chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Helicobacter pylori; felt that he pushed the needle too far into her arm almost like it hit bone.; diarrhea; Tiredness; worse not better; This spontaneous case was reported by a nurse and describes the occurrence of HELICOBACTER INFECTION (Helicobacter pylori) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) for Diarrhea.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (Tiredness) and CONDITION AGGRAVATED (worse not better). On an unknown date, the patient experienced HELICOBACTER INFECTION (Helicobacter pylori) (seriousness criterion medically significant) and VACCINATION SITE REACTION (felt that he pushed the needle too far into her arm almost like it hit bone.). At the time of the report, HELICOBACTER INFECTION (Helicobacter pylori), VACCINATION SITE REACTION (felt that he pushed the needle too far into her arm almost like it hit bone.), DIARRHOEA (diarrhea), ASTHENIA (Tiredness) and CONDITION AGGRAVATED (worse not better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Helicobacter test: negative (Negative) testing negative for H Pylori.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant Medication provided was Immodium. Treatment medication not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time.   This case was linked to MOD-2021-264344 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time
it was painful; rash itching; pain and rash attacked my breasts/rash went to the stomach; Had mine a year ago, In January 2021ust need to get the second and finally shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female 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.   In JAN-2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain (Verbatim: it was painful), itchy rash (Verbatim: rash itching), rash (Verbatim: pain and rash attacked my breasts/rash went to the stomach) and incomplete course of vaccination (Verbatim: Had mine a year ago, In January 2021ust need to get the second and finally shot). The outcome of the pain, itchy rash and rash were not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain, itchy rash and rash to be related to Shingles vaccine.   It was unknown if the company considered the pain, itchy rash and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles vaccine a year ago in January 2021. The patient had the first shingles shot already, when she first knew she was getting the shingles. The reporter stated that it was painful, rash itching and the pain and rash attacked her breasts so she could not and would not put on any bra period only a lite top to cover her top torso and the rash went to the stomach as well it about drove him/her nuts. The patient just need to get the second shingles shot and finally shot and hope to do that soon. Till the time of reporting, the patent did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Bell's Palsy occured on 4 days post injection Patient had no history of Bell's palsy
Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     It was reported that patient had no allergies, had not received any dermal filters, did not have a history of myocarditis or pericarditis, blood clots, heparin induced thrombocytopenia or multisystem inflammatory syndrome after a COVID-19 infection and patient was not immunocompromised.  Concurrent medical conditions included Haemorrhagic disorder (on long-term aspirin therapy or took other blood thinners).    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the dose was administered 12 hours post puncture. The vial was first punctured on 15-Jun-2022 at 9.15 AM and was stored in portable refrigerator post puncture. Vial underwent a temperature excursion of plus 1.9C to plus 6.4 C for 15 mins. Vial was stored in the refrigerator at the time of the excursion. Vial was moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022. The vial was thawed. Proposed desired use by date was 15-Jun-2022 afternoon. It was confirmed that patient was not sick or did not have fever at the time of reporting.  No treatment medications were reported.
Woke up in the middle of the night with swollen lymph nodes, one week after first injection. Can't put arms down, breasts feel swollen as well. Starting to loose sense of taste.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 29th August 2020). On 14th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on left arm. The patient experienced extreme fatigue ever since. The healthcare professional stated that fatigue was so extreme that patient had been woke up in the morning. The patient had checked with her cardiologist and had a catheterization which was clear. The healthcare professional was not sure if it was due to SHINGRIX.
This spontaneous report as received from a medical assistant refers to a currently 30 year old female patient with drug reaction or allergy to codeine. There was no concomitant medication. On an unknown date, in the patient's childhood, she was probably vaccinated with a dose of M-M-R II (dose, lot number and route not reported). It was reported that a patient, who probably had M-M-R II vaccines in childhood, recently came to the office and reported that she had labs drawn for her job (date unspecified) and her MMR titers came back negative. As treatment, on 25-FEB-2014 the patient was vaccinated with a dose of M-M-R II (dose, lot number and route not reported). At the time of the report, the patient's outcome was unknown. Relatedness between the therapy and the event was not reported. Additional information has been requested.
Bell's palsy; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for an unknown indication.     Concomitant products included SILDENAFIL CITRATE (VIAGRA) for an unknown indication.  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did not feel right so she came back to the clinic. Pt reported some numbness & tingling in her arms & hands, nausea, increased anxiety, & shaking.  1mL dexamethasone 4mg/mL given IM to right buttock.  Pt placed on 2LPM 02 via NC for comfort. Pt tolerated well.
The night of the vaccine I had severe chills, I had to a lot of different things to try and warm up. The next day, May 8, 2022 I had a fever of 101.8F. I slept the day away and had the sweets all night. By the evening of May 9, 2022, I felt better and my temperature had returned to normal.
This spontaneous report as received from a pharmacist refers to a 74 year old female patient. No concurrent conditions, medical history and concomitant medications were reported. The excursion occurred on 26-SEP-2016 and the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes and a maximum temperature of 6.2 F for 20 minutes. On 27-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
5 days after receiving his COVID vaccination the patient had a spontaneous (nontraumatic) subarachnoid hemorrhage which was fatal. The patient had previously been stable on his coumadin dosing with therapeutic INRs for the past several months per his wife. At time of presentation his blood pressure in the ER was elevated to 223/94 and his INR was risen to 3.1
fever, severe h/a, vomiting w/in hr of vax & immune globulin;
Gave vaccine @ 1430 2/23/10, that evening she started chilling. She now has chills, achy muscles, sore throat, diaphoretic, dizzy. No site swelling. Within 24 hours they symptoms subsided. After this was sent she called us on 2/25 stating lymph nodes still swollen, but fever is gone.
Ever since vaccination, and starting within next day or two (for over 3 months now, and  every day,) I seem to have PHN  (according to the CDC info,) a numb, tingly feeling,  but without a rash, on the left side of my head, neck and upper trapezius.   Nothing on the right side.   Each attack lasts a couple of minutes, and there are several each day, during any activity, except for driving.   I have not been awakened by it.    For that reason, I was reluctant to have my booster shot yesterday (7/8/21.)    My arm hurts a little and I was very tired last night, but aside from that, nothing new.
Missed second dose (46 days since first one); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)). On 07-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)) had resolved.            No concomitant medication was reported by the reporter. No treatment medications were reported by the reporter.
The day of was very sleepy, I know that is normal. The next day she was screaming and crying inconsolably and arching back in pain all day and night. She never normally cries. Also had diarrhea all day and night. Normally poops 1-2 times a day.
Pt given HIB #4; PREVNAR #4; Hepatitis A #1; MMR #1; Varicella #1 and Influenza #1 on 11-17-08. Pt presented one week later "barely breathing"; flacid and unresponsive to verbal-painful stimuli at 1755-transferred-died at local hospital a couple of hours later.  2/12/09 PCP and hospital records received from FDA.  Pt with mild fever 11/24/08 put down to nap. Ptfound  to be diaphoretic, limp, minimally breathing and non-interactive in crib. Upon arrival of EMS pt noted to be unresponsive to stim, satring with no blink response, pulse 160, RR 32 with rhonchi bilaterally R>L.  Dx with severe croup at local hospital with transport planned to higher level of care. In ER unresponsive in severe respiratory distress, skin mottled, O2 sats 80s-90s on pale toes. Arrived to transfer hospital unresposive to pain, lethargic, initially flaccid then posturing, (+) cervical lymphadenopathy, resp distress with stridor and rhonchi- intubated. Impression-  Respiratory Failure. Cardiac arrest.  CPR unsuccesful.    3/25/09 Autopsy report received with COD: Community Acquired Pneumonia. Manner of Death:  natural.  Final DX: 1) Acute hemorrhage pneumonia, multifocal, community acquired- a) Diffusely firm, edematous and hemorrhagic lungs, bilaterally. b) Histologic exam confirms purulent multifocal pneumonia.   2)  Moderate Cerebral Edema.  3)  Serous Pleural and Peritoneal Effusions.
AFTER VACCINE I FELT VERY LETHARGIC AND WAS NOT WELL FOR WEEKS. AROUND THE 10TH FELT SOMETHING ON SIDE. WENT INTO WORK AND WAS SEEN BY NURSE WHO SAW THE SHINGLES AND BLISTERS AND WAS TOLD TO GO TO THE CLINIC RIGHT AWAY. AT CLINIC I RECEIVED MEDICATION FOR ANTIVIRAL TO STOP THE SPREAD. TOOK PILL FOR 10 DAYS AT 3 A DAY.
Administered expired Moderna Covid-19 vaccine to several patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on approximately 16Dec2021 and the vial did not undergo any temperature excursions. No treatment medications was reported.
Narrative:  The patient received one dose of Janssen COVID 19 vaccine on 6 Jan 2022 and tested positive for COVID 19 on 8 Jan 2022. The patient presented to the ED with shortness of breath and severe pain right thoracic paraspinal region radiating to the right shoulder. Patient had elevated troponin. The patient was admitted to the hospital on 8 Jan 2022 with acute hypoxic respiratory failure, right pleural effusion. The patient was treated with oxygen, remdesivir, and dexamethasone and monitored on telemetry. The patient was discharged on 28 Jan 2022 in stable condition.
NURSE DIDN'T RECONSTITUTE PFIZER VIAL AND 0.3ML OF CONCENTRATED SOLUTION WAS GIVEN TO THE PATIENT.  FACILITY HAS FOLLOWED THE RESIDENT-ONE DAY THE PATIENT DIDN'T FEEL WELL BUT OTHER WISE THE PATIENT HAS BEEN FINE.  NO FURTHER MEDICAL CARE HAS BEEN NEEDED
Pt. developed isolated, singular aphthous ulcer in rt. posterior of mouth.  Atending M.D. says pt has a hx of occurrence of this type ulcer.  Pt. examined by ID doc.  summary opinion:  Ulcer un related to vacination.
Pt experienced numbness, neuralgia, paresthesia along C5-7 dermatome, left arm local reaction for 1 week.
pt states the next day 23MAR96 arm sore;swelling @ site larger than fifty cents piece very red-turned purplish
This spontaneous report was received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent condition, medical history and concomitant medications were not provided. On 12-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K010797, expiry 04-FEB-2016). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & c/o itching all over;inj site pink no other rash given epi & transferred to hosp via amb;
Suspected vaccination failure; both shingles vaccines and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: both shingles vaccines and still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 31-JUL-2023 The case was received from the patient interactive digital media. The patient had both shingles vaccines and still got it and it was awful. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 24-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received expired FLUMIST on 01-Dec-2011. The patient received a repeat dose. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
After a week, red raised spot near injection site, slightly itchy.  Skin felt funny there too. Slightly hard spot.
Presented to ED With complaints of abdominal pain for Several days duration. He denied any hemoptysis, hematemesis or hematochezia thus presented to the ED for further evaluation.  When he arrived to the ED a CT scan of the abdomen obtained was concerning for acute ruptured appendicitis. General surgery was consulted with plans for surgical Intervention. He received IV Zosyn therapy and admitted under hospitalist service for further management.  While in hospital, patient tested positive for Covid 19 and expired on 8/24/2021.
cough, sinus hurts - still have Headache - 48 hrs body ache - 48 hrs chills - 36 hrs
Mom called stating the child received immunizations and that night woke up at 1:30 am crying  and has not stopped. When asked stated warm, but was unaware of temp. Stated very warm last night. Pt is receiving Tylenol.
headache; sinus pressure; This is a spontaneous report from a contactable consumer or other non health-care professional. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution For Injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient states she took one Advil before first dose. Looking for quantitative efficacy information. The patient experienced headache, sinus pressure on an unspecified date following first dose. Outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient throat swelling/closing few minutes after received JJ vaccine. Epi administered and patient taken to ER downstairs
Information has been received from a licensed Practical Nurse (L.P.N.) concerning a 54 year old female patient with diabetes mellitus and allergies to amitriptyline, antihistamine, codeine, iodine, promethazine and spironolactone. On 17SEP2012 the patient was vaccinated with 0.5 ml of PNEUMOVAX 23, intramuscularly (lot # 672370/1851AA; exp date 05AUG2013). Concomitant medications included sitagliptin phosphate (+) metformin hydrochloride (MSD), metoprolol albuterol, CELEXA and omega-3 marine triglycerides. The L.P.N. reported that the patient called the office after developing redness, soreness and warmth at the injection site on 17SEP2012 after receiving a dose of PNEUMOVAX 23. It was reported that the patient sought medical attention. She was treated with ice, TYLENOL and BENADRYL. At the time of the report the patient's outcome was recovering. Additional information is not expected. This is one of three reports from the same source.