chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was 16 years old when they received their first Moderna vaccine.  Because they had received their fist dose, we used the off label direction from CDC to provide the second dose of Moderna.
Narrative: COVID infection after COVID vaccine series 01/14/21 COVID vaccine #1 02/12/21 COVID vaccine #2 09/13/21 c/o cough, congestion, fever, exposed to someone w/COVID; COVID positive 09/14/21 c/o mild myalgia, mild rhinorrhea, fever resolved 09/15/21 c/o cough, rhinorrhea 09/16/21 c/o productive cough (improving), SOB upon walking but improving 09/17/21 c/o minor clear productive cough, SOB 09/18/21 minimal cough 09/19/21 symptoms resolved
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 59 year old male. 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: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient's laboratory data included: SARS-CoV-2 antibody test (NR: not provided) negative with an index of less than 0.01 or normal (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210860141 -COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
After 24 hours I got a stiff neck by night time I could not hold up my head. Could not sleep for the next 24 hours. It is now 10/28/2021 and still have a lot of pain. Don't know if this has anything to do with the shot. The shot was the booster.
This case was reported by a contact via call center representative and described the occurrence of diarrhea in a 52-year-old male patient who received BOOSTRIX (batch number 87PC3?, expiry date 12th SEPTEMBER 2016). On 27th FEBRUARY 2015 10:00, the patient received BOOSTRIX. On 27th FEBRUARY 2015, less than a day after receiving BOOSTRIX, the patient experienced fatigue, vomiting, urine color abnormal, gas pain and eating disorder. On 27th FEBRUARY 2015 11:45, the patient experienced diarrhea and abdominal cramp. On 28th FEBRUARY 2015, the outcome of the vomiting was recovered/resolved. On 1st MARCH 2015, the outcome of the diarrhea, abdominal cramp, fatigue, urine color abnormal, gas pain and eating disorder were recovered/resolved.  The reporter considered the diarrhea, abdominal cramp, fatigue, vomiting, urine color abnormal, gas pain and eating disorder to be possibly related to BOOSTRIX. Additional information received: Reporter which is a GSK employee stated that all symptoms were suspected to be related to the BOOSTRIX vaccine that her husband received. He immediately reported the symptoms to his doctor who unfortunately did not follow up.
Menveo administered with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The patient was administered Menveo by another health care professional. The caller did not had any additional information regarding the patient.  The reporter did not consent to follow-up. Additional supportive information: The patient was administered Menveo powder component after it was reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Patient received Moderna COVID-19 Vaccine at 18:50. She started to have itchiness and redness at site of injection and to her bilateral upper extremities (BUE) (arms, hands) at 19:00. RN who administered the vaccine notified another RN in the clinic to assess the patient and noted redness and hives were visible. Patient complained of itching to BUE and more redness than usual to her eczema. Pharmacist and RN in the clinic gave the patient her first Benadryl 25 mg at 19:15. Patient stated at 19:30 that she would like a second dose of Benadryl as her symptoms were not worsening but not getting better, second dose of Benadryl 25mg given at 19:36. After the second dose, patient stated that her symptoms were not getting worse and that she would like to go home - patient was watched for 1 hour after vaccine administration. A friend came to pick her up at 20:03 and the clinic RNs informed the patient to call Occupational Health or go to ED/ Urgent care if symptoms worsened - patient confirmed understanding.
Normal vaccine related symptoms 24-48 he following vaccine, seemed resolved by day 5. On day 6 starting feeling a burning sensation, a sore developed at the injection site. Today is 17 days post injection, the sore is scabbed and resolving, burning has subsided, but shoulder is tight and somewhat painful when doing something like yoga.
Approx 8 min after receiving seven vaccines pt began complaining of feeling dizzy.  She then slumped to her knees saying she was going to pass out.  A code blue was called and Dr. immediately responded.  Pt had already been assisted to a chair.  She was perspiring and c/o feeling hot.  Dr. gave her Gatorade to drink and ordered Glu which was 97 and Hgb (15.2) BP initially 66/40, 5 min later 70/42.  She was asked to put her head between her knees.  She began to feel better after 15 min later.  She walked to exam room to finish her visit.
Right arm red and swollen from upper deltoid to elbow. Started 3 hours after vaccination.
Experienced flu like symptoms starting 24 hours after shot, including low grade fever, chills, fatigue, headache, nausea, and body aches.  These all started to improve Sunday evening, 4/18,, and I was able to eat a meal.  Around 9:00 pm on 4/18, I noticed a red area around the injection site on my arm.  It felt warm to the touch.  It didn?t seem too swollen, so I went to bed.  I woke up around 2:00am on 4/19 and my upper arm had a large, hard swollen lump at injection site.  It was still red and hot.  I have been taking ibuprofen which is helping with the swelling.  I still have some swelling, a red ?sunburned? area around the injection, and warm to the touch.  I do not have pain or itching? at least at this point at 11:45pm on 4/19.   I was surprised to have a new symptom almost 2.5 days after my shot.
given Menactra on accident due to prescriber in error ordering the dose and the child not getting the Haemophilus Influenzae type B vaccine with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 02-month-old female patient who was given meningococcal a-c-y-w135 (d conj) vaccine [Menactra] on accident due to prescriber in error ordering the dose and the child not getting the haemophilus influenzae type b vaccine (product prescribing error) on 24-Aug-2020 (formulation and strebgth was unknown) (lot number: U6575AB and expiry date: 08-May-2021) via intramuscular route in the left thigh for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included Pedia RX, pneumococcal vaccine conj (PCV-13) and rotavirus vaccine (Rotavirus).  This was an actual medication error case due to product prescribing error (latency same day).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Pt began to feel light headed and dizzy immediately following vaccination. Vaccinator had pt lay on the floor with legs elevated.  Assessed by EMT on site. Allowed to recover then offered water and food. Observed post vaccination and allowed to go home with parent.
No adverse event, however, patient was given a 5th Moderna vaccine instead of a 5th Bivalent booster vaccine. Patient feeling ok and no symptoms reported.
Second dose given Jan 26 (first Jan 4) On March 15 I woke up with pain in my left testicle that grew worse throughout the day. I contacted the health clinic and was referred to the emergency room where an ultrasound indicated possible torsion and was followed up with a bilateral orchidopexy occurring at about 3 AM on March 16. The pain failed to resolve after two weeks and a second ultrasound was taken on April 1 with a diagnosis of testicular cancer on April 2 and a left radical inguinal orchiectomy revealed a T2 nonseminoma with no metasteses on follow-up contrast CT on April 16. Two cycles of bleomycin, etoposide and cisplatin were started on May 3 and finished June 11 and a blood draw and follow-up CT on Sept 27 showed no recurrence; next monitoring follow-up is scheduled for July 2022.
Like most people, I had the arm pain and then I also got a rash from where I got the injection all the way down to just before my elbow The rash began probably within 6 hours after getting the vaccine. I went home and called the DR and had a virtual visit. The symptoms lasted approximately 18 days. After I spoke with the DR, they said before I get my 2nd dose, they had me take 2 tylenol, 2 pepcid 30mins before my 2nd dose and then follow up again 8 hours with medication.  After my second dose I did not have a reaction like my first one, due to taking the medication. It itched but I did not have a rash like this one.
Half dollar sized red area at injection site. Area is warm to touch with slight swelling. Afebrile. Advised to give TYLENOL and apply cool compress.
Approximately 2 hours post injection, I began to feel fatigued and achy. At 3 hours post injection, I had a headache, muscle & joint aches.  I also had slight nausea & a moderately severe stomach ache.  These symptoms began to subside approximately 10 hours post injection with the stomach ache taking an additional 2 hours to resolve (12 hours total).   The injection site was painful the day following the vaccine and did not resolve until 2 days post administration.
This spontaneous report was received from a medical assistant and refers to four patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were unspecified. On four separate unspecified dates, patients were vaccinated with improperly stored ROTATEQ lot # M038744, expiration date: 26-APR-2018 (administered orally; dose was not reported). The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000770: US-009507513-1707USA000769: US-009507513-1706USA008487: US-009507513-1706USA008487: US-009507513-1707USA000794.
Information has been received from a physician and a nurse concerning an 8 year old patient who was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot# 658059/0838U). Subsequently, the day after administration, the patient experienced injection site cellulitis characterized by injection swelling and redness. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
injection site and surface of a few square centimeters swollen and warm.; Itching at the injection site; injection site and surface of a few square centimeters swollen and warm.; pain in the armpit (ganglion) of the arm on the side of the injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site and surface of a few square centimeters swollen and warm.), AXILLARY PAIN (pain in the armpit (ganglion) of the arm on the side of the injection.), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE SWELLING (injection site and surface of a few square centimeters swollen and warm.) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced AXILLARY PAIN (pain in the armpit (ganglion) of the arm on the side of the injection.). On 01-Oct-2021, the patient experienced VACCINATION SITE WARMTH (injection site and surface of a few square centimeters swollen and warm.), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE SWELLING (injection site and surface of a few square centimeters swollen and warm.). At the time of the report, VACCINATION SITE WARMTH (injection site and surface of a few square centimeters swollen and warm.), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE SWELLING (injection site and surface of a few square centimeters swollen and warm.) outcome was unknown and AXILLARY PAIN (pain in the armpit (ganglion) of the arm on the side of the injection.) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No treatment information was provided.  No treatment information was provided by the reporter.
After receiving vaccines pt went to the lab for bloodwork but before labs were drawn he vomited and was noted to be itchy, diffusely red, warm to touch and developing hives within approx 20min after receiving vaccines. Attempted to give pt liquid Benadryl but he spit out most of the medication. Epipen Jr was then given and ambulance was called. Pt taken to local ER.
itchy; red; Little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (red) and DIZZINESS (Little dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (red) and DIZZINESS (Little dizzy). At the time of the report, INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (red) and DIZZINESS (Little dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided
diarrhea; after the injection I got the soreness on the injection site; cramping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: ER8733) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Neuropathy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "unknown", described as "after the injection I got the soreness on the injection site"; DIARRHOEA (non-serious) with onset 26Mar2021, outcome "unknown", described as "diarrhea"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "cramping". Therapeutic measures were not taken as a result of vaccination site pain, diarrhoea, muscle spasms.  Additional information: It was stated that the patient got cramps and then diarrhea and then diarrhea again and nothing else so far.  No follow-up attempts are possible. No further information is expected.
No movement in arm and lymph nodes under armpit were painful. Also, modeled rash around injection site about size of grapefruit. That night, patient had chills and body aches (flu like symptoms) until about 3am 12/7/18. Patient regained full range of motion in arm 12/8/18. Lymph nodes still tender but no more pain. Still currently has rash.
identical symptoms after second booster; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (identical symptoms after second booster) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (identical symptoms after second booster). At the time of the report, IMMUNISATION REACTION (identical symptoms after second booster) outcome was unknown.            No concomitant medications were reported No treatment medication was reported.
elevated PT/INR.  long term use of anticoagulant - medication held for 2 days
Immediately I felt like I was passing out. After resting for a few minutes I was able to resume my activities but I had muscle soreness and some feeling of mobility issues.  After about 2 hours I became nauseated and my skin was tender to the touch.  I had diarrhea for the next several days.  On the evening of the day I had the vaccine, I experienced chills and found it difficult to warm up and get comfortable.  I continued to have some mobility issues and a headache that would not respond to aspirin. Today I am able to eat without difficulty and I no longer have the headache or feeling of nausea. But, I remain significantly tired and I still feel some weakness in my muscles.
1/30/23 I was at home and all of a sudden, I experienced a heart rate that was off the charts, palpitations and flip flops of the heart. I have a cardio mobile and it showed possible Atrial Fibrillation. I did it again, a few minutes later, and it did not say AFIB. I did a third one that came back possible Atrial Fibrillation. I went to the emergency room. My EKG was normal. I followed up with my cardiologist on 2/7/23 and he said I was definitely in AFIB. I began ELIQUIS and flecainide. I have only had two very short episodes since then, that I am aware of.
Fever, pain at injection site rash, body aches golf ball size lump to injection site.
Myocarditis; erratic blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: MYOCARDITIS (medically significant), outcome "unknown"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "erratic blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Abnormal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed a red, hard swelling at injection site. She did not experience any pain or pruritis at the site. Only notice when dressing the hard spot.  Through the day it increased in size to that of a half dollar. Patient took diphenhydramine to alleviate symptoms.  The symptoms resolved and as of 12/18/15 afternoon the site has nearly returned to normal.
back sore due to shoveling snow; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back sore due to shoveling snow) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0066H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose -EW0172) on 24-Jun-2021 and Pfizer (2nd dose - EW0173) on 17-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BACK PAIN (back sore due to shoveling snow). At the time of the report, BACK PAIN (back sore due to shoveling snow) outcome was unknown.            No Concomitant medications were provided The patient wanted to know if he could take Ibuprofen for the back sore.
idiopathic Transverse Myelitis; This is a literature report for the following literature source(s):   A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 12Feb2021, for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 05Mar2021, outcome "unknown", described as "idiopathic Transverse Myelitis". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: Normal. Clinical courses: Headache, cramping after 2nd injection; chills, fatigue, leg pain and difficulty walking by the second day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event transverse myelitis  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
On Tuesday (a week after the shot)  my whole left arm tingled and hurt.  I also noticed a large red circle at the injection site. As the day progressed it started heating  up.  By the end of the day the tingleling stopped but the red circle grew larger and larger and burned.  It was also difficult to move my left arm.   This went on until Saturday afternoon when the redness and burning slowly went away.  The burning wasnt like a sunburn.  It was hot to the touch and felt like it was burning from the inside out.