chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 77 year old male with a PMH of COPD (3L at home) dementia, urinary retention, neurogenic bowel disorder, and depression that presented to the ED on 10/9/21 with complaints of generalized weakness and altered mental status. Patient also endorsed urinary frequency/urgency, abdominal pain, intense headache, chills, and temperature increase from 96.7-99.7. When in the ED patient's temperature was 99.4. Labs were remarkable for:Total bilirubin of 1.3 (0.5 direct), sodium 129, chloride 96, bicarb 19, WBC 19.0 with left shift. CXR showed multifocal airway disease.  UA was not significant for signs of infection. While in the ED patient was started on vancomycin and cefepime. Urine culture was negative. Blood culture was 1/2 gram + bacilli in clusters, coagulase negative. Patient was placed on Azithromycin and Vancomycin was discontinued. CT Abdomen and Pelvis showed no acute process. KUB showed showed no bowel obstruction. Pulmonology was consulted for the patient's pneumonia and recommended 2D echo and follow up. Psychiatry was consulted for the patient's depression and recommended outpatient follow up. Neurology was consulted and recommended the patient remain on Risperdal given depression history and follow up. PMR evaluated the patient and parkinsonism likely secondary to drug reaction, recommended the patient for IPR. Patient's insurance denied IPR after initial application, where his wife appealed and the patient was later accepted. Patient was transferred on 10/14/20.   Within the last 48 hours, patient demonstrated increased O2 needs, with new onset inspiratory wheezing, minimally alleviated with breathing treatments. Last night, patient demonstrating acute hypoxic respiratory failure, where he was on his baseline 4L NC, with SpO2 in low 80s. Patient was then transition to HHF, FiO2 65% with SpO2 92%. CXR reviewed on 10/25 with minimal improvement. EKG shows new onset Afib. Patient was then found to be COVID+ -- where he was transferred out of IPR to PCU. Night team spoke with family where patient's status was changed to NO CODE.   Patient examined this AM. Patient is much more alert and conscious in comparison to yesterday. Wife at bedside. Admits to improvement with SOB when transitioned. Denies any current CP, palpitations, N/V/D.
Patient passed out in store was attended to by store manager and was taken by ambulance to the hospital.
Dermatomyositis - Dx'd 2/2008.  1st Dx'd by rash on knuckles found during DERM visit for acne on 2/7/08.  Pt & mother stated rash had been present for few months.  Rx'd with PLAQUENIL.
vaccine was not diluted; received his first dose of the Pfizer BioNTech Covid 19 vaccine today 30Jul2021 but the vaccine was undiluted; This is a spontaneous report from a contactable nurse. This Nurse reported for a 58-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, via an unspecified route of administration, administered in Deltoid Right on 30Jul2021 (Batch/Lot Number: FA6780; Expiration Date: 26Aug2021) as dose 1, 0.3 ml single (at the age of 58) for COVID-19 immunization. The patient no medical history and no concomitant medications. The patient had no prior vaccination. The administered vaccine was undiluted. Vaccination facility type was workplace clinic. The outcome was unknown.  Amendment: This follow up is being submitted in order to update the narrative  Follow-up (23Aug2021): New information reported from a contactable nurse includes: medical history and vaccination details.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 90 year old female patient. There was no pertinent medical history provided. The patient was allergic to penicillin (unspecified), sulfa and gabapentin. Concomitant therapies included pravastatin, imipramine and omeprazole (manufacturer unknown). On 11-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (route subcutaneous, lot # K020185, expiration date 27-JAN-2016, dose not reported). In an approximately February 2015 (reported as since receipt of ZOSTAVAX), the patient has been recently written prescriptions for FLUTICASONE, the "Z-PAK" and methylprednisone. The reporter noted that the medications might be possibly treatment for a sinus infection. On an unknown date, the patient sought for medical attention. There was no lab diagnostics and studies reported. The patient's outcome was not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Dry mouth at night; cramping in her stomach; IBS maybe actin up; pain at the injection site; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth at night), ABDOMINAL PAIN UPPER (cramping in her stomach), IRRITABLE BOWEL SYNDROME (IBS maybe actin up), VACCINATION SITE PAIN (pain at the injection site) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Feb-2021, the patient experienced DRY MOUTH (Dry mouth at night), ABDOMINAL PAIN UPPER (cramping in her stomach), IRRITABLE BOWEL SYNDROME (IBS maybe actin up), VACCINATION SITE PAIN (pain at the injection site) and NAUSEA (nausea).   At the time of the report, DRY MOUTH (Dry mouth at night), ABDOMINAL PAIN UPPER (cramping in her stomach), IRRITABLE BOWEL SYNDROME (IBS maybe actin up), VACCINATION SITE PAIN (pain at the injection site) and NAUSEA (nausea) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Very sore armpit/swollen lymphnodes. Raised bumps and redness and itchiness all around injection site. All started on 1/24, 6 days after receiving dose 1.
At age 56, I sufferred from shingles. The pain began like lower back pain with a tingling or heat sensation. several weeks later, my doctor suggested that I receive the Zostavax vaccine. My insurance carrier refused to cover the $230 charge. If your recommendation for the vaccine for people under 60 included people younger tha 60 who have had shingles, my carrier would have paid.
Felt cold, head "oozy", nauseated, not tracking well, BP 193/90. She had been working outside in garden before this happened 83 degrees F 100% humidity.
p/vax pt exp severe stomach cramps; diarrhea, slowed p/9days; diarrhea continued;also exp h/a, flu like sx, sore arm;
-patient contracted VARICELLA -patient had body rash diagnosed as VARICELLA 3/5/10 after receiving VARICELLA vaccination.
Headache, fever, shivering, nausea, epigastric pain; symptomatic treatment with Motrin and Pepto-Bismol; all symptoms resolved within 24 hours of onset
resident unresponsive verbally and favoring L side with R side flaccid unable to take AM med. The writer obtained BS 90. The resident has R side face drop with drooling noted. The resident responded to painful stimuli only. Pupils dilated. Supervisor at bedside BS 102 rechecked. The family opted for comfort measures only.  Age 68   On 2/15/2021 Z51.5: ENCOUNTER FOR PALLIATIVE CARE,   Patient expired 2/23/2021
6JAN94 mom states t102, gave APAP as instructed q 4 hrs; 7JAN94 mom states t104, c/o  abdo pains, was pale & lifeless; taken to ER where temp was reduced; MD stated probable react to immun;
Each time I get my covid shot I get incredibly thirsty. my face turns flush, and my heart beat goes up.  This happens about 5 minutes after the shot. The heart rate lasts about 15 min and then goes down. The flush face lasts about an hour to 2 hours and then goes away. This has happened for all of my covid shots. All 3 were with Moderna at different locations.
c/o pain and difficulty of movement in fingers, hands, knees, ankles, and hips. Edema to the hands and fingers.
Administered Monovalent Pfizer Covid vaccine instead of Bivalent Date looked to be expired. Upon calling Pfizer to report and collect information,, discovered, it does not expire until 11/30/22
The day after receiving the Covid vaccine, I began having shortness of breath.  I had no fever. my blood pressure stayed normal, however, my pulse was elevated and my heartbeat accelerated whenever I exerted myself. This continued from Wednesday to Saturday when I began to feel somewhat better.
severe site pain middle of night; continued site pain and hives in armpit beneath it 48 hours later
BY MISTAKE INVOLUNTARY THE SECOND BOOSTER OF PFIZER VACCINE WAS GIVEN TO THE 15 YEAR OLD BOY. NEITHER HIS MOM WAS AWARE HER SON WAS NOT UNDER THE AUTHORIZED AGE. WHEN I REALIZE THE MISTAKE, I CAME BACK TO THE PAPERS AND DOCUMENTS OF THE PATIENT AND EVENTUALLY I CONFIRMED I DID A MISTAKE BY ACCIDENT. IMMEDIATELY I WENT TO LOOK UP IN THE CDC INFORMATION AND CALLED HIS MOM TO APOLOGIZE AND TELL HER TO KEEP HIM UNDER OBSERVATION AND THAT I WOULD BE MONITORING HIM FOR THE NEXT FEW DAYS.
Arm started to hurt and red bands about an inch wide and 3 to 4 inches long lead away from the injection site.  The pain was along the red bands.  They were bright cherry red and the pain was fairly intense for 2 days.  There is no pain now, but the bands of red are still slightly visible.
Narrative: 81 YO M reported pruritic facial flushing and rash throughout trunk, arms, legs, and back after receiving his 3rd COVID-19 ("booster") vaccination. Patient denied dizziness, chest pain, and fever. Patient started next morning after getting the vaccine. Confirmed with patient that there is no new detergent, soap, shampoo that he used. Denied any change in routing that would have put him at risk for exposure to other potential causes for rash (such as poison ivy). Patient was treated at ED with prednisone and diphenhydramine. Of note, patient tried loratadine and OTC hydrocortisone cream prior to seeking further attention at local ED. Patient reports rash cleared up ~ 12 days after starting prednisone and diphenhydramine treatments.
Pt. received vaccine from outside facility. Pt. reports the day after receiving vaccine to ER triage c/o of body aches, upset stomach, and headache. Pt was tachycardic and hypertensive upon arrival. Pt. left clinic at this visit. Pt followed up with PCP for a routine visit ~1.5 months later. Pt denies any symptoms except occasional body aches.
Shoulder pain/ Joint pain; Body ache; Stomach upset; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PF12ERER8729) via an unspecified route of administration in the right arm on 05Apr2021 at 08:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included clinical hyperthyroidism and allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included herbal teas (MANUFACTURER UNKNOWN) and multi vitamin (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: BFEBNTEP6955) via an unspecified route of administration in the right arm on 18Mar2021 at 08:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced shoulder pain, body ache, joint pain and stomach upset. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shoulder pain/ joint pain, body ache and stomach upset was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
No adverse event; Received a regular Moderna COVID19 vaccine instead of receiving a second booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a regular Moderna COVID19 vaccine instead of receiving a second booster) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013b22a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID19 vaccine (Dose 1) and Pfizer COVID19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer COVID19 vaccine and Pfizer COVID19 vaccine.    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received a regular Moderna COVID19 vaccine instead of receiving a second booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a regular Moderna COVID19 vaccine instead of receiving a second booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a regular Moderna COVID19 vaccine instead of receiving a second booster).    No concomitant medication were reported.  Patient's first booster was from Moderna. Patient received a regular Moderna COVID19 vaccine instead of receiving a second booster.   No treatment information was provided by the reporter.
This spontaneous report as received from a registered nurse refers to a 12 months old female patient. Medical history and current conditions were not reported. On 01-MAY-2014, the patient was vaccinated with a dose of VARIVAX (Merck), lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
This is an instance of breakthrough COVID-19 disease after which death occurred, also administration error in interval between doses.   The individual was vaccinated with the Pfizer product on 05/12/2021 and 08/24/2021. Please note the sub-optimal time interval between doses.   The individual became symptomatic for COVID-19 disease on 01/31/2022. The individual was on a trip out of state at the time. The individual was admitted to hospital due to vomiting, thought to be associated with poor control of blood sugar; the individual had Type I Diabetes. The individual died on 02/06/2022.
Erythematous lesion to forearm lasting at least 10 weeks from date of dose 1 (10/3/2022)
Woke up with chills, fever, aching all over, soar throat   fever and chills come a go
Small knot at injection site.  No redness, swelling noted by mother.  Possibility it is from the HIB injection.  Child gets very tense at time of immunizations.
w/in a few hr of vax pt broke out in a raised, red, papular rash which extended over entire body & lasted 4wk;pt was examined by 2 MD who confirmed that this was not varicella or poison ivy;neither MD could dx cause;
about 36hr p/vax pt exp itching of feet & lower legs;subsided spontaneously @ around 2AM on 17OCT97 10PM again exp itching of feet & ankles then noticed hives on feet, ankles & back;phone ER instructed to take DPH;
gave three doses from one expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave three doses from one expired vial) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and UNK) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), ALBUTEROL [SALBUTAMOL], ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, SUCRALFATE (CARAFATE), BUPROPION HYDROCHLORIDE (WELLBUTRIN), CLOPIDOGREL BISULFATE (PLAVIX), DICLOFENAC (VOLTAREN [DICLOFENAC]), FAMOTIDINE (PEPCID [FAMOTIDINE]), HYDROXYZINE, ISOSORBIDE MONONITRATE (IMDUR), METOPROLOL, GLYCERYL TRINITRATE (NITROGLYCERIN), SCOPOLAMINE [HYOSCINE] and SIMETICONE (SIMETHICONE) for an unknown indication.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-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 experienced EXPIRED PRODUCT ADMINISTERED (gave three doses from one expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave three doses from one expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided  The nurse stated the patient did not mention having any adverse events from either dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-124470, US-MODERNATX, INC.-MOD-2021-124502 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-124470:Crosslinked with other patients US-MODERNATX, INC.-MOD-2021-124502:Crosslinked with other patients
puse rate was elevated, had large rash on arm at shot site,chills, and weakness
pt recvd vax;soreness,redness at inject site;redness & soreness inc,knot approx size of quarter;site warm & very tender to touch; feels like a tooth ache all the way to the bone;hurts to raise arm;took ASA;site warm;to use cool packs & dph
Shortness of breath,.  Patient, with history of allergies and asthma, said ""my PCP approved me receiving the Pfizer vaccine and I took 2 Benadryl per advise at 7:30 A.M. (Pfizer vaccine administered around 8:47)  9:13 AM Patient reported feeling some shortness of breath and chest tightness and  took 2 puffs of her Albuterol inhaler. Pulse ox- 99%, Pulse-99, BP 128/74 Lungs clear.  9:20 reports ""SOB and chest tightness ""dissipating, but feels jittery.""  She reports that she has been having to use her Albuterol inhaler more frequently during the past 2 weeks due to seasonal allergies. Observed, symptoms improved 9:42 discharged in stable condition and advised to speak with her MD prior to 2nd vaccine.
I received my first shot of Pfizer on 4/7/2021 in my left arm. About 1 week after getting the vaccine - on 4/14/2021 I noticed a sore in my buttocks- left side. The next day I had another sore appear on my left butt cheek. It started to spread on 4/16/2021-4/18/2021-top of my butt crack-left side & on my inner front thigh-left leg. On 4/19/2021 I went to my doctor and she diagnosed me with Shingles. The doctor prescribed Valacyclovir, which I am currently taking for 7 days. I am supposed to get my 2nd shot on 4/28/2021, however I think I should wait until the Shingles clear/ finish meds. I would like advise on that. How long I should wait / if I should even get the 2nd dose?
Patient stated that he had some pain in the back of his head and upper neck. After 20 minutes patient still reported to have some pain. He left the pharmacy after 30 minutes.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 6 days post expiry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A and 011J20A) for COVID-19  immunization. No medical history reported. On Dec 29, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient administered expired product (vaccine given 6 days post expiry). On Nov 12, 2021, administered expired product (vaccine given 6 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-395985 (patient link).
Patient was asymptomatic, but tested positive prior to admission to rehab facility. Came to hospital originally for chest pain and admitted with NSTEMI.
have had both shots / still break out chronically/suspected vaccination failure; have had both shots / still break out chronically; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shigles vaccine (received original vaccine years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had both shots and the original vaccine years ago and still break out chronically and severely.  It had nothing to do with the vaccine, it's the pervasive nature of the virus. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
extreme vertigo; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and VERTIGO (extreme vertigo) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021M20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, RALOXIFENE and LOSARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VERTIGO (Vertigo). On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (extreme vertigo). The patient was treated with DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) (oral) on 23-Feb-2021 for Sleep loss, at a dose of 1 dosage form. On 19-Feb-2021, VERTIGO (Vertigo) had resolved. On 24-Feb-2021, VERTIGO (extreme vertigo) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was  not applicable   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient details updated, Suspect Product Dose number , Drug Start Date ,Con meds updated, event was added.