chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate vagal reaction/syncope with convulsive activity/seizure. Lasted 1-2 minutes and stopped spontaneously. Subsequent nausea/vomiting. Treated in ED with ZOFRAN and REGLAN.
I have recently had COVID; I have recently had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing), notes: Have ITP and MGUS; "MGUS" (unspecified if ongoing), notes: Have ITP and MGUS. Concomitant medication(s) included: DOPTELET. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I have recently had COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Customer verbatim: Patient had recently had COVID. Due to being on Doptelet she could not take the antiviral. patient had 2 COVID vaccines. She was given the monoclonal antibody infusion instead. Due to the shortage of the monoclonal antibodies are there recommendations for what persons in my situation can do.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
suspected vaccination failure; Shingles very bad.; lot of pain / hurting; itching; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles about 10 year ago), pain and pruritus.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that shingles shot did not work for her husband. He had both his Shingles vaccinations a year ago. The patient experienced Shingles very bad. The patient had Shingles eight years ago, they were not this bad. The patient experienced hurting and itching more than he did when he had Shingles before about ten years ago. He had been to the doctor. The patient went to the doctor next day after he started breaking out. He get a lot of medications and a ointment. The patient was still having a lot of pain. This case was considered as suspected vaccination failure since the details laboratory confirmation of shingles were not provided.
splitting h/a, also unblanced for about 48 hrs; cont w/h/a; starts out like a neck pain & goes around temporal area;
Vasovagal episode - patient complained of tingling all over after 10 min of giving vaccine. BP dropped to 92/62 patient felt light headed. Provider was notified right away after 60min patient was re-evaluated all vitals were normal, EKG normal patient was sent home.
2/21/12 Rash on face - fine rash. 2/23/12 Rash on stomach - fine rash.
Initial and follow-up information has been received through the pregnancy registry from a certified medical assistant concerning a 17 year old black female with asthma, who on 09-MAY-2007 was vaccinated with GARDASIL.  Concomitant suspect therapies included montelukast sodium (SINGULAIR).  Concomitant therapies included fluticasone propionate (+) salmeterol xinafoate (ADVAIR).  The patient was vaccinated while was pregnant.  Patient sought unspecified medical attention and had a positive pregnancy test.  On 11-APR-2007 a routine test for Cystic fibrosis was performed and was negative.  On 12-APR-2007 a routine test for hemoglobin solubility was performed and was negative.  On 23-MAY-2007 a serum alpha-fetoprotein test was performed and was negative.  On 11-SEP-2007 an ultrasound was performed for Oligohydramios and was normal.  The patient's last menstrual period was 29-JAN-2007 with an estimated date of delivery of 05-NOV-2007.  There were no symptoms reported.  Follow-up indicated that on 08-NOV-2007 the patient gave birth to a liveborn female infant.  The infant weighed 2778 grams and her apgar score was 8/9.  It was reported that the baby was born healthy and with no congenital anomalies.  The patient gave birth "40+" weeks from her last menstrual period.  There were no complications during pregnancy, no complications during labor/delivery, and no infections or illnesses during pregnancy.  During the delivery an episiotomy was performed.  It was reported that the patient had one full term delivery and no birth defects or infant complications in previous pregnancies.  The physician reported that "as far as she knew the baby was normal and healthy."  The patient tested positive for Group B streptococcus and was treated.  Additional information is not expected.
10:55 - complains of dizziness and nausea  Immediate assessment by onsite EMS and NP 10:57 - VS 102/63; 76;O2 sat on RA97%.  Provided a fruit and cereal bar, and cool water 11:15  VS- 107/72;P 84. Felt better after eating snack and drinking water. Admitted to not having much to eat or drink prior to coming to clinic. 11:15 - discharged home. Nausea  and dizziness gone.
Right thigh hematoma in a couple of days.  Erythematous rash 6cm x 6.5cm surrounding injection site onset - morning of 4-8-08.  Pruritis and discomfort noted at that time and swelling.  Treated with Claritin syrup 1/4 tsp PO qd x 2d.  Good results.
hypersensitive vasculitis-purpuric-over the lower abd, buttocks, legs;arthralgias, fever elevated (not documented);onset rash 17JUN98;
joint pain in left wrist which follwed by joint swelling left lateral distal ulna which was quite predominant on anatomical postieror side.sought medical assitance from pcplab worked showed elevated; joint pain in left wrist which follwed by joint swelling left lateral distal ulna which was quite predominant on anatomical postieror side.sought medical assitance from pcplab worked showed elevated; positve RA factor; elevated WBC; This is a spontaneous report from a contactable other hcp. A 57-years-old female patient received bnt162b2 (COMIRNATY; Formulation, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jan2021 00:30 (Batch/Lot Number: EL9265), Age at vaccination is 57 year as DOSE 2, SINGLE for covid-19 immunization. Medical history included neoplasm malignant from an unknown date and unknown if ongoing. Concomitant medications included estrogens conjugated taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. The patient experienced joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated and positive ra factor, elevated wbc on 06Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included rheumatoid factor: positive, Sars-cov-2 test: negative, Nasal Swab, white blood cell count: elevated, x-ray: negative on 06Feb2021. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, positive ra factor, elevated wbc. No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (I have a 10 month old and she is currently nursing) in a 10-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding. No Medical History information was reported. On 04-Feb-2021, the mother received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the infant was diagnosed with EXPOSURE VIA BREAST MILK (I have a 10 month old and she is currently nursing). At the time of the report, EXPOSURE VIA BREAST MILK (I have a 10 month old and she is currently nursing) outcome was unknown. No relevant concomitant medications reported. No treatment information was provided.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
low fever around 100 degrees F; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (low fever around 100 degrees F) and VACCINATION SITE PAIN (Sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive for COVID in December. Patient has been tested for COVID several times since then with the last time being in February-all tests have come back positive.). Concurrent medical conditions included Lung disorder, Heart disorder, Diabetes and Deaf.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (low fever around 100 degrees F) and VACCINATION SITE PAIN (Sore arm). On 29-Apr-2021, PYREXIA (low fever around 100 degrees F) and VACCINATION SITE PAIN (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
1 Urticaria 2 lesions 1 inch from varicella injection site. Observed for 20 min without generalized reaction. Gave Benedryl TANNA/C po 2 instructions to give this BIX X 4 doses.
Pain and swelling to injection site with headache for 48 hours after IZ is given.
Tightness in the throat and chest,  rash on neck, headache,  weakness, pain in shoulders and arms and legs feeling to weak to move or lift.
Information has been received from a LPN concerning a 15 week old Caucasian female who on 14-JUL-2000 was vaccinated wih the first dose of Comvax. Concomitant vaccinations that same day included the first dose of Tripedia and the first dose of IPOL. Following vaccination the child cried for four hours. In follow up it was reported that the continuous crying lasted for 3 hours. On 05-DEC-2000 at 3:30 PM, the child was vaccinated with the second dose of Comvax in the left leg. Concomitant vaccination that same day included the second dose of Tripedia and IPOL in the left leg. On 05-DEC-2000 the child developed a rash that resolved in 20-30 minutes. Later the same evening, the facial rash returned and was also seen on the child's arms and legs. The pt's rash resolved within 30 minutes. In follow up, the LPN reported that 15 minutes after vaccination the pt developed hives on her face that disappeared after 20 minutes and later that night the pt developed hives allover her body (previously reported as a rash). It was noted that the pt had hives 3 times. in follow up, the nurse reported that the pt's mother was instructed to give Benadryl. Twenty minutes later, the pt's hives disappeared. There were no other problems. No other information is available.
Patient presented to office for well child exam.  Patient recieved Pentacel in RIght Deltoid.  Late that night/early the next morning patients arm started getting red, not to touch.  Area continued growing bigger and on 8/7/20 was seen back in office by Nurse Practitioner.  Patient was given Rocephen, and given script for Keflex to start if area didn't get any better. Patient reported 8/10/20 patients arm is much better.
After 2 week of the vaccination, the skin suddenly broke into itchy chronic hives that presents for 30-45 min. The hives have been moving all around the body mainly causing itchy bumps and welts on arms,  armpits, back, thighs, around the wait, legs, and crotch areas.  Additionally, the vaccine have also caused dermatographia condition on my skin which I have never had before. I have no allergies or allergic to any food. It has been more than 2 weeks since I have had the symptoms and controlling with the prescribed medication.   Note: No chronic symptoms or side effects was presented after the first two doses of the vaccine.   Initially, my physician prescribed Prednisone tape for 10 days (60, 60, 40, 40, 20, 20, 10, 10, 5, 5 mg each day). That did not calm down the symptoms. Then they prescribed Singulair (Montelukast) and Zyrtec which is currently keeping the symptoms under control.
the corner of my left eye got itchy and swollen; the corner of my left eye got itchy and swollen; very tired; nauseous; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient reported that I received the COVID 19 vaccine today and 2 hours later the corner of my left eye got itchy and swollen. I also got very tried and nauseous. The outcome of the events unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 09-MAY-2016, the patient was inadvertently vaccinated with VARIVAX, lot # L046885, expiry date 23-NOV-2017, 0.5 ml subcutaneous instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Gave undiluted COVID-19 Vaccine.  Parent notified, no s/s reported.  Dr notified
Chief Complaint   hypoxia  History of Present Illness     Pt is a 67F with PMH of COPD, depression, anxiety, possible Afib, possible CHF who presented as a transfer from OSH for hypoxia in the setting of COPD exacerbation and COVID PNA. She also has a hx of left lower lobe lobectomy many years ago for an infection per patient report. She states that she typically wears 4L o2 at home while sleeping and with exertion, but does not require any at rest. She reports that she completed both COVID vaccines about 1-2 months ago. She did have contact with her daughter who also tested positive recently. She reports that she started to feel dyspneic with minimal exertion at home and took her O2 saturations and found them to be in the 70s, so she presented to the ED. She underwent CTA scan in ED and was found to have left lower lobe collapse, severely calcified and ulcerated thoracic aorta with possible intraluminal hanging thrombus and small penetrating aortic ulcer. She was sent here for further work up and management. She denies any etoh or drug use, but has smoked 1-2ppd for 50 years. Mom and dad with hx of cancer. She denies any fevers, chills, chest pain, tightness, pressure, or worsening dyspnea at rest. She does have a productive cough with yellow sputum production and dyspnea with exertion.
9/21/15 urgent care for viral illness and sore throat. 9/25/15 ST, cough, runny nose, negative rapid strep/throat culture. 11/19/15 office visit, ear pain, ST, fatigue, nausea, Dx. viral Mono blood work ordered. 11/23/15 ER (L) sided abdominal pain Dx .constipation, post viral syndrome. 11/25/15 office visit fatigue, generalized weakness, swollen lymph node Dx. fatigue and arthralgia - treated doxycycline x 21 days for possible Lyme. 12/1/15 office visit trouble sleeping, continued joint pain Dx. polyarthralgia. Had normal exam. Referred to Rheumatology. 12/4/15 Rheumatology appointment. Dx. Amplified musculoskeletal pain. Referred to Neurology and Pain Program. 12/4/15 started physical therapy and occupational therapy. 12/15/15 started using wheelchair due to pain and generalized weakness. 1/7/16 appointment with Group for all symptoms previously noted in addition to left sided weakness, (L) knee pain, (L) wrist and thumb pain. Blurry vision and eye pain. Dx. Amplified pain syndrome and Complex Regional Pain Syndrome. 1/26/16 ophthalmology appointment Dx. myopic astigmatism. 2/15/16 direct admission to hospital from Neurology office for (L) sided weakness, (R) eye pain, headaches, right facial twitching. Normal brain MRI and EEG. 3/9/16 office visit for follow up deteriorating neurologic function. 3/11/16 Neurology for f/u visit.
Patient is a 89 y.o. female with history of COPD, CKD IV (with history of 1986 renal transplant) who presented from home (lives with daughter) on 9/20/2023 with shortness of breath and hypoxemia in the setting of COVID-19. Course complicated by hypotonic, hyponatremia possibly in setting of COVID. Nephrology followed, s/p 2 doses tolvaptan and with fluid restriction. She is medically stable for discharge home. Home healthcare was declined.   Acute respiratory failure with hypoxemia, resolved COVID-19 pneumonia - Positive COVID-19: 9/20 at ED - Vaccination status: Vaccinated with Moderna with last dose 2023 - Decadron: Yes. End date 9/28 on discharge - Remdesivir: Yes. end date 9/24 - E consult ID, appreciate recs; no need for home oxygen on discharge; stop decadron on discharge   Hypotonic Hyponatremia - in light of COVID infection and respiratory symptoms above; there does remain concern for SIADH - On admit, Na 123 with nadir of 114 (9/22/23), improving; s/p tolvaptan 9/23 and 9/24; Urine osm pending, urine Na mildly elevated, more consitent with SIADH; TSH wnl; low pre-test concern for cortisol deficiency given labs and pressures - Nephrology followed; will discharge with fluid restriction(1.2L), TID NaCl tablets, and increased home lasix to 40mg PO; daughter was aware of changes and agreeable to this management   Acute on Chronic HFpEF - History of HFpEF with previous hospitalization in 4/2023 for volume overload.  - 12/2022 limited Echo wih EF 65%, mild AS, mild-mod AR, and mild TR; Admit BNP 41.6 K (31.5 K, 1 month prior)  - resume home lasix as noted above   Presumed COPD History of tobacco abuse - Presumed COPD during last admission but no formal PFTs found. Has been following up with respiratory therapy in outpatient setting per the daughter. - Continue home inhalers on discharge; recommend formal PFTs   Hypothyroidism - Daughter confirms that patient takes 50 mcg of levothyroxine, but takes 2 tabs on Sundays. - Continue home synthroid     History of CVA - Continue aspirin.  No acute symptoms at this time.   CKD stage IV History of renal transplant 1986 History of interstitial nephritis - Continue home suppression therapy for now.  Continue to follow renal function.  Nephrology consulted as above   Hypertension, essential - Continue home medications as hemodynamics allow - Renal team added Norvasc daily. She is on Coreg 6.25 mg bid longer term; continue both on dischargeaseline creat 2, stable
Patient called to report on 10/22/19 following vaccination on 10/20/19. She reported that she was experiencing upset stomach without vomiting. She also reported that the injection site area was red and rashy, and that she was experiencing pruritis around the injection site. At this time she has spoken via telephone with her provider but has not been seen in person by a provider or had any interventions.
DIFFICULTY BREATHING, NAUSEA,VERY RAPID HEART BEATS(157BPM) DIZZYNESS,FATIGUE, HEADACHE AND STOMACH ACHE.   TOOK HER TO EMERGENCY ROOM THEY GAVE HER AN IV AND SENT US HOME BECAUSE HER EKG WAS FINE EXCEPT FOR HER RAPID HEARTBEAT.  THE NEXT NIGHT I HAD TO TAKE HER AGAIN FOR THE SAME SYMPTOMS, HER HEARTBEAT WAS 128BPM THEY SENT US HOME AGAIN.  SHE DIDNT FEEL BETTER UNTIL TODAY 08/08/07.  SHE STILL DOESNT FEEL 100% BACK TO NORMAL.
Sporadic itchy spots on her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Sporadic itchy spots on her body) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Sporadic itchy spots on her body). At the time of the report, PRURITUS (Sporadic itchy spots on her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Patient received vaccine (2nd dose of Pfizer vaccine) sometime during the day, and later that night she woke up with severe right leg pain. She continues to have significant right leg pain, especially the right lateral thigh.
This spontaneous case reported by a consumer, describes the occurrence of malaise (didn't feel well at all) and somnolence (wanted to go to bed and sleep) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. February 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2022, patient experienced malaise (didn't feel well at all) and somnolence (wanted to go to bed and sleep). At the time of the report, malaise (didn't feel well at all) and somnolence (wanted to go to bed and sleep) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Patient wanted to know why the dosage for the booster is 5 times of the primary series. She wanted to know if there is any information available about that. She also wanted  to know if she may have the same side effects when she goes for her 2nd dose after 3 weeks. Patient did not elaborate on her adverse reactions. No concomitant medication or treatment information provided.
On day 8 after vaccine woke with significant pain, redness, warmth and swelling.  Several hours later developed fevers, body aches.  Starting on antibiotics, antihistamines and close follow up