chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got one vaccination over 42 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got one vaccination over 42 days ago) in a 22-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got one vaccination over 42 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got one vaccination over 42 days ago) had resolved.            No concomitant medications were reported.  No treatment medications were reported
developed colon cancer; is late getting his second dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of colon cancer in a adult male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   The patient's past medical history included prostate cancer (had prostate cancer prior to getting Twinrix.).   On an unknown date, the patient received the 1st dose of Twinrix and the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced colon cancer (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the colon cancer and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the colon cancer to be related to Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had prostate cancer prior to getting twinrix. After receiving the first dose of twinrix, patient developed colon cancer and will be starting chemotherapy. Pharmacist reported that a patient was late for his second dose of twinrix. Till the time of reporting patient did not receive 2nd dose of twinrix which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked with US2020092763, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020092763:same reporter
Initial report received from Consumer on 23 September 2014. A female patient (age was not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Batch number, expiry date, dose number and route of vaccination was not reported) in the fore arm on an unspecified date. The patient had experienced hard knot at injection site and painful area at injection site on an unspecified date. Lab investigations and corrective treatment were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects was not reported. At the time of this report, the outcome of the event was resolved on an unspecified date. List of documents held by sender: none.
Patient is reporting slight numbness all over body with onset around the time of receiving his first dose of the Moderna vaccine 4/13/21.  Patient is uncertain if vaccine is the cause but reports no other changes around that time.
injection site reaction--redness/swelling approximately 4in by 2.5in in size. patient reported itching
Patient was in for annual visit and advised she was needing a meningococcal vaccine that would be required for college. Pt. stated she will receive today. Patient returned the following day for COVID vaccine and made staff aware patient received dose 2 in Feb 2021 but it was not documented and that she received three doses of the vaccine due to error.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-OCT-2014, the patient was inoculated with ZOSTAVAX at a medical group office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated by a physician from the same medical group for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered not resolved. Causality assessment was related. Additional information has been requested.
Chest pain within 1 hour. Took acetaminophen. Pain was gone in 30 minutes. Headache, body aches ,throwing up and fever of 100.3 within 12  hours that lasted for 24 hours. Two blisters have shown up on my right arm now.  It's been 72 hours since my shot. One the size of a nickel and the other a dime .
Patient returned home after vaccination to experience normal adverse effects such as chills, weakness, and fever that was experienced with the first dose of Shingrix. Patient then fainted at home and hit their head which was also accompanied by ringing in the ears. Patient then began to feel contraction of their nerves and muscles for several hours after their fainting episode.
I developed ringing in my left ear some time after the vaccine. I don't know an exact date as I tried to ignore it for a long time and used some ear wax remover thinking that could be the cause. I didn't seek medical care until last month.
Brain fog for the past 6 days: - unable to focus - unable to perform day to day cognitive tasks (e.g. read an article)  Symptoms have no improved much.
Received the vaccination on 3/24/05 there was no reaction until 3/30/05 when arm became red, ichy, swollen and sore.  Called the doctor and was told to come in that day. At the exam I was told to take ibuprofen and let them know if it got any worse.  3/31/05, the redness and swelling had grown as well as the dull ache. called the on-call doctor, did not receive a call until the morning.  Was told to come in ASAP, went in at 3:00 pm I was told at this time that I was having an allergic reaction to the tetanus shot and was given a prescription for antibiotics.  Also, doctor outlined the affected area to be able to confirm if the swelling decreased.  it did.
Case number PHEH2014US003836 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on an undetermined date in JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 89-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included arthritis, depression, drug allergy, gastritis, hypertension and polymyalgia rheumatica. Concurrent medications included Unknown (Concurrent medications). At the time of event, the subject was already hospitalized for altered mental status, abdominal pain and unsteady gait. On 3 November 2008 at 01:00 the subject received a dose of FLUARIX at 0.5 ml, intravenously, through a peripheral intravenous line in the left wrist. This was the wrong route of administration. FLUARIX should be administered intramuscularly. It was reported that the subject was hospitalised due to the event or that the event prolonged hospitalization. The pharmacist did, however, comment that the event unlikely extended the admission.
strong systemic reaction; Initial information regarding an unsolicited valid non-serious case was received on 16-Sep-2021 from physician (patient) via consumer/ non-health care professional via the Agency (reference number- 00772421).  This case involves a male patient (age unspecified) who experienced strong systemic reaction (adverse event following immunisation), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical treatment, vaccination, concomitant medications and family history were not provided.  The patient's medical history included viral titers increased.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient experienced a non-serious strong systemic reaction (adverse event following immunisation) approximately few months following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Physician reports that he experienced a reaction to the FLUZONE HIGH-DOSE QUADRIVALENT vaccine last year, and he had a strong, systemic reaction to it. He states that his immune system is always primed because he was a pediatrician for so long. He reports that he used to have various viral titers drawn for his job, and they were always surprised at how high his titers were. He believes that he does not need the high dose vaccine due to a very reactive immune system"  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At the time of report, the patient was recovered from the reported event on an unknown date.  The reporter did not report causality of event with suspect vaccine.  There will be no information available on batch number for this case.
Pt came in with hives all over face, arms, legs, torso at 1:35. Mother voiced child had received Immunizations at  12PM and broke out shortly afterwards.
Joint pain, chills, aches, neck stiffness, dizziness,  fever of 100.5
Initial report received from a health care professional on 22 November 2011. A 2-year-old male child received an intramuscular injection (site not reported) of PENTACEL (dose 3), sanofi pasteur Ltd. lot number C3555AA, on 18 March 2010 (at 6 months of age) followed by an intramuscular injection of INFANRIX, GSK lot number AC14B101AA, on 14 December 2010 (at 15 months of age). The patient had no known allergies, no illness at the time of vaccination and no adverse event following prior vaccinations. He took no concomitant medications. The patient received an intramuscular injection (dose 1) of PENTACEL, sanofi pasteur Ltd. lot number C3469AA, on 12 November 2009 and an intramuscular injection (dose 2) of PENTACEL, sanofi pasteur Ltd. lot number C3501AA, on 18 January 2010. Eleven months after receiving the INFANRIX vaccine, on 01 November 2011, the patient was seen by a physician for coughing fits and choking. On 04 November 2011, the patient's final PCR test showed Bordetella pertussis. On 09 November 2011, the patient's NP swab culture showed no Bordetella isolated at 7 days. The outcome was reported as not recovered. Documents held by sender: Laboratory results.
Mouth tasted like metal within 1 minute of receiving the vaccine, but I can still taste food. Scratchy throat within 15 minutes of receiving the vaccines.
Developed nausea and vomiting, insomnia and mild fever approx. 10 hours after vaccine administration. Vomited repeatedly during night. Able to eat soda crackers and sip soda in morning, attended class but felt nausea x 2 days. Well on 3rd day.
Pt called center on 4/19/21.  Pt has history of MVR on warfarin.  Pt c/o Right side leg pain only that started 04/17/2021 and about 4cm bruise in between foot and knee area started on 04/16/2021. Pt took tylenol today an hour ago from call with right side leg pain relief. Can able to walk but slowly.  Strongly urged patient to go to nearest ED for further evaluation and treatment but pt refused and stated will talk to doctor first via phone. Scheduled MD available earliest telephone f/u appointment 4/17/21 at 8pm as per pt request. Advised patient and her daughter to call 911 or go to ED if any emergency sx arises anytime, both assure understanding.   PT also schedule visit with provider.
Started getting really cold /like I'm catching a bad cold; Arm has been very very sore; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Started getting really cold /like I'm catching a bad cold) and PAIN IN EXTREMITY (Arm has been very very sore) 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.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Arm has been very very sore). On an unknown date, the patient experienced NASOPHARYNGITIS (Started getting really cold /like I'm catching a bad cold). At the time of the report, NASOPHARYNGITIS (Started getting really cold /like I'm catching a bad cold) and PAIN IN EXTREMITY (Arm has been very very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported
Employee complained of blurring of vision approximately 12 hours following vaccine. When last checked with Employee on 10/14/11 blurry eyes are still a problem.
This initial spontaneous report was received from a physician referring to a 3 month-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 02-SEP-2015 at 10:12 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Urticarial eruption 4 to 4.5 hrs pos vax;
This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Follow up information has been received from a pharmacist refers to a 65 years old male patient with blood pressure and cholesterol. On 21-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, in the left arm. This is one of several reports received from the same reporter. Additional information has been requested.
Bilateral saddle pulmonary embolus 12 days post 2nd Moderna vaccination,  Shortness of breath worsened 6 days after vaccination, lasting 1 week until presentation to hospital ED. Was found with severe hypoxemia, and bilateral PE and right heart strain requiring interventional radiology procedure and catheter directed thrombolytic therapy, subsequent treatment and follow-up in the ICU Initial Moderna vaccine given 04/12/2021:  Vial number 0 3 0 B21A Second Moderna vaccine given 05/10/2021 file number 031 B 21A  Patient described mild shortness of breath beginning 1 month prior to 1st vaccine, but significant and severe shortness of breath developing less than 1 week after 2nd vaccine
This spontaneous report as received from a female patient of unknown age refers to herself. On 10-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 dose and route unspecified (lot # K007826, expiration date: 03-FEB-2016). On 10-NOV-2014 the patient experienced fever, coughing (extreme coughing), possibly cellulitis and redness from the shoulder down her arm past her elbow. The patient sought medical attention, she called pharmacist. The outcome of the events was reported as not recovered/not resolved. Relatedness between the events and PNEUMOVAX 23 was not provided. Additional information is not expected, because there are no reporter's contact details.
I DEVELOPED A LARGE LUMP ON THE LEFT SIDE OF MY NECK ON MY CAROTID ARTERY AND NECK MUSCLE AREA ON 11/11/2021 THAT FLARES UP DURING THE DAY WHEN I USE MY ARM A LOT WITH ANYTHING I DO, THAT IS THE SAME SIDE OF THE ARM I RECEIVED THE VACCINE AND NOW IT IS ON THE OTHER SIDE OF MY NECK. I HAVE HAD A US SOFT TISSUE NECK ON 11/16/2021, AND CT NECK WITHOUT CONTRAST AND WAS TOLD BY MY RAD WHERE I WORK THAT IT IS DEFINATELY RELATED TO THE VACCINE AND BREAST BIOPSY I HAD TO GET DUE TO LUMP ON MY BREAST ON 11/11/2021. LUMP APPEARED IMMEDIATELY AFTER MY BREAST BIOPSY 2 HOURS AFTER THE PROCEDURE AND STILL REMAINS VISIBLE ON MY NECK BOTH SIDES.
Has muscle problems in all areas of his body; joint pain/pain moved to the right side, then to the elbow; Headache/severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/severe headaches), MYALGIA (Has muscle problems in all areas of his body) and ARTHRALGIA (joint pain/pain moved to the right side, then to the elbow) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache/severe headaches). On an unknown date, the patient experienced MYALGIA (Has muscle problems in all areas of his body) and ARTHRALGIA (joint pain/pain moved to the right side, then to the elbow). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache/severe headaches), MYALGIA (Has muscle problems in all areas of his body) and ARTHRALGIA (joint pain/pain moved to the right side, then to the elbow) had not resolved.            Before getting the shot he probably only had 5 headaches in his life, now he has them all the time. Moderna shipped vials with about 50% more content that it should No concomitant medication was provided Treatment included Tylenol for headaches, it subsidded for a while, and when it comes back and he takes some more. Does not know how much he's taking.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received on 04 nov 2021 contains no new information
received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and directed to our monitoring area. About 8:40am the clinic RN,  went to assess the patient as she began to feel nauseated, began dry heaving without vomiting, had generalized redness, then complained of feeling light headed. She passed out so the RN eased her to the floor. A Rapid Response(RR) was called and the patient was moved to the stretcher. VS were taken and at about 8:50am the RR team arrived and assumed care. Once they arrived the patient began to seize. She was taken to the ER where she had another seizure. She remained in a post-ictal state for most of her stay at our facility.
Exteme face pain--such as pressure from a bad sinus infection.  I do have fillers and botox in my face. There was no visible external swelling.   Took Tylenol to gain relief.
Pt had returned to clinic 1/23/2020 post injection - Pt reports 1 day post-injection, pt had localized swelling, redness and warmth at site of injection. Associated symptoms of fever, chills, nausea, abdominal bloating and fatigue. Fever and chills resolved in 1 day. Pt states took Advil every 8h x 3 days during onset of symptoms. Per pt, symptoms overall resolving but still has fatigue, nausea, abd bloating, mild erythema and warmth to injection site. Pt instructed to apply cold compress and take acetaminophen PRN for localized reaction and pain, respectively. Also advised on BRAT diet. Planning for pt to F/U in 4 days.
Significant arm ache for more than 24 hours.  Significant body ache for ~20 hours.  Unable to stay at work.  [26 hours later only the arm aches somewhat.]
injection received in left deltoid.  Significant lymphatic edema in left axilla with several CM of swelling noted.  Also reported fevers, chills, Nausea, diarrhea, and fatigue.
Hematoma following flu vaccine; induration and erythema also; c/o itch treated with heat packs.
Child had Flu and MENACTRA on 12/13/2016, felt strange that night, had loss of appetite, fatigue. The next day she developed numbness in hands and feet and hyperventilation. She was taken by ambulance to ED. She was given IV fluids. Cl was 97 low. She improved and was discharged from ED.
Onset of a rash approx 2-3 wks following vaccination with SPV and FLUMIST on 07 Nov 10. Per provider, SM is well with pustules on all extremities, palms of both hands, extensor surfaces and associated with itching. She has no other complaints. Pictures were provided and reviewed. Treatment recommendations at that time included antihistamines. Follow up phone call with SM today noted that the rash has not cleared, she is doing better, and that the medication is controlling her itch.
Narrative:  COVID-19 related hospitalization in patient who received J&J COVID vaccine. He developed COVID symptoms (body aches, fever, chills, shortness of breath) 9/28/21. Positive COVID-19 test 9/30/21. Received casirivimab/imdevimab 10/5/21. Had a reaction to monoclonal antibody therapy shortly after completing infusion with hypoxemia (not present on arrival for monoclonal antibody therapy). Admitted 10/5-10/10/21 for COVID pneumonia. Received remdesivir, dexamethasone, IV diuresis and as needed oxygen. Saturating appropriately on room air on 10/9 and became stable for discharge. Five day course of remdesivir completed. Discharged on two additional days of dexamethasone.