chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness in my shoulder that the shot was given in and a burning sensation sometimes; numbness in my shoulder that the shot was given in and a burning sensation sometimes; rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 21Feb2021, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, after the second dose of vaccine, the patient experienced numbness in his shoulder that the shot was given in and a burning sensation sometimes, motor skills were all there, it was just that tight up the knot, numb sensation from the shoulder down to the elbow sometimes. Also, on an unspecified date in Feb2021, after the second dose of vaccine, patient also had a rash, but it went away. The events were reported as non-serious. The clinical outcome for the event rash was resolved on an unspecified date in 2021 and the clinical outcome of all other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling, bruising of shoulder. Started next day, Patient also noticed 3 nosebleeds within 6 hours.
16 hours later chills, fever, nausea and extreme tiredness. Lasted for 24 hours.  A week and one day later had an unexplainable seizure of two to three minutes and afterwards being unconscious for 25 minutes. Cat scan and MRI all normal.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection, lot # J008423 with expiration date 21-JAN-2016, J009243 with expiration date 23-APR-2016 and K011562 with expiration date 08-APR-2017 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
hives all over the body, arm, back and neck; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6208, NDC and UPC number: Unknown, Expiry Date: Unknown) via an unspecified route of administration, administered in left arm on Friday (at the age of 52-years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took COVID-19 shot on Friday, and today afternoon around 12:30 got hives all over the body, arm, back and neck. Patient visited the doctor and suggested not to get the second shot. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Headache & NauseaVomiting Narrative:  Headache & nausea 24 hours.
OVERDOSE; A spontaneous report has been received from a health professional. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number UNKNOWN), via nasal route, for influenza vaccine on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced overdose (preferred term: Overdose).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
large swollen induration (15cm x 15cm) @ site of inj;redness around area on rt upper arm;pt given ice bag & instructed to give DPH & call MD if needed;
COVID infection post vaccination  1 day following vaccination, patient experienced fatigue, myalgia and low grade fever.  RA test positive.  That evening, patient with increasing SOB and increasing oxygen requirement and was admitted for hypoxia + LE swelling.  Although SNF where vaccination took place denied symptoms at time of vaccination, per H&P, increasing oxygen requirements were noted 3 days prior to vaccination.   See H&P below  He is currently residing in a rehab facility following a hospitalization detailed below, but essentially he noted some shortness of breath about 4-5 days ago. They checked his oxygen saturation and noted that he was hypoxic, so started him on oxygen (reportedly 4L NC?). He reports a worsened productive cough; sputum is dark but not bloody in color. He has been fatigued and chilled; he thinks he's been intermittently febrile. No nausea, vomiting, or constipation. He endorses twice daily diarrhea, but he associates this with his bowel regimen. He also has a fair amount of lower extremity swelling which is bothersome to him; he says this has been ongoing since his MVA in January.[KE.4] He was recently seen in Nephrology clinic, where he was started on lasix 40mg daily and started on a low sodium diet[KE.3]. He is unsure if the lasix is helping his swelling, but does have robust urine output after he takes it
Dtap-IPV (Kinrix) was given instead of Tdap.  There was no adverse events.
The whites of my eye turned red/ pink. They did not itch or water. They were not as red the next day. Almost completely gone now after 5 days.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 27 year old female with PENICILLIN allergy and no other medical history who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL on 14-July-2008 and 15-Sep-2008 (1st lot #660557/0072X) 2nd lot #659184/0843X), respectively. Concomitant therapy included diphtheria toxoid/tetanus toxoid which was vaccinated with the first dose of GARDASIL. Subsequently the patient became pregnant after receiving GARDASIL. The due date of pregnant gestation reported as 13-May-2009. No adverse effect reported. Laboratory diagnostic studies included prenatal blood tests. The patient sought unspecified medical attention. Follow up information was received from the registered nurse who reported that the patient had a history of irregular periods and she had reported that she was not pregnant at the time of her vaccination with GARDASIL in September 2008. The reporter administered the vaccine to the patient and estimated that the patient was approximately 5 weeks pregnant at the time of vaccination. On 30-Apr-2009 this patient delivered her baby by c-section following spontaneous rupture of membranes. Amniotic fluids were clear. Patient was GBS negative. Gestational age was 38  weeks +. It was also reported that the patient experienced cholelithiasis during pregnancy on 23-Mar-2009 and underwent a cholecystectomy on 27-May-2009. Upon internal review, c-section following spontaneous rupture of membranes was considered to be an other important medical event. The baby's experience has been captured WAES # 0901USA00343B1. Additional information has been requested.
Patient got second dose of Pfizer of left upper arm. He immediately started to swelling at injection site about 2cm round fluctuant lump. No SOB, dizziness, CP, itchiness,no TTP, AAOx4. VS obtained 1730: BP=106/70 HR:70 O2Sat=97% on RA. Discussed with pt to get PO benadryl/famotadine. Pt declined all medications. Place ice pack on injection site.  Repeat VS: 1745 118/74 HR 77 O2 Sat 97% on RA AAOx4. Reassess site: site lump decreased to 1/2 cm, no TTP, redness, itchiness, SOB , CP, dizziness. Notified pt's boss: himself. Pt stating, "I feel fine."
Patient was administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 17th June 2022) for prophylaxis.   On 28th July 2022, the patient received Havrix. On 28th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comment: The reporter was a practice administrator. The reporter reported that the patient was administered an expired dose of the Havrix vaccine inadvertently. The reporter consented to follow up.  Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Severe flu-like ague,vomiting starting 4-5 hours after innoculations. Temp went up to 101. symptoms lasted 6-8 hours.
bad cold; bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) and NASOPHARYNGITIS (bad cold) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced VACCINATION COMPLICATION (bad reaction). On 14-Jun-2021, the patient experienced NASOPHARYNGITIS (bad cold). At the time of the report, VACCINATION COMPLICATION (bad reaction) and NASOPHARYNGITIS (bad cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  On Tuesday, the patient had a bad reaction.  The patient's treatment medication was not reported.   Reporter did not allow further contact
patient called back around 7 pm on 08/30/19 and reported that she is feeling very cold and been coughing , tired , has been sleeping the whole day and having problem getting a full breath in and out  .  she  stated  that these symptoms started  right when she gets home.  she got the vaccine around 10:30 am and was in  good health at the time
This is a spontaneous report from a non-contactable pharmacist, who is also the patient. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 12Aug (of an unspecified year) at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, 10 days after the vaccination, the patient experienced headaches. He informed his doctor, who admitted him to the hospital to do scans in order to determine the cause of the headaches. Results of the scans were not provided. The clinical outcome of the event, headache, was unknown. No follow up attempts are possible. No further information is expected.
pt recvd vax; fever of 101; v; "felt bad all over"; saw MD 2mar94, c/o feeling tired; 1jun94, tx w/ ATB for viral infect; sx lasted 1 wk; fully recovered;
w/in 24hr of vax hives 1/4" to 1 1/2" & raised, over face, trunk & limbs;went to ER @ hosp;pred given;
Rash from neck to wrist. Bright red. Irregular shapes. Was larger where shots were received. Did not itch lasted 4 weeks. Ended clindamycin 150mg for dental infection that morning. (CLEOCIN).
SORE ARM; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Brief history and medical decision making:  57M with complicated past medical history including Lynch syndrome with nonpolyposis colon cancer diagnosed 2007 s/p colectomy; as well as, a more recent diagnosis of stage III duodenal adenocarcinoma in October 2021 s/p whipple and undergoing chemotherapy. To note, recent hospitalization from 2/5 to 2/25 at hospital for atonic stomach and bilateral hydronephrosis s/p PEG and bilateral PCN placements.  Presented to ED 2/28 with low blood pressure and dizziness. Admitted for AKI and dehydration. Further work up discovered fungemia with candida followed by ID.     Today, the patient developed tachycardia and transient hypotension.   Hg at that time was 5.7.   Transferred to the ICU for concern of hemorrhagic shock.   Once arrived was awake and alert, clinically very pale and dry. Otherwise, mildly tachycardic and otherwise hemodynamically stable. CT scan of the abdomen and pelvic concerning for active hemorrhage of the spleen. Also, concern for ischemia/hemorrahge of the stomach and free peritoneal air.   Case reviewed with surgical oncology.  Plan at this time is to transfusion 2 units of PRBCs, check coags and coordinate IR intervention. Remainder of plan as other detailed below.  Patient w/ 1/3 cultures positive for candida, recent completion of ertapenem course for ESBL w/ negative repeat cultures. Was found to be covid positive 2/22, asymptomatic, now out of isolation precautions. Broadened to Vanc/zosyn in the setting of new hemodynamic instability at time of transfer to ICU.
This patient had a generalized varicella-like rash, maculo-papular, approximately 20 lesions. The first lesion was on the dorsal side of the foot and was fluid-filled. No treatments. Lesions covered to prevent spread of vaccine virus.
pPtient had swelling and red rash and feeling hot and sore in arm that received vaccine for over 1 week after vaccine
Patient presented with symptoms of of URI, shortness of breath, dyspnea on exertion, diaphoresis, chills, and worsening cough. On arrival to ED, O2 sat noted to be 88%, rapid COVID test was positive, and patient was admitted for COVID-19 infection. Patient became fully vaccinated on 03/01/2021 (Moderna). On 08/14/2021, patient passed away due to COVID 19, Cellulitis, Septic Shock, and UTI
Information has been received from a registered nurse concerning a 22 year old female who on 25-JUL-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM in her left arm. Other suspect therapy included a dose of RECOMBIVAX HB (MSD) which was received 2 weeks before 25-JUL-2008. On 25-JUL-2008 the patient developed soreness in the arm which was progressively worse. The patient developed difficulty raising the arm above the head. The patient was treated with the primary care physician. The physician ordered a MRI of the arm that indicated inflammation and the patient was prescribed prednisone. The patient's arm inflammation persisted. There were no other symptoms or treatment reported. The patient sought medical attention in the office. Additional information has been requested.
dizziness a few hours after the shot on May 10th; then fever and muscle aches/chills the following day
* MAR 8th = Vaccine shot * MAR 15th = alleged "sore throat" * MAR 19th = watery eyes; dry eyes;  tired eyes.  Onset of right eye not blinking/closing. * MAR 21st = Emergency Room.  Diagnosed w/ BELLS PALSY.  [Ruled out stroke]  The following week after my vaccination (approximately MAR 15th), I experienced a strange feeling at the back of my throat.  It can best described as a "sore throat".  I noticed it upon waking up.   I could feel it at the back of my throat when swallowing;  the act of swallowing would enable me to "feel" the sensation at the back of my throat.  This was unusual and not normal for me.  I thought I was coming down with a cold virus.  I had not been sick for over a year and thought it was a strange feeling.  I was concerned.  With the recent schools, restaurants, and gyms opening up with less restrictions, I learned from coworkers that there was an increase of illnesses  because our immune systems are not as strong and germs are easily transferable during the usual interactions.  Therefore, I expected my sore throat to be the start of a harmless cold virus.   Then, later in the week (MAR 19th), I noticed my eyes were abnormally dripping tears.  It is my experience that I get this effect in the office setting or during winter when my eyes are "dry".  However, I was neither in the workplace (office), nor was it winter.  I was not sure why my eyes had excessive tears coming out.  Finally, on SUN (MAR 21st), an obvious physical symptom finally became apparent to me and my family members.  My speech was impaired.  I could not chew properly.  I could not drink from a cup.  I struggled during breakfast.  I was not sure if I was having a STROKE.  I recited the alphabet to hear for a slurred speech.  I looked in the mirror, and my smile was not perfect.   I got dressed and went to the Emergency Room.   The doctors performed physical PUSH-PULL tests, eye tests, etc.   DIAGNOSIS = Bells Palsy.     OTHER SYMPTOMS = + shortness of breath.  + leg swelling.  + headaches.  + excruciating pain in the neck, especially during sleep (laying down).
Moderate swelling  in left axilla. Mildly painful. This is fourth shot and I?ve never had this before. Only mild fatigue and headache before.
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; vaccines undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 3:15 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 3:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant medication was provided.  It was unknown whether the patient had ever been diagnosed with/ tested positive for COVID-19.  On an unknown date, patient had received dose 1, dose 2, dose 3 of moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.   Date vial was moved from freezer to refrigerator on 7-Sep-2022. The 2 unbroken cartons had 20 vials.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter
RL developed area of 5x5.5 cm which was swollen, erythema and warm to touch. DX of cellulitis of Right thigh, Keflex given for 7 days 125mg QID. Conditon Resolved.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tinnitus-Severe, Additional Details: Pt called the pharmacy reporting that she has tingling sensation on the arm that is opposite of the arm that got the injection last week, and then she had extreme vertigo and dizziness which resulted her admitted to the ER. Pt also claims that she cannot hear from one side of the ears few days after the vaccine. Pt was advised to consult with a physician, and was also given the janseen phone number to ask about the side effects.
Patient asymptomatic. Tested prior to discharging to another facility and found to be positive.
When went to bed at 10:00 felt weak and violent shakes, could not control my hands. was cold put on sweat shirt and pants,wool socks and a cap and turned up electric blanket. Next morning the shake wee gone  and felt better but weak, next day felt totally normal and strong.
This spontaneous report was received from a Registered Nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 20-MAR-2017, the patient was vaccinated with her first dose of PNEUMOVAX 23, 0.5 ml for prophylaxis, lot # N000508 and expiration date on 19-OCT-2018 (route of administration and anatomical location were not provided). On 30-NOV-2017, the patient was inadvertently administered a second dose of PNEUMOVAX 23, lot # N022704 and expiration date on 27-FEB-2019. No adverse effects were reported for the patient.
Local redness, itching, soreness and inflammation at sub-q injection site on left arm.
2nd dose (1st dose received 1/22/21 Pfizer Lot# EL3247):  Received 2nd dose 2/18/21 at 1900.  2/19/21 woke up at 0700 with chills but afebrile.  Went to work - felt fatigue and brain fog throughout the day.  At 1000 experienced left arm soreness that resolved by 1900.  At 2100 experienced headache, nausea & fatigue and fell asleep very early.  Woke up at 0300 with increased headache and chills - remain afebrile.  Menstrual cycle started 2/19/21 AM - very heavy flow which is unexpected, as cycles have been normal.
Patient was under 18, age 17 and 8 months and vaccine should have been administered at age 18 or >