chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FATIGUE; WEAK; HEADACHE; UNABLE TO FOCUS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, gout, and seasonal type allergies, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 07-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced weak. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced unable to focus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, weak, headache, and unable to focus on 09-MAR-2021. This report was non-serious.
This spontaneous report was received from office manager via field Representative refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot number/expiry date not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected, as there is no consent to contact the physician.
After 4 days of my first dose of moderna vaccine i felt tightening on my throat.  I took benadryl, after like 15mins i started to feel relieved.  That?s why I?m not taking the second dose.  And the. 14 days later after that first dose i woke up in the middle of the night feeling like my chest gonna pop out, i counted my pulae they were normal but i was so weak to even get up and get water on the table which was 6 steps from where i sleep.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) (seriousness criterion hospitalization). The patient was hospitalized for 7 days due to IMMUNISATION REACTION. At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The concomitant medication was not reported.  The treatment medication was not provided. Patient was administered with Moderna COVID-19 vaccine and it put her in hospital for a week.  Company comment- This spontaneous case concerns a female of unknown age with no reported medical history, who experienced unexpected, serious (hospitalization) event of Immunisation reaction which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient was vaccinated with a dose of mRNA-1273 on an unknown date. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.; Sender's Comments: This spontaneous case concerns a female of unknown age with no reported medical history, who experienced unexpected, serious (hospitalization) event of Immunisation reaction which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient was vaccinated with a dose of mRNA-1273 on an unknown date. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.
Swelling of injection site, left arm pit by pec, left neck, and under chin. Fatigue, hard to focus, numbness left elbow and hand/fingers.
This spontaneous report as received from a nurse refers to a 9 months 10 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Client became anxious 5 minutes following injection. Complained of short of Breath, being dizzy .R.N working with her and mom. in observation area,  Assessed by EMT's. Vital signs stable. At 15 minute mark, EMT's evaluated client to be medically Stable and able to be discharged home.
Moderate fever, severe headache, full body chills, sweating, fatigue. Lasted all day 3/27/2021. Treated with ibuprofen, water and sleep.
31 y.o. Male (non-smoker) received first dose Pfizer on 9/14/21 without any side effects noted.  Went to ED 9/15/21 w/ Rt. calf pain and diagnosis of DVT. Sent home with RX for Xarelto .  Prior history of Covid infection in July 2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "UC with ileostomy" (unspecified if ongoing); "UC with ileostomy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 02Jan2015. Past drug history included: Prilosec, reaction(s): "Allergy: Prilosec". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 with Paxlovid and treatment start date was 20Jul2022 and stop date was 25Jul2022.  Clinical information: Paxlovid treatment start date 20Jul2022, treatment stop date 25Jul2022. Device Date 30Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient complained of itchiness on face around right eye - patient also admitted that she was nervous. Slight redness on tip of nose and chin - possibly from wearing a mask, Patient denied any itching or swelling of tongue or lips. patient is alert and oriented
Inadvertent temperature excursion, vaccine stored in freezer beyond allowable two week excursion protocol. Per Pfizer, no concern for any other adverse events, recommended repeating dose.
Patient developed hives, facial swelling, throat swelling/itching, and nausea approximately 13min after vaccination while in observation. Patient immediately taken to Emergency Department where epinephrine was given IM in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course.
Multiple dizzy spells while sitting; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (lot number: EL3248) via an unspecified route of administration in Left arm on 15Jan2021 08:45 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included bupropion, clarithromycin (CLARITIN). The patient previously took cefalexin monohydrate [KEFLEX] and experienced drug hypersensitivity. The patient experienced multiple dizzy spells while sitting on 15Jan2021 14:30 with outcome of unknown. No treatment received for event. The patient was not pregnant.
Did not receive second dose, per HCP; Rash all over; Very red; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose, per HCP), RASH (Rash all over) and ERYTHEMA (Very red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SIMVASTATIN, TERAZOSIN, OMEPRAZOLE and IRBESARTAN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Rash all over) and ERYTHEMA (Very red). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose, per HCP). On 04-Feb-2021, ERYTHEMA (Very red) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose, per HCP) had resolved and RASH (Rash all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Added new events and outcome
Missed the 2nd shot of Moderna vaccine; passed 36th days after receiving the 1st dose of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed 36th days after receiving the 1st dose of vaccine.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history provided by the reporter.     On 15-Apr-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 PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed 36th days after receiving the 1st dose of vaccine.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (passed 36th days after receiving the 1st dose of vaccine.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       the patient had not experienced any side effect with first dose of vaccine ,further patient stated that he  missed the scheduled 2nd dose appointment on 13May2021.
Pt developed erythema and warmth at the site of injection. Parent states the child's arm became swollen during the evening on 7/29/02 date of injection and has got worse over night. Pt given Claritin 5mg and Predisolone 5mg.
it was rpt fr MD concerning pt whose sibling was vax on 13jul98 & on 20jul98 the pt exp a full blown case of varicella. the sibling devel 10-15 lesions
Pt complained of left arm soreness, red, painful. Also complained of chills, nausea, vertigo. No vomiting. Pt states symptoms were resolving by 12/8/05 and resolved by 12/9/05.
Case number PHEH2014US004926 is an initial spontaneous report from a consumer received on 06 Mar 2014. This report refers to a 64 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13412P) intramuscularly into her left arm on 04 Nov 2013. Since her vaccination, she experienced severe pain at the vaccination site on her left arm. In the past four months, the pain only increased. The patient described the pain in the site as hot and burning pain. She woke up from sleep because of the pain and it was tingling. She could not stretch her muscles without thinking of the pain. She had to stretch a lot as she was short and it hurt when she tried to stretch. She was in pain when a tight jacket or shirt was rubbed against the vaccination site. She was compensating for her pain and due to that her back hurt. Her entire left arm above the elbow was paining, but the most severe pain was localized to the areas immediately above and below her left elbow. She did not try to get any pain relief as nothing made the pain better. She had an appointment with a neurologist followed by an appointment with an orthopedist for pain evaluation. The patient did not recovered from the events. The causality and seriousness of the event were not reported.
light headed; Fast pulse; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast pulse) and DIZZINESS (light headed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A25A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis (5 years ago) since 2016. Concomitant products included SPIRONOLACTONE for Fluid retention, MERCAPTOPURINE for Ulcerative colitis, ATORVASTATIN, ASCORBIC ACID (VIT C), VITAMINS NOS (MULTI-VIT), COLECALCIFEROL (VITAMIN D 3) and CALCIUM for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced HEART RATE INCREASED (Fast pulse). On an unknown date, the patient experienced DIZZINESS (light headed). The patient was treated with APIXABAN (ELIQUIS) for Anticoagulant therapy, at a dose of 5 mg. At the time of the report, HEART RATE INCREASED (Fast pulse) had not resolved and DIZZINESS (light headed) outcome was unknown.            The doctor said to stop Eliquis 5 mg from 8-11-2021 for one week. Patient's weight was 140 unit was not mentioned. Since the second vaccine in March, her pulse was continuously around 90 to 110, daily. It doesn't drop. Her normal pulse was around 50-55, before the vaccine   This case was linked to MOD-2021-024617 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: significant follow up received in which  updated the outcome of the event of fast heart rate as not recovered/not resolved. Dizziness was added as an event. iNarrative supplement was updated.
Patient with 3 COVID vaccines who admitted with pulmonary embolism and positive COVID PCR.  Provider d/c note: "50 year old female with PMHx significant for active cholangiocarcinoma s/p unsuccessful chemotherapy, pulmonary embolism on Lovenox, asthma, and depression who presented to the emergency department following a positive COVID-19 test the evening prior to admission. Since she had her diagnosis of a PE she has had shortness of breath but feels that it has worsened in the past week. In addition she endorses nausea, poor appetite, worsening fever, and generalized malaise x3 days. She also had a cough that has become more productive in the last 24 hours. She has not examined her sputum. Patient has recently underwent a second opinion for her cholangiocarcinoma at Clinic, and is set to begin gemcitabine, dose attenuated cisplatin, and durvalumab for further palliation. Infusion was to begin today. She recently underwent a port exchange approximately once week prior to admission, during the procedure was found to have SVC occlusion and required angioplasty.             Upon arrival the patient underwent a CTA, finding a right sided pleural effusion without signs of pulmonary embolism. In addition she was found to have a consolidation in the right lower lobe concerning for pneumonia. She again tested + for COVID-19.    Hospital Course:  1. CAP: from COVID-19 URI with likely supraimposed bacterial PNA. Pt initially febrile though improved. Otherwise hemodynamically stable. Urine strep/legionella Ag negative. Blood cx also negative She was started on empiric ceftriaxone/doxycycline with improvement in symptoms. She was discharged on Levaquin to complete course of abx   2. R pleural effusion: possibly related to above vs malignant effusion. Given elevated INR and lack of hypoxia thoracentesis was deferred   3. Cholangiocarcinoma: follows with Health    4. Hyponatremia: suspectd due to dehydration. Improving    5. Thrombocytopenia: likely reactive-repeat CBC in few days    6. Normocytic anemia    7. Hx PE - Continue Lovenox   8. MDD - Lexapro   Issues Requiring Follow Up:  - Follow up with PCP, oncology"
Extended dosing interval (>42 days); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Extended dosing interval (>42 days)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended dosing interval (>42 days)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Extended dosing interval (>42 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Headache, Nausea, Vomiting, Bleeding Gums, Fever Blisters, Oral Lesions. Metal Taste in Mouth. Only Able to eat soft foods. Jan-May. Took 3 rounds of antiviral.   Also went to dentist because of oral pain.
patient states she had a reaction that started 2 days after the immunization. Patient experienced arm redness, itchy, feverish arm, arm pain, and rash/hives as the reaction was resolving. All reactions were only on the arm that received the injection. she went to the md on day 3 for a cortisone shot and the reaction completely resolved after about 5 days. She is completely better now with no issues per patient.
Feeling symptoms of long covid. Brain fog, irregular heart rate as recorded by a smart watch, lower cardiovascular fitness, lower energy, weaker metabolism, eye floaters, oversleeping, high resting heart rate, high cholesterol.
couldn't swallow normally; I could only breath easily with mouth open; This is a spontaneous report from a contactable consumer (patient) reported herself. A 60-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: not provided), via an unknown route of administration in right arm on 14Mar2021 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization at pharmacy. The patient's medical history included high blood pressure. No Known allergies. She was not allergic to medications, food, or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications in two weeks. On 14Mar2021, half hour after taking the shot, the patient felt that she could not swallow normally and thus felt she could only breath easily with mouth open. The sensation lasted about 30 min. But drinking water helped. She continues to have these episodes intermittently. She started taking allergy pills and nose allergy medicine. She decided not to take the second shot after consulting with her doctor. The doctor told to get the shot at the hospital. It was scary to think that this symptom could become worse with a second shot. She continues to have this sensation once a day about 4times a week. The patient did not result to visit emergency room and physician office. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was unknown if COVID tested post vaccination. No treatment received for event. The outcome of the events was recovered with sequel.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-SEP-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # K009471 and expiry date: 03-JAN-3026) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date0 affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
All-over achiness; Flu-like tender skin; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13May2021 at 07:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to medications, food or other products. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Apr2021 at 08:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had no reaction to first dose. On 13May2021 at 15:30, eight hours after second dose, the patient experienced all-over achiness and flu-like tender skin which and lasted about 30 hours. The events did not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events all-over achiness and flu-like tender skin which included treatment with extra-strength acetaminophen. The clinical outcome of events all-over achiness and flu-like tender skin were resolved on an unknown date in May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling and redness at vaccine site prescribed BACTRIM antibiotics and BENADRYL for 10 days.
Bells Palsy type symptoms starting April 16, gradually increasing in frequency for next 3 and one half weeks and now gradually subsiding. Caused doctor, hospital ER visits and the care of a neurologist.