chrisvoncsefalvay/vaers-outcomes huggingface dataset:
skin rash (felt like sandpaper); joint pain all over his body/knee pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH (skin rash (felt like sandpaper)) and ARTHRALGIA (joint pain all over his body/knee pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (skin rash (felt like sandpaper)) and ARTHRALGIA (joint pain all over his body/knee pain). At the time of the report, RASH (skin rash (felt like sandpaper)) and ARTHRALGIA (joint pain all over his body/knee pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported by reporter. It was reported that patient was kept on steroids and before the vaccine he had mild hip pain.
HERPES ZOSTER IN A CHILD VACCINATED WITH 2 DOSES OF THE VARICELLA VACCINE.
received an expired dose, with no reported adverse event; Initial information received on 07-Jan-2022 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 22 years old male patient who received an expired dose, with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].     The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 07-Jan-2022, the patient received a 1 ml dose once of suspect RABIES (HDC) VACCINE lot T1B491M , expiry date: 07-Dec-2021 via intramuscular route at right deltoid. First time product used : Yes  On 07-JAN-2022 the patient developed a non-serious event "received an expired dose, with no reported adverse event" (expired product administered)(latency: same day) following the administration of RABIES (HDC) VACCINE.  It was reported "Caller states that a patient that was due for their second dose of IMOVAX received a dose of expired product. Caller would like to know if the product was still suitable for use? Caller would also like to know how soon should the patient be revaccinated?  Caller states patient is receiving IMOVAX for a dog bite and was there for their second dose in the series".   Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose, with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain at injection site started the evening of date vaccine was received. resolved in 2 days. Rash at injection site- started with slight irritation on day 10. Rash appeared on day 14. Currently ongoing. Today is day 15 post vaccine  injection.
Pt recvd 2nd dose of vax & exp nausea, vomiting & rt upper quad abdominal pain into back; 17JAN93 c/o being weak & shaky; also exp numbness & burning of the toes & dark yellow to orange urine; presented to ER on 20JAN93;
Pt. c/o sweating, SOB after receiving vaccine. Pt had onlyhad(1) 20oz bottle water allday, wearing 2 masks, room was very warm. Moved pt. to cooler room, gave water, removed 2 masks c social distancing. pt. improved rapidly.
1st dose of covid vaccine with Pfizer. 2nd covid vaccine dose with Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose of covid vaccine with Pfizer. 2nd covid vaccine dose with Moderna vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 26-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose of covid vaccine with Pfizer. 2nd covid vaccine dose with Moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose of covid vaccine with Pfizer. 2nd covid vaccine dose with Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
On 9/25/21, at approximately 10:20am this FNP handed the 0.5ml syringe of the Moderna vaccine to the MA, informing her that it was for the patient requesting her 2nd Moderna. At approximately, 10:45am, MA informed me that she realized she had given the Pfizer vaccine to the patient instead of the Moderna and she had already let the patient leave after waiting 15 mins. The MA stated she verified with the patient her name and that she was there for the "Pfizer" vaccine and the patient replied, "Yes." The MA said, "Maybe the patient didn't hear me well enough."  The patient did not show signs/symptoms of adverse reactions following the vaccination administration during the 15 minute wait time. This FNP reached the pharmacy at approximately 11am to report the error and for further guidance. The pharmacist  contact the clinical director and stated there is no further action to be taken at the time aside from notifying the patient. Once I arrived back at the pharmacy to drop off the vaccines at approximately 1:15pm, I attempted to reach the patient to inform her of the error. I was unable to reach her and did not feel comfortable leaving a voicemail message due to confidentiality/HIPAA rules.
Patient had soreness and mild fever day after shot.  3 days after shot patient developed red hot itchy spots on arm and soreness.  Pt went to urgent care and is being treated for cellulitis today.
Patient found unresponsive due to unknown cause on 5/26 (6 days post-vaccination).  Transferred, noted to be COVID + by NP swab with high cycle threshold on admission, tracheal aspirate was COVID neg.  Patient had prior COIVD infection in Nov. 2020.   Workup for encephalopathy included  MRI (5/27) which revealed  thrombosis of left transverse/sigmoid sinuses and proximal jugular vein. However, platelets were normal 245 x 10^9/L (5/26).
Severe pain at injection site. Started a few hours after injection getting worse until late evening, still quite sore,  two full days later. Using aspercream/lidocaine to manage pain.
Redness, swelling, itchiness 1 day after getting GARDASIL 9 and TRUMENBA on the right arm. It started with induration and redness but then the redness and swelling progressed 2 days after getting shot. Right arm erythema 17cm x 15cm with some induration. Plan: ice for 20 mins. 3 x day, avoid frost bite. Use steroid cream on lesion. Will temporarily hold off on TRUMENBA doses 2 and 3.
Breakthrough case admission after 4 vaccines Moderan 2/5/21 lot# 038K20A;  Moderna 3/5/21 lot# 030A21A;  Moderna 12/4/21 lot# 939909;  Moderna 6/2/22 Lot# 056M21A
Narrative: Patient had 1st dose COVID moderna vaccine on 2/10 at a outpatient drive up vaccine clinic. 2nd COVID moderna vaccine administered on 4/16 while the patient was admitted at hospital for Right midshaft displaced humeral comminuted fracture. Patient admitted on 4/6/21. Patient was discharged to a skilled nursing facility on 4/16/21. There were no known side effects from the 1st dose or 2nd dose of the vaccine. On 5/17/21 the patient's son called the facility to report his father had passed away at his residence on 5/15/21. There are no additional details surrounding the death. Vaccination was not known to have contributed. The patient had end stage COPD on 2L of oxygen and had 5 hospitalizations in the last year all related to respiratory failure. Patient had no prior COVID infection.
Delayed injection site pain; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Delayed injection site pain) and PERIPHERAL SWELLING (Swollen arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Delayed injection site pain) and PERIPHERAL SWELLING (Swollen arm). At the time of the report, INJECTION SITE PAIN (Delayed injection site pain) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
pt recv vax 26MAR97 & 28MAR97 pt exp a rash w/less than 20 lesions on the scalp, back & leg;
Patient received Pfizer COVID vaccine on 3/26/21, 4/12/21, and 10/22/21. On 12/11/21, patient came to our ED with acute encephalopathy and was found to be on acute on chronic renal failure with metabolic acidosis and positive COVID status. Patient was admitted to CCU from 12/11/21 to 12/14/21 (with nephrology and pulmonary consulted), then transferred to med/surgical  unit on 12/14/21, and discharged home with family on 12/16/21. Throughout the hospitalization, patient's AKI on CKD3 and acute metabolic encephalopathy resolved (completed HD on 12/11 and 12/12). In-addition during hospitalization, patient was never hypoxic (asymptomatic from respiratory standpoint) regardless of the positive COVID status.
Vaccine given, 2/9/2021, patient was admitted 9 days later with Covid + pneumonia on 2-18-21.  No antibiotics or antivirals given.  Not clear of overall treatment due to being treated at another facility.
Vaccines were administered by nurse. Patient walked out to the lobby and fainted. Hit her head against the frame of door/wall. Caught by mother. There was loss of consciousness. Within minutes, patient was back to normal. Denies any head pain. No palpable or visible abrasions/bruising. After laying on bed for 10 min and given orange juice, patient's facial color returned to normal. Patient was slightly pale prior to that. After a few minutes of rest, patient was discharged to home.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced an acute allergic reaction and had to go to the emergency room. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
approx 3 days following vax pt devel abdo pain & pain w/breathing; pt also devel general body aches, stomach upset & diarrhea; sx lasted about 10 days;
left arm- rash, fever, swollen, raised, and soreness. patient to take Tylenol, and bendaryl and put ice on the area
Injections site pain and bruising, diarrhea, severe headache, tires, fatigue, muscle cramping shooting pain, nausea, slight fever.
This spontaneous report was received from a physician concerning to a patient of unknown age and gender. On 27-MAR-2013 the patient was vaccinated with a dose of M-M-R II (lot number H013041, expiration date 17-JUL-2014) (dose and route not reported). The vaccine administered was improperly stored, was exposed to 66F since 21-JAN-2013. No adverse effect reported. This case is linked to the following MARRS cases: 1304USA007561, 1304USA008124, 1304USA008125, 1304USA008127, 1304USA008128. Additional information has been requested.
Swelling and severe pain in left arm (injection in L deltoid), swollen and painful left armpit, pain on weakness, and fatigue, severe pain in left arm and entire left side could not lay on left side, swollen aching neck glands, unable to concentrate or think, brain very "foggy" and forgetful, nausea, no appetite, chills, occasionally dizzy.  It is 12/5/14 and I am still having these symptoms.
Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512 and 2014SA063513. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experienced this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described int he adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 3-3year-old female patient (referred to as "patient 5"), received the following vaccines on an unspecified date: INFLUENZA VACCINE (manufacturer and lot number not reported) and PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE (manufacturer and lot number not reported). The patient had a history of rheumatoid arthritis, treated with immunosuppressive therapy. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 101.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She was admitted to the hospital, and was found to have significant leukocytosis with white blood count of 19.2. Non-specific inflammatory markers were elevated, with erythrocyte sedimentation rate of 71 mm/hr and C-reactive protein of 14 mg/dl. While hospitalized, she received aggressive intravenous antibiotic therapy with several different antibiotics due to worsening erythema. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: none.
I started feeling cold symptoms on 5/8/2022, about 1 month after Booster. I took a home test on 5/10/2022 and it came back positive. I went to my doctor and was given Paxlovid.
This is a literature report for the following literature source(s): "Severe Rhabdomyolysis Temporally Associated with sars-cov-2 Vaccine in an Adolescent". A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: RHABDOMYOLYSIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "severe rhabdomyolysis". The patient was hospitalized for rhabdomyolysis (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: Antibody test: Negative; Blood creatine phosphokinase: 246900 IU/l, notes: peak at 92 hours post vaccination; Extensive workup: revealed no alternative causes; SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of rhabdomyolysis. Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-202201114991 Same drug/event and different patient; US-PFIZER INC-202201114990 Same drug/event and different patient; US-PFIZER INC-202201114989 Same drug/event and different patient.
Information has been received from a physician concerning a 15 year old female who was vaccinated with a 0.5 ml dose of GARDASIL about a year ago.  The patient has been chronically ill for a year since receiving GARDASIL and was hospitalized 4 times.  The patient's outcome was unknown at time of reporting.  The patient sought unspecified medical attention.  Additional information has been requested.
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patient concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot # K010215, expiration date 05-MAY-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax;c/o fever & rash;broke out in maculopapular rash on back,neck & stomach;chest cold;T 101;scattered macules on torso;rash may be viral;rxn most likely to be with pertussis;
(not sure of the variety of the flu vaccine, it is whatever the 2019 shot is).  Can't move arm, fever, chills, hives, swelling.  Arm is extremely sensitive to touch.  Hives are red and hot to the touch.  This is the end of the third day and it has not let up although I am able to move my arm a bit more and I don't feel as flush.  Taking ibuprofen and antihistamine.  Did an internet search and this is not uncommon but entirely unacceptable.  I feel I have lost 3 days so far, how long before I get my life back?   I have never had any adverse reaction to any medication or inoculation previously.  This is unbelievably bad... to go from healthy to inability to function because of a preventive shot?
Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female nurse received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 25Jan2021 at 08:15 AM (at the age of 56 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypothyroid and had BNT162B2 vaccine dose 1 on unknown date, lot unknown, administered at 10:45 AM on right arm. The patient had known allergies: Ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium  (SYNTHROID), sertraline hydrochloride (ZOLOFT), liothyronine sodium (CYTOMEL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine, sertraline hydrochloride, liothyronine sodium within 2 weeks of vaccination. On 25Jan2021, at 12:00 PM, the patient experienced Itching, Fever, Chills. No treatment was received for the events Itching, Fever, Chills. The outcome of the events Itching, Fever, Chills was not recovered. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE; CYMBALTA; TOPAMAX; CLONAZEPAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Patient fainted after the vaccine was given. As she was walking away, she felt dizzy and fainted. Patient fell face forward onto the floor, breaking a tooth and biting her lip rather hard. First aid was administered. Mother ended up giving child a dose of acetaminophen. After bleeding had stopped, parents took child to emergency room to be evaluated. I spoke with the father later on and no stitches were needed in the lip, but repair would need to be done to the teeth.