chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MISSED TO TAKE FOURTH DOSE ON TIME/ DID NOT COMPLETE HER IMMUNIZATION ONE WEEK PRIOR TO TRAVELING TO COUNTRY; STOMACH ACHE; TOOK DOSES WITH FOOD OR MILK; This spontaneous case report (PVX2019-1663) was received from a consumer on 25-Jun-2019. It describes a 15-year-old adolescent male consumer who had stomachache, after the administration of oral Vivotif for travelling to an endemic area (Country). He also "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to Country" and "took doses with food or milk."  Case report: The consumer took three doses of Vivotif with food or milk. The doses were taken on 19-Jun-2019, 21-Jun-2019, and 23-Jun-2019, respectively. He forgot to take fourth dose which was due on 25-Jun-2019. However, after the third dose he had bad stomachache. He had a planned trip to country on 27-Jun-2019.  Action taken with Vivotif with respect to the event stomachache was unknown while with respect to the events "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to Country" and "took doses with food or milk" was not applicable.  The consumer had recovered from the event stomachache on 24-Jun-2019 while the clinical outcome of the events "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to Country" and "took doses with food or milk" was unknown.  Company's Comment: In this case, it was reported that a 15-year-old adolescent male consumer had stomachache, after the administration of oral Vivotif. He also "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to country" and "took doses with food or milk". There seems to be a temporal association between the intake of the vaccine and the event. Also, stomachache is labeled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the events "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to Country" and "took doses with food or milk" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 15-year-old adolescent male consumer had stomach ache, after the administration of oral Vivotif. He also "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to country" and "took doses with food or milk". There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach ache is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the events "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to country" and "took doses with food or milk" was considered as not applicable.
Patient started experiencing a bubbly rash on her arm within a couple days of vaccination, she presented at the pharmacy for her second dose and the rash was still large and visible. She did not let us know until she came in for her second dose. She explained it was itchy and had not tried anything as of yet to treat. I advised her to use hydrocortisone cream to help treat and if it did not go away to contact the MD on Monday (past the weekend)
hives in scalp;very swollen & itchy started a couple hr p/2nd dose of vax;
Rash (2? diameter) and firmness at injection site, painful to touch.  Headache, chills, low grade fever, slight sore throat, fatigue
Discomfort; This spontaneous case was reported by an other health care professional and describes the occurrence of DISCOMFORT (Discomfort) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Discomfort). At the time of the report, DISCOMFORT (Discomfort) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-404247 (Patient Link).
Throat swelling; feeling disoriented; Did not receive the 2nd dose within 25-35 days of getting the 1st dose; rash on her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling), DISORIENTATION (feeling disoriented), PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose within 25-35 days of getting the 1st dose) and RASH (rash on her forehead) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling), DISORIENTATION (feeling disoriented), PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose within 25-35 days of getting the 1st dose) and RASH (rash on her forehead). At the time of the report, PHARYNGEAL SWELLING (Throat swelling), DISORIENTATION (feeling disoriented) and RASH (rash on her forehead) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose within 25-35 days of getting the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.  No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: New event missed dose was added
Increased temp. Shaking. Dizziness. Called Dr. on call. Concluded reaction to ZOSTAVAX. High dose flu in past OK. Progressively better tho night. 9/29 still "not right" very tired.
Patient was given a Moderna booster dose on 16Jun2022 and his wife called on 22Jun2022, to inform that her husband should have received a full dose because he is immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given a Moderna booster dose on 16Jun2022 and his wife called on 22Jun2022, to inform that her husband should have received a full dose because he is immunocompromised) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 076C21A and 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Type 2 diabetes mellitus, Cardiovascular disease, unspecified, COPD, Hypertension and Psoriasis.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient was given a Moderna booster dose on 16Jun2022 and his wife called on 22Jun2022, to inform that her husband should have received a full dose because he is immunocompromised). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was given a Moderna booster dose on 16Jun2022 and his wife called on 22Jun2022, to inform that her husband should have received a full dose because he is immunocompromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Information on allergy was not known. The reporter did not whether patient ever had COVID positive test or diagnosis. It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No treatment was given.
1. jaw hurting, painful to chew, crackling in eardrum when chewing. 2. itch started on neck and shoulders (no rash, bumps, nothing). Discovered sporatic small bumps, pimples and stuff that looks like skin tags on sides of stomach. Itch progressed to a rach that felt like elephant skin on back and shoulders. All other parts of upper body still itched even though there wasnt any rash. After 9 months, i still have rash and prickley itch (all over).
The patient was sick for 4 days/sick for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The patient was sick for 4 days/sick for 4 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced VACCINATION COMPLICATION (The patient was sick for 4 days/sick for 4 days). On 20-May-2021, VACCINATION COMPLICATION (The patient was sick for 4 days/sick for 4 days) had resolved.            The patient received their first and second doses of the Moderna COVID-19 vaccine on 16-Apr-2021 and 16-May-2021, respectively.  Reportedly, the patient was sick for 4 days post receiving their second dose starting from 16-May-2021 and recovered on 20-May-2021.  No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up was received on 07-jun-2021 and contains no significant information.
Pt followed up in clinic approximately 1 month after injection reporting pain persisting in area of injection with sensitivity at site and surrounding area.
Patient received a vaccine stored beyond 30 days recommended in the refrigerated state. Event reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. It was  recommended repeating this dose in question. Patient sent a letter to inform them of the need to repeat the dose in question. We are working on a compliance improvement plan. Reinstated vaccination privileges.
pt had complained of headache and CBC did reveal thrombocytopenia. ( Plt 28K) Please note pt has intermittent headaches over the last several months but was not sure if the present one was related to vaccine. He has a remote h/o thrombocytopenia about 15 years ago, but no formal diagnosis and has not checked his platelets in recent years. Hence baseline is not known. h/o splenectomy about 15 years ago, attributes to trauma.
This spontaneous case, initially received on 19-Sep-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. The patient received flu vaccine in the past with no reaction. No concomitant medications. Administration of company suspect drug(s): The patient received AFLURIA from 15-SEP-2016 to 15-SEP-2016. Dose regimen: 0.5 ml one time dose, Route of administration: Intramuscular. Batch number: WT52305. No additional suspect drugs. Adverse reactions/events and outcomes: On 16-Sep-2016, the patient experienced body aches, chills and headache (outcome for all event: recovered / resolved, stop date: 19-Sep-2016). The adverse effects lasted most of the weekend and resolved on 19-Sep-2016. The patient received no other medications. Reporter's comments: The reporter assessed the events as non-serious.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that, on 31-DEC-2014, the patient was administered an expired dose of VARIVAX (Merck) inj (lot # H018794, expiration date 24-OCT-2014), 0.5 ml, subcutaneously. No adverse effects were reported. Additional information has been requested.
during hospitalization in August 2021, pt tested positive for COVID; pt in hospital; 9/16 - 10/1/21 pt hospitalized for renal failure; poor prognosis; pt's condition worsened; family refused SNF again; wished to take pt home on hospice; dc'd to home where pt passed away 9 days later
Pt was given Hepatitis B vaccine #1 in right arm on 04/09/03. About 5 minutes after administration he developed redness and itchiness of right arm and forearm. Rx: Benadryl 25mg IM given 09:46.
Red, extremely itchy patches started within 2 weeks of injection on the arm the vaccine was injected in. Patches multiplied quickly. Started on left armpit, migrated to right armpit, abdomen, upper legs within 2 months. Bruised where spots were present. Scarred skin. 1 year later and patches are still persistent.  Treatment includes topical steroid (triamcinolone) prescribed by doctor.
Patient admitted with high grade AV block, sinus pause, and recurrent syncope. 57-year-old white male with PMH only of cigarette use who notes about 2 weeks of generalized malaise, then in the last 24 hours has had 2 syncopal episodes that were accompanied by diaphoresis only without other prodrome.  He got his second dose of Moderna COVID-19 vaccine on 5/28/21, then on the following day had been working in the barn without any dyspnea chest pain or shortness of breath but felt generally fatigued so went to take a nap.  He got up to check his temperature, then "just hit the floor".  Not preceded by blackout of vision, lightheadedness, chest pain, dyspnea palpitations, nausea but was accompanied by sweats.  He believes he was out only briefly, and when he awoke was not confused and did not have tongue biting or loss of bladder or bowel continence.  He then got up and went about his day normally, then around 2 AM awoke to let the dogs out and had an identical event, but this time hit his chin on a chain saw on the floor and suffered a laceration. He presented to ED for evaluation where his laceration was sutured. He is hemodynamically stable and afebrile. Initial labs and diagnostics are unrevealing and an EKG showed a normal sinus rhythm without acute or chronic ischemic changes.  Noncontrast CT of the head and the face showed no evidence of bony damage, no intracranial bleed or large territory infarct. While in the ED, the patient had a brief bradycardic episode accompanied by diaphoresis although a dedicated strip is not available and it is unclear what his rhythm was.  He did not syncopize.  Hospitalist service was asked to accept for syncope evaluation. When admitting physician saw patient, he reported feeling completely well without any other issues.  He does note he had about 2 weeks of malaise before all of this started and a mild decrease in his ability to work intensely, but had attributed this to cigarette smoking.  Review of systems was essentially negative.  He is a hobby farmer and has had a couple of tick bites this year. While admitting physician was in the room at the end of the visit, the patient had an episode of diaphoresis and went into a high-grade second-degree AV block with disappearance of atrial activity without ventricular escape and lost consciousness for about a second.  No jerking or twitching observed.  The episode a couple of seconds then self terminated and the patient awoke and completely recovered mentation and was in a sinus rhythm.  He was diaphoretic and felt ill afterward this.  He had no chest pain or dyspnea. Immediately after the episode with repeat vitals the patient's heart rate was in the 70s and a normal sinus rhythm and blood pressure is 136/80.  Oxygen saturations are preserved. Not on any rate limiting agents either here in emergency department or at home. Patient found to have P-P interval prolongation with AV block and subsequent sinus arrest possibly situational in the setting of coming off of a colonoscopy and receiving second Moderna COVID-19 vaccine. A pacemaker was placed 6/1/2021 without complication and the patient was discharged in stable condition on 6/2/2021.
From telephone contact received at manufacturer on 11/14/02, it was reported that a 47 year old male was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0927AA) on 11/13/02.  Immediately after the vaccination, the pt felt chest tightness and lung congestion.  He felt no further respiratory distress after the use of inhaler, but felt disoriented and anxious.  After 1 hour, he drove home where he experienced muscle aches, joint stiffness and extremity tingling.  He also reported a restless night sleep, with vivid dreams.  He felt fine in the morning.  He drove to work, but felt dizzy so he returned home.  He will see his physician today at 14:00 11/14/02.
Cellulitis of leg; the patient experienced nausea and vomiting; the patient experienced nausea and vomiting; Indication: vaccinated in an effort to protect patient at high risk for COVID-19; the patient had symptoms of fever and cough and is being tested for COVID-19; the patient had symptoms of fever and cough and is being tested for COVID-19.; This spontaneous report was received from a nurse practitioner referring to an 84-year-old male patient, the patient's pertinent concurrent conditions included unspecified heart disease, chronic kidney disease and heart failure. The patient received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) and unspecified flu vaccine. It was unknown by the reporter if the patient had previous drug reactions or allergies.  On 26-MAR-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscular as vaccinated in an effort to protect patient at high risk for COVID-19 (product use in unapproved indication) (concentration, number of administered dose, vaccination scheme frequency were not reported; lot number S033790 and expiration date 02-AUG-2021).  On 29-MAR-2020 (reported as 3 days later), the patient experienced nausea and vomiting. The patient sought medical attention and on 30-MAR-2020 (reported as next day), the patient was hospitalized and the patient was diagnosed with cellulitis of the leg, also the nurse reported that the patient had symptoms of fever (pyrexia) and cough and was being tested for COVID-19. The patient received unspecified treatment for the events, but it was unknown if another laboratory diagnostic or studies were performed.  The outcome of cough, pyrexia, vomiting, nausea and cellulitis was not provided, but it was reported that the patient was still hospitalized.  The causality assessment between therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events pyrexia, vomiting, nausea and cellulitis was not reported.  The events cough, pyrexia, vomiting, nausea and cellulitis were considered as medically significant.  The reporter considered the events cough, pyrexia, vomiting, nausea and cellulitis as a life threatening and disability.
230PM 21OCT97 & 5PM pt had knot about size large grape, rubbed size inc to 2" wide 3" long, small amount redness about 1" thick, pain only on touch, T100;muscle underarm touchy;touch tender;
constant pain in my neck. On a scale of 1-10 it's a 6-7; Upon getting shot in my left arm, not only did my arm bleed; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 15:00 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation, at 22 years old. The patient has no medical history. The patient's concomitant medications were not reported. Patient is not pregnant. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. On 15Apr2021 15:15, upon getting shot in patient's left arm, not only did patient's arm bleed after, but a minute or two (15:16) after she had a constant pain in her neck. On a scale of 1-10 it's a 6-7. Treatment was not given. Outcome of the event was not recovered.
Albatros sulfate (Proventil) Dexamethasone sod phos (Decadron)  Fever, respiratory breathing problem, vomiting, runny nose, coughing,
Became dizzy and passed out for a few seconds while in observation area approximately 1 minute after receiving vaccine.  Fell and landed on the right side of the face.   Observed for an additional 45 minutes afterward and normal on exam.
Tested positive; This is a spontaneous report from a contactable consumer (wife) received via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0170), via an unspecified route of administration on 02Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that, she and her husband (patient) got their first dose of the Pfizer COVID-19 vaccine on 02Aug2021, then they both tested positive on Aug 12th. Reporter further stated that her husband had no symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Aug2021 tested positive. The clinical outcome for the events was unknown.
Pericarditis. Treatment to do an ibuprofen taper. If symptoms persist, consult cardiologist and get echo.
She had the injection, had the usual side effects, did not have fever, nothing out of the ordinary.  Then on Sunday 2/28/21 at approximately 8:00 AM she started having pressure in her chest, radiating to her left shoulder, left neck, left arm and across the shoulder blades.    She  never had any heart issues or blood pressure issues.    Went to the ER and her cardiac enzymes were elevated, and her EKG's indicated she was having a heart attack.  She was lift flighted to the next major hospital and had a cardiac Cath which found a 25% blockage in one spot.  They are stating that they do not know what caused this.  When she informed them that she had the vaccine they told her to report this information.   Her BP was high in the hospital and did not come down much during the hospital stay.  She was put on Cardizem, and Crestor, as well as started on 81mg aspirin.   She is now under the care of a cardiologist, but has recovered from the initial reactions.
Information was received from a pharmacist concerning unspecified patients (age and gender not provided). On unknown dates, improperly stored dose of PNEUMOVAX 23 (lot # K019561, expiration date 20-APR-2016; and lot# L027732, expiration date 23-FEB-2017) were administered to an unspecified number of unspecified patients (dosages and routes of administration not provided). It was not confirmed by the pharmacist which does were administered from which lot number of PNEUMOVAX 23. No adverse effects were reported. Additional information has been requested.
Pain that radiated to left axillary. ADVIL PRN and warm compress. Pt reports arm pain 4 days after receiving vaccination. Denies any rash, redness, swelling, weakness or numbness. Pain resolved in 1 day with ADVIL.
Post vax, the physician reported that on 05/10/1996, the patient developed chickenpox after being exposed to his mother with shingles. Unspecified medical attention was sought. Additional information has been requested.