chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Phlegm Continued post first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm Continued post first shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Phlegm (Patient states that he had phlegm since after Christmas (about 7 weeks prior to vaccination).).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCTIVE COUGH (Phlegm Continued post first shot). The patient was treated with AZITHROMYCIN on 11-Feb-2021 for Phlegm, at a dose of 1 dosage form. At the time of the report, PRODUCTIVE COUGH (Phlegm Continued post first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative 7 weeks prior to the vaccination and negative (Negative) Negative 3 weeks prior to the vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's doctor prescribed Azithromycin on 11FEB2021  a day before vaccine, but patient did not take it because patient  thought it might interfere with the vaccine efficacy. No concomitant drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-Significant follow up : Address was updated. Email ID was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a Licensed Practical Nurse refers to a 17 year old female patient. No medical history, drug allergy and concurrent conditions was reported. On 10-MAR-1998, the patient was vaccinated with VARIVAX (Merck) dose 1 (Strength, route and lot number were unspecified). Patient's mother told the reporter that her child broken out chickenpox (varicella) on an unknown date in April 2004. It was unspecified whether treatment was given for the event. Nurse then stated that antibody titers were drawn for the patient on 03-MAR-2015, but the results were negative. Patient sought medical attention. No product quality complaint (PQC) involved. The outcome of events were unknown. Reporter causality assessment was not provided. Additional information has been requested.
Patient received Hep A vaccine #1 at 0843. At 1000 mother of patient noticed red hives on patient's left shoulder. At 1030 hives begin to cover the patients entire body. Mother of patient reports one episode of vomitting. Patient reports no signs of breathing difficulty or itching.
Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had neck pain, back pain/has a lot joint neck and back pain, arthralgia and discomfort, with outcome of unknown. Clinical course: The patient received first shot yesterday and experienced a little bit of discomfort, which was not that bad. Nurse told him he will not be able to take Tylenol or ibuprofen. Patient has a lot joint neck and back pain. The patient does not take them regularly but might have taken it the night before the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
3 days p/vax pt had edema & @ the site of inj 4 1/2cm x 5cm indurated rosy patch;mildly tender, warm;
Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves patient of an unknown demographics who received vaccine ADACEL lot number not reported via unknown route in the gluteus instead of the deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided. It was a case of actual medication error due to Vaccine administered at inappropriate site. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and ARTHRALGIA (joint pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     The patient's past medical history included Sickle cell disease.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (Headache) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided          No concomitant medications were reported. No Treatments were reported. Action taken with mRNA-1273 in response to the events was not Applicable.
Fainted about 2 minutes after getting the vaccine. She regained consciousness immediately. Patient was monitored while the ambulance arrived. Patient was assessed by the EMT and mom took patient home. She said she'll consult with her PCP.
Her left arm and her shoulders muscles was sore for a few days; Her left arm and her shoulders muscles was sore for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days). At the time of the report, PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 and contains non-significant information.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Blood Disorder  (diagnosed by MD)-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Medium, Systemic: Nausea-Mild, Additional Details: pt had adverse reaction from covvid vaccine; lead to abnormal menstruation on 9/20. pt managed until 10/25 she noticed spots over her body and torso. Md stated pet. hemmorhage. which led to office visit to treat from abnormal menstruation.
pt recvd vax;devel atrophic condition of muscle & the fat tissue at inject site on rt arm;3rd inject given at alternate sight resulted in no adverse rxn;
After having 36 hours of expected side effects (headache, low grade fever, fatigue, myalgia) then had nausea and fatigue few days.  This past 3 d had horrible headache, then nausea, little diarrhea and fogginess.  I otherwise don?t have evidence of being ill such as fever, myalgia, sore throat.  I realize that similar sx have occurred 2 other times since vaccine # 2 each lasting few days so wanted to report it so you can collect post- marketing data to determine if such things might be related.
A non-serious spontaneous report of administration to 62-year-old was received from a registered nurse/other health professional concerning a 62-year-old female. The patient's medical history included diabetes and chronic lung disease. On 10-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter sponsor causality assessments are not applicable, and the event is considered resolved.
Patient was given Flublox which is recommended for 18 years and up. This patient is 16 years old.
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients did not have drug reactions.  On unknown dates, the patients were vaccinated with improperly store doses of ROTATEQ orally (dose, lot number and expiration date were not reported) for prophylaxis. The temperature exposure was 47-77°F (49°F) for 30 hours. Previous temperature excursion was not reported, and a data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1704USA003069: Original Case : 1704USA003069 US-009507513-1704USA003210: Original Case : 1704USA003069 US-009507513-1704USA003212: Original Case : 1704USA003069.
Soreness at the site of injection no redness at the site.  Rash on back and chest ,  itching .  neck itches also    Caller states got the Moderna vaccine at around 1030 today. About 30 minutes ago noticed some itching and a fine rash on the upper back and chest.   No respiratory symptoms.  Took a claritin  10mg.   if no response an symptoms worsen call 911 or go to the nearest er.
Violent shaking and chills that started at approximately 8:30 p.m., almost 4 hours after vaccine. That continued until  about 12:00 midnight  with a high fever that lasted until 9:00 - 10:00 the following morning. I used Ibuprofen to help with  fever. I did not feel capable of driving and did not seek medical care other than contact with an RN by phone during this time. During the next 2 days I developed a runny nose, occasional cough and was very tired.
11/8/16 received email from HR at pt's worksite stating pt contacted them about a reaction after flu shot. Pt stated she got bursitis. Pt C/O pain to front side of shoulder (L). Pt was given exercises, to help alleviate the pain, by her MD.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 26-JUN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Seizure. Was fussy during the day yesterday. Woke up crying at night. Eyes rolling back, nose and lips turned blue, stiff, no shaking, lasted 2 min, groggy afterwards. Also has some redness/ warmth to left thigh. No fever, but temp 99.9 tymp at 230 am- got some TYLENOL. In ambulance temp was 100.7 rectal. Left leg is a little red and does not want it touched. Tolerating feeds well today. No emesis. Is a good mood. No fever today.
The day after the vaccine, I could not walk because my knees kept collapsing. I had very   very sharp pains in my legs, arms, shoulders, hips, and feet. Burning sensations in my legs. I also started with shortness of breath.  I had muscles spasms in my legs causing involuntary movements. This last until the beginning of May and the pain subsided somewhat. To this day, I still get sharp pains in my legs and cannnot stand more than 10 minutes without a lot of pain.
onset 24hr p/vax little bumps (red) neck & legs & inc in size & spread 48hr all over body;72hr later large raised blotches 6" circumference-diff breathing-face-legs eyes swollen;went to ER;raised pruritic rash over extremities;dx urticaria;
Localized redness, swelling, pain at site of injection. Hives/rash on back as well.
Sore throat; Terrible reflexive barking cough; Severe head congestion; Dose received: 3; A FEW HOURS AFTER BOOSTER INJECTION; Mild fever/Low grade fever; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Sep2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic and autoimmune issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included insulin (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and unspecified vitamins; all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received varenicline tartrate (CHANTIX) and experienced drug allergy. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 43-years-old) and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 11:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On  26Sep2021, it started with typical side effects a few hours after booster dose injection. The patient experienced mild fever, aches and fatigue. The symptoms never discontinued; low grade fever continued for a week following injection. The symptoms began to change on 28Sep2021, moving into severe head congestion. On 30Oct2021, the patient experienced sore throat starting day 5. On 01Oct2021, the patient experienced terrible reflexive barking cough on day 6. The events had resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unspecified cough suppressants, antibiotics and steroid nasal spray.  On 03Oct2021, the patient underwent chest X-ray and the result was clear chest. On the same day, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events mild fever, aches, fatigue, low grade fever continued for a week following injection, severe head congestion, sore throat and terrible reflexive barking cough were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient stated for the first 5 days there was pain at injection site then the next 3 days itch and rash.
Mild headache; fatigue; joint aches; unsettled stomach; overall not well that lasted for 7 days
Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted but seems responsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted from sitting after vaccination. No difficulty breathing/swallow, thus gave water and gatorade. He was responsive to my questions. He has history of anxiety to needles and he did not eat lunch before vaccine. He stayed seated for 1 hour to monitor. Then, walked an aisle before driving home. Asked him to eat first before driving home. Called him twice and he is home and feeling okay. Counseled to call pharmacy if any symptoms of allergic reaction to vaccine.
PATIENT LIED ABOUT PAST MEDICAL HISTORY SUCH AS HIS AGE AND HISTORY OF PAST VACCINATIONS AT VACCINATION CLINIC HELD AT CENTER. UPON SCREENING QUESTIONS HE CLAIMED HE IS OVER 18 AND  NEVER HAD ANY COVID VACCINATIONS IN PAST BUT HE HAD PFIZER 1ST DOSE GIVEN OVER 1 MONTH AGO PER HIS AUNT.  PATIENT RECEIEVED MODERNA VACCINE ON 5/22/2021.  AFTER THE VACCINATION PATIENT WAS MONITORED FOR 30 MIN AND PATIENT DID NOT HAVE ANY REACTIONS TO VACCINE. PATIENT AND HIS AUNT WAS COUNSELD REGARDING VACCINE AND ITS SIDE EFFECTS.
8 days after the vaccine, her arm broke out with swelling and was hot to the touch.  It had a very red, itchy ring around the site of the shot. Did not take anything or put anything on it. Did not let her doctor know.  About 3 days later, it went away.   Got the second shot on day 28 (1/20/21).
induration 3x3 in size, erythema and tenderness at right arm injection site
Sore arm at site of injection; Minor headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 10Mar2021 at 11:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 16:00, the patient experienced sore arm at site of injection and minor headache. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm at site of injection and minor headache were recovered with sequelae on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Patient is a 79 y.o. male patient with history of CAD, GERD, HLD, obesity, OSA, A-fib, anxiety, depression presented to local Hospital with shortness of breath.    Community-acquired bacterial pneumonia  Covid 19 infection Increased in shortness of breath No leukocytosis CXR: right pleural effusion and sm right lung base infiltrate can't be excluded Check flu and Ur antigens neg IV fluids completed Aspiration precautions.   Cough and deep breathing exercises.  Incentive spirometry and pep Continue Levaquin started in the ED. Hemodynamically stable, does not appear septic at this time. Blood Cx NGTD At Baseline 2L NC Covid pos Dexamethasone 6mg PO daily for 10 days total    Atrial fibrillation with RVR History of left ventricular thrombus as above S/p ablation 2004, S/P cardioversion 2019, 2020, 2021 Amiodarone recent, 09/13/22, stopped due to dyspnea Continue home metoprolol, diltiazem, and warfarin. Given 5 mg Cardizem IV and restarted metoprolol BID 11/14/22 Telemetry afib with RVR VR 140s. Unable to increase metoprolol or cardizem secondary to low BP. Start digoxin  11/16/22 VR well controlled. Plan to increase his metoprolol to his home dose and stop digoxin for discharge. SBP low 100s    HFpEF  Hypertension Hyperlipidemia He was given IV Lasix at the outside hospital emergency room, but with patient's BNP being relatively stable, and chest x-ray without any edema, will hold off on further IV diuresis for the moment, and continue home oral loop diuretic.   ECHO 7/2022: EF 50%, filling defect in the apex of LV in images suggesting intra-cavitary thrombus Continue metoprolol and atorvastatin    Thrombocytopenia Likely DITP from levaquin use  PLT 137   Anxiety and depression Continue home Celexa, and quetiapine.  Morbid Obesity Outpatient diet and exercise regimen.   Evaluation for OSA and/or continuation of home CPAP.   BMI: 44.76   OSA Stopped wearing CPAP because didn't think it did anything Continue CPAP while here
He left the hospital, he was 211 pounds. Now he is 215 pounds; It may be water weight, may his sodium is high.; It may be water weight, may his sodium is high.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0170), via an unspecified route of administration, administered in arm left on 30Apr2021 (at the age of 48-year-old) as single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were none. The patient did not administer with additional vaccines on same date of the Pfizer suspect. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left on 09Apr2021 around 9:00 to 10:00 (at the age of 48-year-old) as single dose, for Covid-19 immunization and experienced Heart attack. The patient has no idea he had any heart conditions and his wife had gotten the covid vaccine, hence his wife let him know that he was getting it too. He was being pressured by his wife to get vaccine. After the second dose, the patient was starting to put weight back on. On an unspecified date in 2021, whenever he left the hospital, he was 211 pounds and now he was 215 pounds. It might be water weight, and might his sodium was high, but he was starting to increase in weight. The patient underwent lab tests and procedures which included blood sodium: high (increased) , weight: 211 (increased) and weight: 215 (increased) on an unspecified date in 2021.The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Two days after first vaccination, experienced first grand mal seizure.  Second HPV vaccine two months later, second grand mal seizure within 4 days after vacinnation.  Since the second vaccine and seizure, two more grand mal seizures and several partial seizures.  At least 4 ER visits via ambulance due to seizures.  Abnormal MRI.  Course of anti-seizure medication begun.  Currently being followed by neurologist. Diagnosis of epilepsy.  No prior history of epilepsy or seizures.  No family history of epilepsy.
PATIENT BEGAN TO HAVE SHORTNESS OF BREATH AND PASSED OUT AFTER ADMINISTRATION