chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 year old received Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna booster) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna booster). On 18-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna booster) had resolved.            Patient was administered with Pfizer vaccine and then received the Moderna booster accidentally.  No concomitant medications reported by reporter No treatment medications provided by the reporter.
12 hours after the 2nd injection I developed sudden severe nausea that lasted 24 hours non-stop. I was also very thirsty and had chills. The nausea stopped as suddenly as it started but I had fatigue for a few days afterward. I had slight left arm pain. I had fatigue for several days after I recovered from the nausea.
"moo moo is black"/liquid dark colored; "loose, runny, liquid dark colored stool"; "sore throat"; congestion; runny nose; cough/"coughing up mucus"; headache; "chills"; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED ("moo moo is black"/liquid dark colored), DIARRHOEA ("loose, runny, liquid dark colored stool"), OROPHARYNGEAL PAIN ("sore throat"), NASAL CONGESTION (congestion) and RHINORRHOEA (runny nose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure, Gout and Thyroid disorder NOS. Concomitant products included DILTIAZEM, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), ALLOPURINOL and METHIMAZOLE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced FAECES DISCOLOURED ("moo moo is black"/liquid dark colored), DIARRHOEA ("loose, runny, liquid dark colored stool"), OROPHARYNGEAL PAIN ("sore throat"), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough/"coughing up mucus"), HEADACHE (headache), CHILLS ("chills") and NAUSEA (nausea). At the time of the report, FAECES DISCOLOURED ("moo moo is black"/liquid dark colored), DIARRHOEA ("loose, runny, liquid dark colored stool"), OROPHARYNGEAL PAIN ("sore throat"), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough/"coughing up mucus"), HEADACHE (headache), CHILLS ("chills") and NAUSEA (nausea) outcome was unknown.            Treatment include warm salt water for sore throat, over the counter cough syrup for cough and congestion.
Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 18 months old male patient who was vaccinated with an expired fourth dose of DAPTACEL (lot: C5169AA, expiry date: 16-Mar-2019) via unknown route in the left thigh on 28-Mar-2019. Concomitant medications included PREVNAR 13 for Immunisation. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event. 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 and Module VI of the 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.
A report has been received from a Medical Rep concerning a 8 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 24-OCT-2014. The patient experienced tested positive for Flu A. The outcome of the event of tested positive for Flu A is unknown. The report was considered to be non-serious.
Partial paralysis in legs and face; Partial paralysis in legs and face; 11 year old girl who got your vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARAPARESIS (Partial paralysis in legs and face) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     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 PARAPARESIS (Partial paralysis in legs and face) (seriousness criterion medically significant), FACIAL PARESIS (Partial paralysis in legs and face) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 year old girl who got your vaccine). At the time of the report, PARAPARESIS (Partial paralysis in legs and face) and FACIAL PARESIS (Partial paralysis in legs and face) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 year old girl who got your vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No Treatment medication was provided. It was reported that the 11 year old girl who got vaccine that now has partial paralysis in her legs and face.  Company comment:  This case of product administered to patient of inappropriate age concerns a 11-year-old female patient with no reported medical history who experienced serious unexpected event of paraparesis, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to  unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-447283, MOD-2022-447298, MOD-2022-447300 (Patient Link).; Sender's Comments: This case of product administered to patient of inappropriate age concerns a 11-year-old female patient with no reported medical history who experienced serious unexpected event of paraparesis, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to  unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
inflammatory bowel disease; severe response to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATORY BOWEL DISEASE (inflammatory bowel disease) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATORY BOWEL DISEASE (inflammatory bowel disease) (seriousness criterion medically significant) and VACCINATION COMPLICATION (severe response to the vaccine). At the time of the report, INFLAMMATORY BOWEL DISEASE (inflammatory bowel disease) and VACCINATION COMPLICATION (severe response to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, the previous history of inflammatory bowel disease is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, the previous history of inflammatory bowel disease is a confounder.
Expected arm soreness in the 2 days following vaccination subsided. Then 10 days following vaccination, employee experienced intermittent tenderness and difficulty with her horizontal elevation of arm which has not resolved.
complained of "chest tightness" after receiving the vaccine; being nervous; This is a spontaneous report from contactable Pharmacist. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration in 2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient (healthcare worker) received the Pfizer-BioNTech COVID-19 vaccine in 2020 and complained of chest tightness after receiving the vaccine. Chest tightness resolved quickly and the patient attributed it to being nervous. No medical interventions were received and the patient left the observation area without issue. The outcome of the events was resolved in 2020.  Information about lot/batch number has been requested.
Pt was nervous prior to vaccine administration. After receiving vaccine patient experienced pre-syncopal episode and became dizzy. Reaction nurse evaluated Pt and laid Pt in Trendelenburg pos. Pt began to feel better and was given pretzels and water and then moved to wheelchair. Pt received eval from clinician. VS were appropriate for Pt age and improved after 2nd set of VS. Pt released @ 1408 hrs.
Approximately 1 month after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: slight fever, dry cough and sore throat. I took TYLENOL for treatment although I was not sure if it did help to improve my symptoms. I called my doctor and was advised to isolate myself and to have my symptoms run its course until I can fully recover. As of today 06/22/2022 I am feeling so much better, I still do have a little bit of cough but my energy level has been back to normal.
Rash around injection site and on abdomen on same side, chills, pain around injection site.
06/07- fatigue, muscle soreness 06/08-06/11- extreme fatigue and muscle aches, diarrhea, shivers, night sweats 06/12- fatigue, diarrhea, headache
covid vaccine breakthrough case   dose 1 5/17/21 J&J  1808982
Fever 101.8 to 102 Severe body and muscle aches Severe weakness in legs barely able to walk Severe soreness at injection site Pain in calf and right lower extremity  Extreme fatigue
shortness of breath; Chills; Body Ache; fatigue; Headache; Pain at injection; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (shortness of breath), MYALGIA (Body Ache), CHILLS (Chills), VACCINATION SITE PAIN (Pain at injection) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 11J20A and 064M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection) and HEADACHE (Headache). On 08-Jan-2021, the patient experienced FATIGUE (fatigue). On 09-Jan-2021, the patient experienced MYALGIA (Body Ache). On 06-Feb-2021, the patient experienced DYSPNOEA (shortness of breath) and CHILLS (Chills). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form twice a day and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form twice a day. On 07-Jan-2021, HEADACHE (Headache) had resolved. On 09-Jan-2021, VACCINATION SITE PAIN (Pain at injection) and FATIGUE (fatigue) had resolved. On 10-Jan-2021, MYALGIA (Body Ache) had resolved. On 07-Feb-2021, DYSPNOEA (shortness of breath) and CHILLS (Chills) had resolved. Not Provided      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 were not reported by the reporter.
a four years old patient received a dose of Fluzone Quadrivalent, facility received their shipment this vaccine which were not viable shipment was delayed and took longer than 2 days/No AE; a four years old patient received a dose of Fluzone Quadrivalent, facility received their shipment this vaccine which were not viable shipment was delayed and took longer than 2 days/No AE; Initial information received on 17-Oct-2019 and additional information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves four years old patient (gender unknown) who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled facility received their shipment this vaccine which were not viable shipment was delayed and took longer than 2 days lot UT6686LA, expiry date: 30-JUN-2020 via intramuscular route in the right thigh on 17-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  It was a case of product shipment delay.  At the time of report 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 holders 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.
Getting 2nd shot at day 49 after the 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Getting 2nd shot at day 49 after the 1st shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gallbladder operation NOS (1 week after the 1st vaccine dose was administered).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Getting 2nd shot at day 49 after the 1st shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Getting 2nd shot at day 49 after the 1st shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Tachycardia that started approximately 23 hours after vaccination.  I have a history of heart arrhythmia (atrial flutter and atrial fibrillation) that were treated with ablation in July 2018.  Periodically, I have tachycardia, so I am not sure if this is separate from the shot or not.  Other symptoms are body aches.
Pt had shots mid morning and awoke from nap mid to late afternoon with inconsolable crying and a red swollen left thigh. Would not breastfeed, take a bottle or a pacifier. TYLENOL 50mg PO given as well as diphenhydramine 6 mg PO given. Also cold pack applied to leg.
productive cough and fatigue that began 3 days prior.  Upon arrival, she was hemodynamically stable and saturating well on room air.   \Health authority who confirmed that she was not an appropriate candidate for monoclonal antibody infusion
Patient's legs started itching 3 days later; Patient developed itching on both arms, chest, and her scalp 2 days later,Patient's legs started itching 3 days later; Patient's left arm was sore after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient's left arm was sore after receiving 2nd dose), PRURITUS (Patient developed itching on both arms, chest, and her scalp 2 days later,Patient's legs started itching 3 days later) and PRURITUS (Patient's legs started itching 3 days later) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Patient's left arm was sore after receiving 2nd dose). On 28-Feb-2021, the patient experienced PRURITUS (Patient developed itching on both arms, chest, and her scalp 2 days later,Patient's legs started itching 3 days later). On 01-Mar-2021, the patient experienced PRURITUS (Patient's legs started itching 3 days later). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Patient's left arm was sore after receiving 2nd dose), PRURITUS (Patient developed itching on both arms, chest, and her scalp 2 days later,Patient's legs started itching 3 days later) and PRURITUS (Patient's legs started itching 3 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication also included Cholesterol Medications. Treatment details included Benadryl.   This case was linked to MOD-2021-136997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: TCR document received on 05-MAY-2021 contains significant information. Dose 2 details updated, Action taken, De-challenge and re-challenge updated. No further follow-up requested by the consumer. On 23-Jun-2021: Follow up received on 23-JUN-2021 contains Non-significant information. Reporters contact details updated.
Patient with brittle diabtes and recurrent diabetic ketoacidosis.. Patient received Pfizer booster. developed nausea, vomitting, body aches and chills. Admirred to hospital 12/19/2021 for diabeteic ketoacidosis
Warm to touch, hard in spots and larger than width of all my fingers; itching; Red area getting bigger; swelling; sick to stomach; mild joint pain; fever of 102.5 F; muscle sore; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to stomach), ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger) and ARTHRALGIA (mild joint pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical History.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PRAVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach), ARTHRALGIA (mild joint pain), PYREXIA (fever of 102.5 F), MYALGIA (muscle sore) and INJECTION SITE ERYTHEMA (injection site red). On 29-Jan-2021, the patient experienced ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger) and SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 29-Jan-2021, PYREXIA (fever of 102.5 F) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (sick to stomach), ADMINISTRATION SITE WARMTH (Warm to touch, hard in spots and larger than width of all my fingers), INJECTION SITE PRURITUS (itching), ERYTHEMA (Red area getting bigger), ARTHRALGIA (mild joint pain), MYALGIA (muscle sore), INJECTION SITE ERYTHEMA (injection site red) and SWELLING (swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Pyrexia: fever of 102.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient reported received Pfizer on 5/13 and 6/4.  Patient reported after her COVID vaccine her ?lower half just collapsed?.  On 5/13 patient came to ER for intoxicated with multiple falls.  On 6/6 patient was fell down at her home.
Dose 1 Moderna was on 1/18/2021, and Dose 2 Moderna was on 2/15/2021
Patient felt severe pain at injection site immediately after receiving vaccine.   Within 15 min her arm was hot, red and mildly swollen and severely painful.  During observation period patient felt "high" lightheaded, with blurry vision.  She stated she had not eaten anything since breakfast.  She was given a granola bar and orange juice.  Her symptoms seemed to improve after snack.  After a short persio (10 min) she stated her symptoms returned (lightheaded, "high" ) we called 911 and gave epinephrine 0.5mg IM, diphenhydramine 50mg IM, and diphenhydramine 25mg orally.   Ambulance transported her to ER for assessment.
Pt came to ER c/o sore throat.  Onset 2 days prior.
The day of the shot, (10/06/2020) the nurse said that the needle had broken and thought it was "weird"  I didn't know what to make of that then, but after everything started hurting I was worried that some of the needle might have broken off into my arm. After about ten days it had become incredibly painful.  There was a hot searing pain when I lifted my arm up and out. After 3 months (on 1/6/21) I saw Dr. and she prescribed ibuprofen and rehab. I still had pain after 6 months and went to facility and saw Dr. on 5/5/21 . I got an xray (no needle) . After several tests Dr said I had impingement in the bursa and prescribed a cortisone shot (which I got on 5/24/21)  in 10 days I go to rehab.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL and a dose of either Hep A vaccine (MSD) or HAVRIX at the same time as GARDASIL.  The physician reported that this was not the only office to have this happen.  The outcome was unknown.  No additional Adverse Event (AE) information was reported.  Upon internal review seizure was determined to be an other important medical event.  This is one of several reports from the same source.  Additional information has been requested.
Felt unwell on Wednesday but on Thursday morning I was getting dressed and intended to go back to bed since I did not feel well. Then came back to consciousness on the floor with a definite knot on my head from a fall.  Crash was enough to wake my husband who said I was out about 5 minutes.
Syncope - dizziness x LOC < 5 min at school. 9:30 AM 11-23-11.