chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare student refers to a 56 year old female patient. On 14-AUG-2014 the patient was vaccinated   with ZOSTAVAX, (subcutaneous, 0.65 ml dose number unknown; lot number reported as K000996 EXP 13-MAR-2014). On 14-AUG-2014, the patient experienced injection site was red, tender and swollen. The injection site reaction continued for 4 days. The patient did not seek medical attention and did not received treatment. The outcome of the events was unknown. Additional information hs been requested.
This spontaneous report as received from a physician via field employee refers to multiple unspecified patients of unknown age and gender. Patient's medical history and concurrent condition was not reported. On an unknown dates, multiple patients were vaccinated with PNEUMOVAX23. (Dose, route, Lot number/Expiry date were unspecified). No information on concomitant medications was provided. On an unknown dates, these multiple unspecified patients experienced injection site swelling and injection site bruising. These events lasted for an unspecified amount of time. The action taken, outcome and causality was not reported. No additional information was provided. Additional information has been requested.
Information has been received from a physician concerning a female (demographics not provided), who on unspecified dates was vaccinated with first and second doses, respectively, of GARDASIL (lot# unspecified). It was reported that the patient fainted after receiving the second dose of GARDASIL. It was mentioned that the patient also fainted after the first dose as well. Unspecified medical attention was sought. It was also reported that the patient had recovered from her experience. No further information was provided. Additional information has been requested.
Injection site starting to itch; Getting a little hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site starting to itch) and VACCINATION SITE INDURATION (Getting a little hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CLOPIDOGREL, ERGOCALCIFEROL, GLIPIZIDE, LEVOTHYROXINE, NIFEDIPINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site starting to itch) and VACCINATION SITE INDURATION (Getting a little hard). At the time of the report, VACCINATION SITE PRURITUS (Injection site starting to itch) and VACCINATION SITE INDURATION (Getting a little hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the itching included topical iodine.
Patient complaining of lightheadedness, room-spinning, feeling of falling over. Denies any reaction after the first dose. RRT was called after abnormal vitals obtained (HR 160-180s, BP 80/60, O2sat 97%, RR 18)
Large right frontal intraparenchymal hemorrhage. 3 days' headache and fatigue, some mental confusion. Admitted to hospital through ER Department 8/18/2022, discharged to rehab 8/26/2022.
Diagnosed as injection cellutitis.  Injection administered and prescription of antibiotic 1000 mg/day.
While getting ready for work  after showering on 1/11/2021 before 0630 this morning, I noticed a pretty large bruise on the inner left thigh of my left leg.  I was shocked to see it.  This bruise wasn't present prior to the vaccination.  I also didn't injure my leg which would've caused the bruise.  It isn't painful, but surprised to see it there.   I'm sure the bruise will heal in a few days.  I took a photograph if it and will monitor it.
Arm tenderness that has not gone away. Muscle tightens up if not used. No swelling or bruising. No radiating pain
Enlarge lymph node in axillary area of left arm, red streaks around injection site. Lymph nodes swollen and tender to touch.
Wheezing/coughing/congestion   Dr. Visit prescribed a steroidal inhaler: ?Flovent? 7/21/2021 Follow up visit scheduled in two months.
Scheduled Mammogram/Sonogram revealed abnormal lymph node--right arm pit--had needle biopsy. Noticeable hearing loss in both ears. ENT scheduled MRI on ears. Had dilated both Eustachian tubes. Had tubes put in both ear drums. NOTHING HELPED.
Shooting pain thruout  my body.  Feet and ankles hurt to walk.  Waves of chills.  My feet went numb many times after a pain episode.  I've never had that happen with any of my tick borne illnesses.
Diarrhea; This is a spontaneous report from a contactable consumer. This 35-year-old Male consumer (Patient) reported that who received bnt162b2 (BNT162B2) solution for injection, dose 1 (Batch/Lot Number: EN6203) via an unspecified route of administration, administered in arm left on 28Feb2021 09:30 (at the age of 35-years-old) as dose 1 single for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing other_medical_history: No. Concomitant medication(s) included amoxicillin (AMOXICILLIN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient did not have known allergies. No treatment was received for the adverse events. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Mar2021 09:00 the patient experienced diarrhoea. Outcome of the event was recovered on an unspecified date.    Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Left deltoid with 4.5 cm round pink/blotching elevated area with central induration.
Severe pain in lower back, like I had been punched started Monday morning (3/15). Shingles breakout of blisters Friday morning (3/19). Received Dose #2 ... February 24, 2021. No reaction to Dose #1 and no other reactions other than listed above for Dose #2.
Fever, chills, Bullae type blisters formed on both arms, scalp.
Large red rash on arm - 3.5" x 4" with a red finger leading to arm pit. 1/2" raised bump the size of silver dollar. Swollen and painful under arm - lymph nodes. Pain scale to touch = 8.
Irritation of the outer lips  Redness, cracking, scaling minor swelling.  Some eight days after the first vaccine. Saw nurse practitioner prescribed Zyrtec and Prednisone.  Also recommended a moisturizer.  Using Vaseline with Aloe Vera.  After two days of Pred. no results and received 2nd vaccine.  Moisturizer giving relief of minor cracking and scaling.   Swelling has gone down some.
Itchy red rash started within 2hrs of vaccine. Started at YF site and spread through elbow and up to shoulder. Rash remained approx. 1 wk. Client used OTC anti-itch creams
Patients mother brought him to clinic on 2-25-04, 2 days following vaccines. States child developed redness, swelling and itching 1 day following vaccine. Left upper arm with erythema 9cmx10cm, area warm and slightly raised. No pain with palpation. Recommend cool compress for comfort, monitor site and see provider if no improvement in 1-3 days.
PATIENT EXHIBITED MOUTH NUMBNESS, PALPATING THROAT, THIRST, STICKY EYES, BODY SHAKES AND RED EYES. SYMPTOMS BEGAN 4 HOURS AFTER IMMUNIZATION AND LASTED ABOUT 8 HOURS.
This spontaneous report as received from a physician refers to a 68 years old female patient. The physician reported that after receiving on an unspecified date a dose of ZOSTAVAX subcutaneously, the patient developed "a localized reaction" which consisted of "redness about 2 to 3 inches in diameter around the injection site (date unspecified). It was reported that the patient did not receive treatment for the adverse event. The event lasted 3 weeks and the redness at the injection site disappeared. The patient recovered (date unspecified).
Patient reported that the area on her left arm is red hot, swollen and really hurts after receiving the arexvy and fluzone hd in the left arm.
Swelling, redness, pain, warm to touch, chills, vomiting. Patient called back 9/3/18 reporting it is getting  better, redness has become yellow.
Patient's newborn had large areas of eroded skin on both lower legs and feet. Born at 39.1 weeks, 3.38 kg, APGARS 9 and 9. Other than legs, all other areas of infant's skin normal. No blisters, no bullae, no other lesions. Negative Nikolsky sign.
Approximately 30 min after patient received vaccine, pt called from his office complaining of not being able to focus on his computer screen, his head was spinning, he had hot and cold sweats, he was light headed and his whole body was going numb. Emergency was called to evaluate the patient. At evaluation, pt continued with the symptoms stated above. His blood sugar was 161 and states his blood pressure and heart rate  were elevated.  After some time, patient's vital signs stabilized and patients symptoms had mostly resolved, except some residual tingling.
Admitted to hospital for acute on chronic respiratory failure following covid vaccination.  (patient significantly fatigued, slept most of the day after vaccine, not on BIPAP as needed)  HISTORY OF PRESENT ILLNESS:  patient is a 78 y.o. female with a history of oxygen-dependent chronic obstructive pulmonary disease, obstructive sleep apnea, and persistent atrial fibrillation who presents today with general malaise.  She received her 2nd COVID-19 vaccination yesterday and complained of fatigue, body aches, and general malaise all day.  Later in the evening she noticed that her blood oxygen level was low.  She denies having any more shortness of breath abnormal.  She has had no vomiting, headache, or chest pain.  On arrival she was noted to be febrile and required 6 L supplemental oxygen via nasal cannula.  She usually uses 2 L nasal cannula at baseline, occasionally increasing it to 3 or 4 with exertion.  She also had elevated troponin levels and noted leukocytosis.  There was radiographic evidence of congestive heart failure.  On exam, she is tired and wants to go to sleep.  She is still requiring 4 L of oxygen via nasal cannula.  Her daughter is at bedside.  Plans are discussed for admission and she is agreeable.   ASSESSMENT / PLAN: * Acute on chronic hypoxemic respiratory failure (HCC) Assessment & Plan Admit to medicine- hypoxic requiring 6 L nasal cannula, utilizes 2 L nasal cannula baseline Hypoxia appears to be secondary to robust immune response to COVID-19 vaccination Increased hypoxia, fever, leukocytosis, elevated troponin, radiographic evidence of congestive heart failure Will repeat troponin level in the morning, daily chemistry and blood count, will treat congestive heart failure as below     CHF (congestive heart failure) (HCC) Assessment & Plan Transesophageal echocardiogram from October 2020 noted preserved left ejection fraction, and had no evidence for diastolic dysfunction Radiographic evidence of congestive heart failure, normal BNP, elevated troponin with an increase of 18 at the 2 hour mark, will recheck in the morning As this is her 2nd hospitalization since that echo with hypoxia and concern for CHF, will obtain repeat echocardiogram Received 80 mg IV Lasix in the emergency department, will continue 40 mg IV Lasix 2 times a day Daily weights, 2 L fluid restriction Patient was admitted with acute on chronic hypoxic respiratory failure. I think this is due to acute on chronic diastolic congestive heart failure that was brought on after she was sleeping most of the day without her BiPAP. She says she got her COVID-19 booster shot and felt so tired she slept all day. She did not think she needed her BiPAP during the day even if she was sleeping. She has not had a recent sleep study. Patient is diuresing and will likely be able to discharge tomorrow.
Pt had severe local reaction involving pain in entire arm. Swelling in upper arm and what looks like small abscess formation at injection site. Swelling and pain improved after 48 hours with massage and some ibuprofen; still with pain, swelling in 2" radius around injection site on day 5. Pain and swelling seems to be improving.
Patient received 1st dose of covid (moderna) on 11/24/21 at a outside location. Patient called and was scheduled on pediatric nurse schedule for 2nd dose of covid. Pfizer vaccine was given.
I woke up at 3:30 a.m. very thirsty, have to use the bathroom, throbbing stomach ache, very hungry. I started walking around, got cold and started looking for a sweater and blanket. When I was walking around the house, I got incredibly dizzy and had to grab the wall to stabilize myself. I couldn't see anything (all black) so I laid down on the floor for a minute. My vision was black for about a minute. I stayed on the floor until I could get up and go lay down. I then got the chills and body aches. I took three advil. I've had symptoms for all of my shots, but never have I blacked out. (first three shots were Pfizer, the bivalent was Moderna). Today (the next day) I am very tired and still feel nauseous and dizzy.
Patient reported swelling initially at injection site which spread down to elbow and up to top of shoulder. Also very painful. Called pharmacy 12/20/15 in late afternoon and stated the left arm was three times larger than right and red only on outer aspect of arm. The patient applied cold compress and took ibuprofen to help with pain and swelling. On 12/21/15 the pain has decreased and arm swelling is reduced. still not back to normal but stated he is feeling better. The patient contacted his primary physician on 12/21/15 as well.
vaccinated in her arm then was feeling well but had sore arm; This is a spontaneous report from a contactable nurse (reporting for herself). A 19-year-old female patient to received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 07Jan2021 22:45 (lot number: EL1284) and first dose on 17Dec2020 15:30 (lot number: EK5730); via intramuscular in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was vaccinated in her arm then was feeling well but had sore arm on 19Dec2020, comparable to the flu vaccine. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on unspecified date. No treatment was given to the patient for the event. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Perforated Jejunal diverticulum on 7/22/21. Developed severe upper abdominal pain with no radiation or peritoneal signs. Patient treated with ciprofloxin and flagyl for 10 days with resolution of pain.  Second Pfizer-Biontech on 3/18/2021 - R arm third Pfizer-Biontech on 10/9/2021 - R arm Have had 3 episodes of lower abdominal pain consistent with diverticulitis of colon. Treated with antibiotics (amoxicillin) on 3/5/2021, and Cipro/flagyl on 3/18/2021.   Also have developed enlargement of umbilical hernia since summer 2021.
Red swollen warm painful redness 8 inches in length and 3.5 inches in width pt. does state site is looking better than it did last noc. informed pt. to take otc benadryl and ice to site. if worsen to report back asap.
On 11/13/18, skin reactions occurred 1.5 inches below injection site, arm felt warm to touch, itchy, bright red rash. Lasted 5 days. Patient also felt sick, tired, achy, no reported fever, coughing. Did not seek medical attention.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-JUN-2011, patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z expiry date: 11-NOV-2012. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via sales rep and described the occurrence of generalized rash in a 83-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 82 or 83 years old. The patient received the 1st dose of the SHINGRIX vaccine a couple of months before the date of reporting (exact date of vaccination was unknown). The patient experienced a full body rash. The patient decided not to receive the 2nd dose. The patient did not report the event to her doctor. The caller did not have any additional details.
After the first vaccine my right ring finger began to lock up and become immobilized. After the second shot, the middle finger of my left hand began to lock and my ring finger on my left hand locked up as well after two weeks post second vaccine. I wear braces to extend them so that I can help it from getting worse however there is no improvement overall. I was recommended to do some physical therapy for my hands, twice a week for a few months and they just never improved. Began to seek care and was told to sleep with braces to improve mobility of my fingers however these three fingers still lock up. I do see the orthopedic surgeon on December 2nd to see if there are any answers or treatments that have not been explored.
no additional AE reported; Gardasil 9 was administered during temperature excursion; This spontaneous report was received from a  licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-NOV-2021, the patient was vaccinated an improperly stored (product storage error) dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T030749, expiration date 16-MAR-2023 (dose, route and site of administration were not provided) for prophylaxis. No additional information about the temperature excursion involving suspect vaccine was provided. No additional adverse event was reported (no adverse event).
Vaccine was stored after expiration date in the refrigerator; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
4 different auto immune diseases; Caller states she had an allergic reaction to pneumonia shot 10 years ago.; This is a spontaneous report from a contactable consumer (patient). An adult female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer reported as Pfizer), lot number and expiration date not reported, via an unspecified route of administration on an unspecified date (reported as 10 years ago) at single dose for immunization. The patient medical history was not reported. The patient stated that she was taking 26 different medicines (unspecified). The patient stated she had an allergic reaction to pneumonia shot 10 years ago and has 4 different autoimmune diseases and has a lot of allergies. She was wondering, and trying to find out about the COVID 19 if she should get the thing or not but she can't find out what was there in the Pneumonia Vaccine to see if she should get the COVID 19 Vaccine or if she should wait as both are manufactured by Pfizer. The patient stated that she was getting ready to have some more blood work, about every three months she has blood work done because she has auto immune diseases. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient reports no history of heart problems or history of cardiac symptoms.  She said she has not been under any recent stress.  Patient typically walks 6 miles every day.  On 05/12,  she went out for her normal walk.  She said about 4 miles into the walk, she noticed that her chest was feeling tight, but she continued.  They finished the walk.  She went home.  She took a shower.  She started to have some low back pain.  She said she continued to have some chest tightness.  She said that she had a phone call with the nurse about her recent bladder surgery, and while they were having that conversation, she mentioned the chest tightness and was told to go right away to the hospital.  They went to a HCF.  She said on the way to the HCF, her left arm went numb.  She said when she got to the emergency room, the chest pain was very severe and felt like there was a knife in her chest.  It looks like her initial troponin was 0, and then went up to 1.13.  D-dimer was negative.  Chest x-ray was normal.  EKG showed ST depression in leads 3 and possibly AVF.  She was given aspirin.  A heparin drip was started.  She was taken to the cath lab.  She had no coronary disease.  She had a transthoracic echo that was consistent with Takotsubo with an EF of 38%.  She was started on atorvastatin 40 a day, indomethacin 25 mg 3 a day.  Her carvedilol was stopped, and she was switched to metoprolol 12.5 a day.  They decreased her losartan from 50 a day to 12.5 a day.