00.
Information has been received from a 76 year old female with no medical history and an allergy to monosodium glutamate who on 13-AUG-2008 was vaccinated with ZOSTAVAX, 0.65 mL. Concomitant therapy included PLAVIX. On 13-AUG-2008, the patient experienced redness and small nodules at injection site. It also made a previous rash on her shoulder and chest from the latex in her bra get a little worse. She also This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a 77 year old female with no medical history and an allergy to monosodium glutamate who on 13-AUG-2008 was vaccinated with ZOSTAVAX, 0.65 mL into the left arm. Concomitant therapy included PLAVIX. On 13-AUG-2008 the patient experienced redness and small nodules at injection site. It also made a previous rash on her shoulder and chest from the latex in her bra get a little worse. In follow-up, the physician reported that on 14-AUG-2008, the vaccine made her pre-existing rash worse. The rash lasted 3 days and the patient recovered on 17-AUG-2008. She also experienced a headache. At the time of reporting, the patient was recovering. The patient sought medical attention from a physician. It was reported that in the past she had been on ZOLOFT and experienced diarrhea. There was no product quality complaint. Follow up was received from a physician concerning a female patient with allergies to sulfa, penicillin and MSG, who on 02-JUL-2008 (previously reported as 13-Aug-2008) was vaccinated with a first dose of an unspecified vaccine (MSD) (pharmacist did not know vaccine). It was reported by the physician that on 05-JUL-2008, the patient experienced an unspecified adverse event on same arm and chest. There were local and systemic allergic reactions at the time of vaccination. It was reported: "pharmacist did not know vaccine continued MSG". No further information is available.
Day of shot I felt a little out of it like I felt drunk. This morning I woke up had a 100.1 fever and all my joints hurt like I'm getting the flu.
Weakness; Fever; nausea; vomiting; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (body aches), PYREXIA (Fever), NAUSEA (nausea) and VOMITING (vomiting) in a 63-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (body aches). On an unknown date, the patient experienced ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ASTHENIA (Weakness), MYALGIA (body aches), PYREXIA (Fever), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-080593 (Patient Link).
Injected arm was itchy; Injected arm was painful; Injected arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injected arm was itchy), INJECTION SITE PAIN (Injected arm was painful) and INJECTION SITE SWELLING (Injected arm was swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Injected arm was itchy), INJECTION SITE PAIN (Injected arm was painful) and INJECTION SITE SWELLING (Injected arm was swollen). At the time of the report, INJECTION SITE PRURITUS (Injected arm was itchy), INJECTION SITE PAIN (Injected arm was painful) and INJECTION SITE SWELLING (Injected arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medicines were reported. No Treatment information reported.
a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest; Itching; Immune allergic reaction; This is a spontaneous report from a contactable Physician (her husband). A 75-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6205) via an unspecified route of administration in Arm Right on 05Mar2021 11:34 as single dose for covid-19 immunisation. Medical history included joint injury, prostate infection and gastrooesophageal reflux disease. Concomitant medications were not reported. Patient lab data included blood tests the few days and everything was okay with that. On an unspecified date in mar2021, the patient developed Immune allergic reaction. On 12Mar2021, the patient developed rash and itching. Caller stated that his husband got his first dose of the Pfizer Covid 19 vaccine and developed a rash and itching. His HCP diagnosed this as immune allergic reaction and asked if it is safe for him to get the second dose of the vaccine. Additional Context included, Caller says she is a doctor in private practice in psychiatry. She wanted to see she was concerned and it may not be related to the COVID vaccine but something happened to her husband that she would like to ask if they have had any other reports of this. She confirms she is calling about the Pfizer COVID 19 vaccine. Her husband got the vaccine at the (facility name) on 05Mar2021 and on the 12Mar2021 he developed a rash all over his body well not all over his body but it was on his extremities, the upper and lower extremities and on his chest. He went to see his primary care doctor. She did not know if it was something related to the vaccination or not she doesn't know but he is still suffering from the rash. Patient was prescribed a corticosteroid cream, the itching responds well but the rash in itself is still there. The outcome of the event Immune allergic reaction, and itching was unknown and rash was not resolved.; Sender's Comments: Based on the known safety profile of the vaccine, a temporal relationship between the onset of events and the administration of vaccine cannot be excluded. However, the information mentioned in the report is limited. A complete medical assessment is not possible till information about concomitant medications of patient is provided.
pt recvd vax & 24 hrs p/vax exp drowsy, nervous, tiredness & h/a; was not seen by MD; sx resolved;
injection site hurts a little; She feels tired; Body aches; nausea; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches), NAUSEA (nausea), VACCINATION SITE PAIN (injection site hurts a little) and FATIGUE (She feels tired) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 035580) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (First Primary monovalent dose) on 07-Jan-2021, Moderna COVID-19 vaccine (Second Primary monovalent dose) on 04-Feb-2021, Moderna COVID-19 vaccine (First Monovalent Booster dose) on 12-Feb-2022 and Bivalent Booster dose on 22-Mar-2023. Past adverse reactions to the above products included No adverse event with Bivalent Booster dose, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.   On 19-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 19-Sep-2023, the patient experienced MYALGIA (Body aches), NAUSEA (nausea) and FATIGUE (She feels tired). On 20-Sep-2023, the patient experienced VACCINATION SITE PAIN (injection site hurts a little). At the time of the report, MYALGIA (Body aches) and NAUSEA (nausea) had not resolved and VACCINATION SITE PAIN (injection site hurts a little) and FATIGUE (She feels tired) outcome was unknown.            No concomitant medication was reported. It was reported that after the four shots patient didn't have any side effects. No treatment medication was reported.   Reporter did not allow further contact
pt woke this morning w/inc temp (exact reading unk);mom states arms were twitching;p/1hr, temp was 99, pt had vomited some vegetables & resting comfortably;given APAP on 10AUG95;
Administered a Pfizer vaccine from a vile opened on 5/18/23 at the appointment on 5/19/23. Appointment was at 10am but discovery of the error was not until 4pm. Discussed with a fellow RN in clinic who relayed the situation to our nurse manager. Nurse manager contacted me today (5/22/23) to advise me on how to proceed forward.
This spontaneous report as received from a other registered nurse refers to a 20 year old female patient. The patient's pertinent medical history included asthma and irritable bowel syndrome (IBS). No drug reactions/allergies. On 27-DEC-1993 the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown)) dose 1, 5 MCG/0.5 ml, intramuscular. On 28-JAN-1994 and on 23-MAY-1994 the patient received respectively dose 2 and dose 3 (5MCG/0.5 ml intramuscular). The lot number provided for all 3 of those doses is 1301W. Concomitant therapies included ALBUTEROL. Recently the patient was found to have negative antibody titers for hepatitis B. The outcome and the causal relationship were not provided. Furthermore it was reported that the patient on 28-APR-2014 received a pediatric dose of RECOMBIVAX HB (captured in MARRS 1405USA00093). Additional information has been requested.
On 09/12/21,  I experienced sudden onset, acute pain to my right wrist and arm. Over the next four days, the pain worsened. I was unable to lift heavy objects or perform certain movements without experiencing severe pain. On 09/17/21, I was diagnosed with tendonitis of my right upper extremity. As of today, 10/17/21, I am still experiencing symptoms and limitations the use of my right arm.