chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three days after the vaccine administration patient developed an erythematous and vesicular rash that appeared in a dermatomal pattern. The pain described itching and pain that was described as "needles." He was evaluated at urgent care where a culture was taken (results pending) and the presumptive diagnosis was made of herpes zoster. He was started on acyclovir. I saw him for follow up 13 days after the onset of the rash, which had improved significantly. I did not see any vesicles or active lesions. However, there was healing rash with pinpoint scabbing present along the L2/L3 dermatome.
Arthritis pain in finger of dominant hand on a daily basis, started to occur 2 months after receiving 2nd dose. I wake up with my ring finger folded and all fingers feeling very stiff. I need to stretch my hand to get relief.; Arthritis pain in finger of dominant hand on a daily basis, started to occur 2 months after receiving 2nd dose. I wake up with my ring finger folded and all fingers feeling very stiff. I need to stretch my hand to get relief.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously had shellfish and experienced shellfish allergy. Concomitant medications taken within two weeks of vaccination included low dose acetylsalicylic acid (ASPIRIN). The patient previously took ciprofloxacin (CIPRO) for unknown indication on unknown date and experienced drug allergy. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. 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. The patient experienced arthritis pain in finger of dominant hand on a daily basis, started to occur from 01Jun2021 at 06:30, two months after receiving second dose. The patient woke up with his ring finger folded and all fingers feeling very stiff. The patient needed to stretch his hand to get relief. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event arthritis pain in finger of dominant hand on a daily basis, started to occur from 01Jun2021 at 06:30, two months after receiving second dose; the patient woke up with his ring finger folded and all fingers feeling very stiff; the patient needed to stretch his hand to get relief was not resolved at the time of this report.
Administered pediatric Hepatitis A vaccine instead of adult Hepatitis A vaccine which was indicated.
1 of 5 pts w/in a 33 wk period who exp cellulitis following immun; treated w/ATB (Keflex for 10 days no cultures;
Information has been received from a health professional concerning an 11 year old male with no medical history and no allergies who on 04-APR-2007 was vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck). There were no concomitant medications. On 09-APR-2007 the patient developed a cropped vesicular rash less than 50 lesions on his abdomen and back. He was seen in the office on 16-Apr-2007 where it was determined he was recovering and cleared to go back to school. On 07-May-2007, he was seen in the office with the same symptoms as on 09-Apr-2007, "varicella like lesions" on his back and abdomen. These lesions were new lesions on the same location as the initial "outbreak". No varicella zoster virus (VZV) analysis was done with the initial rash nor with the later recurrence. A teacher is in her first trimester and shows no symptoms but is concerned about exposure because of the "relapse". At the time of this report, the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Got up that morning 08/17/2021, felt nauseated, texted my boss to tell him not feeling well and may not feel like going to work. Got chills, stayed under the blankets all day and then got dehydrated. From 08:00AM-04:00PM. Went to bed. Mastoiditis on the right side of head felt like I was hit with a baseball bat unable to give a specific date.
Client was 7 months pregnant and a varicella shot was given - this (preg.) was not known until client came back 1 month later for 2nd shot.
My arm got sore within an hour of me driving home and got progressively worse throughout the day, I took advil. The next day I had severe chills, and tired, fatigued, and then my body aches. I had a bit of a sore throat. I also had joint pain. I had symptoms for three to four days.
Arm into which vaccine was given was painful and not movable for 24 hours. Patient also had chills lasting 24 hours. Patient reported being fine after 24 hours.
per mom, child awoke next morning with complaints of headache, stomachache, and dizziness.  Temp by mouth ran between 99 - 100 degree F.  States Advil did not help headache.  Child remained in be all day, went to school today but mom states she was dragging.  Did not see doctor.  Mom denies illness before shot or problem with any prior vaccines.
Wakes up in the middle of the night; Flu like symptoms; Pain in right hip and knee; Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second), SLEEP DISORDER (Wakes up in the middle of the night), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (Pain in right hip and knee) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Blood pressure abnormal since May 2013 and Heartburn since May 2013. Concomitant products included LISINOPRIL for Blood pressure abnormal, OMEPRAZOLE for Heartburn.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second). In May 2021, the patient experienced ARTHRALGIA (Pain in right hip and knee). On an unknown date, the patient experienced SLEEP DISORDER (Wakes up in the middle of the night) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PAIN IN EXTREMITY (Trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second) and ARTHRALGIA (Pain in right hip and knee) had not resolved and SLEEP DISORDER (Wakes up in the middle of the night) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            Patient had got X-Rays done for Hip and Knee, results were not provided and was getting physical Therapy done for the same.  Patient received both shots on the left arm and ever since had been having trouble with his 3 fingers which feels like someone hitting them with a hammer for 15-30 second. It being bothering 2-3 times per day and even wakes up in the middle of the night. The family doctor wasn't sure if was related to the vaccine.     Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional event, event outcome, patient demographics, medical history, concomitant medications, reporter contact details updated
LMP 10/26/2021  MODERNA DOSE #1 = 10/13/2021 LOT # 026C21A MODERNA DOSE #2 =  11/8/2021 LOT # 036C21A  EDD 08/10/2022  PATIENT MISCARRIAGE ON 01/19/2022
per patient:  I was awakened at 0145 hours on 11 March with tingling in the RIGHT SIDE of my FACE and JAW. The Right Side of my TONGUE and LOWER JAW along the GUM LINE were EDEMATOUS and worsening as was my Right Cheek. I knew immediately what was occurring as I have a HISTORY of ANAPHYLACTIC Response to BEE STINGS and MUSHROOMS.  I have EPI PENS and BENADRYL with me 24/7. I am also a Registered Nurse. I immediately took 50mg of BENADRYL Orally at 0150 hours, and continued to monitor the progression of my symptoms and my vital signs. By 0330 the tingling in my face and jaw abated.  The Edema began to lessen at approximately 0610.  I DID NOT have to use one of my EPI PENS. I DID NOT make an Emergency Visit to the ER, nor to my physician. (pt also noted she attempted to send in four (4 ) VAERS Reporting Forms to know avail.  I kept receiving "ERROR" COULD NOT SEND" messages and she called the VAERS telephone line 9 times, and left messages with no response).
This non-serious initial spontaneous case, was received from other health professional (nurse) on 18-Oct-2017, concerns a patient of an unspecified age and gender. This refers to 6 out of 24 reports. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
vomiting; dehydration; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01May2021 at 14:30 (Batch/Lot number was not reported) as a single dose for Covid-19 immunisation. Medical history included congenital hydrocephalus with ventriculoperitoneal (VP) shunt. The patient has no known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and patient was not pregnant. Concomitant medications included sertraline hydrochloride (ZOLOFT); bupropion; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and birth control (unspecified), all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 on an unspecified date (Batch/Lot number was not reported) on the left arm for Covid-19 immunization. On 06May2021, it was reported that the patient underwent a hospitalization for 2+ weeks due to uncontrollable vomiting and severe dehydration. No clear diagnosis for what prompted vomiting. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized for vomiting and dehydration for 15 days. The patient was given treatment of fluids, medications, and electrolytes for the events. The patient underwent lab tests which included Covid-19 virus test (nasal swab): negative, on 13May2021. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at about 34 hours post-injection.
Severe pain in the arm where vaccine given, difficulty moving the arm, at about 10pm when getting ready noticed my arm was swollen to about the size of a large orange at site of vaccine, with a rash beginning to form. Took a Benadryl before going to bed. Was not having swelling in the face or difficulty breathing at that time. The next morning the swelling was gone but the rash was worse and continued until 12/16/2018.
Pt reported pain from Tdap, Tdap given in R Deltoid. Pt has blister at injection site.
Body aches, lethargy, sore arm. Felt like I had the flu for 2 days. Slept a lot. Generally uncomfortable. Felt tired for 5 days.
PATIENT WAS GIVEN PEDIATRIC DOSE IN ERROR. PATIENT WAS GIVEN A REPEAT PEDIATRIC DOSE.
Headache, Myalgia, Arthralgia, NauseaVomiting, injection site reaction, chills, fatigue Narrative:  Employee reports injection site pain/soreness which began a few hours after receiving vaccine. Arm swelling and redness began overnight, as well as chills, night sweats, joint pain, severe body aches, headaches, nausea, and insomnia. Reports the following day "felt like I was hit by a truck." Reports took Tylenol 1000mg every 6 hours x 4 doses. Reported felt about 90% better 48 hours after receiving vaccine.
Pain in left lung when lying on left side.  Pain is in upper left lung near collarbone,  and lower left lung near bottom of ribcage.
Relative's husband caught Covid-19 after returning from a vacation.; Relative's husband caught Covid-19 after returning from a vacation.; This is a spontaneous report from a contactable consumer or other non hcp. A adult male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE and dose 1 of bnt162b2 (COMIRNATY, formulation: solution for injection,Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced relative's husband caught covid-19 after returning from a vacation .The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. The outcome of event were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single and on 27Oct2021 as dose 3 (booster), single at the age of 45 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TIROSINT, start date: 01Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to a 61 year old female patient. The patient's concurrent conditions included hypothyroidism. None drug reactions or allergies were reported. On 08-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot #, expiration date were not reported). Concomitant therapies included SYNTHROID. On 08-DEC-2014, the patient experienced redness at her site on injection on her left lateral deltoid area. The physician reported that the area of redness was progressing to the size of approximately 20 cm by 5 cm. On 12-DEC-2014, area appeared to raised. The physician could not determine, at the time of this report, if the patient was developing a rash. The physician reported that the patient denied pain, she did not have fever, body aches and any other symptoms. The physician reported the reddened area was not warm to the touch or indurated. The physician has prescribed to the patient ROCEPHIN and KEFLEX, which did not seem to have any effect. The patient had none lab diagnostic studies performed. The patient sought medical attention. The outcome of event was reported as not recovered. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
pt recvd vax;felt warm to touch & appeared pale;c/o n,no emesis;apap given;c/o sorearm & reluctant to move it;redness & sl swelling from inject site to elbow; MD advised ice pack 15 min & apap;
scratchy throat; sore around the collar bone; could not stop coughing; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (scratchy throat), BONE PAIN (sore around the collar bone) and COUGH (could not stop coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 04-Feb-2021 and Pfizer on 21-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Iodine allergy, Allergy to chemicals (sulfur) and Penicillin allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Nov-2021, the patient experienced THROAT IRRITATION (scratchy throat), BONE PAIN (sore around the collar bone) and COUGH (could not stop coughing). At the time of the report, THROAT IRRITATION (scratchy throat), BONE PAIN (sore around the collar bone) and COUGH (could not stop coughing) outcome was unknown.            Treatment included tea, honey and lemon, cough syrup, hot salt water, menthol, ice
sick for over an entire month; Initial information was received on 08-Oct-2020.  This case involves a patient with an unknown demographic who was sick for over an entire month (malaise), when received INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE (produced by unknown manufacturer, batch number and expiration date were not provided) via an unknown route in the arm for prophylactic vaccination respectively.  On an unknown date, the patient was sick for over an entire month (malaise), unknown latency following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Swelling @ Right deltoid-extended to shoulder, & clavicle area & below deltoid area.  "Twitching & Muscle Spasms" at injection area x 48 hours, and still ongoing. Headache, chills, Fever - 101.9F x 24 hours-onset 24 hours after vaccination given.  Fatigue is ongoing - began 24 hours after vaccination. Motrin taken prn (200mg since onset.)
burning sensation in lips/perioral area w/subsequent vesiculation/burning 13OCT;14OCT scaly area of the angles of the mouth similiar to angular cellitis;tx w/claritin;
A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST, 0.2 Millilitres, Once/Single administration. FLUMIST started on 15-Oct-2012. The patient experienced SWELLED, LIPS WERE BURNING and FACIAL RASH which started on 15-Oct-2012. The outcome of the event of SWELLED, LIPS WERE BURNING and FACIAL RASH is unknown. The report was considered to be non-serious by reporter.
POSSIBLE NSTEMI VS CARDITIS. no significant past medical history who presents for 10 out of 10 epigastric and chest pain.  It has been constant since 4:00 PM yesterday evening, approximately 14 hours prior to presentation.  She says she has had intermittent chest pains over the past week but it only got severe yesterday. Last night she did have left sided jaw-ear pain/numbness, but thought it was from clenching or high blood pressure  She also noted that she had palpitations intermittently over the past week that she noticed while just sitting and playing games on her phone.  She is also had a headache, general malaise and body aches, nausea but no vomiting.  Mild shortness of breath.  No cough.
15 minutes after leaving office, parent noticed face bright red,. Parent advised to monitor child. 6 hours later developed raised rash all over both legs. Provider advised  Benadryl 6.25 mg q6 hours and Tylenol 3/4 tsp q4-6 hours and if gets worse to ER. The next morning parent called an advised as soon as Benadryl wears off, the rash comes back. parent states hives on face, eye and on his back also now.  Pt coming in to see provider this afternoon.
1 hour after the shots patient started with rash on the back of neck and sacral area, then pat got rash on arms and legs too.
Right upper arm suffered "COVID Arm"; large red skin irritation surrounding the injection site and a large area surrounding it, area is slightly swollen and warm and tender to the touch. No itching has occurred.  At around 02:00 AM on the morning of 04/09/21 a fever accompanied by chills, body aches, nausea, sore throat and headache began these symptoms last a few hours and subsided to fatigue for the remainder of 04/09/21.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021 at 11:56 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 09-Sep-2021 at 11:56 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Sep-2021 at 11:56 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.   This case was linked to MOD-2021-405775 (Patient Link).