chrisvoncsefalvay/vaers-outcomes huggingface dataset:
realized 17year old was given the shot in right deltoid; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (realized 17year old was given the shot in right deltoid) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (realized 17year old was given the shot in right deltoid). On 17-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (realized 17year old was given the shot in right deltoid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Case number PHEH2013US008354 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 16-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 05 Apr 2013. It was reported that the vaccine was stored at 33 to 26 F for 19 days and it was not frozen. No side effects was reported following the medication error. No further information was provided.
Fatigue; chills; low-grade fever; muscle aches; nausea; headache; mental fogginess
Bunch of liquid was dripping; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (Bunch of liquid was dripping) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 027A21A and 023M20A) for COVID-19 vaccination.     Concomitant products included DULOXETINE and LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE EXTRAVASATION (Bunch of liquid was dripping). At the time of the report, INJECTION SITE EXTRAVASATION (Bunch of liquid was dripping) outcome was unknown.            No treatment information was provided.  No reported medical history.   The patient stated that she is concerned because her arm was dripping not just wet.doctor who stated they weren't sure what she should do.When she talked to the person who vaccinated her she said if she got at least half she is okay.
throat swelling/closing; throat swelling/closing; Interchange of vaccine products; lip swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lisinopril (LISINOPRIL), (Batch/Lot number: unknown) for blood pressure abnormal. The patient's relevant medical history included: "BP" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (All prior COVID vaccine doses were Moderna doses., Dose Number unknown), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Oct2022, outcome "unknown"; LIP SWELLING (medically significant) with onset 13Oct2022, outcome "unknown"; PHARYNGEAL SWELLING (medically significant), THROAT TIGHTNESS (medically significant) all with onset 14Oct2022, outcome "unknown" and all described as "throat swelling/closing". The events "lip swelling" and "throat swelling/closing" required emergency room visit. The action taken for lisinopril was temporarily withdrawn. Therapeutic measures were taken as a result of lip swelling, pharyngeal swelling, throat tightness.  Clinical course: Patient received Pfizer bivalent booster shot on 13Oct2022 in the AM. She also takes lisinopril and has for 5-7 years. She started experiencing lip swelling by Thursday PM and took benedryl. Still had lip swelling Friday day and Friday evening began to experience throat swelling/closing. Went to ER and received steroids and more benedryl. She will no longer be on lisinopril for her BP as a precaution. No determination was made as to which product may have triggered the reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate
had lymphedema in her left arm; sweats; headache; Chills; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (had lymphedema in her left arm), HYPERHIDROSIS (sweats), HEADACHE (headache), CHILLS (Chills) and FATIGUE (extreme fatigue) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer in 2008. Concurrent medical conditions included Emphysema (Upper left quadrant emphysema). Concomitant products included LISINOPRIL, METOPROLOL, ATORVASTATIN, BRIMONIDINE TARTRATE (ALPHAGAN), TIOTROPIUM BROMIDE (SPIRIVA) and LORAZEPAM for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (Chills) and FATIGUE (extreme fatigue). On 06-Feb-2021, the patient experienced HYPERHIDROSIS (sweats). On 07-Feb-2021, the patient experienced LYMPHOEDEMA (had lymphedema in her left arm). On 14-Feb-2021, HEADACHE (headache), CHILLS (Chills) and FATIGUE (extreme fatigue) had resolved. At the time of the report, LYMPHOEDEMA (had lymphedema in her left arm) and HYPERHIDROSIS (sweats) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Follow up document was received on 19th Feb with following information updated: weight, concomitant drugs, medical histories and new event was added. On 26-Apr-2021: The follow up was received on 26th Apr- only reporter's address was updated.
Approximately 10 minutes after vaccine administration, patient reported wheezing and coughing. Patient received epinephrine IM, IV Benadryl, IV solumedrol and racemic epinephrine SVN. Patient never developed a rash, hypotension, swelling of the lips, mouth or tongue, other GI side effects . Per ER attending and admitting physician, this reaction seems to be a clear exacerbation of the patient's tracheomalacia. The patient was more responsive to racemic epi SVN as opposed to IM epi. Patient admits that psychological stress may have been a component of her symptoms. The admitting physician does not consider this to be an anaphylactic reaction to the vaccination.
I felt dizzy, weak, lethargic, fatigued. I had no appetite, headaches, achy muscles and joints. I also had joint stiffness and joint pain. I have had a drop in my cortisol hormones. My THS levels have been chronically low since I have had the vaccine. I have had weakness and paralysis in my extremities. I have also had unexplained weight loss.
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 October 2011 at approximately 14:00 the subject received unspecified dose of FLULAVAL at 0.5 ml in the left arm. The subject went to the emergency room on 31 October 2011 and was administered antibiotics and pain killers. it was reported that the subjects first day back to work was 03 November 2011 and she was still wearing an immobilizer on her hand. She was schedule for follow-up the week of reporting including an x-ray on her arm since swelling was so severe during the emergency room visit that an x-ray could not be taken. Events reported for this subject with no specific onset dates (2011) included severe swelling, injection site redness, tingling in the left hand, cellulitis in left arm and activities of daily living impaired. All of these events were reported to have been improved as of the day of reporting, 03 November 2011, less than one week following vaccination with FLULAVAL. All events occurred within one week of FLULAVAL administration and onset of extensive swelling of vaccinated limb began sometime between 28 October 2011 and 31 October 2011. It was also noted that the subject "bled a little" with previous flu vaccinations. No specifics were provided.
Addison's Disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570).  A female 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: ADDISON'S DISEASE (medically significant), outcome "unknown". Clinical course: Question: Customer Verbatim: My friend received the Pfizer COVID-19 vaccine and has recently been told that she has Addison's Disease. Is there a link between vaccination and the development of Addison's Disease. Proposed response: 1. Confirm if Non-HCP or HCP .2. Obtain information regarding her friend's development of Addison's disease after receiving the Pfizer COVID-19 vaccine and offer to transfer to agent. 3. If Non-HCP notify that we do not have any information regarding a causal relationship between the Pfizer COVID-19 vaccine and Addison's Disease. Refer to HCP for further guidance (friend's HCP).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Civilian employee noticed the onset of dizziness and lightheadedness then flu-like symptoms commencing 1-2 days after influenza vaccine. Received IM Flu vaccine on 11/17/10. Pt claims the vaccine disturbed her SLE by causing her urinalysis to become abnormal where the UA results had previously been negative. Civilian noted the gradual onset of a "flu-like illness" with upper airway and chest congestion, productive cough with white mucus, chills, malaise, and fatigue. No fever documented. Patient would experience some shortness of breath when going up a flight of stairs about 1-2 weeks later. She took her pulse ox and it measured 93-94%. She was diagnosed with a URI about 2 weeks later and the illness took quite some time to resolve.
I was due for my 2nd booster when I got covid.; I was due for my 2nd booster when I got covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I was due for my 2nd booster when I got covid.". Therapeutic measures were taken as a result of suspected covid-19.  Clinical information: Please answer a question that my doctor and pharmacist could not. I was due for my 2nd booster when I got covid. I took Paxlovid and cancelled my booster appointment. Is there a waiting period after Paxlovid? All 3 vaccines were Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a consumer reporting on a 13 year old daughter. The patient had no pertinent medical history and no drug reactions or allergies. On 19-DEC-2014 the patient was vaccinated with GARDASIL one dose, (dose, route, lot # not reported). There was no concomitant medications. On 24-DEC-2014 the patient experienced grand mal seizure. On 24-DEC-2014 she was with her father when collapsed with her "legs and arms twisted and contorted". The patient's father call an ambulance and daughter was examined at the hospital and released. On 28-DEC-2014 the patient collapsed again, demonstrating the same shaking and seizure-like movements of her arms and legs. The reporter's daughter was transported again by ambulance to the emergency department. Computerized tomogram (CT scan) and unspecified "blood work" (on unknown date in approximately December 2014) were within normal ranges. The patient described her experience as "things started to go blue, her one arm started shaking, and then she did not remember anything until she woke up, and upon awaking, her extremities hurt and tingle". The reporter informed that both episodes of seizure activity last around 3-4 minutes. The patient was not hospitalized and no medications were administered as a treatment. The reporter informed her daughter's pediatricians of grand mal seizures activity and the patient was referred to a neurologist at hospital where she was scheduled for an electroencephalogram (EEG). At the time of report the patient did not recover from the event. Relatedness between the event and GARDASIL was not specified. Upon internal review the event of grand mal seizures was considered to be medically significant.  This is one of several reports received from the same reporter. Additional information has been requested.
COVID arm lasting for more than a week. I have been treating it with ice packs and allergy medication.
Administration site had a large, raised area about 2-3 inch in diameter. It was bruised and painful to the touch and when pressure was applied for approximately one month.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiry date, dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (right arm was sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 019A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (right arm was sore). At the time of the report, INJECTION SITE PAIN (right arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided No treatment information was provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received captured no new information.
Cold; Fall; Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), FALL (Fall) and GAIT DISTURBANCE (Could not walk) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient's past medical history was not reported.  Concurrent medical conditions included Multiple sclerosis.    On 16-Apr-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, the patient experienced NASOPHARYNGITIS (Cold), FALL (Fall) and GAIT DISTURBANCE (Could not walk). At the time of the report, NASOPHARYNGITIS (Cold), FALL (Fall) and GAIT DISTURBANCE (Could not walk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Rash, skin peeling and itchy. Was treated at clinic and given medication listed below.
It was determined that the recipient was administered too much Pfizer vaccine in error.  Upon the discovery, the recipient was notified and given care instructions by the school's physician.  Upon follow-up the next day by the nurse, recipient complained feeling tired and some swelling in arm. Continoius monitoring and follow-up will be made on the recipient's condition and care.
She was not breathing well when we checked on her, and was struggling so we woke her up. Her nostrils were so inflamed the Nasal Clear could not even fit to clear anything. As I was holding her she threw her head back with her eyes rolling backwards, and started shaking. White foam started to come out of her mouth and she was not breathing at all for about 20 seconds. There was no treatment, we immediately took her to the ER where they told us she was just going to be "that" baby that has seizures.
Patient experienced a faint and hit her head after receiving her 11 year old vaccines.  Sustained reddish bruise on L frontal area. No LOC or change in mental status. Felt better after receiving juice, snack and an ice pack.   Patient was observed over a 20 minute period sitting up then standing.  BP was checked and patient felt well at discharge and no longer experiencing any symptoms.  Discharged to home with mother. Follow up phone call that evening confirmed patient was doing well.
Has been seen for mild paresthesias in past.  ABout 30 minutes after vaccination noted return and worsening.  Tingling/burning that continues now on day 4.  NOt severe but definitely worse than in past.tingling/paresthesias in arms
This medically confirmed spontaneous report (initial receipt 31-Jul-2014) concerns a female patient. On an unknown date, the patient received Influenza (batch number not provided). On an unknown date, the patient had a severe reaction to a flu vaccine. The patient developed partial paralysis of her arm. Outcome was reported as unknown.
Arm was extremely sore; nausea; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension, Cholesterol and Anxiety. Concomitant products included CLONAZEPAM for Anxiety, SIMVASTATIN for Cholesterol, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL HCT) and LISINOPRIL for Hypertension, VITAMIN D3 and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided   This case was linked to MOD-2021-365051, MOD-2021-365056 (Patient Link).
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # K025002 with exp. 20-JUL-2017 and lot # L009649 with exp. 29-NOV-2017, (route and dose were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is sitting in observation area and became light-headed. Patient brought to room via wheelchair. Patient lying down with cold pack and drinking water.  Patient stayed in room for approximately 13 minutes and states she feels better. Able to stand without dizziness, Patient left in stable condition.
PCV 7 influenza left arm 2/25/05, HIB right arm 2/25/05. 3/2/05 woke up with red, sore arm, 9x10 cm redness, non tender, no fever.
During the night after the vax was received, the pts arm became red and warm and she developed a rash. By three days post vax the pt had a generalized rash. The physician instructed the pt to take Benadryl. It is unknown whether or not the pt took the Benadryl. The most recent information received reports the condition of the pt is unknown.
Rare pruritic papules and vesicles face, arms, trunk - v mild varicella.
FLU-LIKE SYMPTOMS; LOSS SENSE OF TASTE; CHILLS; JOINT PAIN; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient was previously treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, once a total administered on 15-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 16-MAR-2021, the subject experienced flu-like symptoms. On 16-MAR-2021, the subject experienced loss sense of taste. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced joint pain. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, muscle ache, joint pain, flu-like symptoms, and loss sense of taste. This report was non-serious.
Headache, cough, nausea, severe rash all over my face, neck, back, arms, and legs