chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed cellulitis after being administered a dose of PROQUAD; This spontaneous report was received from a certified medical assistant via company representative regarding a 4 years old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were reported as unknown. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (lot #, expiry date, dose and anatomical location were unspecified) subcutaneously for routine vaccination. Co-suspect therapy included sterile diluent. On an unknown date, the patient experienced cellulitis on unspecified area of the body after being administered the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). On unspecified date, the patient's mother contacted the physician's office and the physician instructed the mother to take the patient to the hospital. It was unknown, whether the patient was admitted to the hospital or discharged on the same day. There was no information about the treatment drugs that were provided to the patient at the hospital. It was reported that the patient was going to the physician's office sometime soon for follow-up. The outcome of the event was reported as recovered. The causality of the event was not reported.  Upon internal review, the event cellulitis was determined to be medically significant.
"Monday of this week, 4 days ago had the COVID vaccine #1 (Moderna) and had fever x1day only and then a lingering headache that is not really improving with ibuprofen."
Extreme pain in arm. Next day swelling and redness, nurse practitioner diagnosed as cellulitis at side of injection on 7-11. Immediately put on an antibiotic (Cephalexin).
Red, swollen arm RUE, blisters with weeping clear fluid noted also no fever but skin warm to touch - redness - edema and redness just above elbow to shoulder - pictures taken.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 4-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 19-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
This spontaneous report was received from a medical assistant via a company representative and refers to a female patient of an unknown age. No information on patient's concurrent conditions, medical history and concomitant medications was provided. On 22-NOV-2013, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot number and expiry date were not provided). On 30-MAY-2017, she received a dose of GARDASIL 9 (dose, route of administration, lot number and expiry date were not provided). No adverse effects were reported. Additional information is not expected as there was no consent to contact physician.
Within 5 minutes of injection, client became flushed and diaphoretic.  She felt extremely nauseated and vomited x1.  Client had not eaten breakfast before injection.  Client monitored for over 1 hour in dark quiet room where client was able to recline and relax.  Vital signs were stable.  No difficulty breathing or swallowing.
Fever and vomiting. The patient presents with fever and vomiting. Mother states patient has had a worsening fever for the last 4 hours. Frequent vomiting since onset. Mother notes patient had his immunizations earlier today. The onset was 4 hours ago. The course/duration of symptoms is worsening. Associated symptoms: vomiting, denies cough and denies diarrhea. Temperature is 102 Fahrenheit on arrival to ED. Risk factors consist of none. Prior episodes: none. Therapy today: Acetaminophen.
The family reports the patient struggled with decreased cognitive function for approximately 24 hours the day following administration of the vaccine.  Examples of the cognitive decrease included difficult and slow speech with difficulty reading and answering basic questions.
Pt is a 90 year old MALE with pmhx of HTN, HLD, chronic  kidney disease Stage III who presented to ED 11/13 for worsening shortness of  breath and recent hx of hemoptysis. Patient states that he began experiencing  shortness of breath last night while sitting watching TV. He began coughing up  bright red blood per patient and witnessed by multiple family members. Denies  sputum production. Denies headaches, chest pain, abdominal pain, N/V, dysuria.  Patient was ultimately brought in to ED 11/13 for evaluation. Of note, patient  received 2 doses Pfizer Covid-19 vaccine in March/April 2021. Per CPRS records,  patient was exposed to Covid-19 shortly after Labor Day, in a group setting with  multiple family members. He tested positive for Covid-19 9/24, and was treated  at home with Regeneron c/b PE (diagnosed on 10/6, requiring hospitalization for  2 days). During 10/12-24 hostpial stay, patient presented with hypoxemia,  dyspnea, and chest/back pain 2/2 large right pneumothorax. Ultimately, he became  s/p pigtail catheter placement by IR x2 with complication of exudative right  sided pleural effusion and persistent volume loss on right side with right sided  tracheal deviation. His previous CT Chest on 10/18 and 10/16 showed  consolidative opacity in RML and RUL likely related to inflammation/fibrosis  which is causing volume loss. Patient is currently now on Eliquis 5mg BID. His  CT scan on 10/23 showed right mediastinal shift, suggestive of  inflammmation/fibrosis and blebs on right lung possibly suggestive of right lung  volume loss, and extensive chest wall emphysema in left lung. Patient ultimately  underwent follow CT scan on 11/1, which showed resolution of apical and basilar  pneumothorax, with posterior right lung concerning for infiltrates (vs. previous  fibrosis) with consistent extensive chest wall emphysema in left lung.   At admission, BP 123/74, with tachycardia (127). It was documented in ED that he  was initially at 91% pulse ox; however, very soon after, patient was found to be  satting at 55% on pulse ox, unable to give full history. Patient was placed on  NRB 15Lm ultimately satting at 97% on pulse ox. Chest x-ray at admission showed  small bilateral pleural effusions and extensive bilateral lung opacities, right  greater than left, increased since prior comparison study. CT thorax showed  enlarging, large right pleural effusion with new small left pleural effusion;  new multifocal septal thickening with groundglass opacity of both lung, highly  concerning for multifocal pneumonia, new fat stranding about the pancreas,  incompletely visualized concerning for pancreatitis. Patient noted to have a  heart rate initially 150 range; EKG showed sinus tachycardia. Patient  subsequently improved with IV fluids. However, given recent complex hx and  tenuous nature of his oxygenation after multiple attempts to deescalate his  oxygen in ED from NRB to Oxymask (patient will sat down to high 80s), patient  was admitted to ICU for stabilization and management."
Erythema, 12 cm oval erythema on upper left thigh, non-tender.
immediately after getting the vaccine he started with like a post nasal drip cough, now he was not sick before or anything like that; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid.  A contactable consumer (patient's wife) reported that a 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included drug hypersensitivity (reported as allergic to penicillin and all Cephalosporins), anaphylactic shock (reported as anaphylactic shock reaction to these medications), cerebrovascular accident (reported as strokes since age 35), paralysis (paralyzed on his right side), cardiac operation (open heart surgery), endarterectomy (had 3 Endarterectomy on his neck which none of them taken), and drug hypersensitivity (allergic to penicillin and all sulphur form drugs). Concomitant medications were not reported. The patient immediately after getting the vaccine started with like a post nasal drip cough on an unspecified date, now he was not sick before or anything like that. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patient of unknown age and gender. 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 ROTATEQ (lot # L042215, expiration date: 02-JUN-2017) (orally, dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 35.8 degrees Fahrenheit for 45 minutes. Data logger was involved. Previous excursions were at the temperature of 35 degrees Fahrenheit for 1 hour. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna vaccine was administered outside of our facility - reported by patient  I95.9 HYPOTENSION 9/20/2021 DELIRIUM I95.9 HYPOTENSION 9/20/2021 ATRIAL FIBRILLATION, PAROXYSMAL
tested as pre-operative procedure/surveillance. No symptoms. Patient was diagnosed with encephalopathy and was transferred to comfort care on 7/11 and died peacefully with family at bedside. He tested positive for COVID w/no symptoms on 06/04/2021 during admission surveillance; LTCF where patient lived had 3 other residents tests positive
14 days after receiving the dose, pt had 3 boils on his face.  Additionally at the location of his vaccination on his arm became red/pink.  An area of 2" circle
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 26 doses from Lot 065K21A Monovalent doses were administered after the BUD to patients. Treatment medications were not reported.
On 4/4/00, mother reports infant had IZ in early AM and by 13:00 had a temp of 102; at 20:00 it was 103. On 04/6/00, temp was 102 during the day and 105 at 16:00. Seen by MD and he thought vaccines were responsible. Used lukewarm baths and Tylenol. On 4/8/00, temp was 103 in early AM and treated with 2 doses of ibuprofen. No redness at the site of the injections.
Like the fact that your COVID vaccine made me go blind in one eye!; Eye Stroke/Ocular vascular disorder; The initial case was missing the following minimum criteria: [ICH- unidentifiable reporter]. Upon receipt of follow-up information on [20Nov2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "Like the fact that your COVID vaccine made me go blind in one eye!"; OCULAR VASCULAR DISORDER (non-serious), outcome "unknown", described as "Eye Stroke/Ocular vascular disorder". The events "like the fact that your covid vaccine made me go blind in one eye!" and "eye stroke/ocular vascular disorder" required physician office visit. The patient underwent the following laboratory tests and procedures: Full series of tests: Unknown results, notes: Had full series of tests to determine why with nothing noted. Clinical course: After receiving the Covid-19 vaccinations, patient had an Eye Stoke. Had full series of tests to determine why with nothing noted. The only explanation was the Pfizer Covid 19 vaccines. Patient was now blind in right eye and not able to do half of what patient was able to do before. Patient one doctor who said Eye Stokes have been associated with vaccine, but that mainstream medical didn't agree.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20Nov2023): This is a spontaneous follow-up report received from a contactable Consumer. Updated information included: Case was updated from invalid to valid. Reporter information (mailing address, phone number and email address), patient information added, lab data added, Historical vaccine added, suspect information (dose number and dose description) and new event (Eye Stroke) added.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient complained almost immediately of a burning sensation on her entire arm, which progressed quickly into itching on the left arm. She denied any SOB or itching of throat or mouth, however within a few minutes the itching progressed to her right side and onto her chest. She then complained of her eyes watering and then stated her chest was growing tight. EMS arrived at this point and took her to the ER
pt says the day after taking the vax she did not have the wear her glasses or take sinus meds.  This lasted until she got the 2nd dose.  After the 1st dose she developed a 102 fever, body aches and pain, constant vomiting, dizziness and vertigo symptoms.  She was so sick she didn't know where she was and felt like she was going die. These symptoms lasted 24 hours.  A week later she bent over to pick up something and experienced another bout with vertigo and fell to the ground. She went to Hospital ER in on 2/2/21.  She was given medicine for pain and vomiting.  She had a broken shoulder so was referred to an Ortho Dr.  She put was put in a sling because the shoulder was crushed and not able to put pins in it.  After 3 weeks after she was able to remove the sling because she stated it felt better and no longer had any pain. She never FU w/ Ortho dr.  On 3/2/21 she went to get her 2nd covid dose and she had 14 days of the same exact symptoms that she had with the 1st dose.  After her symptoms subsided she said she had to start wearing her glasses again and also taking her sinus medicine.  On 4/10/21 all of her symptoms came back as strong as they were before and they lasted 3 days.  The vertigo symptoms were not as strong with this episode.  She took Excedrin for her pain.  On 6/12/21 she states all of her symptoms came back as strong as before and they lasted 3 days again.  This time there was no fever.  She says these symptoms come back every 3 to 4 weeks.
Redness, swelling, soreness and feelings of anger/rage mood changes. Diagnosed with Hypothyroidism in 2004, no family history.
This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK5730, via an unspecified route of administration on 29Dec2020 at 13:30 (at the age of 34 years old) as a single dose in the right arm. Medical history included fibromyalgia, anxiety disorder, and allergy to amoxicillin from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included omeprazole 40mg and duloxetine 120 mg, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020 at 18:30, the patient experienced severe body aches, chills, minor headache, and swollen lymph nodes on neck. On 30Dec2020, the patient experienced productive cough. The patient did not receive treatment for the events. The clinical outcome of body aches, chills, minor headache, swollen lymph nodes on neck, and productive cough was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Swollen left lymph node in underarm/breast area.; This is a spontaneous report from a contactable healthcare professional, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), levonorgestrel (NORTREL), minerals nos, vitamins nos (PRENATAL VITAMINS) and probiotic (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient experienced swollen left lymph node in underarm/breast area. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen left lymph node in underarm/breast area was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Developed localized reaction at the site of the vaccine (right arm), which developed a secondary cellulitis.
I had a little bit of  a fever, a little bit of sinus congestion in my nose, sore throat, maybe a little bit of fatigue, a little bit of a headache, some muscle soreness. Started on 12/29 or 12/30, lasted a few days. None of the symptoms were severe. I didn't really any take any medicine for anything. I tested positive for COVID-19 on 12/30. I tried to schedule an appointment online for PAXLOVID but I never heard back.
I waited the recommended 15 minutes after my vaccine and felt okay.  When I got to my car, my face felt very hot and was flushed and the right side of my tongue felt thick for a day or more.  Yesterday was one week ago from my vaccine and my tongue intermittently still feels thick.  My tongue  feels like it does when novocaine starts to wears off from the dentist.  My right arm also felt sore and puffy; however, there was no skin reaction.  The next day or so the right side of my neck was sore.  As to be expected, my arm was also sore.
Sore arm at injection site.; This is a spontaneous report was received from a non-contactable consumer (Patient). A 72-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202 and expiry date was not reported), via an unspecified route of administration, administered in arm left on 06Mar2021 09:45, as 1st dose, single dose for covid-19 immunisation. The patient's medical history included type 2 diabetes mellitus. The patient's concomitant medications were not reported. The patient had no known allergies. Patient did not receive any other vaccines in 4 weeks. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On an unspecified date in 2021, the patient experienced sore arm at injection site. On an unspecified date in 2021, the patient was recovered from the event.  No follow-up attempts are possible. No further information is expected.
On 7/27/09, Pt. was administered tetanus tox. 0.5ml to (R) deltoid tolerate well. Pt. RTZ on 8-3-09 with c/o inj. site was swollen, red, tender. Noted 9cm induration and redness to (R) deltoid. Pt. currently on KEFLEX 250mg 1 po TID