chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received influenza vaccination on 10/18. Shortly after the injection, the patient experienced swelling at the injection site, hives, and itching all over. Patient reported to urgent care, who transferred patient to ER. Patient was treated with dexamethasone and diphenhydramine and released.
p/vax pt entire thigh was swollen & red 93x4 inch area) w/in 24 p/vax & had lasted 48 to 72hr;
FLUZONE QIV NP to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event; FLUZONE QIV NP to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to cases 2022SA390611, 2022SA390948, 2022SA392303 and 2022SA392234.  This case involves a 17 years old male patient who was given  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] after it was not suitable to use post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2022, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7695JA exp date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On 19-Sep-2022 the patient developed a non-serious event "fluzone qiv np to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event (product temperature excursion issue) (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age. Their pertinent medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with doses of GARDASIL 9, lot # L043213, expiration date: 28-AUG-2017 (routes, anatomical location and doses number were not reported) that were improperly stored. Information regarding concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
25 x 5 cm area of muscle where injected is firm and tender. No erythema noted site of injectin is invisible.
heart disorder; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (heart disorder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     o medical history provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 12-Apr-2021, the patient experienced CARDIAC DISORDER (heart disorder). At the time of the report, CARDIAC DISORDER (heart disorder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.
I had shingles, my doctor gave me a shot; This case was reported by a consumer via interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 09-MAY-2022 Reporter's comment: The case was self reported by the patient via interactive digital media. The patient had shingles and doctor said he had only seen one case worse than him/her. The reporter reported that flesh turned black and doctor gave a dose of Shingles vaccine. At that time patient was getting ready for back surgery. The patient reported that Shingles shot helped to ease terrible pain, so patient was glad that he/she got shingles. The patient asked he/she was the only one to ever make that statement. Additional Supportive Information: The patient had shingles and was administered Shingles vaccine by the doctor, which led to off label use. The follow-up would not possible, as no contact details were available.
pt recv vax 15JUN95 & went to ER 18JUN c/o SOB, sore throat, fever, stuffy nose, lt arm swelling inc, ax lymph node swelling & across lt breast swelling; ER MD put ice on site & gave Motrin; little congested; sinus problems & chest congest
This spontaneous report was received from a 70 year old female consumer regarding herself with Fibromyalgia, Chronic fatigue syndrome, three heart blockages. On 09-NOV-2009, the patient was vaccinated with ZOSTAVAX subcutaneous injection (dose, duration and lot were not reported). Concomitant therapies included metoprolol 12.5 mg qd (manufacturer unknown). In 2011, "sometime in 2011", the patient experienced shingles and the physician prescribed an unspecified antiviral drug. The patient reported that "the shingles clear up after treatment with the antiviral drug. However, the patient developed shingles again sometime in September 2013". No lab diagnostics were performed. On an unknown date, the patient stated visited the emergency room and was treated with unspecified antiviral drug. The patient reported that, "in addition to the being treated with the antiviral drug, the patient used over the counter products included antihistamine tablets (manufacturer unknown), topical antihistamine lotion (manufacturer unknown). The patient also reported that AVELOX "gives her migraines, and makes her stomach feel like it is on fire". The patient also stated Penicillin (manufacturer unknown) KEFLEX, Z-Pac (manufacturer unknown) and CIPRO. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
The morning after I received my first dose, I experienced vaginal bleeding for 3 days and counting, that resembled a period. In addition to the vaginal bleeding I also experienced stomach cramps like you would during your peeiod. Im on the pill, and I was not due for my period for 2 more weeks.
First very high blood pressure a few days later, chest pains aching of all bones, headache, fever, chills, nausea.
very sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (very sick) in an 87-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick). At the time of the report, ILLNESS (very sick) outcome was unknown.        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 medications were reported. No treatment medications were provided.   Reporter did not allow further contact
June 2022 Dx with Acute Macular Neuroretinopathy: Peripheral blindness/ epilepsy/ stroke in occipital lobe/ anti-phospholipid syndrome.
Pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of vax on 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; dx resolved w/in 24 hrs; No further details were provided;
Pfizer  First day within 15 minutes.  Chest tightness. Throat tightness, jaw pain on left side, nausea and headache, left sore arm and left crampy leg.  Pain throughout week.  Today I woke up very lightheaded, dizziness and body twitching.   Last night took hydroxozine 25 mg. I don't think that caused it.
Extreme joint pain (left knee and leg). Still hasn't resolved after 1 month. No change in symptoms following 2nd dose.
Pt. came to the pharmacy on 12/2/2017 stating  that her arm still hurts from the vaccination. She said it hurts to lift arm.
Dose 1: Axillary lymph node swelling & pain Dose 2: 12 hours after dose; fever; neck & back pain; chills - lasted 12 hours
tested a sample from the fetus and that there was GARDASIL-9 vaccine in the sample results; the mother vaccinated with GARDASIL-9 and subsequently had fertility issues/She had a miscarriage; This spontaneous report has been received from a medical student via a company representative referring to a foetus. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On an unknown date, the patient's mother was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, strength, lot # and expiration date were not reported) for prophylaxis. Subsequently the patient's mother had fertility issues. The patient's mother had a miscarriage (fetal exposure during pregnancy).   The doctor tested a sample from the fetus and there was hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (human papilloma virus test positive) in the sample results. The outcome of human papilloma virus test positive was unknown.  The causality between human papilloma virus test positive and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  The case is cross referenced to the case 2109USA005831 due to Parent-Child Link.; Sender's Comments:  US-009507513-2109USA005831:
he experienced dizziness; headache; Nausea; Vomiting; Fever of 100; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Apr2023 as dose 5 (booster), single (Lot number: GL0447) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low Grade Prostate Cancer" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose: , Date: 02Mar2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN6202), administration date: 02Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (2nd dose: , Date: 23Mar2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN6205), administration date: 23Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (3rd dose: , Date: 18Oct2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN0191), administration date: 18Oct2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (4th Dose: , Date: 12Apr2022 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: FK9729), administration date: 12Apr2022, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023), described as "Fever of 100"; NAUSEA (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023); VOMITING (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023); DIZZINESS (non-serious) with onset 26Apr2023, outcome "not recovered", described as "he experienced dizziness"; HEADACHE (non-serious) with onset 26Apr2023, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, headache, nausea, vomiting, pyrexia.  Additional information: Reporter stated her son took the Pfizer Covid 19 Bivalent 2 days ago and he still feels dizzy and he felt nauseous and threw up yesterday. Repoter also reports the patient has pain is in head like a headache. She states he had a fever of 100 yesterday. Treatment: Extra Strength Tylenol. No Prior Vaccinations within 4 weeks to the first administration date of the suspect vaccine.
I have had psoriasis on elbows and one knee for well over 15 years. It was always 100% isolated to both elbows and one knee. Within one month of the J&J vaccine I am seeing an explosion of this condition to other parts of my body knuckles, toes, feet, and my other knee.
Pt contacted clinic on the day after the vaccine was administered -stated c/r felt pain up her neck and back following administration - As the evening progressed she felt muscle pain throughout her body and headache. Clinic advised her to contact her physician. Physician advised MOTRIN. Pt stated symptoms resolving
12/20/21 got the first dose. 12/29/21 started having chest pain, shortness of breath, pain radiating between shoulder blades, heart rate was bouncing between low 40's and upper 180's, headaches, dizziness, and nausea. 12/31/21 contacted cardiologist due to persistent symptoms and was told to take a Covid test, negative. 1/3/22 contacted cardiologist again due to symptoms not resolving, was told to monitor at home. 1/7/22 cardiologist advised to call PCP to start a work up for a clot. PCP then advised I go to the ER. Went to the ER and was started on IV fluids, had blood work drawn, urine analysis, EKG and an X-Ray. They stated the blood work did not indicate a clot and I was discharged home. 1/10/22 I contacted PCP again for continued chest pain, shortness of breath, exhaustion, racing heart rate, high blood pressure, and pain between my shoulders. Was advised that this may be indicative of a vaccine reaction but he was unsure.
Information has been received from a physician concerning her 5 year old daughter who in approximately 2001, was vaccinated with the first dose of varicella virus vaccine live at 12 months of age. Subsequently in late December 2004 the pt experienced a  mild case of breakthrough chicken pox with a  fever of 101 F  and 25-30 chicken pox. Unspecified medical attention was sought. The pt was given Benadryl. Subsequently, a few days later, in late December 2004, completely recovered. It was also noted that 10 other children in the pre school came down with breakthrough at the same time . There was no product quality complaint involved. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE 1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient developed a suspected case of mumps and was hospitalized for an unspecified amount of time. It was reported that "labwork" was done. No further information was available. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a physician via field representative refers to a two patients of unknown age and gender, who on an unknown dates were vaccinated with doses of PNEUMOVAX 23 with the same lot number (not specified) (doses and routes were not reported). On an unknown dates in 2013 (reported as "in about three weeks") patients experienced unspecified injection-site reactions. The outcome of the events was not reported. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source (related MARRS # 1306USA007901). Additional information has been requested.
Started with sore arm, progressed to black and blue mark at injection site, vertigo, arm swelling to elbow and hot and itchy. this is Sunday and I'm still dealing with vertigo.  Last night 50 mg of Benadryl did nothing for my arm. I ended up using a cold pack and then cortisone cream.  that quieted my arm.
Painful swollen lymph nodes in underarm and around collarbone; Swollen lymph nodes in underarm and around collarbone.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer, hypertension, obesity and seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), desvenlafaxine succinate monohydrate (PRISTIQ), spironolactone (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 07Feb2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 16:00, the patient experienced painful swollen lymph nodes in underarm and around collarbone. Nodes ranged between 0.5-3 cm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events painful swollen lymph nodes in underarm and around collarbone was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Booster shot was administered on 4/25/2022 at 10:45 am. Rash occurred on 5/6/2022. Initially an annular lesion appeared on the left forearm (Harold Patch). The rash then spread to the arms, neck, chest, back, abdomen, and upper thighs. The rash consisted of oval lesions following the lines of cleavage. The diagnosis is Pityriasis Rosea. Patient was misdiagnosed by her PCP and given a Medrol dose pack prior to her visit at my Dermatology office on 5/19/2022.
pt recvd vax 26OCT95 2PM & began swelling of rt arm w/in 1hr called daughter @ 830PM stating arm was swollen the size of a fist hot & painful;recvd DPH & Ibprophin
Negative antibodies after 2 doses; Antibodies less 0.02% after two shots; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots) and SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative antibodies after 2 doses) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC), ASPIRIN [ACETYLSALICYLIC ACID], ACETYLSALICYLIC ACID (ECOTRIN), DUTASTERIDE (AVODART), MAGNESIUM, MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]), NYSTATIN (MICOSTATIN), ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL SUCCINATE (TOPROL), HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) and RIVAROXABAN (XARELTO) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots). On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative antibodies after 2 doses). At the time of the report, ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots) and SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative antibodies after 2 doses) outcome was unknown.            No treatment information was provided.
I have 102.8 fever after vaccine; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fever (102.8 degree F).
Patient had red blotches on face about 5 min after receiving vaccines. She was brought into a room with a provider to be looked at and BENADRYL given. She was observed for 30 mins at which time the redness had gone and she was allowed to leave with parents.
No adverse reaction; Wrong dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Wrong dose administered) and NO ADVERSE EVENT (No adverse reaction) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 microgram. In December 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Wrong dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INCORRECT DOSE ADMINISTERED (Wrong dose administered) had resolved and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Wrong dose administered).   Concomitant medication was not provided. Treatment information was not reported.