chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis L Upper Arm swollen, red, itchy 3 x 5
Patient got a red rash around the area of the vaccination approximately 30 minutes later after getting vaccine. Pt also feels she was improperly immunized.
Pt devel macular, pruritic dermatitis all over body 2 days p/Td vax; tx w/an antihistamine;
Received FLUZONE and ADACEL Tdap on 10/17/13. On 11/7 had severe neck pain. Following that, I have had migrating joint pain and swelling. Doctor tested for Lyme, inflammation, RA and autoimmune disease - all negative. Not getting better. Treatment is NSAIDs and they don't help.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash appearing initially on his mid-torso, and radiating thereafter onto his upper and lower back. In response to these complaints, on or about 03-OCT-2016, the patient presented to a physician and was diagnosed as suffering from shingles. 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
severe abdo pain & nausea p/2nd dose of vax; pain still persists; relieved somewhat w/Donatal; past history of dog bite 1 month ago but no rabies treatment; wound was cleaned; tetanus was current; no allergies or medications;
Chief Complaint: Headache (New Onset or New Symptoms) (sore throat, congestion, reported temp 102, chills x 1 week, hx of right toe amputations with recent positive cultures)
?COVID arm?:  swelling and redness 4 inches in diameter around injection site that lasted 2+ weeks. Fever, sweating, chills, body aches, fatigue that lasted 24 hours
Narrative: Pt was vaccinated with 2nd dose of Moderna on 4/29/21 around 16:06. On 4/30/21 he contacted nurse triage with c/o of waking up at 0630 with tongue swelling, difficulty swallowing, and vomiting x 3. He was instructed to to the ED. On presentation, his exam was unremarkable with no tongue swelling noted and he stated that his symptoms were decreasing. He was discharged home from the ED.
This spontaneous report as received from a consumer refers to a 28 year old female patient (also reported as unspecified family member). The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient received unspecified number of doses of GARDASIL (lot # and expiry date were not reported), back when it first came out and experienced side effects from the vaccine and is now bedridden(disability). The reporter states that that no one was able to figure out what's wrong with the patient despite all the tests performed. The outcome of the adverse events were considered as not recovered. Causality assessment was not provided. No PQC involved. No further information was provided.
Localized redness, swelling and warm at site of Tdap injection (L deltoid) afebrile (98.6).
TWO DOSES OF THE JANSSEN VACCINE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced two doses of the janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two doses of the janssen vaccine was not reported. This report was non-serious.
Diagnosed with severe depression at the time of discharge; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (Diagnosed with severe depression at the time of discharge). ) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ZOLPIDEM for Difficulty sleeping.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Wife went to doctor on 05Apr2021 and was diagnosed with depression. On 28Apr2021, wife was hospitalized due to depression. According to the husband, wife damaged and burned his car and so he had to send her to the hospital. On 14May2021, wife was discharged and diagnosed with severe depression and was prescribed with 3 medications. On 14-May-2021, the patient experienced DEPRESSION (Diagnosed with severe depression at the time of discharge). The patient was hospitalized from 28-Apr-2021 to 14-May-2021 due to DEPRESSION. The patient was treated with FLUOXETINE HCL for Adverse event, at a dose of 20 mg once a day; OLANZAPINE for Adverse event, at a dose of 10 mg once a day and TRAZODONE for Adverse event, at a dose of 50 mg once a day. At the time of the report, DEPRESSION (Diagnosed with severe depression at the time of discharge) outcome was unknown.            This case was linked to MOD-2021-221012 (Patient Link).; Sender's Comments: Limited information regarding this event has been provided at this time. Further information has been requested.
Information has been received from a 74 year old female consumer with a penicillin allergy and no other reported medical history who on 12 Oct 2006 was vaccinated with a dose of Zostavax. There was no concomitant medication. On 03 Nov 2006 the patient had an outbreak of shingles. She went to see her ENT specialist and her oncologist who diagnosed her. There were no laboratory tests performed. As of 12 Dec 2006 the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. 6/17/10 Additional informatin indicated indicated that there was no adverse reaction after appropriate evaluation. No further information is available.
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 9 weeks old (also reported as 10 weeks) male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007838: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837:
Approximately 13 hours after receiving the Moderna Covid 19 Booster vaccine I developed an acute case of cutaneous hyperesthesia. This symptom lasted close to 31 hours and was tx with tylenol 500mg  2x.
Cough; hoarseness; watery, itching eyes; extreme fatigue. Continued about 48 hours.
a diminished response to the 23-valent pneumococcal polysaccharide vaccine;   This literature marketed report has been received from the author of a published article titled as stated above referring to a 65-year-old female patient.  The patient was referred from otolaryngology for evaluation of several years of long-standing chronic rhinosinusitis with nasal polyposis (CRS w NP). Her symptoms included mucopurulent drainage, congestion, and facial pain without anosmia. Computed tomography (CT) sinus was notable for septal deviation with opacification of the left frontal, paranasal, maxillary, and ethmoid sinuses. She underwent endoscopic sinus surgery several months prior without significant improvement. Operative cultures grew penicillium and beta-hemolytic streptococcus, and pathology showed benign inflammatory changes. Consequently, allergic fungal rhinosinusitis (AFRS) was the leading diagnosis. Symptoms persisted for several years despite multiple courses of oral and intranasal steroids, antihistamines, and leukotriene modifiers. She had no history of pneumonia or recurrent infections. An allergic and immunologic workup was initiated upon consultation in our clinic. Labs revealed normal immunoglobulins, protective tetanus/diphtheria titers but a diminished response to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot# and expiration date were not reported) for prophylaxis (3 protective titers post-vaccination) (Therapeutic response decreased). Total Immunoglobulin E (IgE) was 1161 international unit per litre (IU/L). Specific IgE testing for molds was negative. The patient was diagnosed with specific antibody deficiency.   The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article has been requested.
Patient reported that the night she received the flu vaccine she experienced tingling in the fingers of her right hand. Her right arm was also swollen and warm to the touch at the site of injection. She also reported that she could not sleep at all that night because of the pain to the area.
Redness, warmth and hematoma surrounding injection site. Pt reports subjective fevers. Pt treated with ibuprofen prescription and scheduled for F/U visit. Pt educated on S/S of anaphylaxis and going to ED.
Bad headache, fever, severe chills, weakness, rapid heartbeat  This lasted until approximately 8:00 PM.
I ache all over; chills temp says 99; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (I ache all over) and CHILLS (chills temp says 99) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced MYALGIA (I ache all over) and CHILLS (chills temp says 99). At the time of the report, MYALGIA (I ache all over) and CHILLS (chills temp says 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2023: Live follow up received: Date of administration of suspect added and narrative was updated.
Narrative: Patient reported throat closing shortly after receiving Pfizer Covid vaccine and was taken to the emergency department where she was treated for anaphylaxis. She received a dose of epinephrine IM and methylprednisolone IV. Patient was able to be discharged from emergency department following treatment without additional intervention.
Crying and irritability hours after vaccine given.  Decreased mouth intake.  At night baby developed shallow poor sleeping/breathing while sleeping difficult.  24 hours to arose, pale.  911 called, baby was fine upon arrival.  Taken to ER, normal exam.  Seen in office on 11/28/2003-fine.
17-year-old male with a past medical history notable for autism who presents with 3-day history of worsening tachypnea, shortness of breath tachycardia.  Patient presents with elevated BNP and troponin as well as severely depressed LV function on echocardiogram with associated EKG changes. Echo on admission with EF 22% and severe acute LV systolic and diastolic heart failure. Now on milrinone 0.5 mcg/kg/min, Lasix 20 mg IV q8h. Repeat 5/18 today continues with severe dysfunction, EF 28%.  Troponin 0.09, BNP 616. Started carvedilol 5/19.
Arm redness/entire upper left arm was red; Fatigue; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Arm redness/entire upper left arm was red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Lymph node dissection (Around the time she got the first dose, she was recovering from surgery (two lymph nodes were removed due to the cancer).) in January 2021. Concurrent medical conditions included Cancer. Concomitant products included GABAPENTIN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Arm redness/entire upper left arm was red). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) and PYREXIA (Fever) had resolved and VACCINATION SITE ERYTHEMA (Arm redness/entire upper left arm was red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. For second shot she was with radiation.  The arm redness didn't start until 2 days after second shot, and it lasted several days, might be a week.   This case was linked to MOD-2021-328337, MOD-2021-328319 (Patient Link).
Mom noticed that patient was not acting normally at about 17:00 on the day the vaccines were given.  She was sleeping more and wouldn't feed.  Mom and patient laid down at 20:00 and fell asleep.  When Mom woke up at 23:30, the patient was dead and cold.
itching and hives which made her sleepy; ear pain; body aches; headache; itching; hives; "Covid Arm" (left Arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("Covid Arm" (left Arm)), SOMNOLENCE (itching and hives which made her sleepy), PRURITUS (itching), URTICARIA (hives) and EAR PAIN (ear pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Thyroid disorder and ADHD. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (RITALIN), Adderal and ATOMOXETINE HYDROCHLORIDE (STRATTERA) for ADHD, INSULIN for Diabetes, LEVOTHYROXINE for Thyroid disorder.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE REACTION ("Covid Arm" (left Arm)). On 12-May-2021, the patient experienced PRURITUS (itching), URTICARIA (hives) and HEADACHE (headache). On 13-May-2021, the patient experienced EAR PAIN (ear pain) and MYALGIA (body aches). On an unknown date, the patient experienced SOMNOLENCE (itching and hives which made her sleepy). At the time of the report, VACCINATION SITE REACTION ("Covid Arm" (left Arm)), SOMNOLENCE (itching and hives which made her sleepy), PRURITUS (itching), URTICARIA (hives), EAR PAIN (ear pain), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include Benadryl for itching and hives.
Swelling, redness, and itching at site of injection, symptoms not present at time of injection but onset 8 days later
generalized body aches; felt tired/exhaustion; sleepy; abdominal cramp; an episode of loose bowel movement; This is a spontaneous report from a contactable Physician (patient).  A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (vaccine location: arm left) on 15Dec2020 16:00 at single dose and the second dose via an unspecified route of administration (vaccine location: arm left) (lot number: EL1284; expiration date not provided) on 05Jan2021 15:45 at single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide. It was reported that in the evening of 05Jan2021 at 19:30, the patient felt tired and sleepy. Patient also had abdominal cramp followed by an episode of loose bowel movement. The tiredness and exhaustion continued until the following morning associated with generalized body aches. It was reported that patient was feeling better by 12:00 noon the following day. It was reported that no treatment was received for the adverse events. It was also reported that prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering/resolving.
this is not a acutal event. as per cdc vaccine is good till 10/21/22
Information has been received from a 21 years old female patient referring to herself. The patient's pertinent medical history and concomitant medications were reported as none. The patient was not allergic to any medication. On 12-JUL-2017 (also reported as 5 weeks ago) the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not reported) for prevention (prophylaxis). At the time the patient was administered the GARDASIL 9 she did not know she was pregnant (exposure during pregnancy). The patient became pregnant with LMP (last menstrual period) of 14-JUN-2017 and EDD (estimated date of delivery) of 21-MAR-2018. The patient's gestational age was 9 weeks today. The pregnancy outcome was pending. The outcome of exposure during pregnancy was unknown. The date the pregnancy was confirmed could not be confirmed. Initially, the patient was told by her physician's office that she would still be able to receive the second and third dose in the GARDASIL 9 series even though she was pregnant. The patient went to the physician's office for the second dose. They would not administer the second dose and provided her with information to call the Pregnancy Registry. There was no product quality complaint involved.
Patient Received dose of Varicella on 3/7/06 presented at ER on 3/9/06 with SX of hives per PT DX by PAC with Allergic reaction to medicinal biological substance.
thyroiditis; Thyrotoxicosis; This literature-non-study case was reported in a literature article and describes the occurrence of HYPERTHYROIDISM (Thyrotoxicosis) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:(Privacy)    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 THYROIDITIS (thyroiditis) and HYPERTHYROIDISM (Thyrotoxicosis) (seriousness criterion medically significant). At the time of the report, THYROIDITIS (thyroiditis) and HYPERTHYROIDISM (Thyrotoxicosis) was resolving. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid stimulating immunoglobulin: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THYROIDITIS (thyroiditis) and HYPERTHYROIDISM (Thyrotoxicosis) to be related.    Relevant concomitant medications were not reported.  Treatment information was not provided. Company Comment: This case concerns a 37-year-old, male patient with no medical history reported, who experienced the unexpected non-serious AESIs of thyroiditis with Thyrotoxicosis. The events occurred at approximately 10-20 days after a dose of mRNA-1273 vaccine. Thyroid stimulating immunoglobulin was negative  and no autonomous nodules were found. The patient was treated with non-steroidal anti-inflammatory drugs. The outcome was recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 37-year-old, male patient with no medical history reported, who experienced the unexpected non-serious AESIs of thyroiditis with Thyrotoxicosis. The events occurred at approximately 10-20 days after a dose of mRNA-1273 vaccine. Thyroid stimulating immunoglobulin was negative  and no autonomous nodules were found. The patient was treated with non-steroidal anti-inflammatory drugs. The outcome was recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
At approx. 1238, pt reported feeling lightheaded to vaccinator. Pt was assisted into anti-gravity chair. Pt appeared anxious and reported hx of lightheadedness and fuzzy vision after prior vaccinations. Pt stated "I'm not good with needles". Pt given water and emesis bag. Pt denied needing to vomit. Vital signs assessed at approx. 1240. BP 140/80 mmHg, PR 88 BPM, SpO2 99% RA. Patient advised to wait for 30 mins for further observation. At approx. 1310, vitals reassessed. BP 154/94 mmHg, PR 72 bpm, SpO2 98% RA. Pt advised to sign up with CDC V-safe. Pt left facility at approx. 1314 with steady gait and unlabored breathing..