chrisvoncsefalvay/vaers-outcomes huggingface dataset:
throat tightness, trouble swallowing, chest tightness, dizziness, slurred speech
dizziness; Phlegm dark in color; Extremely tired and fatigued; Little bit of a cough; felt like sore throat; He felt like he got the flu; This is a spontaneous report from a contactable consumer or other non hcp. A 54-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: ER8735)), dose 1 via an unspecified route of administration, administered in the right arm on 14May2021 11:00 in the morning, Friday (age at the time of vaccination 54-Year-old), as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient stated he was calling regarding the Covid 19 Pfizer vaccine and wanted to report his side effects. On an unspecified date May2021, the patient had felt like sore throat and he felt like he got the flu. On 17May2021, Monday, the patient had extremely tired and fatigued, little bit of a cough and has stayed the same. 18May2021, Tuesday, the patient had phlegm dark in color on Tuesday and Wednesday. On 19May2021, Wednesday, the patient had dizziness. It started Monday and has slowly progressed. It gets worse and worse every day. Was just a couple of moments where he would stand up and feel out of sync. It had not happened yet today. Just a couple of times when he coughed, he felt like he had a sore throat. Lives in the northwest and there are allergies all around them. He put it off at first as allergies, but this doesn't feel like allergies. Patient received the treatment as Ibuprofen. The patient did not go to emergency room and physician office. The pressure from everybody. He all-ready got COVID once before and thought he was pretty good. Everyone at work wants them to get it. Wants to go out and live life again. If he gets the vaccine, he can go places. The clinical outcome of the events extremely tired and fatigued, little bit of a cough, was not recovered, remaining all the events was unknown.   Information Lot/Batch number is available; Further information has been requested.
Pentacel was reconstituted with Merck & CO sterile diluent instead of the diluent that is provided with the vaccine.
Fever, Chills, Muscle Aches, Dry Cough and Diarrhea and pain and swelling at the injection site. They began at around 6:00p and lasted for about 36 hours. The fever was 101 and then subsided for awhile and then would come and go. for about 36 hours until it was finally back to normal
Breakthrough COVID infections; Breakthrough COVID infections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 29Sep2021; LEVOXYL; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199), administration date: 16Mar2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318), administration date: 23Feb2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 17Jan2022, outcome "recovering" and all described as "Breakthrough COVID infections". The event "breakthrough covid infections" and "breakthrough covid infections" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: covid-19: (24Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical course: The patient took other vaccine in four weeks. No COVID prior vaccination. The patient tested COVID post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Engerix B 10mg birth to 19 years of age dosage form dispensed instead of adult dosing Engerix B 20mg
This spontaneous report was received from a Nurse refers to a 18 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX Lot # H014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2013, (Oka/Merck) VARIVAX was stored for -13.9 C for 8 hours. On 29-OCT-2014, the (Oka/Merck) VARIVAX was stored for -12.8 C for 4 hours. On 14-NOV-2013, the (Oka/Merck) VARIVAX was stored for -11.4 c for 1.5 hours. On 26-MAR-2014, the (Oka/Merck) VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the (Oka/Merck) VARIVAX was stored for -13.8 for a total of 5 hours. Since the overall average for (Oka/Merck) VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. The case is linked to the case 1405USA015833, 1405USA015834, 1405USA015836, 1405USA015837, 1405USA014838, 1405USA015839, 1405USA015840, 1405USA015841, 1405USA015842 and 1405US008798 (same reporter link).
Nausea started around 9 pm; Severe vomiting shortly after until 3am; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 06May2021 at 11:30 at the age of 42-years-old as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received ELIQUIS on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 21:00, the patient experienced nausea started around 21:00 and then had severe vomiting shortly after until 03:00. The shot was given at 11:30. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting was resolved on 07May2021 at 03:00 and nausea was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
At approximately 6:45pm on the day of the vaccination, I noticed two  1? hives on my right thigh.  They were  red, raised, hot and itchy. I was awakened at approximately 10:45pm  by uncontrollable shivers and convulsions, which lasted around 45 minutes.  There was no fever. The next day (10/04/2019), I was fatigued, with a headache and light sensitivity.  Another hive appeared on my right buttocks. I took ibuprofen on the day of the vaccination to alleviate soreness at the injection spot.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On 06-APR-2018, the patient was vaccinated with an expired dose of VAQTA injection (strength and dose were not provided) (lot # N012324, expiration date: 05-APR-2018) intramuscularly for prophylaxis. No adverse effects were reported. No further details was provided. There was no product quality complaint (PQC) reported.
I received botox and Juvederm exactly 1 week prior to vaccination.  After the Pfizer vaccine I have developed a droopy left eye.  The droopy eye was not present prior to the vaccination and I was 1 week post botox/juvederm injection .  No other facial asymmetry noted.  Following up with my primary MD about eye and to discuss my second dose which is scheduled tomorrow 1/12/2021
12/26/2022 I started experiencing having sea sickness like symptoms. After reaching out to my health care provider I was diagnosed with Positional Vertigo.  I was prescribed Meclizine. Symptoms lasted 2 weeks.
Patient unexpectedly died on 2/17 after 14 days of receiving first dose of COVID-19 vaccine. EMS presumed it could be from possible myocardial infarction.
Pt. called in 2 days after receiving immunization complaining of red bulls eye on arm. It was itchy and warm to touch.
REDNESS AND SWELLING AT THE INJECTION SITE WHICH RESULTED IN DIAGNOSED CELLULITIS
Don't actually know if it is related but I got the Shingles.  Since Shingles is a virus related thing I thought I should report it just so that you have the data.  I am still fighting the pain, but I have gotten mostly past the rash outbreak.  Doctor from University recognized the Shingles when I went in complaining about my shoulder and arm pain, but we ran no tests for Shingles itself.  He just knew what it was.
Patient was only given diluent. Assistant did not dilute medication to inject, only gave the diluent without the medication.
ACUTE RESPIRATORY FAILURE HYPOXIA 3/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
my lower back also hands shake; 1st vaccine gave me pain in my joints; pain in my joints and across my lower back; This is a spontaneous report received from a non-contactable reporter consumer or other non HCP. The reporter is the patient reported that  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 11:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 2021, outcome "not recovered", described as "my lower back also hands shake"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "1st vaccine gave me pain in my joints"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain in my joints and across my lower back".  Additional information:-Patient had not received any other vaccine within 4 weeks.Adverse event follows that 1st vaccine gave me pain in my joints and across my lower back also hands shake 2 shot made joint pain worse lower back made it hard to get up and walk.Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
4/10/2002-child received routine immunization on 04/08/2002. Mom states she noticed right thigh swelling on Tuesday 04/09/2002 during bath. Gave Motrin and cool compresses. More swelling on 04/10/2002. Child brought to HD right thigh from groin to knee edematous and firm, warm to touch. ambulates 3 diff.. Advised to see Dr. today 04/11/2002. Child saw Dr. Was put on Benadryl & Amoxicillin . Improvement noted pm 04/11/2002. 04/15/2002-Edema gone, child doing well.
Dizzy; Incoherrent; Sick; Disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INCOHERENT (Incoherrent), ILLNESS (Sick) and DISORIENTATION (Disoriented) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Dizzy), INCOHERENT (Incoherrent), ILLNESS (Sick) and DISORIENTATION (Disoriented). On 04-Mar-2021, DIZZINESS (Dizzy), INCOHERENT (Incoherrent), ILLNESS (Sick) and DISORIENTATION (Disoriented) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, all the symptoms lasted for about two hours and the patient seemed fine at time of reporting.   No treatment information was provided.   Reporter did not allow further contact
Shingles, pain (started ~7/11/2021) and rash (started ~7/13/2021) along the left side. Started Valacyclovir TID 7/15/2021. Symptoms fully resolved by 7/24/2021
After receiving covid vaccine it actually woke her up, even after 1st dose; This is a spontaneous report from a contactable consumer (patient's daughter) received via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included ongoing Alzheimer's. Concomitant medications were not reported. The patient has Alzheimer's and after receiving the vaccination, it woke her up, on an unspecified date. The clinical outcome of "after receiving covid vaccine it actually woke her up, even after 1st dose" was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A patient (age and gender unknown), on an unspecified date. Relevant medical history, concomitant medications and past product history were unknown. On an unknown date following administration of the vaccination, the patient developed difficulty in sleeping. At the time of this report, the outcome of the event was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further information expected.
Given the vaccine on day 31 days of expiry; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021.    This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the first and second dose of the vaccine in the left. No treatment medication was reported. No Concomitant medication was reported.
Fever days past; migraines 3+ days post vaccination; hives/rash on back + front on neck, arms, and legs
headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.
Redness and swelling noticed after receiving the TDAP. Area is circle 35mm x 20mm in size symptoms relieved with cold pack and Tylenol.
Night received vaccine started developing red spots arm, which Dr diagnosed as cellulitis on 7/26/15. Received cephalexin for cellulitis.
Local: redness in the site of injection, painful to touch,  swollen, all the area extended 6 inches around, (about 15 cm), Also had headache and tiredness
Within 48 hours pt developed swelling, induration, warm to touch, measuring 5 cm width by 10 cm on L deltoid area, no fever, seen at clinic. Treated cellulitis area with Clindamycin 30mg/kg/day and BENADRYL. F/U with pediatrician with in 48 hours.
Fever; Arm pain; Headache; Chills; Rash from site to hairline; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) via an unspecified route of administration in the right arm on 08Apr2021 at 18:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included celiac disease. The patient previously took penicillin and experienced penicillin allergy. Other medication taken within two weeks prior to vaccination included FemCon from unknown date for unknown indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the right arm on 18Mar2021 at 16:15 (at the age of 32-years-old) as a single dose for COVID-19 immunization. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 01:00 the patient experienced fever, arm pain, headache, chills, rash from site to her hairline. The events did not result 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 which included treatment with Benadryl. The clinical outcome of the events fever, arm pain, headache, chills, rash from site to hairline was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
a male patient missed the third dose of the GARDASIL 9 series; This spontaneous report was received from a student pharmacist referring to a male patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On an unknown date, the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient missed the third dose (inappropriate schedule of product administration).
After the vaccine, I had burning and hurting in my arm that lasted for 10 to 15 minutes. On Wednesday, I developed a cough, chills and fatigue that lasted all day. On Thursday, I was better. On Friday, I noticed swelling under my arm but closer to my breast.  I went to see my MD and was given something for the cough. My MD wants to watch the swelling under my arm for the next two weeks.
He believes the trouble started in the wake of his CoViD-19 immunizations (Moderna #1was given on 2/12/2021 and #2 was given on 3/12).  Both shots were given into the left arm.  He reports some soreness at the injection site on the left arm after both shots, but this soreness has persisted with some stiffness and difficulty abducting the arm beyond 90 degrees.  Two weeks after the first shot, his right shoulder started hurting also, worst distal to the glenohumeral fossa without radiation, also aggravated with abduction beyond 90 degrees.  Some soft tissue swelling was noted around the hand.   Simvastatin was discontinued with no improvement in symptoms.  Labs showed a sed rate of 54 mm/hr and C-reactive protein of 46 mg/L.  Blood cultures were drawn which were negative, suggesting no evidence of osteomyelitis flare.  He was started on prednisone 15 mg PO daily on 4/5/2021 with rapid and dramatic improvement in symptoms.  Presumptive diagnosis is polymyalgia rheumatica, but he had no previous history of same, and onset of symptoms was remarkably close to the immunizations.
Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.; has not received the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not have an adverse reaction to the vaccine, nor was the vaccine expired.  Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-237452 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information included patient's demographics, date of first dose, second dose details and earlier events removed and one event added.
This case was reported by a nurse and described the occurrence of dizziness in patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to HAVRIX 1440. Additional details were provided as follows: The age at vaccination was not reported. The patients had adverse reaction to medication. The customer had been notified in writing that their complaint was forwarded to GlaxoSmithKline vaccines for investigation and said that to respond directly to the complainant in this matter and copy Agency at provided address. This case is 1 of the 4 cases reported by the same reporter.
(R) arm -( MENVEO) 11 x 6 cm  raised, indurated, warm flat - topped nodule. (L) arm (TDAP) 6 x 6 cm raised, indurated, warm flat - topped nodule.
Patient reported getting injection site pain an inflammation around 3pm same day of vaccination. Only on left arm. Pharmacist on duty advised to take BENADRYL. Approximately 24hrs later, patient reports swelling/pain is reduced.