chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin reaction around site of injection within weeks of vaccine. Then generalizing over entire skin surface over next 3-4 months.
Positive blood culture for pneumococcus. This is the report on the little girl I called about in October. She had had Prevnar and became ill, 2 months later with pneumococcus illness. An isolate was not available for CDC. On 11/6/01, the doctor just faxed me the form and he did put the vaccine dates on it but didn't send them in a progress report. They are: 3/20/01, Prevnar #1, right thigh lot 472548; 7/3/01, Prevnar #2, right thigh lot 473349; 8/7/01, Prevnar #3, right thigh lot 480895. I wasn't sure if I could add to his form.
Anemia, Elevated Ferritin, Inflammatory markers, Transaminitis, Splenomegaly, Lymphadenopathy, HLH syndrome
This spontaneous report as received from a registered nurse via a company representative refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of MMR II (lot # and dose not provided) subcutaneous in the anterolateral aspect of the thigh. No adverse effects were reported. Additional information has been requested.
Patient described feeling like something was "off " as soon as needle punctured her arm. She had a red, raised local reaction at the injection site, and developed a rash that spread all the way to her elbow. This resolved within a week of injection. She also described feeling like she was coming down with something, a general sickness feeling that kept her in bed. Approximately 11 days after injection she experienced a breakout of hives across her chest and forearm that she is still experiencing at 13 days post vaccine.
Swollen arm from elbow to shoulder with rash. Sore to touch. Felt Hard per patient. Lasted about 6 days and has been getting better daily.
Red, hot to the touch, swollen, splotchy, rash, itchy not about 3" by 2", swollen, Pain from shoulder into armpit.
pt recvd vax & the same day exp swelling @ the elbow & wrist followed by stiffness of the elbow; sx progressed over the next wk; 1 wk p/inject exp shooting pains in the arm @ inject site & into shoulder; elbow site was erythematous & warm;
Presented to the ED w c/o of SOB; found to be positive for COVID-19. Tx w/steroids, vitamin-C, O2, & zinc.  Patient's oxygen saturations improved and pt dc'd on room air.
From initial information received on 01/22/2003, it was reported that a 63 year old male patient received ACTHIB, Lot # UB405AA, given intra-muscular in the left arm and MENOMUNE A/C/Y/W - 135, Lot # UB256AA, given subcutaneous in the right arm on 01/22/2003.  Ten minutes after vaccination, patient's blood pressure increased from 142/78 to 182/100 and his face and neck were flushed.  Patient was administered with 50 milligrams of Benadryl-blood pressure-200/120, and also given 30-50 milligrams of Prednisone for 2 days.  It was reported that the patient did recover and had no illnesses at time of vaccination.  Patient had a pre-existing diagnosis of allergies and being anxious.
Following administration of vaccine (oral rotavirus and DTAP/Polio/IPV given on contralateral thigh) to R thigh, induration noted which did not improve, and eventually started to drain pustular material. Surgical consultation and U/S of soft tissue found features c/w abcess, however surgical I&D cancelled as lesion auto resolved ~3 months later. Subsequent 3rd dose of same vaccine to different location on same thigh 5/8/18 resulted in another large probable abscess at the site (presently 3x3.5cm), prompting allergy and surgery consultations.
Second vaccine on 1/25/21 at 12:00  symptoms began on 1/26/21 at 12:00 and lasted until 1/27/21 in the afternoon.     Temp was 99.5-99.8  body aches throughout   nausea  extreme fatigue
Low grade fever, changed to high fever 6 hours later, vomiting 2 hours later. Vomiting next 4 days, fever next 3 days, irritable, Rash on back and torso began 05/07/2011 9:00PM, Diarrhea on 05/08/11 through 05/09/11. Rash remains.
On 10/27/21, patient received flu vaccine prior to admission. On 10/29/21, patient began to feel tingling in finger and toe, and weakness of hands and feet.  At the ED visit, patient struggled to walk.  No associated abnormal neurological symptoms such as TIA, loss of balance, loss of vision or speech. There was no history of brain or spine injury or infection, no episode of nausea vomiting, no exposure to cat or recent travel and no known sick contacts.  Symptoms of left upper and lower face muscle weakness, decreased reflexes left greater than right arms and legs as well as ataxia and therefore concerning for Miller Fisher Variant of GBS. Patient was treated with IVIG for 5 days. and high dose Solumedrol for 1 day.  Patient showed daily improvement in his gait with good walking without much assistance and recovering reflexes in lower and upper extremities.
Comirnaty 12+ (COVID) 23-24 SDV by Pfizer Hot shoulder at injection site sore throat ache all over very tired headache cough
Fatigue; difficulty concentrating; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 16:00 (Lot number: EW0169) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN; CLARITIN [CLARITHROMYCIN].  The following information was reported: FATIGUE (non-serious) with onset 19Apr2021 07:00, outcome "recovered" (Apr2021), described as "Fatigue"; DISTURBANCE IN ATTENTION (non-serious) with onset 19Apr2021 07:00, outcome "recovered" (Apr2021), described as "difficulty concentrating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, disturbance in attention.  Additional Information: Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks: Atorvastatin 20mg, Claritin. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Had no known allergies.   No follow-up attempts are possible. No further information is expected.
31Jan91 1st dose of vax,pt /win 25 min fainted& recoverd spontaneously.5Feb91 devloped petechial rash on arms.Pt c/o inc fatigue,inc wt loss & progression of petechial rash.Exam revealed petechial rash w/o adenopathy or hs megaly...see WORM
woke up with a big red irritations s that looks like a silver dollar; other spot looks like the size of a dime where he got his shot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (woke up with a big red irritations s that looks like a silver dollar) and VACCINATION SITE ERYTHEMA (other spot looks like the size of a dime where he got his shot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ERYTHEMA (woke up with a big red irritations s that looks like a silver dollar) and VACCINATION SITE ERYTHEMA (other spot looks like the size of a dime where he got his shot). At the time of the report, ERYTHEMA (woke up with a big red irritations s that looks like a silver dollar) and VACCINATION SITE ERYTHEMA (other spot looks like the size of a dime where he got his shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided.
Patient received PNEUMOVAX on 11/30/10 at our outpt clinic. Within 24 hours she developed marked swelling and erythema with the appearance of cellulitis. She was hospitalized in the observation unit and treated empirically with antibiotics. She was discharged on PO Clindamycin.
Patient received Moderna vaccine. Was given 0.5 cc dose instead of 0.25 cc recommendations.
Longer more painfu, heavier periods since I received the vaccine. My periods have been over a week and prior to this it was only 4 days and very light.
50 mm induration and erythema, warm to touch beginning the morning after injection. Client states putting ice to site made it worse.
Patient complained of severe headache and leg pain 30 minutes following the vaccine, she was advised by CPNP, who had ordered the vaccine at her well visit appointment, to go to the ED.
Seizure-like side effect about 10:15 (5 min) after vaccine was given. Pt was laid down and observed in knee-chest position for 15 - 20 min.
Sweating, shortness of breath, sweating, back spasms. 911 called. Patient refused transport, reported feeling better.
This spontaneous report was received from a 68 year old female patient. The patients concurrent condition included diabetes and allergy to ZOCOR, captured in case #1505USA04238. On an unknown date in October 2011 the patient was vaccinated with ZOSTAVAX, 1 injection (strength, route, lot number and expiration dates were not reported). Concomitant therapies included HUMALOG, NEXIUM, PLAVIX, BENICAR, NEURONTIN, low dose baby aspirin and metapleural. On an unknown date in 2013 (reported as 2 years after ZOSTAVAX) the patient experienced shingles pain. Around 01-APR-2015 the patient experienced another episode of shingles pain in both of her breasts and sides. The patient had sought medical attention and she was treated with LIDODERM patch and oral pain medication. A mammogram and ultrasound of breasts were performed on 11-MAY-2015 and nothing was found. The patient reported that the shingles pain never broke into rash but was excruciatingly painful but was less painful than the last shingles pain. She stated that the shingles pain happened every 3 to 4 years. there was no product quality complaint involved. The outcome of the events was unknown. The causality of the events was not reported. Additional information has been requested.
sore arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 021b21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Arthritis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-116630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received captured reporter contact details, product information and outcome.
Information has been received from a physician concerning a 3 month old male who was a premature baby who was vaccinated with a 2 mL oral dose of Rotateq. It was noted that it was "not certain that the patient had only one dose prior" to the adverse event. Concomitant therapy included SYNAGIS. Subsequently the patient developed ileus and was hospitalized for approximately 4 days. Subsequently, the patient recovered. The physician stated that he dose not believe that the ileus is related to Rotateq. There was no product quality complaint involved. Additional information has been requested.
On Friday 4/16/04 pt developed a "quarter-sized" , reddened, hot, swollen area to injection site of varicella vaccine. ON 4/17/04 developed 6-12 1g spots on face and body. Mother reports no fever by thermometer but child "felt warm". Also child "ill appearing." By Tuesday, 4/20/04, the spots were gone and just had a faint red area at injection site. Required only TLC at home.
May 1-2: Slight headache, body aches, fatigue, sore arm. Took an extra strength Tylenol once.  May 9: Rash/Hive at injection site, red, swollen, itchy, soreness, tightness. Measured 6 inches long and 2.5 inches wide. Took certirizine 10mg.
LOW WHITE BLOOD COUNT; LOW THYROID STIMULATING HORMONE; CHILLS; SORENESS AT INJECTION SITE; MILD SINUS HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included leflunomide for rheumatoid arthritis, and levothyroxine sodium. On 30-JUN-2020, Laboratory data included: White blood cell count (NR: not provided) 3.8 10*9/L. On 21-OCT-2020, Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.67, and White blood cell count (NR: not provided) 3.9 10*9/L. On 22-JAN-2021, Laboratory data included: White blood cell count (NR: not provided) 3.4 10*9/L. On 10-MAR-2021, the subject experienced mild sinus headache. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced soreness at injection site. On 14-APR-2021, Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.41. On 06-MAY-2021, the subject experienced low thyroid stimulating hormone. Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.20. On 14-MAY-2021, the subject experienced low white blood count. Laboratory data included: White blood cell count (NR: not provided) 2.4 10*9/L. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild sinus headache, chills, soreness at injection site, low white blood count and low thyroid stimulating hormone was not reported. This report was non-serious.
Pt received Flu Mist vaccine 1 week ago and since that time has c/o HA's 5-6 times per day x 7 days. * pt should cont daily Nasonex.  Will switch pt to Zyrtec 10 mg nightly to monitor for any improvement in sx's. * will send pt to allergy clinic for further evaluation and mngt in sx control. * mom can give Tylenol alternated w/motrin prn for HA relief.
Patient presented with positional chest pain that developed 1 day after the vaccine was administered. Was found to have mild elevations in inflammatory markers and with T wave flattening on EKG. Admitted for observation for presumptive pericarditis. Did have URI symptoms w/ runny nose on admission and siblings with cough/runny nose at home
3 days after Flu-Mist developed urticaria.  The wheals spread and coalesced and had the appearance of erythema multiforme by the next day. Low grade fever, 99.1 with mild cough and rhinorrhea noted.  Otherwise, child acting and playing normally.
Reaction on left leg, redness and bumps around site of vaccine, Rash (bumps) did spread throughout both legs, no other parts affected.  Benadryl/Diphenhydramine 2.5ml po given at 1130, and Dexamethasone 0.5ml po at 1150.
liquid vial not reconstitutied with powder vial; only liquid vial administered; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31st May 2023) for prophylaxis.   On 9th August 2022, the patient received Menveo. On 9th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.      Additional Information: GSK receipt date: 9-Aug-2022 Reporter's comment: Medical doctor reported that a patient received only the liquid vial of Menveo without reconstitution with the powder vial. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of only the liquid vial of Menveo without reconstitution with the powder vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
COVID-19 symptoms started on 11/15/2021, tested positive with antigen test on 11/16/2021. My symptoms were basically cold-like symptoms with low grade fever, some coughing, and just generally not feeling great. Treatments included fluids, rest, and on 11/18/2021 I got the monoclonal antibodies infusion. I had one night of pretty good chills after that, and then I felt a lot better. Symptoms lasted about through the following, Tuesday 11/23/2021.
8 y/o patient came in for 1st covid and adult pfizer dose was administered.  It was reported on to onsite provider and patient's parents were informed. Patient was monitored and parents were advice to continue monitoring and if  symptoms appear to contact provider.
Initial unsolicited report received from a consumer via other company (Pfizer) (Reference Number: 2016353319) on 27 July 2016. This case involves an female patient (age was not reported) who was vaccinated with a dose of Flu shot (batch number, expiration date, route and site of administration was not reported) on an unknown date. Patient had seizure following the pneumonia vaccine in 2000. The patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination with a flu shot that had thimerosal, the patient experienced her throat closed up but she never stopped breathing. It was reported that this was happened on 15 or more years ago. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
admitted with humerous fx from fall, rhabdo, afib with rvr, COVID + asymptomatic at time of admit , placed on zinc. O2 at 2L.  NonSTEMI 2. COVID pnuemonia. stated deamethasone. Hypoxia. O2 increased to 4L. possibly had covid X 2weeks. Out of window for remdisivir.  rhabdo resolving. paroximal AFIB, rate controlled. PT wants to go home. O2 at 3L at DC
Extreme Pain; Affected my immune system; Throwing up; Fever; Can't eat; Headache; Feels like every bone is inflamed; This case was reported by a consumer and described the occurrence of pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia.   On 6th September 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, less than a day after receiving Shingrix, the patient experienced pain, immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation. On an unknown date, the outcome of the pain was unknown and the outcome of the immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation were not recovered/not resolved.   It was unknown if the reporter considered the pain, immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation to be related to Shingrix.  Additional details were provided as follows: The patient experienced extreme pain, fever, thrown up after receiving Shingrix. The patient stated her immune system was affected. The patient had history of severe fibromyalgia, which she had kept on sheet. The patient asked how long would the symptoms would last or if she would have them for the rest her life. The patient had researched it online and felt she should not have had the vaccine with the autoimmune problems. The patient was unable to eat since she had received Shingrix. The patient felt like every bone was inflamed. She wanted the company to know that they should have a warning with patients with a history of auto-immune disease not to receive Shingrix. The reporter permitted to contact her physician.
Woke at 3am with chills, body aches, headache and fever.  Fever was 2 degrees higher than normal temp and continued until about 8pm when I took ibuprofen.  Symptoms were gone when I woke up on 3/6.  On 3/8 I experienced swollen glands and a cold sore.  the right side of my face was achy.  Ibuprofen helped.
12hr p/vax pt had high tactile fever & had a sz @ home that lasted about 1min turning blue over the face;did not need to give resuscitation;took pt to ER did spinal tap, blood tests-all nl;then later EEG also nl;
Developed Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the health department nurse. It was reported that, in October 2019, the patient was seen by her primary health physician and was diagnosed and treated for shingles. The reporter consented to follow up. The reporter did not have the physician name or contact information.
Discharge Provider: Private Primary Care Provider at Discharge: Private Admission Date: 7/15/2022 Discharge Date: 07/18/2022 Discharge disposition: Home Condition on discharge: Stable.  GI bleed [K92.2]   ADMISSION AND DISCHARGE DIAGNOSES:  HOSPITAL COURSE:   Acute blood loss anemia -No acute bleeding on EGD and colonoscopy.  GI will see outpatient for possible endoscopic ultrasound versus video capsule study.  Continue on PPI. -Discussed with GI prior to DC, no further workup planned inpatient.  -Hemoglobin stabilized and improving prior to discharge.  Symptomatically much improved.   Syncope secondary to hypovolemia in setting of profound anemia   - secondary to decreased oral intake and GIB - CTA negative for PE - ECHO normal - No arrhythmia detected on tele    COVID positive - vaccinated and boosted - symptom onset 7/9, COVID + 7/13 - CTA negative for PE or infiltrates - received 2 doses of Paxlovid - no indication for further therapy at this time    Abnormal EKG. New problem.  accelerated junctional rhythm that overrides her sinus node. Benign in etiology per EP
About 30 mins after shot my face turned bright red. Lasted until the night. Around 10pm on 3/31/21 had a headache so took Tylenol. Went to bed but was restless all night. Around 4am woke up with chills/freezing, body aches and headache. Took Advil. Fever was up and down all day reaching as high as 100.5 was restless all day. Felt very uncomfortable in my own skin. Took Advil through the day. The chills, body aches and fever ended around 11pm on the night of 4/1/21. Was finally able to fall asleep. Woke up at 7am on 4/2/21 with no fever but still had headache. Took Tylenol for headache. Also my sugar levels were running in the 200?s-300?s. I have never had trouble sleeping in my life so it was a very weird feeling not being able to sleep or take a nap. I felt so restless and uncomfortable in my own skin. Glad that feeling finally passed.
I had shingles rashes on my neck and back of head.  I never had shingles before.
Recurrent aspiration pneumonia. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.