chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HPI:  Patient is a 61-year-old male with a history of essential hypertension, hyperlipidemia, OSA on CPAP and poorly controlled type 2 diabetes for which he is noncompliant with medications.  Patient states that over the past several days he has had vague epigastric and periumbilical pain which acutely worsened on Saturday.  The pain felt like hunger pain and he has been unable to eat since.  That was associated with generalized aches and pains, chills, subjective fever and decreased oral intake.  Interestingly enough patient is fully vaccinated against COVID-19.  His wife recently tested positive recently.  He presented to the emergency room  for the above complaints.  Other than tachycardia on presentation his vital signs were stable.  His symptoms and lab findings were consistent with DKA and he was started on an insulin drip and admitted to ICU at hospital.  DKA resolved quickly with treatment.  He is COVID PCR returned positive however he had minimal respiratory symptoms.  Hemoglobin on presentation was 10.4.   Admitted to the hospital patient was treated for DKA.  DKA resolved however patient hemoglobin dropped from 10.4 on admission to 6.1 the following morning.  He was transfused 2 units packed red blood cells however hemoglobin remained at 5.7 posttransfusion.  3 additional units were given and hemoglobin improved to 10 and has remained stable since.  EGD was done by GI showing a large necrotic mass in the duodenum.  No active bleeding identified during EGD.  Patient was subsequently transferred to another Hospital for further evaluation of necrotic mass in duodenum.  He will be evaluated by general surgery. DISCHARGE DIAGNOSES:   1.  Upper GI bleed secondary to duodenal ulcers 2.  Acute anemia secondary to GI bleed 3.  Hemorrhagic/hypovolemic shock from GI bleed  4 DKA on admission, resolved 5  COVID-19 positive, asymptomatic 6.  Leukocytosis, improved 7.  Atypical chest pain, resolved     HOSPITAL COURSE:   Patient 61 y.o. male, with a history of essential hypertension, hyperlipidemia, OSA on CPAP and poorly controlled type 2 diabetes, admitted with upper GI bleed, hemoglobin on admission was 6.1, s/p total 6 units of PRBCs transfusion.  Patient underwent EGD on 1/24/2022 with 3 nonbleeding duodenal ulcers.  Hemoglobin dropped from 9.5-7.7 with maroon stools, repeat EGD on 1/26 showed no mass lesion, no obvious malignancy.  Discontinued PTA aspirin which was placed for primary prevention of CV disease.  Patient has DKA on admission, resolved during hospital stay, resumed home regimen, adjust insulin outpatient as per blood sugars.  Patient is COVID-19 was positive, no symptoms.  Patient was stable at the time of discharge, hemoglobin was 8.3, no active bleeding noted.  Plan to discharge patient on PPI twice daily to home with outpatient PT, follow-up with GI as scheduled.
Patient had swelling and redness in area of injection physician treated pt on 10/25 with cephalexin 500 twice daily for 7 days.
This spontaneous report has been received from a 100 years old female consumer with sulfur allergy. The patient was vaccinated with 1 dose ZOSTAVAX on 30-NOV-2012. No other co-suspects were reported. Concomitant medications included ASPIRIN and VESICARE. On 30-NOV-2012 the patient experienced puffiness around the injection site and redness around the injection site. Caller stated there was no rash, just red and puffy around the area towards the back of the arm. No treatment information was reported. The outcome of puffiness around the injection site and redness around the injection site is unknown. The relatedness for puffiness around the injection site and redness around the injection site was not reported for ZOSTAVAX. Additional information is not expected.
soreness, stomach problems, constipated took prune juice, milkamagnesia, next day felt,  bad chills, has not gotten out of bad, no energy, weak feeling in her legs,  3rd day hand were very hot, have no energy at night lots of chills, pain between shoulder blades, no apatite, pain in legs and still weak today.
By 6 pm 3/2/21 my arm was getting very sore, hurt to move it, was warm and had a lump. By 9pm was starting to get achy and generally not feeling well. by 10 pm I had a temp of 101. Took Ibuprofen and went to bed. Woke up at 4am temp was 101.5, had chills and could not get warm Took Tylenol. continued to have chills and achy till 3pm. Started feeling better after that was just very lethargic and arm still sore.
UNIT HAD AN EXCURSION THAT WAS NOT CAUGHT UNTIL AFTER VACCINE WAS ADMINISTERED. PATIENT WAS CALLED BY PROVIDER AND MADE AAWARE. NO TREATMENT NEEDED AT THIS TIME
Pain and swelling at injection location; Pain and swelling at injection location; Swollen lymph node on left side neck area; Tiredness/Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 12:15 (Lot number: PH8028) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Nut and shellfish allergy" (unspecified if ongoing); "Nut and shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140), administration date: 21Dec2020, when the patient was 52 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1284), administration date: 11Jan2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 28Oct2021 07:00, outcome "recovering" and all described as "Pain and swelling at injection location"; LYMPHADENOPATHY (non-serious) with onset 28Oct2021 07:00, outcome "recovering", described as "Swollen lymph node on left side neck area"; FATIGUE (non-serious) with onset 28Oct2021 07:00, outcome "recovering", described as "Tiredness/Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, lymphadenopathy, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and it was not fully known list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Joint aching next day after Moderna Covid-19 injection administration; Shortness of breath; fast heart rate twice a day that lasts 10seconds per day; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint aching next day after Moderna Covid-19 injection administration), DYSPNOEA (Shortness of breath), HEART RATE INCREASED (fast heart rate twice a day that lasts 10seconds per day), FATIGUE (Tiredness) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Apr-2021, the patient experienced ARTHRALGIA (Joint aching next day after Moderna Covid-19 injection administration), DYSPNOEA (Shortness of breath), HEART RATE INCREASED (fast heart rate twice a day that lasts 10seconds per day), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Joint aching next day after Moderna Covid-19 injection administration), DYSPNOEA (Shortness of breath), HEART RATE INCREASED (fast heart rate twice a day that lasts 10seconds per day), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown Treatment information was unknown
24JUL91 @9PM noticed "couldn't smoke right", noticed lt side face "droopy"; States has "bad tooth on lt"; "had funny feeling tongue for 2 days" a/received MMR vax; MD felt may have "Bell's Palsy";
This is a spontaneous report from a contactable consumer (patient). This 67-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via unspecified route of administration on 06Apr2021 at 10:00 am in left arm as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included metoprolol taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204), via unspecified route of administration on 16Mar2021 at 10:00 am into left arm as a single dose for COVID-19 immunization. The patient did not have any allergies. Patient did not receive any other vaccine within 4 weeks prior to the vaccine.Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 12:00 am, two days after the vaccine, patient experienced shortness of breath and extreme fatigue as well as body aches, sore arm and headaches then went to an emergency clinic, was tested for COVID, and given antibiotics for a bronchitis infection. Patient was extremely exhausted and trouble breathing for 2 months and have been out of work since the vaccine. The patient had a second COVID test as well as bloodwork, chest X-ray with resulting negative. Pulmonary dr next. Ordered pulmonary function test, nuclear lung scan and Doppler with normal result and COVID-19 test (Nasal Swab) on 09Apr2021 with negative result. Patient visited to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Two days after receiving the vaccination, experienced two seizures about 2 hours apart; This is a spontaneous report from a contactable consumer(patient). A 18-year-old male patient received the first dose of BNT162B2 (lot number: E13249), via an unspecified route of administration in right arm, on 15Feb2021 11:00 AM at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Adult Residential Facility. The patient's medical history included developmentally disabled, seizures, malaria at birth. Known allergies included Shrimp, Penicillin and Amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included aripiprazole 5 mg, aripiprazole 10 mg, escitalopram. Two days after receiving the vaccination, the patient experienced two seizures about 2 hours apart on 17Feb2021 14:00. The patient had not had a seizure in 6 months. No treatment was received for the event. The outcome of the event was recovered in Feb2021.
None - vaccine expired 1/16/08 and vaccine given 2/7/08.
Chills, 102.3 Fever, Nausea, Waves of Vertigo
Nasal congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021(at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medication, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control from an unknown date for unspecified indication and unknown if ongoing. On 02Mar2021 at 05:00, the patient experienced nasal congestion. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nasal congestion was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Within 3 days left arm began to swell and turn blotchy red with some bumpy (hive-like) areas.  Under left arm-swollen glands.
This is a spontaneous report from a contactable physician and nurse via Pfizer sales representative. This physician and nurse reported similar events for 6 patients. This is 1st of 6 reports. An approximate 16-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose (1st dose) for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash\hives following first dose of meningococcal group b rlp2086 on an unspecified date. The outcome of the events was recovered after few days. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017286372 same reporter/product/event, different patient; US-PFIZER INC-2017286373 same reporter/product/event, different patient; US-PFIZER INC-2017286375 same reporter/product/event, different patient; US-PFIZER INC-2017286374 same reporter/product/event, different patient; US-PFIZER INC-2017286371 same reporter/product/event, different patient ;US-PFIZER INC-2017286375 same reporter/product/events, different patient.
This is a spontaneous report from a contactable consumer (patient). An 89-years-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (by injection once to left arm) on 22Jan2021 COVID-19 immunization since patient was in an independent facility with 238 residents. The patient had no relevant medical history. There were no concomitant medications. She said she got her first COVID-19 Vaccine dose on a Friday. She said she had no pain in her arm after receiving the first COVID-19 Vaccine, but then on 26Jan2021 she noticed about 8 hives right at her waist line. She asked if the hives were a reaction to the COVID-19 Vaccine. She said her skin was red and puffy in 8 different places on her waistline. She said her skin on her waistline looks like what happens when being allergic to something. She said she lives in an independent living community, and the COVID-19 Vaccine was provided to the residents in a group setting. She said no COVID-19 Vaccine immunization cards were provided at the time of vaccination. Patient reported "you know when the person gets hives, you get blisters, red blisters and now they are getting worse" and asked if that was a side effect from the vaccine." She was fine for a couple days, then noticed, and she doesn't know if this is a side effect or not, the waistline, she has about 5, states "you know when a person gets hives in the skin, it is raised and red? Is that a side effect?" States she shrunk (onset date not reported). There was a doctor there she would see her week and would show her, she will be giving her a physical. Patient would try to get physical therapy there. She further stated it looks like hives, she was looking now, she has 8 hives, they were the same color, and it was also itchy. She was not given a vaccine card. She was brought into a dining room, one area aside, there was a nurse, and applications already filled out, she has no idea what her number was, but after the injection she was put in another room, and sat for 15 minutes, to make sure no reaction, and there wasn't, she had no pain in arm, she felt well, but this showed up. She has to go back in 3 weeks for second injection. No investigation assessment was performed. The outcome of shrunk was unknown and not recovered (ongoing) for the other events. Information about Batch/Lot number has been requested.
when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine; when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment medications were reported   This case was linked to MOD-2021-028589 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up information received on 29 Apr 2021 contains non-significant information - Reporter's email address added On 20-Jul-2021: Follow-up information received on 20 Jul 2021 contains no new information.
pt recv vax & over the next 3 days pt devel an inj site rxn @ the site of vax;pain in the right arm, shoulder & chest;fever of 101 to 101.6;chills;& a rash like measles on chest;
RotaTeq vaccine: 100 degree fever at approx. 8:30 AM following administration.  Gastrointestinal gurgling sounds and forced/loud gas throughout night (not normal for this child).
Top lip was numb; Sore in mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Top lip was numb) and ORAL PAIN (Sore in mouth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Top lip was numb) and ORAL PAIN (Sore in mouth). At the time of the report, HYPOAESTHESIA ORAL (Top lip was numb) and ORAL PAIN (Sore in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Redness, swelling, heat, pain, decreased range of motion, fever, chills, myalgia, fatigued, headache, nausea w/o emesis, "My hair hurts"
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 036C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19 through PCR test.) on 05-Oct-2020 and Dialysis (Dialysis three times weekly.) since an unknown date. Concurrent medical conditions included Type II diabetes mellitus (Most recent A1C (July 2021), required increase in insulin) since July 2021, Hypertension (Controlled), Depression (No current exacerbation per patient), End stage renal disease (ESRD) (Controlled- Dialysis three times weekly.) and Heart failure (Controlled).   On 24-Sep-2021 at 9:29 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2020, Polymerase chain reaction: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication reported included Insulin for Type II diabetes mellitus. No treatment information was provided.  It was reported that the patient was given 0.5 mL Moderna vaccine out of a vial that had been at room temperature since 1558 hours on 21-Oct-2021. Puncture time of vial was 1558 hours on 21-Oct-2021 with expiration time of 0358 hours in 22-Oct-2021. The dose was given from the same vial to the patient at 0830 hours on 22-Oct-2021. The patient was notified and was advised to monitor for adverse effects. The patient denied of having any side effects at the time of follow up.  The reporter stated that they already reported to agency.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow-up received contains significant information which included patient demographics, medical history and preexisting conditions, lab information, dosage information of suspect drug, concomitant medication and event description. Updated all the received information.
Vaccine administered at 0959. At 1004 observation nurse noticed patient was diaphoretic and patient stated she was feeling nauseous, light headed and felt throat pain and short of breath. At this point nurse checked vital signs. The pulse o2 sat was 78% heart rate of 85. 1005 patient vs bp 125/76 rr 22 sat 82% unable to check temp patient still diaphoretic patient stated she is able to breath now. Staff lead made aware. 1007 ems call initiated. 1008 as per patient throat pain subsided patient denies SOB. 1018 EMS on site patient and refuses any further hospital evaluation. 1020 vs 110/82 hr 74 sat 99%. 1030 As per Doctor on call, contraindication for 2nd Moderna vaccine. Patient made aware and agreed to recommedation. Teaching on further allergic reaction advised to call 911 if symptoms occur.
Watery stools hourly, along with vomiting on 7.6.13 and 7.7.13. No other family or contacts have been sick. Fussy, poor eating. Had seedy stool 7.9.13 but then had another watery stool. Appetite is improving as of 7.9.13.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: COLD TO TOUCH AND SWEATING, DIFFICULTY HEARING-Mild, Systemic: Flushed / Sweating-Medium