chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case was created for patient 17 out of 17 patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up received contains Patient demographics updated On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Obesity; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 02Aug2022 as dose 2 (orange cap), single (Lot number: FL8095) at the age of 11 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1 (Orange cap), Anatomical site of injection: unknown, Route of administration: Intramuscular, Batch/Lot number: FL8094), administration date: 12Jul2022, when the patient was 11-year-old, for COVID-19 immunization.  The following information was reported: OBESITY (non-serious) with onset 08Sep2022, outcome "not recovered".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102420 Same patient, different vaccine dose and different event.;
sharp pain in chest and heart; sharp pain in chest and heart; muscle pain; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (sharp pain in chest and heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-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 ANGINA PECTORIS (sharp pain in chest and heart) (seriousness criterion medically significant), CHEST PAIN (sharp pain in chest and heart), MYALGIA (muscle pain) and HEADACHE (headaches). At the time of the report, ANGINA PECTORIS (sharp pain in chest and heart), CHEST PAIN (sharp pain in chest and heart), MYALGIA (muscle pain) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter. It was reported that the patient worked at the hospital and they are mandating vaccines by Oct2021  Treatment information was not reported by reporter.  Company Comment: Very limited information regarding this event has been provided at this time. Further information is not expected..The event was downgrade due the patient did not seek medical help.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not expected..The event was downgrade due the patient did not seek medical help.
7 days after first dose I experienced swelling, redness and itching in left arm at the injection site.  Presumed to be ?Covid arm? I applied ice packs on 3/25 and began taking Claritin and using hydrocortisone cream to manage itching on 3/26.  Swelling was resolved through ice packs within 24 hours. Redness and itching have continued with Claritin and hydrocortisone providing  temporary relief, but it appears to be improving. The area of redness spread  and traveled further down the arm from the injection site but looks to be dissipating. As of 4/1, rash is fading, only the outer edge remains slightly itchy.
Left arm where dtap and polio was given is red and warm to touch.  Not painful.  Moving fine, no fever, no other s/s illness
Pt recvd 1st dose of Hep B vax in APR91; approx 1/2 hr p/vax pt exp a mild asthma attack which remitted w/the use of bronchodilators; pt recovered;
Prior to vaccine administration, patient was unable to be found in system, patient was asked prior Hx of Hep A vaccination and denied prior Hep A vaccination. Patient risk factors for Hep A included homelessness. Hep A vaccine screening form completed and patient was administered a single dose of Havrix into left deltoid. No adverse reactions or side effects noted post-administration. After returning from the field, RN was able to find patient vaccination record which noted that the patient had already received 2 doses of Hepatitis A.  Dose 1: 9/20/2017, Dose 2: 1/13/2020. Third dose administered on 5/12/2023. Entered into record. Leadership was notified of incident and directed RN to comlpete VAERS form and internal incident report.
presented with two days of worsening chest pain and chest pressure diagnosed with myocarditis with elevated troponin levels, esr and crp normal required hospitalization overnight for monitoring normal EKGs and Echo treated with ibuprofen with improvement in chest pain
24 hrs post vax, 1 of 4 pt's exp h/a, swelling & pain @ inject site, inability to move arm, & fever of 101-103 for 3 days; tx APAP for pain & fever;
Zoster like rash appeared on left side of abdomen. Small in size, did not seek treatment.
13 minutes after receiving nasal vaccine the student c/o feeling well- dizziness, weakness, red rash noted on upper chest, cheek, face, and arm. Student was alert and responsive x3. No respiratory distress no facial swelling and lungs were clear. Students mother came and took her to ER.
He began having a fever on Thursday night up to 102/he woke up again with a fever this morning; This is a spontaneous report from a contactable consumer. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Jun2021 as 2nd dose single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 13May2021 as single dose for COVID-19 immunisation. On 03Jun2021 the reporter reported that the patient began having a fever on Thursday night up to 102 but she has been able to keep it under control with Ibuprofen. She reports concern that he woke up again with a fever this morning and didn't know if she should be worried, asking, how long should the fevers last? Reporter stated that she already gave all of the adverse event information to someone else to file a report, no reference number for that encounter. Treatment was received for fever with ibuprofen. The patient underwent lab tests and procedures which included body temperature: 102 on an unspecified date. Outcome of the event was unknown.  Information about the lot/batch number has been requested.
I was having atrial fibrillation with uncontrol rhythm activity.  I have a blood clot in my heart.  I am going to be having a procedure for that.  I went to the ER twice.
Lightheadedness, BP 127/71, HR70, RR16. Patient stayed until felt better, laid down for 7 minutes and verbalized feeling better. Left in stable condition
This spontaneous report as received from a nurse refers to a multiple number of patients (also reported as "a lot") of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified series of M-M-R II (therapy type, dose, dose number, intervals, anatomical location and route of administration were not reported). On unknown dates, the patients who had received a M-M-R II "were testing negative for titers of some of the antigens". The reporter also stated, that "some of the soldiers were receiving 3 to 5 doses of M-M-R II" for revaccination on unknown dates. The outcome of the event of "negative titers of some of the antigens" was unknown. The relatedness between the event of event of "negative titers of some of the antigens" and M-M-R II was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient experienced redness and swelling for 3 days, induration 2x2cm and erythema 2.5cm x 1cm at the injection site.
Elder's vital signs prior to administration of COVID-19 vaccine were BP- 102/66, Pulse- 70, Resp- 18, Temp- 97.6, 97% O2 sat, approximately 30 minutes post vaccine administration, Elder's vital signs were BP- 114/77, Pulse- 140, Resp- 18, Temp- 98.3, 96% O2 sat. Elder was monitored closely with NO adverse signs or symptoms from elevated pulse. Elder's heart rhythm was normal no arrhythmias noted. Vital signs were subsequently taken and pulse varied between 123 and 142. MD was notified and no orders given at this time other than to monitor Elder closely. At approximately 2pm, Nurse was in re-assessing Elder and Elder's pulse was noted to be abnormal. Still rapid at 140 BPM but now rhythm is abnormal. 12 lead EKG was performed and results were interpreted as Atrial flutter. MD was notified and EKG strip was sent to MD. MD consulted with ER MD. MD ordered an additional dose of Metoprolol 50mg to be administered now, recheck pulse in 30 mins. Pulse was 144 and irregular at recheck at approximately 1730.
Swelling at the site, Day one was about size of a 50 cent piece Day two- size of a baseball and was very itchy Day Three- size of a Softball and is very itchy  and more than fills the palm of your hand
SWELLING; Itching; BURNING AFTER INJECTION; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (SWELLING), PRURITUS (Itching) and INJECTION SITE PAIN (BURNING AFTER INJECTION) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 09-Apr-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF,solution for injection in pre-filled pen. On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (SWELLING), PRURITUS (Itching) and INJECTION SITE PAIN (BURNING AFTER INJECTION). At the time of the report, SWELLING (SWELLING) and PRURITUS (Itching) outcome was unknown and INJECTION SITE PAIN (BURNING AFTER INJECTION) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of burning after injection with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of swelling and itching with Humira (adalimumab) was no reasonable possibility.  No treatment medications were reported.
Doses were given beyond 30 days shelf life; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given beyond 30 days shelf life) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given beyond 30 days shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given beyond 30 days shelf life) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received and contain Non significant information.
Development of (L) arm numbness/weakness within 3-4 hours following vaccination. Symptoms resolved after 36 hrs. Development of transient (L) eye loss of peripheral vision (black curtain) 18 hours after vaccination. Resolved after 15 min.
12/7/2020 started not 'feeling up to par' in the evening; achy, sore, body chills, headache, dizziness. Did not take temperature. Symptoms lasted for approximately later the following evening.
Pharmacy called me in yesterday for 2nd dose of SHINGRIX inj. Went in around 6pm and received injection in my left arm. Pretty sore as it was last time, however, all day today I have been running a low grade fever, chills, stomach pain (not cramps), headaches and fatigued...barely keep my head up fatigue. This did not happen on the first dose and not sure if this is normal.
arm pain not as bad as the first dose some itchiness  and rash but not as significant and as long-standing as the first dose fever up to 101.5 (I tend to have low blood pressure and low body temperature so this was significant for me) mostly 99.9 pains in every joint an orfice (teeth, ears, knees, ankles, and lower back were the most sidgnificant)  my skin hurt it was hard to move or get up or talk weakness lethargy sleeping from Wednesday night until Friday morning but fitful pained sleep wet stool with water at one point thursday morning i wanted to poop and vomit at the same time so I chose not to do either. I felt if I pushed to allow the stool to come out my vomit would also project, so I refused period came two weeks early very heavy unusual in perimenopause and I don't get hot flashes but sweat sometimes witout being hot. Now with no fever I was constantly sweating all day Friday up until Sunday Stayed in bed two days no appetite, slight nausea Forced myself to go downstairs saturday but bathing and putting on my clothes was too much so I had to rest for half an hour before doing so. I had to teach a class of 13 to 15-year-olds and talking was labored like I was gasping for breath (40 minutes). Sat still for the rest of the day and felt better Sunday better but the headache is the only issue and on and off nausea especially when asleep Today headache is more prominent, perhaps because I left the house for the first time and went grocery shopping The doctor said to take Tylenol but I have not since the fever broke. Only took two acetamophin on Thursday  She also said to report my symptoms Wondering if the headache, brain fog, and lethargy will go away after period ends, more than likely by Friday. It is petering off.
PATIENT WAS GIVEN UNDILUTED VACCINE. VACCINE WAS ADMINISTERED WITHOUT BEING DILUTED. NO ADVERSE REACTIONS REGISTERED. UNABLE TO CONTACT PARENTS FOR MORE INFORMATION ABOUT PATIENT STATUS
Initial report received on 14 August 2009 from a physician.  A 14 year old male patient, whose medical history was unknown, received a first intramuscular injection of MENACTRA (lot number U2868AA) on 16 March 2009.  It was unknown if the patient had an illness at the time of vaccination.  In June 2009, the patient developed alopecia on the head and increased levels of aluminum in the blood.  At the time of the report, the patient had not yet been seen by the physician.  The patient's outcome was unknown.  No further information was available at the time of the report.
Felt like I had extra saliva running in mouth; Fatigue; Chills; Headache; Fever; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), SALIVARY HYPERSECRETION (Felt like I had extra saliva running in mouth), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced COUGH (Dry cough). On 28-Mar-2021, the patient experienced PYREXIA (Fever). On 29-Mar-2021, the patient experienced SALIVARY HYPERSECRETION (Felt like I had extra saliva running in mouth), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. On 01-Apr-2021, COUGH (Dry cough), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) had resolved. At the time of the report, SALIVARY HYPERSECRETION (Felt like I had extra saliva running in mouth) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test positive: Positive. On 14-Apr-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (IUnknown), the reporter did not provide any causality assessments.
approx 4 hr p/vax awoke from nap screaming x 1 hr & subsequently pt slept; evaluated in ofc 1 hr;
Pt was given second Hep A shot 22 days too soon. First dose was given on 6/10/2015.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received SHINGRIX (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis. On 15th January 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The batch number of SHINGRIX was updated from G729L to GZ29L, as per sales data sheet. The patient experienced redness and soreness at injection site after receiving SHINGRIX vaccine.
Took one dose of expired Vivotif; Spontaneous report received on 08FEB2021.  A pharmacist reported that a consumer "took one dose of expired Vivotif" (PT: Expired product administered). The consumer was receiving Vivotif (expiry date: Jun 2020) for immunisation. In Jan 2021, the consumer took one dose of expired Vivotif. The pharmacist stated that the consumer was doing just fine and had not experienced any side effects. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer took one dose of expired Vivotif (expired product administered) and was doing well. Considering the nature of the event, the causality of expired product administered is assessed as not applicable to Vivotif.; Sender's Comments: It was reported that a consumer took one dose of expired Vivotif (expired product administered) and was doing well. Considering the nature of the event, the causality of expired product administered is assessed as not applicable to Vivotif.
High fever to 104F and vesicular rash, 4 days after MMR, VZV, Prevnar and HIB given.
always gets the flu within a few days of the shot; Initial information received on 24-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a non-Healthcare Professional.  This case involves an unknown age female patient who always gets the flu within a few days of the shot while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, expiry date and lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "always gets the flu within a few days of the shot" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Never had the flu shot and never had the flu. The GF (girlfriend) is forced to get it at work and automatically schedules time off as she always gets the flu within a few days of the shot. She actually writes her prediction on the calendar."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (always gets the flu within a few days of the shot).  At time of reporting, the outcome was Unknown for the event always gets the flu within a few days of the shot.