chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; vaccine leaked out as if there was something weak with the needle; vaccine leaked when being administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT LEAKAGE (vaccine leaked out as if there was something weak with the needle), INCORRECT DOSE ADMINISTERED (vaccine leaked when being administered) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 17-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced PRODUCT LEAKAGE (vaccine leaked out as if there was something weak with the needle) and INCORRECT DOSE ADMINISTERED (vaccine leaked when being administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LEAKAGE (vaccine leaked out as if there was something weak with the needle), INCORRECT DOSE ADMINISTERED (vaccine leaked when being administered) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT LEAKAGE (vaccine leaked out as if there was something weak with the needle) and INCORRECT DOSE ADMINISTERED (vaccine leaked when being administered).    No concomitant medications were reported.  Patient had 1 Moderna booster prior to this dose.   It was reported that after injecting the bivalent booster dose part of the vaccine leaked out as if there was something weak with the needle or there was a "clicking mechanism" that was heard.   No treatment medications were reported.
Patient experienced left sided numbness of ear, neck, and hand within 15 minutes of receiving first dose of  Pfizer COVID-19 vaccine, lot # EN6198. The symptoms were resolved during patient assessment, and did not require use of any medications. Patient has a history of extensive left sided nerve damage. Patient was released from the Vaccine Clinic. While patient did not need to receive care from ER, they were given  instructions about symptoms that would warrant going to ER.
Pt endorsed severe chest pain the day after receiving the vaccine. Pt's BP was 156/98 and HR was 102. Pt was sent to emergency room and discharged back to facility a few hours later with a diagnosis of Unspecified Chest Pain.
COVID ARM; big red whelp; immediate itching; States the injection was not administered in muscle, states "it was low on my arm"; felt flu like; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (States the injection was not administered in muscle, states "it was low on my arm"), INFLUENZA LIKE ILLNESS (felt flu like), INJECTION SITE REACTION (COVID ARM), PRURITUS (immediate itching) and URTICARIA (big red whelp) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROCODONE for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (States the injection was not administered in muscle, states "it was low on my arm"), INFLUENZA LIKE ILLNESS (felt flu like) and PRURITUS (immediate itching). On 17-Mar-2021, the patient experienced INJECTION SITE REACTION (COVID ARM) and URTICARIA (big red whelp). The patient was treated with HYDROCORTISONE ongoing since an unknown date at a dose of 1 dosage form. On 15-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (States the injection was not administered in muscle, states "it was low on my arm") had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (felt flu like), INJECTION SITE REACTION (COVID ARM), PRURITUS (immediate itching) and URTICARIA (big red whelp) outcome was unknown.
This spontaneous report as received from a pharmacist refers to a 58 year old female patient. The patient had none pertinent medical history and none drug reactions or allergies. On 25-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). The patient did not take any concomitant medication. On 26-OCT-2014, the patient developed a tender, raised 5-6 inch rash at the injection site. On 26-OCT-2014, the patient also experienced fatigue and body aches. The patient sought medical attention, she was evaluated by the unspecified nurse practitioner but no treatment was prescribed. No lab diagnostics studies were performed. The outcome of body aches and fatigue was reported as recovering/resolving as the patient was still experiencing this symptoms. The outcome of a tender, raised 5-6 inch rash at the injection site was reported as recovered/resolved on an unspecified date in October 2014. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. Additional information is not expected because there is no reporter's consent to further contact.
Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Pt received COVID Bivalent moderna booster in left delt, Fluad in right delt. felt fine for around 2 minutes before head tilted back and pt lost consciousness, excessive sweating.  pt still felt bad when he woke up. blood pressure 145/84, pulse 54. shaky, weak. water and orange juice did not resolve symptoms. wife drove pt to local urgent care. will follow up with pt tomorrow.
Arm where injection was given felt like it was severely sunburned, extreme muscle/joint pain, fatigue, fever, stuffy nose, runny nose, swollen red arm after injection, raised red rash around injection site and up onto shoulder (looks like welts and is very sensitive)
This spontaneous report was received from a medical assistant via a field employee regarding an unspecified patient. No information about medical history, drug reactions and allergies were specified. On an unknown date the patient ws vaccinated with PNEUMOVAX23 (dose not reported), subcutaneously. No concomitant reactions were reported. On an unknown date the patient developed an unspecified reaction to PNEUMOVAX23. The outcome of the event is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
felt like she should go to bed and sleep; vomiting/Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting; nausea/Bad nausea/ Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting; extreme fatigue which made her so tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt like she should go to bed and sleep), VOMITING (vomiting/Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting), NAUSEA (nausea/Bad nausea/ Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting) and FATIGUE (extreme fatigue which made her so tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cerebellar ataxia (neurological condition).   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced SOMNOLENCE (felt like she should go to bed and sleep). 04-Sep-2021, the patient experienced VOMITING (vomiting/Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting), NAUSEA (nausea/Bad nausea/ Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting) and FATIGUE (extreme fatigue which made her so tired). At the time of the report, SOMNOLENCE (felt like she should go to bed and sleep) and FATIGUE (extreme fatigue which made her so tired) outcome was unknown and VOMITING (vomiting/Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting) and NAUSEA (nausea/Bad nausea/ Today morning (08Sep2021), after having tea with breakfast caller felt nauseated and felt like vomiting) had not resolved.            Concomitant medications were not reported  No treatment information was provided.  On 04-Sep-2021, The patient developed some side effects, including nausea, vomiting and extreme fatigue which made her so tired and felt like she should go to bed and sleep.  On 04-Sep-2021 and 05-Sep-2021, The patient tried to eat a little bit but could not keep it down in her stomach due to bad nausea and vomiting.  On 06-Sep-2021 and 07-Sep-2021, The patient could eat a little and could keep it down.   On 08-Sep-2021, Morning after having tea with breakfast patient felt nauseated and felt like vomiting.
Chills, fever, heart racing, swollen axial lymph nodes, headache and teeth pain. Symptoms are resolving.
This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient were inadvertently vaccinated with the expired doses of PNEUMOVAX 23 (lot # J005071, expiration date 19-JAN-2015; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
parent reports itchy and red but reports not painful. For location, parent reports legs. For duration, parent reports has noted for <1 week. For onset/timing, parent reports abrupt onset. For context, parent reports no new foods, no new detergents or skin products, no cold sxs, no insect bites, no plant exposure, and no one else with similar rash. For aggravating factors, parent reports nothing makes it worse. For associated symptoms, parent reports no fever, no cold symptoms, no nausea, no vomiting, no diarrhea, and no urinary symptoms.  started on Zyrtec
Patient noticed red, papular swelling over injection site with 2 other lesion near the site hour after injection and no soreness or urticaria response.
12/8 itching, pain at site, warm to touch, 8" x 6". 12/9 larger area - very sore. 12/10 seen doctor cellulitis.
Child presented with fever 101.2 and full body rash upon waking morning of 08/13/2019. Child also presenting as feeling unwell (crying, whining, comfort nursing) As of evening 08/14/2019 fever has lowered to 100.7. Rash remains unchanged.  Child also has Thrush, which presented 08/11/2019.
I notice this ONLY upon waking, while still lying in bed. NOT every day, but has happened anywhere from 1 to 5 days out of 7 since first occurrence. Upon breathing deeply through the nose, at the end of the breath, I feel a sensation (mild pain) behind my left breast, seemingly in lung or near heart. On each breath. Occasionally, when I have turned on my left side (during this same waking time), I have had a more widespread pain along the side of my body next to my left breast. This is not being felt IN my breast, but behind or beside.
Anal Swelling, Internal Cyst, Anal infection leakage, bleeding since March 30th, 2021. Anus swells every three days, then discharge with pus and blood. Development of Pilonidal cyst/sinus. Pressure and pain at anus.
Fever; Head and body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) and HEADACHE (Head and body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Head and body aches). The patient was treated with IBUPROFEN on 02-Apr-2021 at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and HEADACHE (Head and body aches) outcome was unknown.            No concomitant product reported by the reporter
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0342F1A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Chronic fatigue, Restless legs, Post-traumatic stress disorder and Allergy to antibiotic (Vancomycin). Concomitant products included PACLITAXEL from 21-May-2022 to 29-May-2022 for an unknown indication.    On 07-Nov-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency; METHYLPREDNISOLONE at a dose of 4 milligram and DOXYCYCLINE MONOHYDRATE at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.            On 21-MAY-2022, Patient received Cough medicine and medicine was stopped on 27-MAY-2022. On 6-JUN-2022, the 16th day after start of COVID symptoms patient experienced fever, chills, body ache, diarrhea, headache, fatigue and appetite loss which were resolved. She became very fatigued and got a fever. She had issues with breathing.  Company Comment: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 4 days. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 4 days. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), FEELING ABNORMAL (head fog), LETHARGY (lethargic) and PAIN IN EXTREMITY (sore arm) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Mar-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), FEELING ABNORMAL (head fog), LETHARGY (lethargic) and PAIN IN EXTREMITY (sore arm). On 30-Mar-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (breast feeding), FEELING ABNORMAL (head fog) and LETHARGY (lethargic) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. It was reported, patient had a child on 25-OCT-2021.
Cellulitis of the upper arm, went to urgent care and received antibiotic treatment approximately 2 weeks after receiving vaccination.
Information has been received from a pharmacist concerning a 69 year old male who on 23-OCT-2006 was vaccinated with Pneumovax 23 (lot #654981/0674F). On an unspecified date, the patient sought medical attention. The symptoms on 24-OCT-2006 were a sore arm from elbow to shoulder in the injection site arm. The patient could not move the arm without pain. The patient was also nauseous. The pharmacist reported that it was unknown how soon after the vaccination the symptoms occurred. The patient's current state was unknown. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and Research and was released by the agency. Additional information has been requested.
Patient developed a low grade fever around 30 hours following the vaccines. Her stool changed from seedy and normal liquid based to extremely seedy and thick. At 48 hours she developed significant mucus in her stool and we followed up with a pediatrician. When her symptoms did not improve or resolve by the following week we provided a stool sample and she tested positive for rotavirus as well as blood in her stool. The pediatrician advised that patient may have a dairy or egg allergy. She is exclusively breastfed and I, the mother, am consuming an entirely vegan diet and patient has not shown any improvement at this time. We met with a lactation consultant on May 21st (prior to her being vaccinated) and she was diagnosed with mild GERD but they were confident after examining her and her stool that she did not have any food allergies. My husband and I are confident that her symptoms are a direct result of the rotavirus vaccine and are extremely discouraged that we have not been able to get her well.
Narrative:  46yo female patient died at outside facility on 12/23/2021 with diagnosis of STEMI/Sinus Tachycardia, - heart condition. (pt presented to ER - was evaluated and transferred to hospital for heart cath procedure- where pt later died) Past Medical Condition: Esophageal varices (SCT 28670008) Nondependent alcohol abuse in remission (SCT 191884001) Intracavitary uterine fibroid (SCT 25911Cervical disc disorder (SCT 425878001) Severe alcohol dependence (SCT 713862009Alcohol-induced mood disorder (SCT Depressive disorder (SCT 35489007) Anxiety (SCT 48694002) Alcohol intoxication (SCT 25702006) Alcohol intake exceeds recommended daily limit (SCT 429775004) Heavy cigarette smoker (20-39 cigs/day) Alcoholic liver disease (SCT 41309000) Hepatic fibrosis (SCT 62484002) Alcoholic fatty liver (SCT 50325005) Polyp of colon (SCT 68496003) Liver mass (SCT 300332007) Dislocation of patellofemoral joint (SCTJoint pain (SCT 57676002) Hearing loss (SCT 15188001) Heart murmur (SCT 88610006) Constipation (SCT 14760008) Musculoskeletal pain (SCT 279069000) Pt had received covid vaccines on 8/31/21 & 6/8/21, 5/11/21 at non-facility site (grocery store). Pt died of heart attack. This death is likely not related to the vaccinations due to patient's length of time from vaccine administration.
This spontaneous report as received from a Pharmacy Technician refers to a 45 year old female patient. Patient's drug reaction/allergies (current conditions) included hydrocodone allergy and penicillin allergy. No pertinent medical history was reported. On 27-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, 1 dosage form (DF), unknown frequency into right arm, lot # N013521, Exp date: 23-JAN-2019 for vaccination. Concomitant medications included ibuprofen and PROZAC. On 28-FEB-2018, the patient experienced dizziness and pain in the right part of her body (pain started in the right side of arm pit, up to the joint of the shoulder, radiating down to the elbow and on to the back of the shoulder), (dizziness, arthralgia, irradiating pain, pain in right arm). No further information was provided. No treatment was given for the events. No lab diagnostics/studies were performed. There was no sought to medical attention and no intervention to prevent seriousness criteria. No product quality compliant (PQC) was present. The outcome of events were reported as not recovered. The reporter did not report the causal relation of events with respect to PNEUMOVAX 23.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. On an unknown date, the patient was vaccinated with 2 doses of PNEUMOVAX 23 (dose, frequency and route were not reported) within a year. No adverse effects were reported. Additional information has been requested.
I developed a lump under my arm after #1, It went away then returned after #2, then went away. After vaccination #3, the lump returned and has not gone away. It has not been at least 6 weeks. When I went to get a routine mammogram this week I was turned away and referred back to my doctor, due to the lump. They asked my doctor to look at it and if appropriate, order more advanced diagnostics. The lump is located on the underside of my arm, opposite the injection. It is soil, somewhat painful, and seems to vary in size from day to day. It was not there before #1 and it has not entirely gone away since it first appeared. I have an appointment with my doctor tomorrow morning.
L delt-approx. 1 inch below injection site-baseball size area of tenderness, erythema, edema to site.
Received a 3rd COVID shot, will state None of the Above for Item 21 because we were unable to get a hold of the nursing staff to see how patient is doing.
Large area of induration progressively spreading starting on day after vaccination. Not painful or bothersome.
Patient received HPV and influenza vaccine on a mobile medical van.  After vaccine administration client reported feeling lightheaded and had delayed verbal responses. Client observed to sway in his seated position but did not fall or lose consciousness. Blood pressure, heart and oxygen saturation vitals were gathered. Patient given snacks and bottled water. Cooled with ice packs and elevated legs.  Client still reported feeling lightheaded. Patient walked into school accompanied but with no assistance. School Principal was notified of condition and student's family was notified. In the school patient given milk and cereal but still was swaying with delayed verbal responses and reported feeling dizzy. Vitals were taken again. Decision to call 911 for further assessment was made. Relayed patient's condition to paramedics on ambulance. Family member accompanied student on ambulance to hospital. Patient never appeared to lose consciousness, remained verbally responsive and answered questions appropriately throughout whole encounter.
This spontaneous report as received from a medical assistant refers to a patient of unknown age.    On an unknown date the patient was vaccinated with a dose of improperly stored VAQTA lot # N020689 expiry date 22-OCT-2018 (product storage error) for prophylaxis. The medical assistant reports that the details of the excursion are unknown as they are due to a shipping issue. No adverse effects reported. No additional information provided. Temperature and time frame was unknown by reporter. No previous temperature excursion was involved. The digital data logger was not involved. This is one of the two reports linked via same reporter link.; Sender's Comments:  US-009507513-1801USA014574: