chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old was administered adult dose; 17 year old was administered adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 10th May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The nurse reported that the patient was administered adult dose of Havrix. Health care professional (HCP) wanted to know how to proceed in this situation and if there was any further information available to be sent. The reporter consented to follow up. Additional Supportive Information: The 17 years old patient received adult dose of Havrix, which led to overdose and adult product administered to child.
This spontaneous report was received from a physician refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On 08-AUG-2016, the patient was vaccinated with dose 4 of RECOMBIVAX HB (dosing details not provided via intramuscular route, (extra dose administered). Physician reported that the patient received rest of the 3 vaccine doses on 03-FEB-2016, 11-MAR-2016 and 18-JUL-2016, respectively. There were no known adverse effects. Additional information has been requested.
This spontaneous report as received from a healthcare student refers to a patient (age and gender unspecified). On 27-MAY-2011 and on 27-JAN-2014, the patient was vaccinated with GARDASIL, strength 120Y (dose and frequency unspecified), intramuscular. Concomitant medication was unspecified. No adverse symptoms reported. No product quality complaint was involved. The outcome of events was unknown. No further information was provided. Additional information has been requested.
Immediately after IM administration of vaccine in R deltoid, patient experienced syncope. She was in a seated position and head tilted back against wall behind her. Husband and son were also present in room and helped stabilize head/neck and check for responsiveness. She became verbally unresponsive but visually still appeared to be breathing. Had pallor, shook a few times involuntarily, eyes rolled back into head. Tears were noted to be coming out of eyes bilaterally.  Despite patient marking "No" in response to vaccine screening questions about prior vaccine reactions, the husband and son told me "Don't worry, this always happens with vaccines/medical procedures".  I indicated I still needed to contact 911.  Left pt breifly in care of husband who moved her from seated position to flat on back on floor.  Fire department responded immediately - patient was responsive/coherent within 2 to 3 minutes of event but stated she was dizzy. Patient was encouraged to lay on gurney by medical personnel and given supplemental oxygen.  BP (taken by emergency staff) = 117/73, pulse 62.  Patient reiterated she experiences these episodes often at medical procedures & declined to go to Emergency Room (signed waiver).  After sitting for a bit , patient returned home with husband and son.
20 minutes after injection my heart started beating rapidly and then it went into Atrial Fibulation. This irregular rhythm lasted for about 45 minutes and then converted back to sinus rhythm.
Received flu shot at 1:45pm and 4:45 started feeling bad, palate swelling, eyes turned very red/blood shot, felt lungs filling with mucus  called Pharmacy to describe where shot was administered, they suggested taking Benedryl immediately, took a second dose 4 hours later.
Starting on 4/18/2021... started to feel soreness/discomfort in my left armpit. By 4/19/2021 MORNING... it was swollen, too (it currently feels like an apricot/peach is in my armpit)
Patient had sore arm and temperature evening of 5-7-19.  On 5-9-19, inside arm was red and swollen from elbow upward for about 6 inches and tender to touch. Patient's cardiologist advised him to show injection site to pharmacy and to let his doctor look at his arm.
Soreness, heat and itchiness at the vaccine site that started 8 days after injection.  I used Benadryl antihistamine gel on it.
Fever, chills, headaches, sore arm, sadness, crying, heavy chest, puffing of face (just slightly), head fog, dizziness, cold sweats, anxiousness
vomiting; fever of 99.9F; feeling weak; Sick; This is a spontaneous report from a contactable consumer via Pfizer sponsored program.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 21Mar2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. The patient got the 2nd dose on 21Mar2021 and 7 days later on 28Mar2021patient was sick. On 30Mar2021, patient experienced vomiting, fever of 99.9F/99.7 and feeling weak. Patient wants to know if these are all normal or if he should take patient to the hospital. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
We have received a shipment of the new bivalent COVID boosters. We have to stock these in the same machines as the monovalent vaccines. I can anticipate this will be a great source of mix-up for our staff as they look identical except for the small wording on the front. Do you have any suggestions for proactively combating this issues? Thank you so much. Contributing Factors Similar labels/packaging. Severity Circumstances or events have capacity to cause error
sick in bed for 4 days; Low grade temperature 101.5 fever; Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 10Sep2021 12:30 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "TBI" (unspecified if ongoing); "migraines" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "sick in bed for 4 days "; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Low grade temperature 101.5 fever"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Chills"; HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, pyrexia, chills, headache.  Additional information- The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2nd Moderna vaccine on 8.21.  4-5 days later rash under left axilla, followed by chest pain and tightness.  Worse lying down.  Pain 5 on 0-10 pain scale, to 10 at night., worse lying on right side.  Rash persists as of 9.2.21.  Exam shows no adenopathy, and a macular rash, 2-3 mm clustered from the anterior left pectoral area  to the anterior left thorax, confluent and hyper pigmented in the axilla on the left, with chest wall tenderness.  Photos available.
HIVES ON BOTH PALM OF HANDS AND FEET, SCATTERED THROUGHOUT BODY (LARGE SIZE)
After I had my shots, I started to notice that I was getting extra heart beats that felt very out of rhythm. I was getting dizzy, lightheaded, and out-of-breath doing things that I had previous done every day, such as walking the stairs at work. I could feel the extra heart beats when I'd be at the gym exerting myself a bit, and I would feel dizzy. Then, on June 20th, while I was riding a stationary bike, I lost consciousness and fell to the floor.
Mom noticed on 8/24/17 evening. She had a small lump on the outside (Lt) thigh. On 8/25/17 the lump was as big as a 50 cent piece an red/swollen and warm to touch. No fever.
HE SAID HE WAS HAVING STRANGE FEELINGS LIKE HE WAS HAVING TROUBLE BREATHING, BUT ADMITTED IT MAY BE ANXIETY.  I HAD A FRIEND/COWORKER SIT WITH HIM WITHIN SIGHT FOR OVER 30 MIN AND CHECKED IN WITH HIM Q10MIN. HE SAID IT WAS GETTING BETTER AND THERE WERE NO OTHER SYMPTOMS DEVELOPING. HE HAD NO WHEEZING OR DIFFICULTY BREATHING  AT THE TIME I RELEASE HIM. I COUNSELED WHAT TO DO IF IT WORSENS OR OTHER SYMPTOMS DEVELOP. HE WAS GOING HOME AND HIS PARENTS WERE THERE AND HIS DAD IS AN EMT.
Information was received from an office manager concerning six children who were vaccinated with a dose of Prevnar. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Patient with Pfizer COVID vaccinations x2, last dose 04/29/21, who admitted with complications of COVID.  Provider d/c note below:  "Reason for Admission: 48 YO black male with PMH of epilepsy who presented to the ED for chief complaint of ""shortness of breath."" He was diagnosed with acute CHF due to suspected viral cardiomyopathy from COVID (tested positive 12/25).   Brief Summary of Hospital Stay: The pt's respiratory insufficiency was mild and resolved with lasix and decadron. An initial echo showed and EF of 21%, which improved to 30-35% in 2 days (12/28). Cardiology saw the pt and started BB, ARB, lasix, and a life vest which was placed on discharge. Consider entresto as outpatient.  He will need further insurance approval if the life vest is to continue more than 30 days.    Issues Requiring Follow Up: Pt to see PCP and cardiology in follow up. Cardiology please ensure insurance coverage for life-vest as needed. PCP and cardiology: please review echo, labs, and imaging as below:"
Vertigo, vomiting, dizziness, labyrinthitis, and subsequent hearing loss of right ear.
Numbness/tingling, mouth fullness, epinephrine administered, continued to have symptoms, along with racing heart. EMS arrived within 5 minutes and continued to monitor patient until 12:25.  Patient declined transport to ED for continued monitoring.
Death 3/30/2021 Causes of death listed on death certificate: 1) Respiratory distress  2) ITP  3) COVID 19  4) Dementia  Other: acute cardiopulmonary failure
the patient states that the injection site is very itchy and she can still see the actual injection site of the needle
I don't remember having a reaction to the vaccine. A couple of weeks later, I wasn't feeling good with mainly joint and muscle pain. It was all a gradual progression so I can't say an exact date of when it started. I had a quarterly doctor appointment in December 2021, and we discussed my symptoms. I had blood work done and it showed inflammatory markers. I was referred to a Rheumatologist and was diagnosed with polymyalgia rheumatica. I am taking prednisone for my symptoms.
Started on 11/15/10 day vaccine was given area was hot, swollen, red, pt had fever felt weakness. Patient had local reaction 5 x 5 cm on site of TDAP injection was given.
Patient reported that his arm has been sore and painful since he received his flu shot in September. Patient mentioned that he initially attributes the pain to his history of a torn rotator cuff in his left arm which he admitted that he failed to mention prior to receiving his flu shot. He stated that he had an X-ray done and he is awaiting an MRI to further investigate why the pain is worsening. He also asked for a copy of his PQCF because he needed it for school records which I provided to him.
CHILLS, SORE THROAT, SWOLLEN THROAT GLANDS, VOMITING. TOOK EXCEDRIN IN THE MIDDLE OF THE NIGHT FOR SORE THROAT. RESTED FOR 48 HOURS.
Pt received 1st dose of GARDASIL. Pt began seizing in approx 3-4 seconds after receiving GARDASIL vaccine.
redness on her upper arm; bigger swelling on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (bigger swelling on upper arm) and ERYTHEMA (redness on her upper arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (bigger swelling on upper arm). On 26-May-2021, the patient experienced ERYTHEMA (redness on her upper arm). At the time of the report, PERIPHERAL SWELLING (bigger swelling on upper arm) and ERYTHEMA (redness on her upper arm) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    This case was linked to MOD-2021-176435 (Patient Link).
Reddened, raised area at injection site (left deltoid). 4cm x 2cm with the area warm to touch and slightly sore, denies any itching.
Swelling, redness, pain, itching, lump at and around injection site; headache, lethargy, sore throat beginning within 24 hours of second shot.
Severe confusion, loss of memory, fatigue, muscle pain, joint pain, rash on abdomen, chest, upper thighs, underarms., & eye twitching.
8/3/05 - "Little Redness" about 50 cent size around injection site left leg. Showed increase in size. 8/4/05 Increase in size - erythema about 10 x 14 cm with centralized 4 x 8 area of induration warm. 8/5/05 Hot to touch developed several vesicles in center of induration. Treated with ointment for presumed cellulitis.
Cold chills, no fever. Headache and body ache. Nausea (mild)
On Monday March 15th 2021 at 410pm I was getting off work.  I was driving through the main gate and at the 2nd light I made a right turn. Travel about 12 feet after the turn and was hit with vertigo. I immediately pulled off the road over to the right and close my eyes for 15 minutes. It settle down enough for me to make it home. I arrived at my home a 420pm and the vertigo started up again to the point of me throwing up and not being able to walk straight. I never had vertigo before and I had to stay home from work the next couple of days hoping it would go away. Then on Thursday March 18th my fiancé took me to an URGENT CARE I was diagnose with Benign Paroxysmal Vertigo. I was prescribed meclizine 25mg tablet and given instructions on how to perform the Epley Maneuvers. On Saturday March 27th im still at home because of the vertigo. I'm to afraid to drive but the nausea has stop. My fiancé took me back to the urgent care clinic where they prescribe me Hydroxyzine HCI 25mg.  On Tuesday April 13th im still at home because of vertigo and im afraid to drive.  I was walking up my stairs and got extremely dizzy and fell down. My fiancé took me the Emergency Room. They diagnosed me with Benign Paroxysmal positional vertigo and conducted several test. The test were; LAB TEST: ALL test were within normal limits    CBC WITH DIFFERENTIAL AUTO, COMPREHENSIVE METABOLIC PANEL, MAGNESIUM SERUM, URINALYSIS POC IMAGING TEST:All test were normal CT CTA HEAD, NECK..EKG 12 LEAD.. On Tuesday April 20th with the help of meclizine I was able to go back to work. My dizziness and vertigo is better when im sitting or laying down. My doctor referred me to Physical Therapy to have vestibule rehab done. I started my vestibule rehab on Wednesday September the 8th. Currently im still experiencing dizziness and vertigo.
Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) 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 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
ASYMPTOMATIC ATRIAL FIBRILLATION; This spontaneous report received from a consumer concerned a 57 year old white, not Hispanic or Latino male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, frequency one total, administered on 11-MAR-2021 on left deltoid for prophylactic vaccination.  No concomitant medications were reported.  On 29-JUL-2021, the patient went for a well check up and the EKG (Electrocardiography) showed atrial fibrillation, the patient visited to emergency room, as the patient experienced asymptomatic atrial fibrillation, was hospitalized and treated with some type of medication (beta blocker) and was fine.  Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, EKG (Electrocardiography) (NR: not provided) Atrial Fibrillation, Echocardiogram (NR: not provided) Normal, and Venogram (NR: not provided) Normal.  The number of days hospitalized was not reported. Patient was on medication to keep to his heart in check and had an appointment on the 2nd week of September with the cardiologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asymptomatic atrial fibrillation. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210835730-Covid-19 vaccine ad26.cov2.s-asymptomatic atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Nausea in AM,; fever (103.4 F measured) ~20 hours after the second dose. Fever was gone the following morning. Less severe,; but soreness at injection site; joint aches.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 19Mar2021 at 17:00 (at the age of 36-year-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. On 10Apr2021 at 09:45, the patient experienced nausea. Approximately 20 hours after vaccination, the patient experienced fever (103.4 F measured). Fever was gone the following morning. Less severe, but soreness at injection site and joint aches were there. The clinical outcome of the events nausea, fever, soreness at injection site and joint aches were recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severely terrible sore throat when swallowing; Severely terrible sore throat when swallowing; Raspy voice like losing it; Bad joint pain; Body aches; Headache; Runny nose; hot flashed; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101863713.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (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: OROPHARYNGEAL PAIN (non-serious), DYSPHAGIA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Severely terrible sore throat when swallowing"; DYSPHONIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Raspy voice like losing it"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Bad joint pain"; PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset Dec2021, outcome "not recovered", described as "Headache"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "not recovered", described as "Runny nose"; HOT FLUSH (non-serious) with onset Dec2021, outcome "not recovered", described as "hot flashed"; FATIGUE (non-serious) with onset Dec2021, outcome "not recovered", described as "Fatigue".  Additional information: The patient reported that is it typical if she just got her first Pfizer covid vaccine dose it's been 6 days now I have a severely terrible sore throat when swallowing and raspy voice like losing it. The first few days I have bad joint pain and body aches, headache, runny nose, child's, hot flashed, fatigue and still have some of them still. But now it's this throat.  The lot number for bnt162b2 was not provided and will be requested during follow up.