chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unknown exact time of onset.  Client came back in to the health department after she had been up to get her hair done.  Her arm was quite swollen and warm to touch.  She had good pulses and good sensation, but it did hurt due to the swelling.  Encouraged ice packs off and on for the next day or so.  To take Benadryl as recomended. And to have someone drive for her and maybe stay with her while she was taking the Benadryl.   She did the recommendations and on 10/22/2015 she was much better.
Between series 1 & series 2 of anthrax vaccination soldier developed rash resembling pimples near vaccination site.  This rash appears in clusters & spread to soldiers right & left shoulders chest, back & neck.  Treated w/ 2 cycles of prednisone.  Rash remained.  Soldier takes BENADRYL to aid in relief of itchiness of rash.  Dermatologist diagnosed rash as acneiform.  Rash still present 4 month after 1st vaccination.
Left armpit lymph node with mild palpable tenderness with edema the size of the palm of her hand. She also had low grade fever and mild fatigue mild body aches the same day of injection of this vaccine.
DAPT given IM in right arm 5/9/03 with 5 year well exam. Patient was seen 5/11/03 AM with right arm swelling, temperature 96.5. Paarent reports temp 5/10/03 was 102. Patient given Augmentin for cellulitis. PO medicine not started and redness increasing in PM 5/11/03. Patient admitted to hospital for cellulitis vs. DAPT reaction. The discharge summary states immunization reaction.
Blurry vision started late January, double vision mid March, diagnosed with myasthenia gravis April 23
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5 ml (unspecified dose) with lot number reported as K011188 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Mom called office 3:50 PM left thigh very swollen, warm to touch. Seen in office, erythema 1x 1.5 cm. Induration 3 cm. Temp 98.6, no problem with first shots. Appears to be a local reaction to Hib. HR 20, RR 24-28.
patient complained of numbness to right side of face and mild difficulty in swallowing.  Also complained of headache.
C/o right arm pain evening after vaccine administrated. red, Warm,slightly,swollen right deltoid,administered tylenol every 4 hours for pain/discomfort.
Information has been received from a physician concerning a 9-month-old female who on 28-AUG-2007 was vaccinated with an oral 2 ml dose of ROTATEQ.  Concomitant vaccination included PEDVAXHIB (OMPC) (manufacturer unknown), PEDIARIX and PREVNAR.  On 19-MAR-2008 the patient experienced abdominal pain after receiving ROTATEQ.  The patient was taken to the emergency room and was diagnosed with intussusception and was hospitalized.  A barium enema was given and the patient was released on 20-Mar-2008.  The outcome was reported as recovering.  No product quality complaint was involved.  Additional information has been requested.  4/30/2008 MR reeived for DOS 3/19-20/2008 with Final DX: Intussusception s/p reduction by air enema. Pt presented to ER with 4 day hx of abdominal pain and NBNB emesis.  PE (+) for slight abd distention. Successfully reduced by Air Enema.  No further vomiting or fever. Left purulent ear effusion noted prior to d/c. Sent home with azithromycin if pt develops ear pain.
Vaccination site pain; booster; Off label use; COVID-19; COVID-19; This is a solicited report from a non-interventional study report from FACILITATED COLLECT based on the information received by Pfizer from regulatory authority (MFR Control No. 21K-163-4102071-00).  A contactable consumer (patient) reported that a 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single (at the age of 49-years-old) for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe adult Crohn's disease. Medical history included, none. The patient's concomitant medications were not reported. Historical Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 intramuscular on unspecified dates (Batch/Lot number was not reported) both as single doses (at the age of 49-years-old) for COVID-19 immunization. Solicited report from the (country) by a consumer of a 49-year-old female with events of non-serious patient had a sore arm after getting booster shot and COVID-19 with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced patient had a sore arm after getting booster shot. In Sep2021, the patient experienced COVID-19. On an unknown date, patient had a sore arm after getting booster shot resolved. PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on Sep2021. Action taken for HUMIRA was unknown. The outcome of the event COVID-19 was Not recovered/not resolved while for Vaccination site pain was Recovered/resolved on an unspecified date.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of patient had a sore arm after getting booster shot and COVID-19 was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the events of patient had a sore arm after getting booster shot and COVID-19 was Possible.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, suspected covid19 and vaccination site pain cannot be totally excluded.
Seizure, almost exactly 4 days (96 hrs) post vax. No fever, seizure lasted ~ 1 min. He went unconscious then into postictal
Patient called the pharmacy complaining of joint pain following her immunization.  She said her arm was sore and she felt like it was very challenging to raise her arm above her head (specifically in the joint). Symptoms began the night of 11/2/20.  Told patient that injection site reactions are common and to try to see if Tylenol would help relieve her pain.  She called pharmacy back 11/3/20 and said that pain had improved but her joint was still sore.  I administered the vaccine in her deltoid muscle but she had a very small arm. She is concerned about bursitis based on our conversation on 11/3.  I told patient to reach out to primary care provider if it does not heal within 3-5 days.
p/vax consisted of ataxia/dizziness;vertigo, n/v began which lasted 2 days;sl ataxia;remained p/5 days;
46 Patients received expired Moderna Covid-19 vaccine on 10NOV2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (46 Patients received expired Moderna Covid-19 vaccine on 10NOV2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (46 Patients received expired Moderna Covid-19 vaccine on 10NOV2021). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (46 Patients received expired Moderna Covid-19 vaccine on 10NOV2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received contains no new information On 12-Nov-2021: Follow up received on 12-Nov-2021 reported no Known Adverse events. On 13-Nov-2021: Follow-up information received on 15-Nov-2021:  On 16-Nov-2021: Non-significant Follow Up appended
insignificant leakage of vaccine during second dose administration; insignificant leakage of vaccine during second dose administration; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (insignificant leakage of vaccine during second dose administration) and DEVICE CONNECTION ISSUE (insignificant leakage of vaccine during second dose administration) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to UNK dosage form. On 09-Apr-2021, the patient experienced UNDERDOSE (insignificant leakage of vaccine during second dose administration) and DEVICE CONNECTION ISSUE (insignificant leakage of vaccine during second dose administration). On 09-Apr-2021, UNDERDOSE (insignificant leakage of vaccine during second dose administration) and DEVICE CONNECTION ISSUE (insignificant leakage of vaccine during second dose administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that During the second dose administration the insignificant leakage of vaccine occurred.No concomitant medications were reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
Patient developed cellulitis of her right arm, extending from the area of the Pneumovax vaccine.  Symptoms began approximately 12 hours after vaccination (fever of 102, redness extending distally and medially from the injection site, pain, body aches).  She sought ER care and was started on Keflex, but symptoms worsened.  She was subsequently treated with doxycycline, and symptoms improved.
I received my vaccine on 12/08/2021. On the morning of 06/08/2022 I woke up with a sore throat. I did a at home Covid test and PCR. They were negative. I sought help through a virtual doctor and was told that it was a viral upper respiratory infection. I used NYQUIL and MUCINEX and currently still feeling ill. I took another at home test last night (06/09/2022) and tested positive for Covid.
Systemic: Patient had severe bloody nose about 30 minutes after-Medium, Additional Details: Patient received her 1st dose of covid vaccine and then sat and waited 15 minutes, then shopped in-store for around 10 min after, then walked to the bus stop across the street and started to have a fairly severe bloody nose. Asked if she wanted me to call the paramedics, and she did, but was not taken with them, was ok to go home. She stated that she does have chronic nose bleeds during times of stress, and had a stressful morning with her daughter at appointments.
started with headache, fever, hot flashes bone pain...after 2 weeks the headaches continue, my lower back bone ( where years ago I had pain) has returned and several times at night whilelying in bed I have a tightmess in my legs.
intractable headache with photophobia since first shot one month ago, worsened after second shot three days ago. Increased pain in joints and racing heart
Pain at injection sight  6 days after 1st injection sight along with numbing and  stiffness  in fingers.  Current treatment: over the counter pain reliever  (Advil)
Initial unsolicited report received from a consumer on 18 March 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone Quadrivalent) and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number, dose, expiration date, route and site  of administration was not reported for both the vaccines) in November 2014 (unspecified date). Patient's illness at time of vaccination was reported as not feeling well when she received vaccines and pre-existing physician diagnosed allergies, birth defects, medical conditions included allergies to thimerosal, eggs and statin drugs. Patient had diabetes, "fluid on her heart", hypothyroidism and elevated cholesterol. Concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced vomiting, diarrhea and did not feel well. Patient was exhausted since receipt of vaccines. It was reported that since June, 2015 (unspecified date), patient had difficulty swallowing, had "heart pains", shortness of breath and had severe stomach ache. Patient required emergency room or doctor visit. Lab data and corrective treatment was not reported. The patient had not recovered from the above mentioned events. List of documents held by sender: none.
Heart rate increase. Short of breath. Tingling in hands and arms. Light headed. Bad taste in mouth.
Extreme Vertigo causing vomiting and inability to walk. Ambulance was called and I was taken to the ER. I was then admitted to the hospital to address symptoms. Stayed in hospital for 3 days. I'm still suffering from dizziness and fatigue as of today.
PATIENT NOTED SWELLING BEGAN AFTER VACCINE PROVIDED LATE IN EVENING. DID NOT HAVE SIGNS OR SYMPTOMS DURING 15 MINUTE PERIOD OF WAITING OR WITHIN 30 MINUTES OF WATCH TIME.  WHEN PATIENT REACHED OUT TO PHARMACY, SHE WAS TOLD TO GO TO URGENT CARE FOR FOLLOW-UP, URGENT CARE STATED PATIENT TO TAKE BENADRYL OR OTC ANTI-HISTAMINE.
RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/13/21. ON 02/21/21 REPORTED TO ICC WITH COMPLAINT OF SINUS PROBLEM (SINUS PRESSURE, HEADACHE, COUGH - ALL GOING ON X1 WK) DIAGNOSED WITH ACUTE RECURRENT FRONTAL SINUSITIS AND SUBACUTE FRONTAL SINUSITIS.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in approximately 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016429, expiration date 09-AUG-2017 or lot # L024993, expiration date 17-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 lot # L016429 experienced a temperature excursion of 14.2 degrees Celsius for 1 hour 40 minutes on 03-FEB-2016, 9.4 degrees Celsius for 40 minutes on 23-FEB-2016, 8.5 degrees Celsius for 1 hour on 11-MAR-2016, 8.5 degrees Celsius for 30 minutes on 16-MAR-2016, 10.6 degrees Celsius for 1 hour 50 minutes on 23-MAR-2016, 17.2 degrees Celsius for 5 hours 40 minutes on 05-APR-2016 and 9 degrees Celsius for 4 hours 50 minutes on 19-APR-2016. Administered doses of GARDASIL 9 lot # L024993 experienced a temperature excursion of 17.2 degrees Celsius for 5 hours 40 minutes on 05-APR-2016 and 9 degrees Celsius for 4 hours 50 minutes on 19-APR-2016. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009026: US-009507513-1612USA009027.
Fever 100.4 with vomiting morning after receiving vaccines. Complained of "chills" evening after receiving vaccines (same day).
It is five weeks since 2nd pfizer dose.  Patient has had a constant fever ever since.  Untreated, it always returns to 100.3. With Naproxen 500 2x daily and extra strength tylenol 2x daily, temp hovers between 99.1 and 99.4. It is occasionally normal for an hour 1st thing in the morning.  If we let the anti inflammatories wear off, he is tired, irritable, and seems to show signs of work-related cognitive decline and has social cognition challenges.
lost hearing of her right ear; ringing on her ears / tinnitus; has had migraines everyday ever since; brain fog; vision problems; a bad headache on the frontal lobe like if she had an aneurism; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (lost hearing of her right ear) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEAFNESS (lost hearing of her right ear) (seriousness criterion medically significant), TINNITUS (ringing on her ears / tinnitus), MIGRAINE (has had migraines everyday ever since), FEELING ABNORMAL (brain fog), VISUAL IMPAIRMENT (vision problems) and HEADACHE (a bad headache on the frontal lobe like if she had an aneurism). At the time of the report, DEAFNESS (lost hearing of her right ear), TINNITUS (ringing on her ears / tinnitus), MIGRAINE (has had migraines everyday ever since), FEELING ABNORMAL (brain fog), VISUAL IMPAIRMENT (vision problems) and HEADACHE (a bad headache on the frontal lobe like if she had an aneurism) outcome was unknown.            The patient went to MRI and the results were unknown. She went to a neurologist.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.   This case was linked to MOD-2021-305139 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.
Has temp of 102, hurts to move, body achy all over, crying from pain, has not called MD, called at 10:30 this am.  Encouraged to call MD.
Right shoulder pain specifically subacromial, right sided neck pain. Significant pain with active ROM of right shoulder. Suspected SIRVA.
He reported feeling palpitations in the area of ??the abs. Vitals are taken 150/90 BP, 113 pulse sat 99% 36.3 Temp 246 of his sugar Patient indicates not having taken the medications on the day Dr. is consulted, who indicates Observe for 30 min and make a reevaluation. at 11:30 130/80 BP 110 pulse 242 dext 36.2 temp. Dr. indicates that he can be discharged and recommends the intake of medication and food to the patient.
3 days after 2nd dose of Moderna, experience tinnitus (3/13/21). Unrelenting x months. No other neurological findings. Tinnitus confirmed, had canceling audio waves technology in clinic rendering relief. Return of symptoms when left clinic. Aug 2021: 15d course of methylprednisolone yielded complete relief. Now 1 wk after cessation, return of lower grade tinnitus, that is intermittent.
PATIENT RECIEVED FLUZONE VACCINE ON 10/24/07. 2 DAYS LATER, PATIENT STATES SHE NOTICED A RASH FORMING ON SHOULDER/NECK AREA. PATIENT NOTIFIED US ON 10/29/07 TO INFORM US OF RASH AND SAID SHE WAS NOT SURE IF IT WAS DUE TO VACCINE OR IF IT WAS A SHINGLES FLARE-UP. PATIENT STATES RASH IS CURRENTLY FADING
Totally knocked on my butt sick for a full 3 days; Migraine so bad patient couldn't see; Diarrhea; Upset digestive system; Not a place on body that didn't hurt; Initial information was received on 01-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case is linked to cases 2020SA348514 and 2020SA348515.  This case involves patient with unknown demography who was totally knocked on butt sick for a full 3 days (illness), migraine so bad patient couldn't see (migraine), diarrhea (diarrhoea), upset digestive system (dyspepsia) and not a place on body that didn't hurt (pain), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE taken 2 years ago and still ended up in isolation at the Hospital for the "B" strain of flu.  Medical history, past medical treatments, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was totally knocked on butt sick for a full 3 days (illness), migraine so bad patient couldn't see (migraine), diarrhea (diarrhoea), upset digestive system (dyspepsia) and not a place on body that didn't hurt (pain), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome was unknown for all the events.  There will be no information on the batch number for this case.
pt recv vax; rt clavicle area swollen; lymphadenitis in region of DT boost;cervical & axillary
1/21/22 61 yr/o female who presents with right sided pleuritic chest pain.  Symptoms have been present for the past 2 days.  The patient has history of asthma, acute on chronic respiratory failure, is on 3 L/min oxygen via nasal cannula at baseline.  States she has increased her oxygen use to 4 L/min when active but has maintained her baseline oxygen rate while at rest.  Reports productive cough since onset of symptoms..  No fevers or chills.  Patient has been compliant with her dialysis schedule.  Patient arrives via EMS.  Vital stable during transport per EMS.  Patient reports sharp pain in her right lower chest which is worse with deep breaths.  Reports associated dyspnea.  Denies any abdominal pain Review of Systems  Constitutional: Negative for chills and fever.  Respiratory: Positive for shortness of breath. Negative for cough.   Cardiovascular: Positive for chest pain. Negative for leg swelling.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Skin: Negative for rash.  Neurological: Negative for dizziness and headaches.  All other systems reviewed and are negative.