chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SOB; High fever (103.9-104); Sweating; Chills; Body aches; Not feeling well; This is a spontaneous report received from a contactable consumer (patient). This is the second of two reports for the same patient with reoccurring events separated in time.  A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular route administered in the right arm (reported as R deltoid) on 07Jan2021 at the age of 55-years old (Batch/Lot Number: EK9231) as a single dose for COVID-19 immunization at a hospital. Medical history included COVID-19 from Jul2020 to an unknown date (the patient was not admitted to the hospital due COVID-19, treatment included an inhaler and the patient was still experiencing the event), headache from Jul2020 to an unknown date, chills from Jul2020 to an unknown date, not feeling well from Jul2020 to an unknown date. The patient previously received the first dose of BNT162B2 via intramuscular route administered in the right arm (reported as R deltoid) on 17Dec2020 at the age of 55 years-old, (Batch/Lot Number: EK5730) as a single dose for COVID-19 immunisation. After the first dose of BNT162B2, the patient experienced chills, body aches, fever, shortness of breath, tired, headache, at 03.00 am and Not feeling well, lymph node swollen under right arm with severe pain along with injection site pain. The patient did not have any other vaccination within 4 weeks prior to getting the BNT162B2. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication from 2008 and ongoing; estradiol (Manufacturer unknown) taken for an unspecified indication from 2008 and ongoing; hydrochlorothiazide (Manufacturer unknown) taken for an unspecified indication from 2008 and ongoing. On 07Jan2021 at 22:30, after the second dose of BNT162B2, the patient experienced chills, body ache, high fever (103 degree celsius-104), shortness of breath, not feeling well and sweating. The patient continues to have shortness of breath with any activity. The events did not require emergency room or physician office visit. The patient was not hospitalized. Treatment included antipyretic Tylenol/Ibuprofen Oral (PO) 500mg/800mg after the vaccination for fever, an inhaler for shortness of breath. The outcome of chills, high fever was recovered. The outcome of shortness of breath and not feeling well was not recovered. The outcome of body aches, sweating was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020503298 same patient, drug/ different dose, event
Bell's Palsy; This is a spontaneous report from a contactable Consumer.  This 66-year-old female consumer reported that received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), via an unspecified route of administration on 12Feb2021 (at the age of 67-year-old) at 05:45 PM in the left arm at single dose for COVID-19 immunization. She had received the first dose of BNT162B2 on 22Jan2021, at 06:00 PM in the left arm. The patient had no history of allergies to medications, food, or other products. Medical history included Thyroid, Panic Disorder, Mild Depression. Concomitant medications included levothyroxine, simvastatin, trazodone, clonazepam. The patient reported that early in the day, on 12Feb2021, before receiving her second dose, she began to feel something odd going on with her mouth. She couldn't really identify it, but she felt like something wasn't quite the same. It was very mild, so she brushed it off. She had her second vaccine dose, on 12Feb2021 at 5 pm. By about 7 pm that night, she was rushed to the University Name Emergency room and was diagnosed with Bell's Palsy. She was treated with Prednisone 10MG X3, valACYclovir 1g X3, polyviny. At the time of reporting the patient had not recovered.
gave expired dose to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AB, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that a nurse gave an expired dose of Bexsero to a patient, which led to expired vaccine used. The reporter consented to follow up.
Narrative: 85yo male patient with CURRENT PROBLEM LIST: Diabetes mellitus without complication Gastroesophageal reflux disease Postsurgical Aortocoronary Bypass Status Hyperlipidemia Hypertension (SCT 38341003) Hypertrophy (Benign) of Prostate TOBACCO USE DISORDER Coronary artery disease IRRITABLE BOWEL SYNDROME Died on 11/21/21 location & cause of death unknown. Pt had received covid vaccines at outside facility provider on 1/13/21 & 2/10/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Fetus stopped growing at 6 weeks, 3 days. I found out on 11/14 at 9 weeks, 5 days. Natural miscarriage began on 11/25/09.11/30/09 Medical records received. OB/GYN notes.  DOS range 11/3-11/30 Primigravida. LMP 9/9/09. EDD 6/15/10.  Beta HCG decreased. Prob early SAB. U/S notes not likely to be a viable pregnancy.
Patient received Havrix 1440/ml as dose 1 for hepatitis A series and not the Havrix 720/0.5ml. Patient did not have any reported adverse events, no treatments occurred as a result.
Initial information was received from other healthcare professional on 14 January 2014. This patient of unknown age and gender whose medical history and concomitant medication was not reported had received PENTACEL (dose, route, form and anatomical site of administration not reported) of incorrect reconstitution. The hib portion with sterile water was reconstituted and have not given the dtap/ipv. Hib portion was not counted as valid. It was advised to administer a PENTACEL.
Pt received vaccine beyond recommendation age parameters. No s/s of adverse reaction noted. Error noted upon completion of quarterly vaccine report
G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 3/17/2022 ADENOMA, LEFT ADRENAL GLAND G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 3/17/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 3/17/2022 URINARY RETENTION G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 3/17/2022 ANEMIA G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 3/17/2022 URETERAL OBSTRUCTION
Patient experienced shortness of breath and chest pain resulting in a visit to the ER (02/07/2021) where doctors found multiple blood clots in lungs as well as decreased heart function due to stress on cardiac system. Patient was hospitalized for 3 days and had to have an INR procedure to remove the blood clots (Patient is now on blood thinner and diagnosed with Antiphospholipid Syndrome after event.)
suspected vaccination failure; shingles; 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.   The patient's past medical history included shingles (twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Patient was administered 0.5ml of booster dose in stead 0.25. No adverse reaction reported.none
5/14/11 intussusception ileocolic. 5/16/11 recurrent intussusception.
TINGLING SENSATION TO FACE, PALAPTAIONS, AND SHAKINESS WHICH STARTED SHORTLY AFTER RECEIVINGA DOSE OF MODERNA.  CASE WENT TO HOSPITAL EMERGENCY DEPARTMENT AND WAS TREATED WITH BENADRYL FOR AN ALLERGIC REACTION/DISPOSITION.   SYMPTOMS RESOLVED WITH MEDICATION AFTER A COUPLE HOURS CASE REPORTS.
Erythema and indurated area on left inner thigh 4cm X 6cm; started this AM.
The pt experienced a fever, emesis, irritability and leukocytosis. Diagnosed with possible reaction to vaccine
I experience 5 days of debilitating tachycardia and low blood pressure and fatigue with the first shot.  The same happened with the second shot but it lasted for weeks.
rash on his face and scalp; This case was reported by a nurse via sales rep and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, immediately after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Shortly after vaccination in late September 2019, and since then the patient had experienced a rash on his face and scalp which comes and goes. The patient was due for the second dose of Shingrix but the reporter was unsure if they should give that vaccine to the patient. The reporter was not sure if the rash came from Shingrix. The reporter consented to follow up.
Nausea/vomiting, muscle aches esp on left arm shoulder and left side of neck. Fever-101.2 (reported), shaking (mild hand tremor) and cold sweats- Hives (reported)
Patient had gotten her second covid vaccine this morning at 10:30. Around noon today she felt that her throat was closing but was able to eat and drink fine and without difficulties. Patient noticed about 1655 that the roof of her mouth is numb. Patient then started noticing numbness going to the left side of her face on her way home and came to the ER. She noticed the numbness to the left cheek and jaw bone. She denies numbness to her upper forehead, nose or jaw line.
Client told her family member that she was dizzy while ambulating to the EMT observation area. Staff overheard and alerted EMT  that the client reported dizziness. The client ambulated to the anti-gravity chair and sat down. The following was obtained with assistance of translator. Vitals obtained at 1:07 PM were as follows: BP 138/88, O2 95, HR 85 BPM. The client also reported chest pain. The client subsequently stated the chest pain was improving. Vitals obtained at 1:16PM were as follows: BP 130/86, HR 72 BPM, O2 98%. The client reported itching in her throat but no inflammation. Client reported a history of anaphylactic reaction to penicillin. The client stated her current symptoms felt similar to her reaction to Penicillin, but not as severe. The client also reported itching. The client reported that she developed itchiness in her throat after receiving the 1st COVID vaccine Pfizer that lasted about 3 days. Recommended administration of Diphenhydramine IM. The client denied any previous allergy to Diphenhydramine and provided verbal consent to receive Diphenhydramine IM. Noted flushing of the client's face. Administered Diphenhydramine 50mg Lot# 020020 Exp: 02/2022 IM into the right deltoid muscle at 1:23PM. The client then reported feeling throat obstruction, dizziness, and tingling in her hands bilaterally. EMS was activated at 1:24PM . The client reported dizziness. Vitals obtained at 1:26PM were as follows: BP 146/96, O2 96%, HR 82 BPM, and RR 22. The client reported difficulty taking a deep breath. Noted no use of accessory muscles, no visible swelling, no pallor, or flushing. The client reported chest pain and shortness of breath at 1:29PM. EMS assumed care at 1:33PM. Client signed AMA form and refused transport from Fire Department at 1:37PM. The client ambulated unassisted with a steady gait at 1:39PM.
Whole body myalgias from day one to day four post vaccine Migraine from day two to day four post vaccine  Fatigue from day one to day five post vaccine Sweats and low grade fever from day zero to day two post vaccine Spreading , tender lymphadenothy from day one onwards post vaccine; started with suboccipital lymphadenopathy one day 2, spread to bilateral axillary areas day 3 and to neck and groin areas Neck lymphadenopathy associated with dysphasia and sore throat
made us both sick; we had weakness; we had chills; we had body aches; This case was reported by a consumer and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for tolerance of 1st dose refer case US2020AMR044287).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, weakness, chills and general body pain. On an unknown date, the outcome of the sickness, weakness, chills and general body pain were unknown.   It was unknown if the reporter considered the sickness, weakness, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and had weakness, chills, body aches and sickness. This is 1 of the 4 linked cases reported by the same reporter.
PATIENT FELL TO THE FLOOR HAD A FAINTING EPISODE WITH SEIZURE LIKE MANIFESTATION SYMPTOMS WHICH INCLUDED CLINCHED MOUTH, SPASTIC ARMS WITH CONSTRACTING MOVEMENT, EYES ROLLED BACK AND PATIENT ALSO URINATED HERSELF AFTER ABOUT 20-30 SECONDS PATIENT REACTED TO BE ALERT X3 THEN STATED DID NOT KNOW WHAT HAPPENED.  WAS PLACED IN AN EXAMINING ROOM AND WAS EXAMINED BY DR.
Information has been received from a physician via a company representative referring to an approximately 67 years old female patient. The patient was allergic to iodine, dyes and sulfonamides. The patient had no medical history. Concomitant therapies included NEXIUM, VASOTEC, albuterol sulfate (manufacturer unknown) and ATIVAN. On 29-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # reported as 1035882, expiration date 19-APR-2017, dose not reported) intramuscularly. In 2016 (reported as "subsequently"), the patient developed pulmonary granuloma and fever. On 13-AUG-2016, the patient went to a walk in clinic and was given doxycycline. The outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 was not provided. The physician asked a lot check for 1035882. Lot number 1035882 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent). Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe
hives on her arm that started 2cm below the vaccination site- hives on face and forehead; arm as burning hot; throat felt weird; right upper arm started itching like crazy; Chest was kind of red; Rash on her arm spread a little more; flushing; fever; chills; A spontaneous report was received from a consumer concerning a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events of flushing, ears were hot,  had  fever, chills, typical reactions, right upper arm started itching like crazy, had hives on her arm that started 2cm below the vaccination site and her arm was burning hot, chest was kind of red,  throat felt weird ,  had some hives on her face and forehead and the rash on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On   09-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch no: unknown) in the right upper arm for prophylaxis of COVID-19 infection.  On 09-JAN-2021, the patient experienced flushing, ears was hot, had fever, chills, typical reaction and these was completely fine by the next day. On 17-JAN-2021, the patient experienced her right arm itching like crazy, had hives on the arm started below the vaccination site, arm was burning hot, chest was kind of red, and her throat felt weird. Later at the night, the patient had hives on face and forehead, rash on the arm spread a little more.  The patient was tested COVID-19 negative. The patient had taken Benadryl for the throat irritation.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events flushing, ears was hot, had fever, chills, typical reaction was recovered by the next day. The outcome of the events right arm itching like crazy, hives on the arm below the vaccination site, arm  burning hot, chest  kind of red, and  throat felt weird,  hives on face and forehead, rash on the arm was not recovered/resolved.  Recoded events (Vaccination site warmth and Vaccination site pruritus)
Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 28-jan-2022; We've 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 (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 28-jan-2022) in a 65-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) .25 milliliter. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 28-jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 28-jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
This is a spontaneous report obtained from a contactable consumer (lawyer who is the patient). This 25-year-old female patient received, on 29Apr2015, the first dose of TRUMENBA intramuscular in the left upper at 0.5 ml, single. Relevant medical history included heartburn on an unspecified date in Apr2015 and dermatologic urticarial. Concomitant medications included ZANTAC taken as needed for heartburn. On 29Apr2015, the patient experienced lots and severe pain at the injection site and pain in arm. Patient mentioned that she did not receive any treatment for the adverse events. The patient did not recover from sore arm while she recovered from the pain at the injection site. Follow-up (26Jun2015): Follow-up attempts completed. No further information expected. Follow-up (10Jul2015): New information reported from a contactable consumer includes: updated date of vaccination, medical history, concomitant medication, onset date of the event, outcome.
Pt c/o "itchiness" on her arms, legs and abdomen. EMS present and attended to pt.
He lost 11 lbs; muscle pain; fatigue; nauseous; The strange taste in his mouth; abdomen area is also tender to touch; he started having (horrific) diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (he started having (horrific) diarrhea), WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue) and NAUSEA (nauseous) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 015M20A, 038A21A and 959904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tetracycline).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced DIARRHOEA (he started having (horrific) diarrhea). On an unknown date, the patient experienced WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue), NAUSEA (nauseous), TASTE DISORDER (The strange taste in his mouth) and ABDOMINAL TENDERNESS (abdomen area is also tender to touch). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 16-May-2022, DIARRHOEA (he started having (horrific) diarrhea) had resolved. At the time of the report, WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue), NAUSEA (nauseous) and ABDOMINAL TENDERNESS (abdomen area is also tender to touch) outcome was unknown and TASTE DISORDER (The strange taste in his mouth) had not resolved.            No concomitant medications was reported.   This case was linked to MOD-2022-571226, MOD-2022-571142, MOD-2022-571162 (Patient Link).
A report was received from a health care professional on 13 November 2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, the vaccinees inadvertently received 0.25 ml of Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.