chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bloody diarrhea; STOMACH CRAMPS; VOMITING; DIARRHEA; NAUSEA; EXTREME HEADACHE; FLUSHED; CHILLS; Muscle burning sensation; FATIGUE; Pricking skin sensation; BODY ACHE; This spontaneous report received from a patient concerned a 53 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: 201A21A) dose was not reported, administered on 07-APR-2021 at 14:30 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021 at 22:00, the patient had body aches, all her big muscles were burning/had pain, extreme headache, flushed, fatigue, chills, and prickly skin. She has received ibuprofen and drinking ginger ale since 22:00 to try to keep things down. On 09-APR-2021, she got up with stomach cramps, diarrhea, nausea, vomiting, continuous body aches/burning muscles, extreme headache, chills, fatigue, prickly skin and flushed. On 10-APR-2021, she still had slight headache, prickly skin, body aches, chills, worse stomach cramps, diarrhea and vomiting and blood in the diarrhea. She tried to call family doctor but they were closed. She will go to doctor or emergency room on Monday (12-APR-2021). If bleeding in diarrhea gets worse, she will go to ER this weekend.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed, muscle burning sensation, fatigue, and nausea on 09-APR-2021, and had not recovered from body ache, pricking skin sensation, chills, diarrhea, vomiting, bloody diarrhea, stomach cramps, and extreme headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421312-covid-19 vaccine ad26.cov2.s -blood in diarrhea. This event is considered unassessable. The event 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.
NSTEMI likely caused by Myocarditis starting with intermittent chest pain on 3/6/21 that was treated with aspirin and carvedilol QD.
Patient came back said that he had fever up to 104. There is a red bump on his shoulder. He took some Benadryl and his MD prescribed Bactrim for him.
Patient seen approximately 2 weeks post vaccination for blistering rash and Dx with vaccine induced Varicella.
low 02 sats, with shortness of breath increased pulse rate (120) low BP vomited x 1   she was given a breathing tx and starte 02, she was then sent out to the hospital, paramedics could not get a BP, she was transported to the nearest hospital
Has 8 vesicles on trunk legs and arms x 2-3 days, no fever, varicella.
Infant ready for discharge.  Noc of 11/18 till 11/19. Became dysphoriec RDS healing intubation, central line placement, multiple tasts, antibiotics, extubated 11/20 14:40. Home on nasal cannula O2 11/28
Headache; Vomiting; Nausea; profusely sweating on and off through the day; No appetite; Stomach pain; stomach cramps; This is a spontaneous report from a contactable nurse. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included bronchiolitis obliterans, spinal fusion, lung lobectomy, traumatic brain injury(TBI) and known allergies to vancomycin, codeine, large doses of prednisone. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included too many to name due to several injuries while deployed in army and was on a strict lung medication regimen. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 06:30, the patient experienced vomiting, stomach pain, stomach cramps, nausea, profusely sweating on and off through the day, no appetite and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with fluids, ondansetron (ZOFRAN), dicycloverine hydrochloride (BENTYL), omeprazole (MANUFACTURER UNKNOWN), famotidine (PEPCID), over the counter (OTC) bismuth subsalicylate (PEPTO-BISMOL) started from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, stomach pain, stomach cramps, nausea, profusely sweating on and off through the day, no appetite and headache was recovering at the time of this report.
Patient was previously immunized and doses were overlooked on transcription resulting in patient receiving extra dose of above vaccines.  No adverse reaction has been noted.
Psoriatic arthritis flare up; Pain in hands and feet with Humira (adalimumab); Sick; Swollen from neck to wrist; Vertigo; Redness from neck to wrist; Sore from neck to wrist; Felt achy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in a 58-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In January 2021, the patient experienced ILLNESS (Sick), SWELLING (Swollen from neck to wrist), VERTIGO (Vertigo), ERYTHEMA (Redness from neck to wrist), NECK PAIN (Sore from neck to wrist), PAIN (Felt achy) and HEADACHE (Headache). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in hands and feet with Humira (adalimumab)). In 2021, ILLNESS (Sick), SWELLING (Swollen from neck to wrist), VERTIGO (Vertigo), ERYTHEMA (Redness from neck to wrist), NECK PAIN (Sore from neck to wrist), PAIN (Felt achy) and HEADACHE (Headache) had resolved. At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) had not resolved and PAIN IN EXTREMITY (Pain in hands and feet with Humira (adalimumab)) outcome was unknown.            No concomitant medications were reported.   It was unknown if patient was enrolled in a Covid-19 vaccine trial.   The reporter's causality for the event(s) of sick, swollen from neck to wrist, vertigo, headache, redness from neck to wrist, sore from neck to wrist, felt achy and pain in hands and feet was not provided. The reporter's causality for the event(s) of psoriatic arthritis flare up with Humira(adalimumab) was a reasonable possibility.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Mother said baby lesions on legs, soles of feet, abdomin, face, especially left cheek and also chest and arms. Back was Clear. Rash was described as raised whelps, pale in color and of various sizes.  Clusters at thigh injection sites.
Swelling/warmth at injection site. Treatment ice to Left shoulder four times a day for 48 hours.
Patient states warm, red area around injection site that started as 2x2" and over 2 days has increased to 5x3 to 4" area. The area is raised and warm with a soft outside area and hard inside area. Pt also reports fever but no temperature taken.
At 10:20am the patient received their dose of the Moderna  Covid-19 vaccine. At 10:25am they began to feel hot, lightheaded, dizzy, and nauseous. A nurse was alerted and the patient was brought back to the clinic from the waiting room where they were placed in to a supine position with head elevated on an exam table. They were given a glass of water and their blood pressure was assessed. At 10:27am their blood pressure was 90/60. Their blood pressure was reassessed at 10:33am and it was 100/70. At 10:35am the patient stated that they felt better and they were escorted out of the clinic.
itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (itchy) and RASH (rash). At the time of the report, PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included no information.
Client contacted Health Department on 8/27/21 and stated he has a black eye with blurry vision, denies any injury to the eye and concerned that it might be a side effect of the vaccine. Instructed to go to urgent. Client stated he is going to his primary care doctor. Called client to follow up after appointment and he stated he was prescribed a steroid and had his blood drawn. He is awaiting results at home.
Got the vaccine, was diagnosed with Shingles; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 16th July 2022, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: Additional Information: GSK Receipt Date: 16-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had received Shingles vaccine a year ago and was diagnosed with Shingles in the morning of reporting. The doctor said patient could still get Shingles even if the patient had been vaccinated, but usually it was a milder case. The doctor gave the patient anti-viral medicine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact detail were available.
Alopecia areata onset approximately 6 weeks after vaccination. Began as sporadic bald spots in scalp, progressing to complete hair loss over scalp and entire body.
Woke up with severe itching on right arm and when I got the lights on, saw that I was covered in hives (there were large red welts). I took 2 benadryl and within about 15 minutes the itching was subsiding and the hives started to go away. Within the hour, both were completely gone and 8 hours later still ok.  I had taken benadryl prior to the injection as a precaution (maybe why I didn't experience anything for several hours).  DId not experience any itching or hives anywhere else other than the injection arm.
Shortly after immunization my daughter began to have a multitude of health issues including fatigue, tachycardia, pain in chest, severe headaches, insomnia, dizziness, nausea, light sensitivity, tremors, joint pain, coldness/chills, digestive problems, shooting nerve pain, ear pain and difficulty concentrating. She developed a bad cold then flu bug late Jan early Feb. All the other symptoms above followed and stuck around for several months.
Copied from patient self report that was submitted in writing to clinic on 8/21/17:  "Following my pneumonia booster last Thursday a.m. I experienced severe arm soreness, some swelling & redness, and a flu like illness very bad Fri. and Sat. And not yet well. Just reporting as I have not had any significant reactions in the past."
Several hours after injection I developed severe itching. Took 50 mg Benadryl and 20 mg famotadine. Next morning had some itching, but better. Took 25 mg of Benadryl,  later that developed hives on my chest, under breasts, and face.  Continued with Benadryl and famotadine for two more days. (4 days total). 5th day I was fine, no more symptoms.
Patient is a 79 y.o. male with a history of CVA with left hemiplegia, prostate cancer and recent admission 5/12/235/15/23 for acute CVA who presented to RMH 6/2/2023 with progressive shortness of breath and positive COVID at facility.    1. COVID-19 Infection: Symptom onset 5/29/23 with headache, tested positive 6/2/23 at SNF. Decadron x 10 days continued; weaned off O2. Isolation per protocol.  2. Acute on Chronic Respiratory Failure: ABG on admit showed pH 7.33 and CO2 56.9 indicative of chronic retention. SaO2 88% on admit due to COVID; weaned off O2 gradually.  3. Elevated Troponin: Prior troponin 24, 25 noted in 2019. Troponin 25 on 6/2/23. Suspected demand. EKG 6/2/23 showed bifascicular block without ST changes noted. No further evaluation necessary. 4. Bifascicular Block: Noted on EKGs prior to admission with RBBB and LAFB. s/p loop recorder 2016 and 2019. Follows with Dr. (EP)TTE 5/14/23 with slightly abnormal septal wall motion, EF 55%.  5. Dysphagia: Due to CVA in 5/2023. MBS 5/13/23 showed aspiration and patient placed on nectar thick liquids. SLP followed. 6. CVA: Multiple with residual left hemiplegia (requiring wheelchair) and residual dysphagia. Follows with Dr. (PMR) and, CNP (Neuro). Home ASA, Plavix and statin resumed. 7. Hypothyroidism: S/p thyroidectomy in 1995. Home medications resumed. 8. Prostate Adenocarcinoma: Per history. Follows with Dr.  9. Code status: Full code, patient transitioned to DNR-CCA prior admission but was uncertain this admit.  10. DVT Prophylaxis: Lovenox
Patient received the vaccine on June 14th and experienced a seizure like event which the administrator attributed to prior Covid 19 diagnosis from January.  No further events until June 27 after travelling all day /dehydration to another locale when he experienced a grand mal type seizure. The healthcare facility attributed to dehydration as all vitals normal/alert and after IV / hydration discharged.  No further symptoms/events until travelling back to his home locale on July 2 when a similar event resulted in his being transported to a hospital. Vitals normal, Labs normal, CT without contrast normal, no indication of thrombosis and discharged to return to his home locale on July 3rd. Scheduled to see doctor.
Abdominal pain x weeks, nausea, muscle aches, chills, severe fatigue x weeks. Responded to corticosteroid IV.
No adverse effects; pateint received an expired dose of M-M-R-II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-DEC-2019, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection recombinant human albumin (rHA), lot # N032749 and expiry date 20-NOV-2019, at a dose of 1 dosage form for prophylaxis, (strength, route and anatomical location were not reported). No adverse effects were reported. No PQC was reported. The outcome of expired product administered was unknown.
Pain-5, swollen, red,itchy, raised skin margin, initially- 1.5? by 2.5? then tripled in area within 4 hrs.  Nurse noted injection given I low and in back edge of arm (subcutaneous  Dr  prescribed ZPack Arithromycin 6 tabs and Benydril
1st dose of the Moderna Covid-19 vaccine on 18Feb2021 and wants to get the 2nd dose today (19Jul2021); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 18Feb2021 and wants to get the 2nd dose today (19Jul2021)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 18Feb2021 and wants to get the 2nd dose today (19Jul2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 18Feb2021 and wants to get the 2nd dose today (19Jul2021)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information not provided.
generalized sz w/twitching, eyes rolled blue lips, lasted < 1 min; febrile asymptomatic the next day;
Severe diarrhea, chills, lack of balance,  weakness, arm pain. Pain in the back of my head.
This child is 18 months old and should have gotten fluzone 0.25mg. I gave 0.5ml dose. I contacted the parent and he was notified of wrong dose given. RN on staff did notify him of increased risk of redness and swelling at site and possible fever. Employee was notified and she advised that parent and supervisor must be notified which they both were. Incident form filled out for our office. Child and parents did remain in the office for longer than 15 minutes and the child had no reaction at that time.
We were under the impression we administered the Pfizer Bivalent COVID booster but we actually administered the Pfizer Monovalent COVID vaccine in error. The patient was made aware and offered CDC guidance on how to proceed.
Patient reports that she woke up in the middle of the night after the shot with severe pain in her arm.
Swollen arm; Warm to touch; Rash; Low grade fever of 99.8F; Joints pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), RASH (Rash), PYREXIA (Low grade fever of 99.8F) and ARTHRALGIA (Joints pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced ARTHRALGIA (Joints pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), RASH (Rash) and PYREXIA (Low grade fever of 99.8F). The patient was treated with IBUPROFEN at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. On 25-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), RASH (Rash), PYREXIA (Low grade fever of 99.8F) and ARTHRALGIA (Joints pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact.
Information has been received from an approximately 83 year old female consumer with "no reported pertinent medical history", drug reactions or an allergy who on 07-APR-2007 was vaccinated with a "single dose of the series" of ZOSTAVAX. Concomitant therapy included LEVOXYL, atenolol, PAXIL, HYZAAR, PROTONIX, COUMADIN and oxygen. The patient reported that in the "middle of September" she had a small outbreak of shingles. She noted she had "red pimple like dots", that were red, itchy and gave her a "twinge of a headache that lasted for a second". They started on the hairline down to her forehead. The patient was seen by her physician and diagnosed with a mild case of shingles. At the time of reporting the consumer was not yet recovered. She noted that "this has lasted for about six weeks and she still has the rash". There were no lab diagnostics studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is follow-up to report (s) previously submitted on 12/21/2007. Follow up information was received from a physician's assistant who reported "I am unaware of any patient of mine who had an adverse reaction to ZOSTAVAX". No further information is expected.
Severe pain in the arm after both shots. Exhaustion and upset stomach after second immunization. Approx 1 month after second immunization, left side of my face went slack unable to drink without a straw for 5 days. Hospitalized overnight to verify it wasn't a stroke and was Bells Palsy.
Patient developed left eye swelling, cough, wheezing, shortness of breath 4-5 hours after injection administration. Mother called EMS to take patient to hospital where he was treated for symptoms.
positive test for COVID on 10/14/21; pt staying in SNF; lethargy, weakness, decreased appetite; pt found deceased in the SNF and pronounced dead; per death certificate, the causes of death were:  failure to thrive secondary to ESRD, dementia, CHF, Complicated by COVID 19.
2 Days after the shot I got hives on my arm.  I have had chronic hives since my last Moderna vaccine in Feb. 2021.  I am taking 2 Allegra, 2 Pepcid and 1 Claritan to control my hives.  I was hive free for 2 weeks with these medicines, but have had hives again since getting my Booster shot.  The hives aren't as widespread as before, I am assuming the antihistamines I am taking are helping keep them under control.  I always get my hives at night after sitting or laying down so I think they are caused from heat and/or pressure.  I have gotten hives after all 3 shots so I am assuming there is a connection to the vaccines.