chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She fell and broke her hip; She fell and broke her hip; Lost balance; Not able to get her second dose bacuse both hospital and rehab center had only Pfizer's vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP FRACTURE (She fell and broke her hip), FALL (She fell and broke her hip) and BALANCE DISORDER (Lost balance) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HIP FRACTURE (She fell and broke her hip) (seriousness criterion hospitalization), FALL (She fell and broke her hip) (seriousness criterion hospitalization), BALANCE DISORDER (Lost balance) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Not able to get her second dose bacuse both hospital and rehab center had only Pfizer's vaccine). The patient was treated with Surgery for Hip fracture. On 01-Apr-2021, INCOMPLETE COURSE OF VACCINATION (Not able to get her second dose bacuse both hospital and rehab center had only Pfizer's vaccine) had resolved. At the time of the report, HIP FRACTURE (She fell and broke her hip), FALL (She fell and broke her hip) and BALANCE DISORDER (Lost balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Per patient she was working in the garage, "doing something stupid" and lost her balance and fell right on her hip. She had surgery and now is in a rehabilitation center, but doing much better.  Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 06-APR-2022 Reporter's Comment: No patient's details were provided when asked. The lot number was unavailable when asked. The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Tingling sensation at injection site that traveled down arm and to chest.  tachycardia "sense of doom" light-headed.
Mom phoned to report had hives at injection site, itching, fever, swelling to upper left arm, neck and face. Went to ER after 5:00pm on 1-23-15 for evaulation/treatment.
9:00 am vaccination received 2:00pm same day of vaccination: sore arm. 5:30pm Face puffed up.  Temperature and heightened sense of swaying, bobbing - I have an underlining condition - Mal De Debarquement Syndrom, balance disorder. Swaying went from 3-4 on a scale of 1-10 to 5-6. 8:30 pm weakness, tiredness.  Over night 2 bouts of vertigo. 7:00 am next day (12/15/2021), vertigo upon standing,  1:00 pm Temperature on and off, Face still puffed up. Still heightened sense of swaying, off balance,
Received first shot around 1pm, started to experience intense shoulder pain and immobility in evening. Took ibuprofen to minimize pain, reports it did not help. This morning he reported the event and says his shoulder is still very sore but can move it this morning.
This case was reported by a physician and described the occurrence of fever in a 6-month-old female subject who was vaccinated with Pediarix for prophylaxis. Concurrent medical conditions included viral exanthem. On 03 April 2007 the subject received 3rd dose of Pediarix. Within hours of vaccination with Pediarix, the subject experienced fever. The fever continued for three more days and ranged from 103 to 106 degrees. The subject also experienced morbilliform rash and edema of hands and feet. The reporter described the subject as having a "Kawasaki like presentation" (did not diagnosis Kawasaki syndrome). The subject was hospitalized. On 12 April 2007, the events were resolved. The physician did not make note of the causality of the events with Pediarix; however, she did not that the events could have been associated with a concurrent medical condition of viral exanthema. records received 6/7/07-Hospital records for DOS 4/5-4/607 and 4/7-4/10/07. DC DX: Left otitis media. Viral exanthem. 3 day history of fever and 2 day history of rash. Spike fevers of 102 and at medical mall temp recorded as 106. Erythematous rash on trunk and quickly spread to limbs and face. Emesis. Watery diarrhea for 2 days.
Ringing in ears, tinnitus Ringing worse in left ear, left side is where vaccine was administered Started 1-2 hours after vaccination symptoms have not lessened over time disorientation, inability to sleep, anxiety, are some resulting symptoms
Severe Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe Fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Severe Fatigue). At the time of the report, FATIGUE (Severe Fatigue) outcome was unknown.            No adverse events were experienced on first dose. Patient took Lorazepam because she was really scared and anxious about the symptoms she had. No Concomitant medications were reported   This case was linked to MOD-2021-385969 (Patient Link).
Hives and generalized rash from thighs to neck. Numbness and swelling of both hands, numbness in lips and swelling of the face, pt's mother described "orange peel" appearance described by ER physician.
I got one papulovesicle on my left side of back with a little itching at first day and became seven papulovesicles today with the paint the left side of breast.  I had suffered Herpes zoster 20 years ago.  I thought this symptoms might be reactivation of Zoster.
On my second dose I pass out; I bled so much; hit her head on the cement; scar on my face; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EL9265) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot number: unknown), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, medically significant), outcome "unknown", described as "On my second dose I pass out"; HAEMORRHAGE (hospitalization, medically significant), outcome "unknown", described as "I bled so much"; HEAD INJURY (hospitalization), outcome "unknown", described as "hit her head on the cement"; SCAR (non-serious), outcome "unknown", described as "scar on my face". The events required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results.  Clinical course: she already has two vaccines and two boosters. When she got her second Pfizer Covid-19 vaccine, she had to go to an internal medicine doctor because she hit her head on the cement. Was rushed to the hospital by an ambulance and was at the hospital for over 10 hours. She has to get them at the doctors office because her doctor wants to monitor her. Plans on getting the fifth vaccine dose, but wants to know how long it is going to provide protection. Patient mentioned: "I want them to know that I refuse to get it. They can't even give me the information. After first, the second, first booster, second booster, now this one, and they don't know. I don't think any of the vaccines protect, none of them protect us, not one of this". On her second dose she passed out and was in the Hospital for over 10 hours. They had to do a CAT scan, she bled so much, she had a scar on face because of it. She had to be careful, she could not read because they did not know if she had a concussion. she could not do anything, she bled like crazy, her head bounced in the cement after waiting after what they recommend to wait, this happened to her 2 minutes after walking out of the place.
Dose 1 of Covid19 Pfizer vaccine administered 12/30/20 & dose 2 of Covid19 Pfizer vaccine administered 1/20/21. Patient tested positive for Covid19  on 2/12/21 in the nursing and during hospital admission on 2/18/21. Patient with severe respiratory distress, on Remdesivir since 2/18/21.
Fever nausea head ache light headed day after vaccine treated with Advil and Benadryl.  Symptoms continued for about a week.
Medical center learned of a method used to administer Pfizer COFID-19 vaccine that may have resulted in a slightly lower than recommended dose of Pfizer COVID-19 vaccine between October 25, 2021 and December 10, 2021.   Medical center consulted with experts in infectious diseases and vaccine science as well as Pfizer, the vaccine manufacturer, and reviewed guidelines from the Centers for Disease Control (CDC). In accordance with CDC guidelines,  Medical center is offering a repeat dose of Pfizer vaccine to members who wish to receive it.
Pt recvd vax 16DEC92 & exp a recurrence of swelling in joints, pain in joints & tendons; sx resolved in approx 1 wk; lab eval was neg for anti-HBs; MD recommended that pt not recvd 3rd dose;
Fever, arm pain, spreading rash on left arm (continued to spread for 5 days), itching, rapid heart rate on day 3 (150 beats per minute resting pulse).  One month later, heart rate continues to be higher than previous rate although rarely over 130 bpm. Rash and arm pain/itching has gone away.
Information has been received from a health professional concerning a 4 yr old female who on 16Dec05 was vaccinated with hep A virus vaccine inactivated (lot649459/0287R) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine in different locations. The night of 16Dec05 the pt experienced swelling of both upper and lower eyelids. The pt received diphenhydramine (Benadryl) and recovered from swelling both upper and lower eyelids the next morning. This was the first dose of Vaqta, but she had received the other two vaccines in the past without reaction. Additional information is not expected.
Possible local reaction to vaccine red area left thigh 3.5 x 2.2 cm
p/vax pt started to cry, cried for over 3hrs, mom took to ER, in route pt slumped over, could not rouse pt w/verbal stimulation, was roused w/pinch.
This spontaneous report was received from a medical assistant who reported that PROQUAD (Merck) reached temperatures that were outside the prescribing information. No adverse effects reported. Follow up information has been received from the clinical manager. The clinical manager stated, she did not have any patient identifiers or dates of vaccine administration, but provided lot number: K002037 valid for V221 expiration date: 10-AUG-2015 and lot number: J006162 expiration date: 30-NOV-2014 and for PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse via a field representative concerning a 15 year old female patient. The patient's pertinent medical history, drug reactions and concomitant medications were not provided. On 26-APR-2016 the patient received her third dose of GARDASIL 9 injection (route reported as injection, lot# and dosage not provided). The patient's mother contacted the physician's office and reported the patient was experiencing an injection site rash and a lump on 26-APR-2016 (onset date also reported as unspecified date) for an unspecified reason. The mother scheduled a physician's visit for the patient but she did not provide the date. The outcome of the events, and the causality of the events with GARDASIL 9 was not reported. Additional information has been requested.
COUGHING UP PHLEGM; GENERAL COLD-LIKE SYMPTOMS; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced swelling at injection site. On 02-JUL-2021, the subject experienced coughing up phlegm. On 02-JUL-2021, the subject experienced general cold-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling at injection site, and had not recovered from coughing up phlegm, and general cold-like symptoms. This report was non-serious.
So it was a very sudden and severe vertigo episode. I had the spinning kind of vertigo where the room was spinning for a week. I was not actually to get to Urgent care on 12/01/2021. At urgent care they did an EKG and they just checked my vision. They gave me meclizine and Flonase. I went to my doctor on 12/07/2021, she sent me for a MRI and a MRA, blood work and BP check. I continued with the meclizine after that visit. I followed up with my doctor via a phone call follow-up visit 12/23/2021. During the phone call I was feeling better that on 12/07/2021, I was told to call if I felt poorly again. I was better enough not to need to go back. About 2 months later I ended up having balance issues again, I did not go to the doctor. I did not mention this to the doctor, that whole time and continuing now I have a ringing or screeching in my ears. I have recovered from the vertigo, but the ringing in my ears is not getting better.
Headache, Myalgia, Fever, Employee developed fever, chills, HA, myalgias, and arm soreness 11 hours after the 2nd COVID vaccine Narrative: Employee developed fever, chills, HA, myalgias, and arm soreness 11 hours after the 2nd COVID vaccine. She was much improved the next day.
Patient states it started the day of shot with shoulder, arms, hip stiffness and so bad it was very difficult to get around.  Presented to ER on 2/21/21 stating he hadn't felt good all week.  C/o weakness, dizziness and shortness of breath and pain on right side ribs from coughing.  Diagnosis: Pneumonitis, Hypoxia
Patient signed up under 2nd dose and this was only the first dose.  Client is only 17 years old.
Pt was seen 11/07 for 2 month physical evaluation and received Hepatitis B vax. No problems occurred while in the office. He apparently developed respiratory problems on the car ride home and was transferred to the hospital ER and then to another hospital by ambulance. He expired on 11/09/2000.
Administered 1st dose of Moderna Covid -19 vaccine to a 15 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna Covid -19 vaccine to a 15 year old patient) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna Covid -19 vaccine to a 15 year old patient). On 05-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna Covid -19 vaccine to a 15 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  Patient does not have any allergies and not taking any medications or vitamins.
Temp > 100 F - oral. Aches, stiffness, headache, skin tender to touch started @ noon 1/19 and continuing as of 10/22 requiring time off work.  Temp currently 100.3 with ibuprofen.
PT RECEIVED VACCINE TOO EARLY, NO ADVERSE REACTION NOTED, WILL SCHEDULE FOR ANOTHER INJECTION .
My skin has become sensitive to even slight scrapes.  Minutes after any contact such as drying off with a towel after a shower, my skin becomes red, swollen, itchy and burining.   The symptoms last for 30 to 90 minutes.
After receiving 4 vaccines on September 21, 2012 including DTAP, IPV, Hep B and the flu shot my son who was four had huge swelling the size at the injections site making his leg double in size which did not come down for days.  Almost immediately he developed nasal congestion and chronic cough.  Within a month of the vaccinations my son out of nowhere came down with a headache so extreme he could not even sit upright. The emergency room doctors had never seen anything like it and they were considering a spinal tap to check for infection.  He vomited a few times and went to sleep and upon awakening his pain had lessened. However every day after that for the next two years had a mild to extreme headache.  After two months of an everyday headache his doctor ordered an MRI which came out normal but our lives were anything but normal.  Desperate to help him we had his vision checked as well had testing for allergies conducted.  My son who had up to these vaccinations only one ear infection in his life and never any allergies also developed extreme ear swelling and drainage problems and had tubes put in his ears in January 2013 along with and adenoidectomy.  We were hopeful that the headaches would ease but they did not.  We heard about a neurological chiropractor and started seeing him on a bi-weekly basis and then monthly.  This helped a bit but his chronic headaches persist.  I have kept documentation and have copies of his medical records as well as documentation from his kindergarten and first grade teacher who can verify his continued suffering.
PATIENT STATED SHE HAD MALAISE, HEADACHE, FATIGUE, NAUSEA, LOW GRADE FEVER AND CHILLS FOR ABOUT 36 HOURS.  ARM SORENESS THAT LASTED ABOUT 7 DAYS.  SHE THEN WAS DIAGNOSED WITH BELL'S PALSEY ON 03/09/2021 AND IS CURRENTLY BEING TREATED.
1. 3 days profound body weakness, pain in head & all muscles  2. Urinating frequency increase and pain urinating followed inability to urinate . Legs painful andsense of compression up to mid thigh 3. ER treated for urinary track infection, hospital for 2 days 4. Home on antibiotic urine frequency goes to 40x and bowel and bladder stop working back to ER catheterized 5. Home Catheterized nov  19 to dec  1. Removed then re-catheterized ? unable to urinate. Legs continue to be painful but getting weaker and unstable. 6. Referred by  Urology to neurogenic bladder specialist  7. Under  hospital ongoing with urologist and head of neuro muscular research
Circular rash 2 inches in diameter with raised, hard center at injection site for monkeypox noticed in the morning 10/27 and worsened throughout the day. Itchiness responds to hydrocortisone. No further symptoms at this time
site red,sore devel papular rash @ site;rx DPH elixir;
Passed out; Dizziness; Blurry vision; Stomach ache; Headache; Was throwing up; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Headache) and VOMITING (Was throwing up). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and VOMITING (Was throwing up) had resolved and ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Vaccination taken after 5 PM. Nothing felt at the injection site. No other side effects reported. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1st and 2nd hurt really bad at injection site/her arm was so sore/whole arm hurt/Her husband had the same experience; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 80-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "1st and 2nd hurt really bad at injection site/her arm was so sore/whole arm hurt/Her husband had the same experience".  Additional Information: The reporter was going to have surgery on her lungs and wants to know if she should have the Pfizer Covid vaccine 2023-24 formula before or after she has surgery. She stated she had 4 Covid vaccines in the past, all Pfizer and with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad. For the second two, she asked them not to pinch up her skin and her arm wasn't sore. Her husband had the same experience.    The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309532 same reporter, vaccine, different patient and event;