chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever on 3/16/11, Rash on 3/17/11. Brought to health dept by parent to ck. rash. Had varicella rash on torso, less rash on face & extremities. No fever (98.3) at time of visit.
Localized redness at site " cellulitis" Pt treated with Cephalexin 500mg PO QID X 10 days.
ARM SWOLLEN SHOULDER TO ELBOW, RED, HOT MD DIAGNOSED AS CELLULITIS.
Generalized/global urticaria. No other symptoms, but intense pruritus that comes in waves to different parts of the body at different times. If any itching or pressure (such as "sit bones" under buttocks, waistband site, or elbows on office chair armrests) is applied, the site breaks out in wheals. If ignored, the itch goes away within minutes; if pressure/itching is stopped, the wheal slowly goes down and is barely visible after 24 hours.
Chest pain on left side, pain shooting down left arm, shortness of breath, dizzy, light headed, back pain.
UrticariaPruritus Narrative:  Severe urticaria head to toe started 12/29/21. Multiple doses of diphenhydramine provided no relief. Saw my PCP on 12/30/21 who started me on prednisone 60mg taper for 9 days, Pepcid daily, and Zyrtec  10mg daily in addition to continuing diphenhydramine 50mg q6h. No change in urticaria occurred until about 4 days later. Slightly improvement in itchiness and redness occurred daily going forward. I saw an allergist on 01/03/21 who said my reaction was due to Moderna booster dose I received. She increased my Zyrtec to 10mg QID and Pepcid BID, said to continue with diphenhydramine and finish out prednisone taper. My symptoms were improving slightly each day as long as I took the antihistamines, steroids and H2 blocker as directed without missing any doses. When the prednisone taper was completed I had a flare up/starting getting worse again. PCP prescribed additional prednisone 60mg taper x9 days. Allergist also added Singulair 10mg at bedtime. Symptoms continue to resolve; I can now take Pepcid BID, Singulair at bedtime, and Zyrtec at bedtime and my symptoms are controlled. However, I still to this day have some breakthrough hives all day long but are much worse if I don't take the bedrime regimen.
Patient reported redness and pain at injection site about an hour or more after receiving injection.  Then she noticed a black and blue appeared and a red band appeared across her upper arm. By the next day the redness eventually spread to  under her arm pit. She came into the pharmacy to tell us and she was advised to see the clinic doctor immediately.
Day 11 post vaccine (1/8/2021) a large red, swollen, itchy circular area showed around vaccine injection site. Larger than a quarter but smaller than a softball size. Benadryl and hydrocortisone needed.
Made sick; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare via social media professional.   This case is linked to cases 2020SA294157 and 2020SA294158 (same reporter).  This case involves patient (unknown demograhics) who got sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
pt developed an injection site reaction resulting in a mass 4 cm in diameter, area was erythematous, warm to touch & firm, treated with Atarax, resolved
Cyanotic spell, lethargy; admitted to hospital and treated with antibiotics and Acyclovir. Urine culture grew Gardnerella vaginalis, blood culture and CSF negative. UGI: mild reflux, Renal US NL. Sent home on apnea monitor. CXR and EKG NL.  Final Diagnosis: apneic spell, gastroesophageal reflux disease, and urinary tract infection.
Could not lift my left arm over my head.; sore left arm./Arm pain from booster dose was far worse than pain from flu and pneumonia vaccines; felt wiped out after her booster dose./went home to go to bed.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift my left arm over my head.), VACCINATION SITE PAIN (sore left arm./Arm pain from booster dose was far worse than pain from flu and pneumonia vaccines) and FATIGUE (felt wiped out after her booster dose./went home to go to bed.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 017B21A and 037B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM EXTRA STRENGTH) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift my left arm over my head.), VACCINATION SITE PAIN (sore left arm./Arm pain from booster dose was far worse than pain from flu and pneumonia vaccines) and FATIGUE (felt wiped out after her booster dose./went home to go to bed.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift my left arm over my head.), VACCINATION SITE PAIN (sore left arm./Arm pain from booster dose was far worse than pain from flu and pneumonia vaccines) and FATIGUE (felt wiped out after her booster dose./went home to go to bed.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was reported that arm pain from booster dose was far worse than pain from flu and pneumonia vaccines.   This case was linked to MOD-2021-409876, MOD-2021-409868 (Patient Link).
Brain swelling sensation/ like it was swelling again; Severe pressure in my head; Extreme fatigue for 4 days; Sore arm; It felt like I had just had the surgery again.This sensation tapered off over a month/ brain swelling sensation; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 09:15 (Lot Number: EL9261) (at the age of 45-years-old) as dose 1, single for covid-19 immunisation. Medical history included brain surgery, brain bleed and brain blood clotting throughout patient's brain in 2018, small stroke, sulfa allergy, gluten allergy and rice allergy. Concomitant medications within 2 weeks of vaccination included apixaban (ELIQUIS), baclofen and daily vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took Vicodin and Celebrex, and experienced allergy with both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient stated that she was an early vaxer in January due to medical status. This first dose of the vaccine resulted in severe pressure in her head, like it was swelling again, it felt like she had just had the surgery again. This sensation tapered off over a month. She had extreme fatigue for 4 days and sore arm but those weren't a big deal. The onset of all the events was reported as 26Jan2021 21:15. The events did not cause hospitalization. The patient did not receive treatment for the events. It was the brain swelling sensation that resulted in her not getting the 2nd vaccine. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
It flared up my chronic myacenea and it made me really weak. It made my arm really tingling  and numb. I was weak from about 10 pm until the next night at 10 pm.   It caused an increase of diarrhea and nauseous, too, and those symptoms  lasted for about three days.
1: Mild soreness at injection site, lasted about a day or so.  Reported for statistical reasons. 2: Mild Fever (101.2), mild headache, drowsiness, went away within 24 hours.  Reported for statistical reasons. 3: Reddish brown splotches on the tips of a few fingers (right thumb and forefinger, left index and big finger, a bit on left thumb); these are fading but are still visible 60 hours after injection.  Reported because it's odd.  Note: This is the second shot.  After my first shot I had no reactions at all.  (I didn't even feel it go in).
PAIN ON THE LEFT LEG RADIATING TO RIGHT SIDE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pain on the left leg radiating to right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on the left leg radiating to right side. This report was non-serious.
No adverse effects; patient was administered improperly stored VAQTA; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history, concomitant medications, and drug reactions or allergies were not reported.  On 22-MAY-2019, the patient received an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R034339 with expiration date 23-NOV-2019 (strength, dose, route of administration were not reported), for prophylaxis. The dose of hepatitis a vaccine, inactivated (VAQTA) was exposed to a temperature excursion above 47 degrees Fahrenheit (°F) (9 degrees Centigrade (°C)) (49.3 F) during a timeframe of 44 minutes, which was not detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.    This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1905USA011328:
Information has been received from a dentist concerning her 13 year old daughter who on 08-APR-2009 was vaccinated with the first dose of GARDASIL. On 09-APR-2009 the patient experienced abdominal pain and shivering. The patient's abdominal pain and shivering persisted. The patient sought unspecified medical attention. No further information is available.
Soreness at injection site; rash on neck; scratchy and itchy throat; itchy lips; itchy skin; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ENG 6199, Expiration date: not reported), via an unspecified route of administration in arm left on 06Mar2021 at 13:45 (at the age of 36-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included Hypothyroidism, ADHD, GAD. The patient had no known allergies. The patient's concomitant medications in two weeks included lisdexamfetamine mesylate (VYVANSE), guanfacine hydrochloride (INTUNIV), escitalopram, levothyroxine sodium (SYNTHROID), vitamin, all were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 06Mar2021 at 18:00, the patient experienced soreness at injection site, rash on neck, scratchy and itchy throat, itchy lips, itchy skin. Treatment was not received for the events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
AFTER VACCINATION, PATIENT HAD A BLACK OUT/FAINTING SPELL DURING HER 15 MINUTES OBSERVATION  AT THE PHARMACY.  PATIENT STATED SHE FELL DOWN AND BUMP THE BACK OF HER HEAD.  PATIENT ABLE TO GAIN CONCIOUSNESS  AND DENIED EMERGENCY HELP.  PATIENT SAT AT THE PHARMACY WAITING AREA FOR APPROXIMATELY 45 MINUTES BEFORE SOMEONE PICKS HER UP.
Cerebellar Stroke; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via unspecified route of administration in the left arm on 15Apr2021 11:30AM at age of 51-year-old at single dose for COVID-19 immunisation. Medical history included known allergies to Mango. Other Medical history included neuropathy and benign prostatic hyperplasia (BPH). There was no covid prior vaccination. There was no other vaccine in four weeks. There were concomitant medications in two weeks: pregabalin (LYRICA), morniflumate (FLOMAX) and nortriptyline. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730) in left arm on 25Mar2021 04:30PM at 51-year-old at single dose for COVID-19 immunisation. Patient experienced adverse event: cerebellar stroke on 18Apr2021 06:45PM. Patient resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalization for 2 days. Patient received treatment included computerised tomogram (CT scan), magnetic resonance imaging (MRI), Echocardiogram (TEE) and MyCare Link. Covid test post vaccination included: Nasal Swab on 18Apr2021: Negative. Patient was recovering from event.
Patient had 4cm contusion with localized swelling and erythema traveling down inner bicep.
Staff administered the Pfizer Bivalent after it had expired. Vial had been punctured 1 day earlier. Pt had no known or reported side effects. Pt contacted by telephone to advise that he received an expired vaccine.
I was vaccinated and got the booster. 3 months later I got sick with Omicron; I was vaccinated and got the booster. 3 months later I got sick with Omicron; I was vaccinated and got the booster. 3 months later I got sick with Omicron; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "I am 65 with COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "I was vaccinated and got the booster. 3 months later I got sick with Omicron". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: i got sick with omicron, notes: 3 months later I got sick with Omicron. Clinical Information: Patient was 65 with COPD. she was vaccinated and got the booster. 3 months later she got sick with Omicron.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Acute Cholecystitis leading to Cholecystectomy on 11/9/21
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 97 went to the hospital the week of 3/15/21 for knee pain. When he came home his mental status was altered requiring readmission where he was diagnosed with kidney failure and sent home on hospice.
After receiving the Shingrix Vaccine about 6 to 7 days later I started seeing and feeling itchy hives on the right side of my neck, in cluster. it has now been one week and not getting better. I also got one hive next to my lip and one hive on my left side of neck
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a elderly female patient who received SHINGRIX. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown deltoid. The Registered Pharmacist reported that the patient was in her 70's. The patient experienced achiness. Only partial information was provided by the reporter.
My husband is having tremors. He felt bad, achey with chills yesterday, and had visible tremors. Today, he feels better, but still has the tremors. I am concerned-he's felt bad every time he's had the vaccine-but the tremors are new.
Chills.; Able to swallow water but had difficulty swallowing on my own. Lasted 90 minutes.; Tingling lips; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration in right arm on 24Feb2021 16:45 as single dose for covid-19 immunization. The patient was 69-years-old and was not pregnant at the time of vaccination. The patients medical history included inflammatory arthritis. The patient had no known allergies. The patient received unspecified medication in two weeks at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient did not undergo COVID test post vaccination. On 24Feb2021 at 16:45, the patient experienced difficulty swallowing which was approximately 15 minutes after receiving vaccine. The patient was able to swallow water but had difficulty swallowing on her own and it lasted up to 90 minutes, tingling lips which was lasted approximately 60 minutes, chills onset 30 minutes after vaccine and lasted for 60 minutes. The patient did not receive any treatment for the events. The outcome of the events was recovering.
Information has been received from a nurse concerning a patient who on an unspecified date was vaccinated with 0.5 ml injection of PNEUMOVAX 23 (lot # not reported). Subsequently the patient experienced extreme redness pain at the injection site. The patient's adverse experience improved on therapy. The patient went to the emergency room. Follow-up information has been received from a reporter who mentioned that the lot# for PNEUMOVAX 23 was 662270/1135Y. All telephone attempts to obtain follow up information have been  unsuccessful. Additional information has been requested.
Information has been received from a health professional concerning an 8 yr old female with no medical history and no allergies, who on 10Feb98 was vaccinated with a 0.5ml SC first dose in the right thigh of varicella virus vaccine live (lot 622969/0423E). There was no illness at the time of vaccination. It was reported that the pt started with scattered lesions yesterday, on 13Apr05 and was seen in the office today with 20 classic varicella lesions on her trunk and abdomen. No fever was noted. The pt's status was reported as not recovered. There were no laboratory or diagnostic test performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that on 14Apr05 the pt experienced 20 scattered classic varicella lesions on trunk and abdomen. Symptomatic relief was given and the pt was afebrile. Subsequently the pt recovered. Additional information is not expected.
July: burning sensation at bottom of feet. Aug: heels started hurting. Then legs started hurting & getting shakey. Oct: pain spread to hands. Dec: burning sensation around waist & in arms. Walking & standing difficult after few mins.
Pt had a high fever early in the afternoon. After her nap the fever dropped to about 100. After about an hour of normal activity, she slumped over in her chair and started convulsing. and stopped breathing. After mouth to mouth was given she began breathing on her own. The paramedic took her to the hospital.  05/01/2007 MR received for ER visit of 11/25/2006 for c/o fever and seizure activity x1.  Infant became stiff, turned blue and was not breathing x 30 sec. per parents. PE: (+) for rhinorrhea, pharyngeal erythema, and tonsillar exudate.  Temp in ER was 104'F rectally.  Otherwise WNL. DX: Febrile Seizure. Viral Syndrome. 05/17/2007 Vax record received.  Vax for 11/21/2006  Prevnar- Wyeth-BO8691F Hib-Aventis-UE054AA Flu-unknown. Info updated in VAERS database and submitted for scanning.
11/12/11 - Fever, pain, redness at injection site. 11/16/11 - Went to the doctor, was given an injection of antibiotic & oral AUGMENTIN & oral prednisone for infection.
Assessment: Local reaction to influenza vaccine, initial encounter. Cellulitis of left upper arm, KEFLEX 500 MG capsule. Very large local reaction to influenza vaccine given 2 days ago. Likely an inflammatory reaction, but because of size, and significant warm and inflammation, will treat for cellulitis in case there is a component of bacterial infection. No systemic signs of illness at this point. Plan: Cephalexin as written. Instructed to follow up if this is worsening, for reassessment. Worsened and pt went to ER: mupirocin, no dose recorded, clindamycin HCL 450 mg.
Vaccine administered and in the "late evening" of the same day the patient noted "bumps on her face." She states "I thought it was acne." She then got additional bumps across her forehead and neck. Pt took antihistamine and symptoms did not progress past this point.