chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "little bit of arthritis" (unspecified if ongoing); "Left branch bundle blockage" (unspecified if ongoing), notes: has had all her life, takes no medication for this and there is no treatment; "Post traumatic stress syndrome" (ongoing); "Asthma" (ongoing); "Panic attacks for no reason. Suffers greatly for anxiety" (ongoing), notes: Panic attacks for no reason. Suffers greatly for anxiety; "Osteoporosis" (ongoing), notes: diagnosed 7 years ago. Concomitant medication(s) included: XANAX taken for post-traumatic stress disorder, generalised anxiety disorder, start date: 2004 (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing); PROLIA subcutaneous taken for osteoporosis. Vaccination history included: BNT162b2 (Dose 1, Lot No: ER2613), administration date: 19Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "1st one she felt a little foggy and maybe just a little tired", "maybe just a little tired"; BNT162b2 (Dose 2, Lot No: EW0153), administration date: 09Apr2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "lot more fatigued"; BNT162b2 (Dose 3, Lot No: FH8020), administration date: 19Oct2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "maybe just a little tired", "felt a little foggy"; BNT162b2 (Dose 4, Lot No: FK9894), administration date: 08Apr2022, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "a little soreness at site", "A little fatigued", "Went to outdoor wedding in Maine last September and got pneumonia from kids running around"; BNT162b2, BNT162b2 omi ba.4-5 (Dose 5, Lot No: GH9693), administration date: 05Oct2022, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "In the last year she developed asthma", "Has every Pfizer Covid vaccine put out. Had experience with each but this was more extreme". The following information was reported: FATIGUE (non-serious) with onset May2023, outcome "unknown", described as "Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Covid vaccine: Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired.
Tachycardia, irregular heart beats, migraine, rush that looked like cellulitis near the site of the shot and in the hand of left arm, weakness. This lasted for one week and then mitigated. The rush disappeared completely. The heart rate has not yet normalized entirely.
pt recv vax & exp shaking, unresponsive, rolling eyes;no temp;sz;
Mild flu like reacton, local inflammation to Tdap. Febrile, stomach ache, sore throat since Tdap administered (4-11-06).
woke up with extreme joint pain  persists: difficult to move, sit, sleep   fatigue
Upper body tremors and stiffening of legs began 1 week post vaccination. Tremors did not stop when arms were held down. Tremors occur when falling asleep, when going through developmental growth spurts, or when becoming ill. Tremors occur 2 or more times a week and have continued to current date
Generalized malaise, muscle ache, & fever; localized swelling, skin color change, and extreme tenderness persisting for > 10 days.
sharp pains in a small area behind the bottom rib on my right side/ pain later moved around toward the front of right side and spread out more laterally; Pleurisy; Fever; Runny nose; Neck is getting stiff; 5 inch red circle around injection area; Little raised around injection site; Injection site is itchy; Slight headache; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (sharp pains in a small area behind the bottom rib on my right side/ pain later moved around toward the front of right side and spread out more laterally), PLEURISY (Pleurisy), RHINORRHOEA (Runny nose), MUSCULOSKELETAL STIFFNESS (Neck is getting stiff) and VACCINATION SITE ERYTHEMA (5 inch red circle around injection area) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036K20A and 02GL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for Cholesterol, VITAMIN D3, LISINOPRIL, GLUCOSAMINE & CHONDORITIN and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced RHINORRHOEA (Runny nose), MUSCULOSKELETAL STIFFNESS (Neck is getting stiff), VACCINATION SITE ERYTHEMA (5 inch red circle around injection area), VACCINATION SITE SWELLING (Little raised around injection site), VACCINATION SITE PRURITUS (Injection site is itchy) and HEADACHE (Slight headache). On 12-Feb-2021, the patient experienced PYREXIA (Fever). On 15-Feb-2021, the patient experienced PLEURISY (Pleurisy). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (sharp pains in a small area behind the bottom rib on my right side/ pain later moved around toward the front of right side and spread out more laterally). On 13-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, MUSCULOSKELETAL CHEST PAIN (sharp pains in a small area behind the bottom rib on my right side/ pain later moved around toward the front of right side and spread out more laterally), RHINORRHOEA (Runny nose), MUSCULOSKELETAL STIFFNESS (Neck is getting stiff), VACCINATION SITE ERYTHEMA (5 inch red circle around injection area), VACCINATION SITE SWELLING (Little raised around injection site), VACCINATION SITE PRURITUS (Injection site is itchy) and HEADACHE (Slight headache) outcome was unknown and PLEURISY (Pleurisy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Events added, concomitant medications added. Patient demographics were added.
During the safety briefing by staff, participant became unresponsive; participant was administered Epi Pen  0.3 mg in left thigh.   EMS was called.  Participant then aroused and was assisted by staff to observation tent.  Initially denied history of passing out with injections, however, later stated he had.  Participant was incontinent of urine.   Oxygen saturation - 99%,  pulse 66. EMS arrived and assessed participant, BS 112, & offered to take to E.D. for further evaluation, however, participant declined & left with wife.  Called to f/u on 3/3/21 and stated he had visited his physician and had no further concerns.
Initial misuse reprot received from a healthcare professional on 04-Dec-2013: The patient had received ActHIB. ActHIB reconstituted with sterile water instead of ActHIB diluent and administered. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Information has been received from a medical assistant concerning a 13 year old female patient who on 31-AUG-2009 at 10:00 am was vaccinated with the first dose of GARDASIL (lot number not reported). On 01-SEP-2009, around 01:00 am, the patient woke up and she had shortness of breath. The patient's mother gave the patient BENADRYL and they called the clinic because they were worried. Per medical assistant, she followed up with the patient on 01-SEP-2009 and she learned that the patient had recovered. Follow-up information was received from the medical assistant who reported that the patient is a female with no known drug allergies or medical conditions and on 31-AUG-2009 at around 10:30 (also reported as 10:00 am) in the morning received a first dose of GARDASIL (lot# 663452/0671Y) into her left deltoid. It was reported that the patient's mother called and stated that on 01-SEP-2009 at around 1:00 am, the patient complained of trouble breathing through her nose taking a deep breath and throat feeling tight. The patient took multiple doses of BENADRYL throughout the next day. Symptoms did resolve. No further information is available.
Pt presented on 5DEC91 w/ 40 x 70 cm red area on thigh; only sl warm to touch flat, darker red area in center w/3 white spots; outer ring of lighter red; pt had no fever & leg was not tender to touch;
Red, itchy rash on L arm (still present) w/ similar rash on R arm already resolved, lo grade fever (101 at day care), responding to antipyretics, lethargic for a while but recovered spontaneously.
pt recv vax 1OCT95 & devel an inj site rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;
Patient potentially received more than the recommended dose of the Pfizer vaccine. As of Sunday 4/4, patient's only complaint is mild arm soreness at the injection site.
Contracted virus after vaccination; Contracted virus after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415).  A male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted virus after vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea 2-3 nights per week started 3 days after the 2nd dose of vaccine given. On 9/15/21 chronic nausea and vomiting started and never ended. 1 year later still has same symptoms. Was diagnosed with gastroparesis in Dec 2021. Has failed all meds to treat gastroparesis. Progressed from NJ feeding tube to GJ feeding tube with minimal success. Awaiting definitive POTS diagnosis. Weight loss of 30 lbs. Has been unable to attend school since late Fall of 2021 due to severity of symptoms. Has been hospitalized with Hospital numerous times for testing, rehydration etc.
Report concerning a pregnant female who was splashed in the eye with the vaccine when her daughter was vaccinated with MMR. The woman sought unspecified medical treatment, however, it was noted that she did not complain of any symptoms.
flu-like (no fever) for 24 hours, rash on stomach (not raised, just red & blotchy) lasted 2.5 weeks
Fever (39.1C), bright red rash in groin, up sides and involving axilla and neck crease (anterior and posterior).
Patient had a Brief syncopal episode that lasted approximately 5-10 seconds. Patient was layed done and after approximately 3-5 min patient felt better and went home with parents. It was also a very hot day and warm in the store.
10:50 am on 03/17/2021-Patient experienced flushing and warmth in her chest that initially resolved.  At approximately 11:00 am, patient experienced unremitting flushing.  Decision made to activate Adverse Reaction standing order per protocol.  11:05 am BP was 142/92 and HR was 74. Diphenhydramine 50 mg administered in left deltoid at 11:08 am.  At 11:10 am BP was 188/110 and HR 88.  At 11:15 am BP 200/120 and HR 92.  At 11:20 am BP 208/120 and HR 78.  At 11:25 am BP 208/100 and HR 76.  Patient remained alert and oriented throughout entirety of event.  Denies SOB and chest pain.  11:22 AM emergency medical was activated. At 11:34 AM EMS personnel arrived on scene and assumed care of patient. Patient was transported to Medical center
Two weeks following dose 2 of Engerix-B, the vaccinee died. The autopsy showed that the vaccinee had a hole in her heart.
Information has been received from a physician concerning her 12 year old daughter who was vaccinated with Gardasil. Concomitant therapy included Menactra. Within 24 hours post vaccination, the reporter indicated that her daughter developed swelling, warmth and redness at the injection site. The symptoms resolved within a week. Unspecified medical attention was sought. No other information was available. Additional information has been requested.
Headache; Muscle pain; joint pain; Cold; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (joint pain). On 14-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, NASOPHARYNGITIS (Cold), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            No treatment medication provided. No concomitant medication provided.  Action taken with mRNA-1273 in response to the event was not applicable.
On 10/23/2013 pt presented with soreness in LT Deltoid.
vaccine did not come to room temperature before administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT PREPARATION ERROR (vaccine did not come to room temperature before administration) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (vaccine did not come to room temperature before administration). At the time of the report, PRODUCT PREPARATION ERROR (vaccine did not come to room temperature before administration) 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 corrective treatment was provided.
Employee complained of jaw pain, slurred speech and then passed out. Difficulty in moving hands and with communicating. Occurred 15 minutes after flu shot. Pt given Benedryl, steroids, Zofran in ED. Pt observed for several hours then released.
I started feeling like I had a tickle in my throat on Wednesday 04/20/22 and feeling a bit sluggish. I took a PCR test on Friday 04/22/22 and it came back positive for COVID.
lymph nodes behind her jaw got swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes behind her jaw got swollen".  Additional information: Patient age was reported as 55 (units: unknown). It was reported that, the patient received the 1st dose of the Pfizer covid vaccine on Wednesday night. Her lymph nodes behind her jaw got swollen 2 days later. She is not feeling any other side effects. The patient would like to know how long the side effect of swollen lymph nodes could last. The patient would like to know whether she could get the 2nd dose of the covid vaccine based on her side effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dose 3 (booster), single; Preeclampsia; Gestational Hypertension; The patient was pregnant/ Gestational period 37; This is a spontaneous report received from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number 301458A), via unspecified route of administration in left arm on 02Oct2021 13:15 (at the age of 31-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included gestational diabetes from unspecified date. The patient had no known allergies. The patient did not have COVID-19 prior vaccination. The patient's concomitant medications within 2 weeks included unspecified pre-natal vitamin. The patient previously received BNT162B2 via unspecified route of administration in left arm on 11Feb2021 12:00 PM (lot number EL9266) (at the age of 31-year-old) and via unspecified route of administration in left arm on 03Mar2021 12:00 PM (lot number EN6202) (at the age of 31-year-old) for COVID-19 immunization. The patient received other unspecified vaccine (reported as Sanofi-Pasteur) within 4 weeks from vaccination on 29Sep2021 (lot number UT7330MA) administered in left arm. The patient was pregnant. Last menstrual date was 15Jan2021 and delivery date was 06Oct2021. Gestational period 37. The patient experienced gestational hypertension and preeclampsia on 05Oct2021 09:30 AM. The events required doctor or other healthcare professional office/clinic visit. The events were reported as serious with hospitalization criterion with number of days of hospitalization reported as 4. Treatment received due to the events included magnesium. The patient was tested for COVID-19 post-vaccination on 12Oct2021 with test type nasal swab and negative result. The outcome of the events was unknown for "the patient was pregnant/ gestational period 37" and resolving for all other events.
an improperly stored vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.      On 25-JAN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength and route of administration were not reported, lot # S035534 is an invalid lot # for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S035534 is a valid lot # for olmesartan medoxomil (OLMESARTAN), expiration date was reported as 04-NOV-2021) 1 injection (1 dosage form) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of above 9 degree Celsius (13.4 degree Celsius) for a time frame of 2 hours and 9 minutes, as recorded by the digital data logger. There were no previous temperature excursions.
SLIGHT MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced slight muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight muscle pain. This report was non-serious. This case, involving the same patient is linked to 20211127326.
taste loss; Couldn't see; Couldn't eat for 9 days; Couldn't walk; Food taste like poison/Water taste like sugar; Couldn't remember anything/Can't remember how to do things, like cooking, and playing guitar/Mind is not there; Brain went back into her childhood; Felt like she been poisoned; Body jerking and shaking; Body jerking and shaking; Couldn't shut her brain down for 9 days; Arm was hurting and burning after injection; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (taste loss), VISUAL IMPAIRMENT (Couldn't see), DECREASED APPETITE (Couldn't eat for 9 days), GAIT DISTURBANCE (Couldn't walk) and TASTE DISORDER (Food taste like poison/Water taste like sugar) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (taste loss), VISUAL IMPAIRMENT (Couldn't see), DECREASED APPETITE (Couldn't eat for 9 days), GAIT DISTURBANCE (Couldn't walk), TASTE DISORDER (Food taste like poison/Water taste like sugar), AMNESIA (Couldn't remember anything/Can't remember how to do things, like cooking, and playing guitar/Mind is not there), FEELING ABNORMAL (Brain went back into her childhood), FEELING ABNORMAL (Felt like she been poisoned), DYSKINESIA (Body jerking and shaking), TREMOR (Body jerking and shaking), FEELING ABNORMAL (Couldn't shut her brain down for 9 days) and VACCINATION SITE PAIN (Arm was hurting and burning after injection). At the time of the report, AGEUSIA (taste loss), VISUAL IMPAIRMENT (Couldn't see), DECREASED APPETITE (Couldn't eat for 9 days), GAIT DISTURBANCE (Couldn't walk), TASTE DISORDER (Food taste like poison/Water taste like sugar), AMNESIA (Couldn't remember anything/Can't remember how to do things, like cooking, and playing guitar/Mind is not there), FEELING ABNORMAL (Brain went back into her childhood), FEELING ABNORMAL (Felt like she been poisoned), DYSKINESIA (Body jerking and shaking), TREMOR (Body jerking and shaking), FEELING ABNORMAL (Couldn't shut her brain down for 9 days) and VACCINATION SITE PAIN (Arm was hurting and burning after injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
pt recvd vax & w/in 15 mins of the inject devel erythema; 2 hrs later pt devel an 18-20 cm wide vesicle on arm; sloughing resulted in superficial ulceration; also devel 8-10 cm area of eschar @ the site;
Pfizer 3/24/21, 4/21/21, 11/22/21 (+) on 6/17/22
INABILITY TO SWALLOW EVEN HER OWN SPIT FOR 3 DAY
Patient received DTaP instead of Tdap. 10-30-07 headache, arm pain. Given Tylenol
01/18/22 presents to ED for "abnormal blood work". PMHx of "renal transplant in 2018"