chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID-19 positive) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 25-Apr-2022, the patient experienced COVID-19 (Tested COVID-19 positive). At the time of the report, COVID-19 (Tested COVID-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of tested COVID-19 positive with Rinvoq (upadacitinib) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Adverse Event: Red painful right eye and swollen right side of face.  All Blood tests and MRI of eye orbit and brain were normal. Dental X-rays and CT scans of head and face were normal.  Eye drops (Lotomax,  Prednosolone, Difluprednate, Prolensa) have no affect. Valacyclovir HCL 500 mg and Prednisone at 60 mg had no affect on the red eye though mild affect on face pain.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 3 years old (also reported as 3 years and 9 months) female patient who was inadvertently vaccinated with 0.25 ml one time dose of FLUZONE QUADRIVALENT (Batch number: UT6315RA and expiry date: 30-Jun-2019) via intramuscular route on 11-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines: None. It was a case of actual medication error due to vaccine underdose because patient was vaccinated with 0.25 ml dose of the following vaccination. It was unknown if any adverse event was occurred o not following the vaccination. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
Initial solicited report received from an investigator (Defense Health Agency) in the above mentioned trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 00.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves an 18-year-old male subject with significant medical history of dizziness or fainting spells who developed myocarditis unspecified and acute pericarditis unspecified with favorable temporal association post vaccination with ACAM2000. Myocarditis and pericarditis are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
The patient received DTap  IPV but not Hib component of Pentacel; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old female patient who received DTap - IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without Hib component.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Apr-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6215AC.  It was of actual medication error due to  inappropriate reconstitution technique.  No adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
101 farenheit fever, body aches, chills, sweats, lethargy, headache
With the first dose her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (With the first dose her arm was sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (With the first dose her arm was sore). At the time of the report, PAIN IN EXTREMITY (With the first dose her arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-435127, MOD-2021-435156 (Patient Link).
Nails turned black; My left arm; right middle finger from the very tip is swollen like severely swollen and sore; My left arm; right middle finger from the very tip is swollen like severely swollen and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "I do not hear too well" (unspecified if ongoing), notes: Verbatim: Consumer stated, I do not hear too well. The patient's concomitant medications were not reported. The following information was reported: NAIL DISCOLOURATION (non-serious) with onset May2021, outcome "unknown", described as "Nails turned black"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset May2021, outcome "unknown" and all described as "My left arm; right middle finger from the very tip is swollen like severely swollen and sore".  Additional Information: When probed for the concern, Consumer stated, I got Pfizer shot last Thursday and couple of days later my left arm, couple of days later my right middle finger from the very tip is swollen like severely swollen and sore like I hit it with a hammer the nails turned black and all that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014US014474, is an initial spontaneous report received from a nurse on 17 Jul 2014 with a follow-up received on 18 Aug 2014. This report refers to a male patient of unknown age. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: M14031 and C4565AA), intramuscularly that was reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 15 Jul 2014 at 12:23. No adverse reaction reported following this administration error. Follow-up received from a nurse on 18 Aug 2014: Time of vaccination and batch number of vaccine was updated.
muscle sore extreme , and at 9pm pt said she felt extreme drowsiness. and sleepy. and feels this is side effect from her vaccine, this am she feels fine
Extreme somnolence, slept 18 hours the next day after shot, muscles hurt.  Then over the next few days, developed gradually increasing intermittent  pain and stiffness in both hands as well as intermittent paresthesias in finger tips. Also can't make a fist.
I was having a sore throat for about a week. That weekend I started coughing, sneezing, I had a low-grade fever, and I had a headache. I took a COVID-19 home test, and it was positive. I reached out to my health care provider, and they did give me PAXLOVID, but I did not end up taking anything for it. I still have a pretty bad cough and I was given a cough medicine and an inhaler as well.
The parent noticed at 5 PM on 10/17/00, redness of the patients nose and under both eyes, spreading to back of his neck, trunk, extremities; perineal areas, also he became congested. Took the patient to Wadley Regional Medical Center ER evaluated and was told was due to MMR vaccination; patient also diagnosed with left ear infection and put on antibiotics and cough medication.
Information has been received form a registered nurse concerning a female patient at an elementary school of kindergarten to fourth grade, who on 8/31/98 was vaccinated with a dose of varicella virus vaccine live (lot # 626767/0668H). Between 3/1/04 and 4/5/04, the patient developed breakthrough varicella. The patient had lass than fifty pox and was afebrile. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned other cases of breakthrough varicella at the same elementary school (WAES0404USA01117, 0404USA01259 through 0404USA01262, 0404USA01264 and 0404USA01265). Additional information is not available.
Information has been received from a physician concerning a 13 month old male who on 8/5/06, at 12 months of age, was vaccinated with a dose of MMR II/Varicella. On 9/1/06 the pt broke out in a papulo-bullous rash which began with persistent fever. On 9/14/06 he was admitted to the hospital PICU in respiratory failure. He had greater than 300 lesions in various stages and persistent fever. He has been found to have profound panhypogammaglobulemia and moderate lymphopenia, mild hepatitis but doses not have significant leukopenia or thrombocytopenia. He dose have a bilateral interstitial hemmorhagic pneumonitis. Skin is + VZ DFA, HSV neg. Skin biopsy viral cultures are pending. Skin cultures were also MRSA+, HIV DNA PCR results were pending and complete immunologic testing is underway. On 9/18/06 the physician reported that the pt was probable immunodeficiency and disseminated vaccine related VZ. The pt very likely has a severe T cell deficiency, confirmatory evaluation was pending. The pt had a lymphocytic evaluation at 2 months of age with a CD4 count of 1%, at which time he was admitted for a severe MRSA skin infection. This test result was not known when he received his MMR II/varicella vaccine. The pt's HIV serology was neg and IgG was low normal at 2 months of age. The pt was enrolled in the Varicella zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild type WT VZV strain or with the manufacturer vaccine VZV strain. Additional information has been requested.
9 days after injection - red hive-like spot at injection site. It is warm to the touch and itchy. It has grown each day and is currently about 4.5? across. The redness has decreased.
This spontaneous report was received from a registered nurse refers to a male patient of unknown age. No relevant medical history was reported. On an unknown date, an unspecified patient was vaccinated with a dose of M-M-R II (dose and route of administration was not provided). No concomitant medication was provided. On an unknown date, the patient was tested for titers sometime last week which showed that the patient had immunity to measles and mumps but not to rubella. The nurse did not feel comfortable providing patient information. No treatment was given for the event. The outcome of the event was unknown. Additional information has been requested.
Had some body aches; Slight headache; Rash kind of came on my right thigh, it is almost like, I don't know like maybe poison ivy, something like that; Rash kind of came on my right thigh, it is almost like, I don't know like maybe poison ivy, something like that; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced had some body aches, slight headache, rash kind of came on my right thigh, it is almost like, i don't know like maybe poison ivy, something like that on an unspecified date. Clinical course was reported as I am about three weeks and to this vaccine, I have to take this other injection, I am scheduled to take this next Tuesday and for the last couple of days, I have had some body aches, kind of slight headache and a rash kind of came on my right thigh, it is almost like, I don't know like maybe poison ivy, something like that. I am just wondering if this is attached to the shot because when I got the shot, from that day and up until now, I was doing fantastic. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
muscle pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Paxlovid was given on start date of 14Jun2022 and stop date of 19Jun2022 with Indication of Treatment of COVID-19. Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient was previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ADMINISTRATION ERROR We had our drive through influenza clinic at our hall.  We utilize volunteers throughout, including volunteer nurses. We administered a High Dose influenza meant for 65 and older to this 64 year old.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a 67 year old male patient. On an unknown date in June 2015 (reported as two years ago), the patient was vaccinated with PREVNAR 13. No other information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in May 2017 (reported as last week), the patient was vaccinated with PNEUMOVAX 23, injection in the arm (dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2017 (reported as after receiving PNEUMOVAX 23), the patient's arm was swollen from injection site to elbow accompanied by being red, hot, and painful. The patient sought medical attention by contacting the office. On the next day, 02-JUN-2017, the patient was coming in for a follow-up visit. At the time of the report, the patient did not recover from the adverse events. There was no product quality complaint involved. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Developed Pneumonia  Started with Fever (101.5) within 90 minutes, chills, aches, soreness.   Next several days continued with fever as high as 102.5, continued chills, aches soreness Went to urgent care on 4/6/2021 and was diagnosed with Pneumonia and developed rash on arm where blood pressure was taken.  Rash was 6 x 6 inches (I have a picture).
Swelling of the arm; Tiredness; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), FATIGUE (Tiredness) and MYALGIA (Body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling of the arm), FATIGUE (Tiredness) and MYALGIA (Body aches). At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), FATIGUE (Tiredness) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information included Paracetamol but not specified for which dose it was taken.
No aditional adverse event reported; Pediatric patient inadvertently administered an adult dose of VAQTA; Pediatric patient inadvertently administered an adult dose of VAQTA; This spontaneous report was received from a registered nurse referring to a 6-year-old patient (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On 30-AUG-2021, the pediatric patient was inadvertently vaccinated with an adult dose (product administered to patient of inappropriate age and incorrect dose administered)of hepatitis a vaccine, inactivated(VAQTA), 1 milliliter for prophylaxis (route of administration, lot number, and expiration date were not reported).  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000557:
Joint pain and exhaustion started 1st week after vaccine and persist. May 1 started body aches, sore throat, temp 101.8 deg, swollen glands in neck, tonsils, uvula. Aches, sore throat, fever gone May 4. Swollen glands persist of May 19. Seen in ER- cervical adenopathy. Prescribed MEDROL DOSEPAK.
painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she was taking the chance on a shingles vaccine.  It was painful but he/she survived. The follow up would not possible as no contact details were available.
Red spot at area of injection site. Pain at injection site. Severe joint pain for 48 hours.
Intermittent fever and chills, moderate to severe muscle and joint aches, moderate to severe headache, nausea. Time course was 36 hours, treated with acetaminophen, rest.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: blood pressure 144/81. no history of high blood pressure