chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Vaccines were not frozen at time of administration. Vials only punctured right before administration - during COVID-19 vaccine clinic all doses were drawn from vial due to high-pace clinic. On 11-Jan-2021, Excursion time was 2 PM, temp was 35, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021, Vial was moved to clinic on 11-Jan-2021. 9 vial was moved to clinic. Vaccine BUD date was 07-Feb-2021. Vials only punctured right before administration Fisher brand traceable temperature monitor was used to record hourly temperatures. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F Vaccination time reported 4:21:00 PM dated 11-Jan-2021. Treatment medication were not reported.
Patient reports received Moderna covid vaccination #1 in RT arm a Clinic on 9/29/21, reports RT arm and RT neck pain day 9/29.  Reports 9/30 and 10/1 symptoms include headache; RT upper arm injection site pain and swelling; RT neck and ear pain; numbness Rt face and from RT upper arm to RT hand; swollen lymph nodes RT side of neck; not feeling well. EE reports palpitations and anxiety secondary to symptoms. EE denies difficulty breathing, speaking, or swallowing.  EE advised to seek medical care and notify clinic.  outcome pending
headache; body ache; pain at injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VACCINATION SITE PAIN (pain at injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 02-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.
48 hrs after injection pt had 1 1/2" x 3/4" red/hot area on Rt thigh.
Patient developed a rash (spots) in both arms after 12 minutes of administration. She said it was not itching that much but she felt a tingling sensation. I provided 50mg of benadryl liquid  and made patient wait 15 more minutes ( 30 minutes total) patient went home after feeling ok. She will be called tomorrow to reassess.
ringing in ears for 2 hours with blurred /decrease in vision which still remains, frequent headaches
Symptoms were extreme increased thirst, frequent urination, extreme hunger, weight loss, fatigue, and blurred vision.
Information was received on 03-APR-2017 from a nurse practitioner (also reported as registered nurse) regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 22-MAR-2017 the child was administered a third dose of VARIVAX (considered inappropriate schedule of vaccine administration). The dates of administration for the first and second doses of VARIVAX that the patient received were unspecified. No adverse effects were reported. Action taken was not applicable and outcome was not provided. No further information was provided. Additional information has been requested.
Heart palpatations dizziness. Heart cath, stress test, given ctapress, Topral XL. Symptoms started to increase on 7Mar03. Emergency room visit diagnosed with palpatations. Cardiology consult given. I ignored symptoms for about two weeks.
Less than 3 weeks after receiving this dose, I was in the hospital for spontaneous bilateral pulmonary embolisms. I do not know if these events are related, since I do have a family history of blood clots, but I have never had problems before and was not injured prior to the onset of the embolisms.
Pt when asked he stated that this was his first vaccine. When paperwork was brought back to health department and clerk was imputting pt was found to have had a Janssen Vaccine on 04/06/2021 at Health Dept.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients. The patients received doses of ROTATEQ and GARDASIL on unspecified dates that were improperly stored since an unspecified date in April 2012 until an unspecified date in April 2014. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
The case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 19 September 2013. Four patients (no information was provided regarding the patients) had received an expired dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Mild itchy, red, raised rash, started the following morning on abdomen then spread covering body.
Patient developed severe headache 5/9/21, described as squeezing pain as a band around his head. Headache not relieved by meds. Symptoms worsened and 2 weeks later wife noticed abnormal gait then found patient unresponsive. Admitted to hospital and found to have intracranial and subarachnoid hemorrhage.
Headache; This spontaneous case was received on 17-Oct-2021 from other non-healthcare professional via regulatory authority (reference number: SEQW21-04037) and concerned a 98-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 07-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Fluad Quad, the patient experienced the worst headache ever later that day.  On 08-Oct-2021, the patient recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked with teh case 202103901 (the same reporter).  Company comment: The event of 'headache' was assessed as related to Fluad Quadrivalent.; Sender's Comments: The event of 'headache' was assessed as related to Fluad Quadrivalent.
felt sick, shaky; feeling hot; intermittent nausea; Shaky; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick, shaky), FEELING HOT (feeling hot), NAUSEA (intermittent nausea), HEADACHE (Headache) and CHILLS (Shaky) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Shingles on 16-Apr-2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (Headache). On 14-May-2021, the patient experienced ILLNESS (felt sick, shaky), FEELING HOT (feeling hot), NAUSEA (intermittent nausea) and CHILLS (Shaky). At the time of the report, ILLNESS (felt sick, shaky), FEELING HOT (feeling hot), NAUSEA (intermittent nausea), HEADACHE (Headache) and CHILLS (Shaky) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-JUN-2021: Contain Non significant information On 16-Jul-2021: Follow up received on 16-JUL-2021: Events outcome was updated to recovered.
diarrhea; Information has been received from the patient's mother via an employee referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.     On an unknown date in February 1988 (reported as 32 years ago), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status unknown, (subcutaneous; strength, frequency, lot number and expiration date unknown) for prophylaxis.   On unknown date in 1988 (reported as shortly afterwards, 32 years ago), the patient developed severe diarrhea. The patient was seen by an unknown physician who prescribed an unknown treatment. It was unknown if any lab diagnostics or studies were performed for the event. On an unknown date, the patient recovered from the event. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Itching; Muscle pain; Rash and itching hives in face and in other parts of body; Rash and itching hives in face and in other parts of body; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date: unknown), via an unspecified route of administration on an unspecified date, 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itching, muscle pain, rash, and itching hives in face and in other parts of the body. The patient mentioned that these were some type of reactions from the first shot that the patient had of the COVID-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
4 days after vaccine arm started aching. Shot given on 4-11-11 symptoms started on 4-15-11. On 4-17-11 arm swollen & hot. Ached clear to wrist. On 4-18-11 pt was dizzy & uncoordinated with itching over entire body. Started on steroids on 4-18-11.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 17 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
He began getting dizzy immediately after vaccine - pale, sweating, and felt like he was going to vomit.  He remained in the IMZ room for observation and applied a cool compress to forehead and back of neck.  Coloring came back after about 10-15 minutes and he said he felt better.  Also mentioned that this happened to him after he got a TDap vaccine about 15 years ago - he said it is a mental thing with him and does not like to get vaccines.
I tested positive for Covid-19 on August 5, 2022 I experienced high fever 104.00, severe sinus headache, severe cough, nausea, diarrhea, loss taste and smell, sore throat, I was taking Tylenol and I was prescribed Paxlovid.
Diarrhea/My diarrhea symptoms are anywhere from 3-8 times per day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EN6203 6121) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing), notes: High Blood pressure; "High Cholesterol" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PROPRANOLOL; LISINOPRIL; OMEPRAZOLE. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". Vaccination history included: Bnt162b2 (Dose number: 1, lot number: EL9262 5121, vaccine location: Left arm), administration date: 06Feb2021, for COVID-19 immunization, reaction(s): "No adverse effect". The following information was reported: DIARRHOEA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "Diarrhea/My diarrhea symptoms are anywhere from 3-8 times per day". The event "diarrhea/my diarrhea symptoms are anywhere from 3-8 times per day" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Patient received dose: 3, lot number: 301358A, vaccine location: Left arm), administration date: 01Oct2021, for COVID-19 immunization.The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine. I did not have adverse effects from either of the first two doses of the Covid vaccines. Diarrhea has continued even after my booster shot (3rd overall shot). Prior to vaccination, the patient was not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.
Flu-like symptoms - fever, chills, nausea, body aches - for one week, Followed by itching scalp and back that flared up with small bumps on head, back of neck, middle back and groin that came and went for several weeks. Returned vigorously in January 2019 with raised patches of scaly skin on forehead, eyebrows and tops of ears. Small bumps alsoappeared in v-shape on upper chest. Bumps on back expanded to back of waist. Extreme itching. In January Dr. prescribed prednisone and topical cream. The prednisone diminished the symptoms, but as I tapered off it was apparent the cream was not having a noticeable effect and symptoms returned. During this time I have had 4 extreme genital herpes flareups. Since I was diagnosed over 30 years ago I have rarely had more than 1 or 2 flareups per year. Also in January the Dr. prescribed Valcyclovir to try to stave off the herpes flare ups. I am now on prednisone and Valcyclovir almost constantly. When I reduce or stop the prednisone or stop the Valcyclovir, the itching, bumpy skin and scaly patches return and I get the foreshadowing of a herpes outbreak. I have also experienced some persistent gastrointestinal upset, inner ear inflammation, and balance problems.
Patient provided different names, as a result vaccinated several times. 2/9/2021 - Moderna. 3/9/2021 - Moderna. 5/26/2021 - J&J. 11/8/2021 - Moderna. 2/23/2022 - Moderna.
Narrative:  COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 08/27 COVID swab, result: detected 08/27 pt cc: NO SYMPTOMS exposure: unknown
She's been having a fever for the last 3 days; Lost of appetite; Weak - almost collapsed half way to the bathroom; Never been so sick; it's been up to 103 degrees; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost of appetite), ASTHENIA (Weak - almost collapsed half way to the bathroom), ILLNESS (Never been so sick), PYREXIA (it's been up to 103 degrees) and PYREXIA (She's been having a fever for the last 3 days) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced DECREASED APPETITE (Lost of appetite), ASTHENIA (Weak - almost collapsed half way to the bathroom), ILLNESS (Never been so sick) and PYREXIA (it's been up to 103 degrees). On an unknown date, the patient experienced PYREXIA (She's been having a fever for the last 3 days). On 08-Feb-2021, DECREASED APPETITE (Lost of appetite), ASTHENIA (Weak - almost collapsed half way to the bathroom), ILLNESS (Never been so sick) and PYREXIA (it's been up to 103 degrees) had resolved. At the time of the report, PYREXIA (She's been having a fever for the last 3 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 103 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included high blood pressure pills. Treatment medications included Fever reducers- over the counter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2021: Adverse event information was updated.
Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/30/21 (ER8727) Pfizer Dose 2 4/21/21 (ER8731) COVID Positive 11/30/21 COVID Positive 12/2/21  12/2/21: Patient is a 59-year-old male with past medical history significant for COPD, OSA on CPAP, obesity, hyperlipidemia, history of PE currently anticoagulated on Eliquis, IFG, hypertension, and anxiety.  The patient presents to the ED today via EMS from home with complaints of worsening shortness of breath.  The patient tested positive for COVID-19 3 days ago.  The patient states his symptoms started on 11/26/2021.  He states his shortness of breath has worsened over the last 2 days and admits to frequent cough attacks causing him to become lightheaded and significantly dyspneic.  The patient's accompanying symptoms include fever, chills, cough, dizziness, lightheadedness, nausea and fatigue.  The patient denies any chest pain, diarrhea, loss of taste or smell, vomiting or abdominal pain.  The patient has been using albuterol nebulizer treatments at home without relief of symptoms. The patient denies ever being on oxygen supplementation in the past.  The patient is vaccinated against COVID-19.  The patient denies any alcohol abuse, illicit drug abuse or tobacco use.  The patient is a former smoker, quit 5 years ago.   The patient presents via EMS - his oxygen saturation was 87% on room air EN route, patient was placed on 4 L oxygen via nasal cannula to maintain O2 saturations greater than 90%.  Upon arrival to ED patient's temperature is 100.9°, heart rate 91, respirations 18, pulse ox 93% on 4 L oxygen via nasal cannula, blood pressure 125/94.  Chest x-ray reveals patchy bilateral pulmonary infiltrate/airspace disease consistent with COVID-19 pneumonia.  Patient's laboratory findings are significant for sodium 132, chloride 95, glucose 112, calc Osmo 266, CRP 12.70, D-dimer 0.78.  Patient received 1 g p.o. Tylenol, DuoNeb x1, 500 mg IV azithromycin, 1 g IV Rocephin, 6 mg IV Decadron in ED.  12/6/21: 59-year-old man who presented worsening fever, myalgias, shortness of breath following diagnosis of COVID-19 infection 3 days prior.  He was found to be hypoxic on evaluation in the emergency department requiring initiation of supplemental oxygen, Chest x-ray demonstrated bilateral patchy infiltrates.  He was admitted to the hospitalist service where he was started on treatment with IV Decadron, remdesivir and empiric antibiotic therapy.  Abruptly worsening oxygen requirements were noted requiring initiation of high-flow oxygen up to 12 liters/minute.  Pulmonary was consulted, he was given a dose of Actemra with marked in improvement in CRP levels and subsequent improvement in oxygen requirements.  Oxygen walk was done for home determination done today, he did not meet criteria for home oxygen at this time.  He has been discharged in stable medical condition to continue outpatient follow-up.