chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 50-year-old female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at the time of vaccination was 49 years. Concomitant medications included hydrochlorothiazide, and losartan potassium.  On 29-APR-2022, Covid symptoms (suspected covid-19 infection and suspected clinical vaccination failure) returned a week after patient stopped taking paxlovid, without lung issues. Treatment medication included Paxlovid from 18-APR-2022 to 22-APR-2022 for covid 19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231595.; Sender's Comments: V0: 20220531795-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
She got her vaccine around 1:00 on Sunday, 10/15/23.  Just underneath where the injection went in she has a collection of 4-5 knots that are sore to the touch.  She applied some heat to it this morning to help relieve some of the symptoms, which has helped.  She took 1 Tylenol 500  mg on Sunday, and she took one yesterday before she went to work.  She noticed this after work last night when she got home from work, she works the 2nd shift.  She is aware of swelling, and got the 1st shingle shot on 8/15/23 and had no reaction like this one.  It is real hard and reminds her of a lump that she had on her breast in the past.  She has had breast cancer and caught that in time on her left breast and had a lumpectomy.  It d She did have chemo and radiation on that in 2015.  She has not called her doctor yet about the lump, and plans to call him in a few minutes.  She got the flu shot and the pneumonia shot in the last couple of months and had no reactions to any of those vaccines.  She got a little sick with the flu shot for 2-3 days.
After the vaccine I had a sore arm. Then the next day I was really tired and dizzy. In July 2021 I went to the doctor and discovered that I had high blood pressure at that time that was at stroke level. I also had a slight heart attack but no permanent damage was done. The doctor said to keep an eye on it, take medications, exercise, and diet. In February 2022 I found out that I had a slight blockage in my heart at 20% or 30%. I was prescribed Amlodipine 5mg 1xday, Atorvastatin 40mg 1xday, Losartan 100mg 1xday, and Metoprolol 25mg 1xday. I was also prescribed Nitroglycerin but I haven't had to take any of that medication.
Severe chills,/shivering, severe headache and muscle/body aches., muscle weakness, extreme fatigue . Have been ongoing now for 30 hours.
erythema, swelling, very painful at the site and still is as of today (12/23/2020), warmth, tenderness. all of this is in the arm and the surrounding areas where the injection site was
rash (unknown area; not at injection site); This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   Concurrent medical conditions included yeast infection (in an unknown area).   On 27th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th March 2019, 1 days after receiving Shingrix, the patient experienced rash. The action taken with Shingrix was unknown. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the left arm. The patient expereinced rash on an unknown area (not at injection site).
1 WEEK OF FLU LIKE SYMPTOMS AND JOINT PAIN AFTER DOSE.  RESOLUTION OF FLU LIKE SYMPTOMS BUT CONTINUATION OF JOINT PAIN IN BOTH HANDS TO PRESENT 2/18/2022.  DESCRIBED AS BILATERAL FINGER JOINT PAIN "LEVEL 5" IN ALL JOINTS OF THE FINGERS.  PATIENT SELF-TREATED WITH HEAT AND OTC IBUPROFEN AND ACETAMINOPHEN WITHOUT RESOLUTION.  CURRENTLY UNRESOLVED AT GREATER THAN 2 MONTHS POST VACCINE.  PATIENT ADVISED TO FOLLOW UP WITH PCP FOR EVALUATION.
Administered 0.25ml of Moderna. As an organ transplant recipient, she should have had 3 full doses. Per CDC guidelines, administered 0.5ml dose today (3/17/22) and will administer a 0.25ml booster dose after 3 months. No adverse events reported
c/o "itchiness" on arm and back; observed red raised descending rash from nape of neck to lower back and banding clavicle area; elevated B/P 167/111 HR 89/79; became anxious and diaphoretic; declined treatment/transport to ED however agreed to walk over to ED accompanied by RN. Evaluated by ED Triage RN , not checked in ED. Also reported has chest tightness with reaction. Patients reported ED doctor told him to take Benadryl. But he was working and wanted to continue to work so took Zyrtec instead. Still have the rash just above the injection site?comes and goes.
Information has been received from a 69 yr old female with elevated triglycerides and depression who on 19May05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine in the left arm (route not reported). Concomitant therapy included cetirizine hydrochloride (Zyrtec), fenofibrate (Tricor) and amitriptyline hydrochloride. On 19May05 the pt developed injection site reaction with swelling down and under the upper arm. The pt reported "It looked like an octopus, swollen red, hot and sore". The pt sought medical attention and was treated in the ER but not admitted. 24 hrs later, the pt recovered. No further information is available.
Extremely sore right arm; long-lasting headache; sore shoulders; overall achiness; fatigue; This is a spontaneous report from a contactable consumer. A 21-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP6955, Expiry date: unknown) via an unspecified route of administration, administered in Right Arm on 22Mar2021 11:15 (at the age of 21-years-old) as dose 1, single for covid-19 immunization. Medical history included known allergies with sulfa. The patient had covid-19 prior vaccination. Covid was not tested post vaccination. The patient did not receive any other vaccine within 4 weeks or two weeks. The concomitant medications were not reported. On 23Mar2021 12:00, the patient experienced extremely sore right arm, long-lasting headache, sore shoulders, overall achiness and fatigue. The patient did not receive ant treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Case number PHHY2011AR38458, is a spontaneous report from a physician received on 05 May 2011: This report refers to a 5-year-old male patient. He was vaccinated with AGRIPPAL S1 (batch number unknown) on 28 Apr 2011. The patient was healthy before vaccination. On 29 Apr 2011, 24 hours after vaccination, the patient started with behavioral disorders and experienced afebrile tonic-clonic seizure on the right side of her body, and then it was generalized with vomiting and ocular retroversion. The patient arrived to the emergency room of the clinic on post-ictal state where anticonvulsants were administered. Due to respiratory depression caused by drugs (unspecified), the patient was intubated. Then, the patient was transferred to other clinic. Different investigational studies were performed. Computed brain scan, electroencephalogram (EEG), cephalo-rachidian-liquid (CRL) puncture were normal and blood cultures were negative. Polymerase chain reaction (PCR) for Epstein-Barr virus (EMB), cytomegalovirus (CMV) and enteroviruses were negative. Neurological examination was normal. The patient was treated with ceftriaxone, acyclovir and anticonvulsants. At the time of this report, the child was completely recovered.
No treatment was needed but on Days 1-2 he had arm pain and body aches. On Day 3, 12/21/21, he woke up with 4-5 large (quarter-sized) hives on both right and left arms. They resolved within 24 hours without treatment.
Pt developed temp of 105 on 6/11/01. Pt was given Motrin for fever. Temp controlled with medication. Pt also developed small swollen area and rash at site of vax.
arm tenderness/ soreness; arm tenderness/ soreness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 12 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENDERNESS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm tenderness/ soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2013US023742 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 77-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: Jun 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following the maladministration.
Swelling, redness, oozing, pain of injection arm, general malaise- returned to vaccine site at CVS and had NP examine, steroid prescribed, also made visit to my mother?s internal medicine dr and he examined as well; my mom was told to discontinue steroids and not to get 2nd dose of vaccine.
That night I had pain in my joints, then within 24 hours I felt severe pain in my knees, and I couldn't walk 3 days. Had appt. on 3/15 at a family medical facility and the Dr. ordered 2 x-rays on each knee. Left one was more severe. 3/19/2021 I got a steroid injection in my left knee but it didn't seem to help. I started having a lot of pain in my shoulders and I was sent to Physical Therapy. From there I was sent to a Dr. in sports medicine at a clinic. He ordered another x-ray of both my shoulders and left knee. 5/14/2021 I saw an Orthopedic Specialist and had scan of my left knee and shoulders. A gel was applied to my knee and I was given a steroid for my shoulder.
This case was reported by a healthcare professional and described the occurrence of fatigue in a 15-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  No other vaccinations given on the same day as Flulaval.  No relevant medical history or concurrent medications.  On 24 November 2007 at 15:47 the subject inadvertently received unspecified dose of Flulaval (.5 ml, unknown, right arm) and experienced a vaccination error as she as supposed to received a pediatric vaccine.  On 01 December 2007, 7 days after vaccination with Flulaval, the subject experienced mild fatigue.  She was seen by a physician on 03 December 2007 because the fatigue persisted. No medications or treatment were prescribed during the visit.  Subject was told to follow up if her symptom changed.  At the time of reporting the fatigue was unresolved.  The healthcare professional considered the fatigue was probably related to vaccination with Flulaval.
Client and taken to clinic to lay down . Blood pressure lowered to 92/73 pulse 88  client assessed for approximately one hour was dismissed home  Noted to have a steady gait on discharge and no dizziness. Client was assisted to her car per wheelchair.
She presented to the physician with complications after vaccines and complained of arm pain and swelling, traveling downwards after vaccination 3 days after and pt stated that she did get a fever of 101 one day ago. Patient received pain and swelling medications to help with the complications of the swelling and the pain.
No additional adverse events were reported in this case.; patient who received first dose of GARDASIL-9 at age 13 and second dose at age 17, which is outside of the recommended dosing schedule in the prescribing information; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unspecified date in approximately 2017, when the patient was 13-year-old, she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number, and expiration date were not reported). Then, on 21-JAN-2021, when the patient was 17-year-old, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe lot # S033308 with an expiration date on 08-APR-2022, at a dose of 0.5 milliliter for prophylaxis (route and anatomical location were not provided); which is outside of the recommended dosing schedule in the prescribing information (inappropriate schedule of product administration). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Approximately 6 -8  hours post vaccine I began with chills that were so severe I could physically not stop shaking, had burning skin that was felt through my clothes, pain urinating, horrendous headache, sore skin where it was painful to even lay down, nausea, and overwhelming tiredness.  My husband reported that I was continually groaning in my sleep. This continued for 24-36 hours.  On the 25th I woke up feeling fine. This duplicates the symptoms of my first vaccine but at that time I had begun with a cold which my M.D. felt was probably the reason. I now believe that I had an adverse reaction both times.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Additional Details: 911 WAS CALLED AND RESPONDED TO PHARMACY. PT WAS HYPOTENSIVE. PT'S HUSBAND WAS CALLED TO TRANSPORT PT HOME
Have a temperature; Achy / Soreness; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose few months ago for tolerance refer case US2020AMR199029).   On 2nd October 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, less than a day after receiving Shingrix, the patient experienced fever, pain and chills. On an unknown date, the outcome of the fever, pain and chills were unknown.   It was unknown if the reporter considered the fever, pain and chills to be related to Shingrix.  Additional details were provided  as follows: The age at vaccination was not reported. The age group was not reported but captured adult as per vaccine indication. The patient was vaccinated with 2nd dose of Shingrix. After vaccination patient had temperature, achy, chills and soreness. This case was linked with case US2020AMR199029 by patient link.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199029:same reporter
When giving the vaccine, the shot seemed to be slow to "go."  Upon applying further pressure, the shot ran down the patient's arm as a foamy mess.  Needle/syringe was discarded and a new shot was prepared and given.  Other than having to get stuck twice, there were no adverse issues for the patient
LOCAL SKIN IRRITATION. RED AND LITTLE SORE WHEN SHE MOVES ARM.
1. Day after vaccination developed hive-like red rash over entire body except face, feet, and fingers.  Experienced brief periods of dizziness and confusion. Experienced  ?eye migraines? with haloes throughout the day following vaccination. Dizziness and confusion lasted only briefly and only the. day following vaccination.  Eye migraines/haloes also lasted only the day following vaccination. Rash lasted approximately one week and disappeared without treatment.  Took photos of rash. 2. Approximately one week later, after rash abated, experienced tiny skin blisters over entire body including face, feet, and fingers.  Blisters disappeared in approximately one week. 3. Unknown if related: approximately one week after blisters disappeared experienced swollen patches on scalp along with lesions that have multiplied.
arm where i got the shot is itchy; arm where i got the shot is raised; arm where i got the shot is red; 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 VACCINATION SITE PRURITUS (arm where i got the shot is itchy), VACCINATION SITE SWELLING (arm where i got the shot is raised) and VACCINATION SITE ERYTHEMA (arm where i got the shot is red) 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm where i got the shot is itchy), VACCINATION SITE SWELLING (arm where i got the shot is raised) and VACCINATION SITE ERYTHEMA (arm where i got the shot is red). At the time of the report, VACCINATION SITE PRURITUS (arm where i got the shot is itchy), VACCINATION SITE SWELLING (arm where i got the shot is raised) and VACCINATION SITE ERYTHEMA (arm where i got the shot is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided No treatment medications provided
Storage in clinical practice; No adverse event on patient; This spontaneous report was received from an office manager, referring to a 12-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with an improperly storage human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (valid lot #1775811, expiration date: 07-DEC-2023; valid lot #1775827, expiration date: 27-JUN-2024, valid lot #U032681, expiration date: 26-OCT-2023, valid lot #1780876, expiration date: 09-NOV-2023, valid lot #W009829, expiration date: 19-OCT-2024) administered for prophylaxis (dose, frequency, strength, anatomical location and route of administration were not provided). Temperature excursion occurred during a total time of 25 minutes. Three excursions were reported (on 09-SEP-2022 for 8 minutes, on 16-SEP-2023 for 5 minutes, and on 03-JAN-2023 for 12 minutes). Excursions were not noted until after the fact, due to employee error of cleaning data logger more than once a day. At the reporting time, the outcome of the event was unknown.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Swelling and tenderness of entire face noted the next am. Did not respond to Benadryl. No respiratory distress.
This study case was received from the investigator in a trial on 23 January 2014. A 25 year-old male subject had received on 06 January 2014 the following vaccines: ACAM2000 (lot number, route and of administration not reported), anthrax (manufacturer, lot number, route and site of administration not reported) and typhoid (manufacturer, lot number, route, and site of administration not reported) and seven days later, experienced shortness of breath one time during exercise. On 14 January 2014, the subject had a normal troponin and a normal ECG. According to the investigator, cardiac etiology could not be ruled out and the subject was referred appropriately, no further information was expected to follow. Actions taken were none. Outcome was recovered on 13 January 2014. According to the investigator, the event of shortness of breath was considered mild, an "other important event" and possibly related to vaccination. Documents held by sender: none.
Patient admitted 7/19/2022 on Observation Status  with significant weakness after being diagnosed with COVID on 7/15/22.  Discharged to rehab facility.
Short lived soreness of arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (short lived soreness of arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine)(Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (short lived soreness of arm). At the time of the report, PAIN IN EXTREMITY (short lived soreness of arm) had resolved.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
Vaccine given 11/19/03 approx 10:30 am. Came in the next day and c/o pain in right arm that had begun that night after vaccine to swell and was painful.  Still swollen 3 1/2 inches below vaccine site and hot to touch the next day.
Patient received vaccine 11/8/21 at 9:15am. No reactions at time. Well child exam unremarkable. Dr. received a call from  ER that parents had called 911 around 4:15am because they found the child unresponsive. Child was transferred to ER and later pronounced deceased, possible SIDS.
This spontaneous report as received from a physician refers to a 65 year old female patient. The patient was enrolled in a patient support program. In approximately June 2015 (referred as like in June), the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not provided) instead of PREVNAR. In 2015 (unspecified date), the patient experienced pneumonia streptococcal referred as "strep pneumonia bacteremia, and her serotype was 23F". The physician stated that the patient was at the hospital at that time (hospitalization could not be ruled out). At the time of the report, the patient was in there in both vaccines. The outcome of pneumonia streptococcal was unknown. Additional information is not expected as the reporter refused additional contact.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 22-AUG-2013 the patient was vaccinated with ZOSTAVAX (route and dose unknown) lot # 672608/1715AA  dose 1. No other suspect therapy or concomitant medication was reported. On 22-AUG-2013, the patient was administered an expired dose of ZOSTAVAX that may have also been stored improperly. No adverse effects were reported. Additional information has been requested.