chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported. It was reported that a temperature excursion occurred several days ago in the freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
Patient received second dose of Moderna COVID-19 Vaccine on 08/27/2021. Pfizer COVID-19 Vaccine was administered as a booster on 12/09/21.  The patient received the COVID-19 booster vaccine too soon and did not wait 6 months after completing the primary COVID-19 vaccine series.
Pt experienced dizziness and vomiting X 2 and vital signs were stable. Pt was given Antivert for dizziness and recovered on 11/11/1999.
Head ache, fever, chills, tired, muscle ache lasted 5 days, less severe on day 4 and 5.  Treated with rest and lots of water.
Shot given at 10 AM. 10 hours later developed fever, chills, & urticarial type rash 2-3 cm proximal to injection site.
No reported ADR from first vaccine dose. Patient experienced localized erythema and warmth with pruritis after second vaccine dose. He also had emesis that appears to be unrelated to the vaccination as staff observed patient to be eating very fast prior to emesis.
bad metal taste in her mouth; got really sick; headache; very sore arm; got really sick at hospital for a while and decided not to take the; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bad metal taste in her mouth), ILLNESS (got really sick), HEADACHE (headache), MYALGIA (very sore arm) and PRODUCT DOSE OMISSION ISSUE (got really sick at hospital for a while and decided not to take the) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (bad metal taste in her mouth), ILLNESS (got really sick), HEADACHE (headache), MYALGIA (very sore arm) and PRODUCT DOSE OMISSION ISSUE (got really sick at hospital for a while and decided not to take the). At the time of the report, DYSGEUSIA (bad metal taste in her mouth), ILLNESS (got really sick) and HEADACHE (headache) outcome was unknown and MYALGIA (very sore arm) and PRODUCT DOSE OMISSION ISSUE (got really sick at hospital for a while and decided not to take the) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C2119) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications was provided.
Unknown - Staff informed by Supervisor that someone needed to be checked . Upon contact pt was found sitting in chair . Alert and oriented . states "I'm fine now" Pt denies all complaints. No distress noted . Patient checked out and left at appropiate time.
Fever over 100 for over 48 hours, severe joint inflammation and pain, chills, restlessness, excessive fatigue. Symptoms continue at this time.
Initially after first dose of Janssen Covid vaccine patient was initially on guerney but states he felt fine and was then assisted to a chair. Four minutes after vaccine, patient was sitting in chair and was observed to slump in chair and was then assisted to the floor. Patient had syncopal episode. Immediately ammonia was placed under his nose and patient aroused. Patient is cool and clammy.  Cold ice pack applied to back of head and neck. Vital signs taken pulse 80, respirations 20, blood pressure 126/79, and 02 sat 100%. Patient is alert and oriented x4 and states "this always happens." Oxygen applied at 4 liters per minute via simple mask.  Patient assisted slowly to a sitting position. Tolerated well. Patient assisted to gurney by Nurses. Vital signs rechecked, blood pressure is 132/65, pulse 69, 02 sat is 99% on room air. Patient transferred to nurse treatment room via gurney in stable condition with nurse assistance. Report given to Nurse.
FEVER , CHILLS , HEADACHES , MUSCLE ACHE , JOINT PAIN , SWEATING , EAR ACHE ( LIKE EARS ARE POPPED , AND EXCESSIVE RINGING ) , HIVES ALL OVER BODY DIFFERENT TIME PERIODS , BUT SUBSIDES,   FEVER DID NOT BREAK TILL DAY 2 . LOSS OF APPETITE.  FATIGUE. COUGHING.
feeling run down; achy; feverish; head ache; feeling unwell /malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), administration date 12Oct2021 at the age of 63 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS. Vaccination history included: BNT162B2 (Dose:01), when the patient was 63 years old, for COVID-19 Immunization; BNT162B2 (Dose:02), when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: DEPRESSED MOOD (non-serious) with onset Oct2021, outcome "unknown", described as "feeling run down"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "achy"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "feverish"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "head ache"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "feeling unwell /malaise". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller reports receiving Pfizer booster dose 12Oct2021 and experiencing feeling run down, achy and feverish. Temperature 10.4. Initially had headache that was gone. Caller stated he was feeling unwell, no muscle pain but malaise. Caller stated he was on a blood thinner Eliquis. Caller asked can he take Tylenol for the symptoms he was experiencing.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(R) LE numbness, gait difficulty abnormal MRI signal mltple T spine cord levels. Most enhanced conus.
Pt is a college student. She received her 1st Covid vaccine (Pfizer) on 4/15/2021 at 4:30 pm. On 4/16/2021, pt woke up with elevated heart rate and dizzy spells. Had 2 episodes of syncope. (Was seen at Urgent Care but transferred. Pt was given IV fluids. Advised to monitor for tachycardia, dizziness. if symptoms persisted-advised to see PCP for Holter monitor. Pt reports heart rate ranges 90-100. OCC dizziness with change of position. no further syncope.
Mother noticed hive like rash on patient's neck 7am 8-6-08, the morning after vaccinations. Rash became progressively worse involving face, wrist, ankles & back over the course of 2 days.Patient was fussier than usual. Benadryl used with little affect, changed to Xyzal & added Zantac. Seen in office on 8-6-08 & 8-8-08. Phone check with mother 8-11-08 rash is resolving.
Red area about the size of her hand around the injection site. A little swollen and hot to the touch.
slight fever in the evening, fever spike of 102 by 2am on 6/19, fever continued until 06/20
rash on back, screaming for 4 hrs went to ER: MD gave pediaprofin
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, VARIVAX (Merck) underwent a temperature excursion and was administered to an unspecified amount of patients. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a pharmacist referring to a 63 years old male patient. The patient's medical history, concurrent condition and concomitant therapy were unknown. On 03-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 injection (lot # M024673, expiration date 17-NOV-2017, dose unknown) intramuscularly. On an unknown date in September 2016, after the administration, the patient experienced extreme pain at the injection site with inability to lift the affected arm, and also experienced fever of 102 Fahrenheit degree (F). No lab diagnosis was performed. The pain and fever resolved in 2 days without requiring treatment. The outcome of inability to lift the affect arm was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The pharmacist was requesting a lot check of lot # M024673. This is one of several reports received from the same reporter. Additional information has been requested.
DIZZINESS; LOOSE STOOL; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 11:00 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced loose stool. On 02-APR-2021, the subject experienced weakness. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, loose stool, weakness, chills, and fever on 03-APR-2021. This report was non-serious.
High BP, Pounding in the ears   SVT During stress test 4-28-21
1130AM pt called to report feeling nauseated approx 10 mins p/vax; noticed red blotches on neck approx 45min p/recvd vax;
Extreme body aches starting at vaccine spot; fever within 12 hrs; chills & hot alternating - in other words the flu - dose should be adjusted by weight class not age;  my 17 yr old son received a lower dose b/c he is 17 even though he outweighs me by at lest 30 lbs - much closer to my husbands size than I am yet my husband & I received the same dose b/c we are both over 18 - this is not a good system & does not make sense scientifically - and you know that.
Patient experienced numbness, weakness in left arm (vaccine admin in left)and both legs.  Metallic taste in mouth. Clammy feeling all over.  Redness, raised area where vaccine admin.
my husband just has little swollen in his face.; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife).   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 22Apr2021 (batch or lot Number: EW0172) as dose 1, single dose for covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 13May2021 (batch or lot number: EW0172) as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, the patient experienced little swollen in his face. Patient's wife stated that we took it at the same time but my husband just has little swollen in his face. But like a little grooving in the face but no other thing. Investigation assessment reported as yes. The outcome of the event was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient got 3 doses of Shingrix instead of 2.  Patient didn't remember that she already got 2 doses in 2019.  She got the 3rd dose on 3/22/2023 and came to get another one 5/22/2023.  Pharmacist checked and discovered patient already got 3.
tenderness; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). At the time of the report, TENDERNESS (tenderness), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient received new Moderna formulation 2023-2024 on 09-Oct-2023 (batch no: 3030535).  Patient had received booster dose last year and other previous doses. Patient had headache, tenderness, fever, chills with previous doses of the COVID-19 vaccines. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745395 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745395:Spikevax 2023-24 case (Same patient)
Swelling at injection site, warm to touch, sore, achy, within 12 hours, sore to the touch, no fever. Apply icepack to area swelling reduced. Ibuprofen reduced pain by 24 hours.
Within two hours of receiving the vaccine, the patient developed a rash on his chest and abdomen. It moved to his back. This rash was small raised bumps and were itchy. 24 hours later, it looks more like hives on his abdomen. The bumpy rash stayed consistent, and the hives went away until a few days later a very red and inflamed rash developed on his neck, eyes, chin, cheeks, forehead. this has stayed consistent and the hives-like rash is back on his abdomen.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M033611, expiration date on 02-MAR-2018, lot # M039202, expiration date on 11-MAR-2018 and lot # L015460, expiration date on 20-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit for 70 minutes. Data logger was involved in recording of the temperature excursions. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005091.
AMNEA OF DREAM, LOST OF MEMORY 1/30/08-records received-C/O chronic right shoulder pain due to complete rotator cuff tear, seen for pain management, irritability, inactive at home, behavior changes since return from deployment. Receiving physical therapy. Follow-up Information 30-APR-2008: HPB, Dreams Trouble, Bones Pain
Received DTaP and IPV right deltoid 5/2/03. Returned 5/5/03. Father stated right arm red, swollen, over weekend - on exam 5/5 redness right arm, shoulder to elbow - 2/3 circumference of arm - warm to touch, able to use arm.
Covid monitoring documentation. PT admitted 1/16/22 documented to have positive covid. PT received Janssen 3/09/21 Lot 1802068 for dose 1. PT received Pfizer Booster on 11/01/21 Lot 32030BD.
This spontaneous report as received from a pharmacist via a field employee refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX in the arm (dose, route, lot number expiry date were not provided). Other suspect therapies included a dose of Influenza virus vaccine (unspecified)(manufacturer unknown) in the same arm (dose and route were not provided). Concomitant medication was not provided. On an unknown date, the patient developed swelling and erythema in that same arm in the general area of the immunizations. The outcome of developed swelling and erythema in that same arm in the general area of the immunizations was reported as recovered (date not reported in 2014). Additional information has been requested.
Pt with sore throat approximately one week post vaccination.  Currently ongoing workup requiring biopsy and imaging
Arm swelling day after recieving Pneumovax 23. Left arm & MD prescribed Bactrim to treat possible bacterial skin infection.
Bells Palsy symptoms; A spontaneous report was received from a consumer who was also a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy symptoms/ facial paralysis.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included duloxetine hydrochloride.  On 29 Jan 2021, approximately seven days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot# 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient went to the dentist and started to develop Bell's palsy symptoms afterwards. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, Bell's palsy symptoms, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's unspecified dental procedure may have been contributory.
Approximately 2 minutes after receiving vaccine, her arm/hand started tingling and going numb from the top of her arm down.  Moving her arm seemed to help, as did rubbing it, but after 40 minutes, it was still tingling, though getting better.
Up and down fever of 101.9; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Up and down fever of 101.9) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 046821A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 21-Apr-2021, the patient experienced PYREXIA (Up and down fever of 101.9). At the time of the report, PYREXIA (Up and down fever of 101.9) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 101.9 (High) fever of 100.4, then went down, and is now 101.9.         No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Presented to the Clinic on 8/3/06 with c/o Nausea and Vomiting x 3 days. Diarrhea and extreme headaches for 3 days. Diagnosed with smallpox vaccine reaction and gastroenteritis. Phenergan 25mg ordered. Quarters x 24 hours and follow up at clinic in am.