chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine placed in a hazard ziplock bag (temperature excursion or expired); Expired Vaccine Used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine placed in a hazard ziplock bag (temperature excursion or expired)) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in a hazard ziplock bag (temperature excursion or expired)) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, PRODUCT STORAGE ERROR (Vaccine placed in a hazard ziplock bag (temperature excursion or expired)) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) 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.   Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up received and it contains NNI
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site rash, Vaccination site mass, Vaccination site warmth
Clinical narrative: On an unknown date, the patient reports developing shivering and rash, bump and warm at injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shivering, rash, bump, warm was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity, Pyrexia
Clinical narrative: he got 2 moderna doses back to back within 5-10 minutes of each other.; pain in arm; Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (he got 2 moderna doses back to back within 5-10 minutes of each other.), PAIN IN EXTREMITY (pain in arm) and PYREXIA (Fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 25-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021 at 4:05 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 25-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (he got 2 moderna doses back to back within 5-10 minutes of each other.), PAIN IN EXTREMITY (pain in arm) and PYREXIA (Fever). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at a dose of 2 dosage form. On 25-Feb-2021, ACCIDENTAL OVERDOSE (he got 2 moderna doses back to back within 5-10 minutes of each other.) had resolved. On 26-Feb-2021, PAIN IN EXTREMITY (pain in arm) and PYREXIA (Fever) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up received and events added Fever and Pain in arm
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Used on a 17year 10 month old patient; A spontaneous report, was received from a other health care professional, concerning a 17-year-old and 10 months old Female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273)/(vaccine administered to patient of inappropriate age).  The patient's medical history, concomitant history, lab data was not reported.  On 17 Feb 2021 the patient received her first of the two planned vaccine doses of mRNA-1273 (Batch number: 012M20A) via intramuscular route on her left deltoid for prophylaxis of COVID-19 infection.  On 17 Feb 2021, Vaccine was administered on a 17 year 10 months old patient. The reporter noted the age recommendation was not noticed prior to vaccination. There were no Adverse events experienced. There was no treatment information provided.  The action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered as recovered.  Follow-up received on 28 MAR 2021 included Vaccine dose details, and the patient's demographic details.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown), with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: in bed all day; A Spontaneous  report was received through a phone call, that the patient is a female who received the first dose of Moderna's COVID-19  vaccine mRNA-1273 she was experienced bed all day.  The patient medical history was not reported by the reporter.There is no concomitant list.   A patient called in to report that her friends mom got the first dose of the vaccine and she was in bed all day. The patient did not want to talk to the Med info team. Treatment information is not provided by reporter.  The action taken with mRNA-1273 in response to the dose is unknown.  The outcome of event experienced  bed all day is unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: Lethargic; Chills; Hot & Fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), CHILLS (Chills) and PYREXIA (Hot & Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced LETHARGY (Lethargic), CHILLS (Chills) and PYREXIA (Hot & Fever). At the time of the report, LETHARGY (Lethargic), CHILLS (Chills) and PYREXIA (Hot & Fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second shot given 20 days after first one; A spontaneous report was received from a client manager at group home concerning a 26 year-old-male, who received second dose of vaccination 20 days after the first dose.   The patient's medical history was not reported. Concomitant medications were not reported.  On 29 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via an unknown route for prophylaxis of COVID-19 infection.  On 18 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) via an unknown route for prophylaxis of COVID-19 infection. The patient was given second shot 20 days after the first one.  Laboratory tests was not reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events is not applicable as the individual received both the doses.  The outcome of the event inappropriate schedule of vaccination is resolved on 18-FEB-2021.; Reporter's Comments: This case concerns a 26-year-old male patient who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose; Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose; Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose; Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), HEADACHE (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), MYALGIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) and PYREXIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HYPERHIDROSIS (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), HEADACHE (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), MYALGIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) and PYREXIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose). At the time of the report, HYPERHIDROSIS (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), HEADACHE (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), MYALGIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) and PYREXIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 104 High. On 24-Feb-2021, SARS-CoV-2 test: positive positive covid  positive around sometime in November..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. Treatment details included Tylenol.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose; Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose; Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose; Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), HEADACHE (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), MYALGIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) and PYREXIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HYPERHIDROSIS (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), HEADACHE (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), MYALGIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) and PYREXIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose). At the time of the report, HYPERHIDROSIS (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), HEADACHE (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose), MYALGIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) and PYREXIA (Patient got Fever~104,headache,bodyaches, and sweat 12 hours after receiving 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 104 High. On 24-Feb-2021, SARS-CoV-2 test: positive positive covid  positive around sometime in November..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. Treatment details included Tylenol.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Hypoacusis, Lymph node pain, Vaccination site pain
Clinical narrative: behind ear lymph node soreness that she cannot hear well; behind ear lymph node soreness that she cannot hear well; bad stomach pain; slight headache; soreness L arm of injection; tenderness L arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (bad stomach pain), HYPOACUSIS (behind ear lymph node soreness that she cannot hear well), VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection) and LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), PROGESTERONE, PANTOPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FLECAINIDE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection) and HEADACHE (slight headache). On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (bad stomach pain). On an unknown date, the patient experienced HYPOACUSIS (behind ear lymph node soreness that she cannot hear well) and LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well). At the time of the report, ABDOMINAL PAIN UPPER (bad stomach pain), HYPOACUSIS (behind ear lymph node soreness that she cannot hear well), VACCINATION SITE PAIN (soreness L arm of injection), VACCINATION SITE PAIN (tenderness L arm of injection), LYMPH NODE PAIN (behind ear lymph node soreness that she cannot hear well) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        .
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Influenza like illness, Nasal congestion, Productive cough
Clinical narrative: sneezing a lot; flu-like symptoms; runny nose; feels congested stuffy nose; her head feels congested; cough bringing up phlegm; feels a little tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose) and HEAD DISCOMFORT (her head feels congested) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, ATORVASTATIN and VITAMINS NOS for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose), HEAD DISCOMFORT (her head feels congested), PRODUCTIVE COUGH (cough bringing up phlegm) and FATIGUE (feels a little tired). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose), HEAD DISCOMFORT (her head feels congested), PRODUCTIVE COUGH (cough bringing up phlegm) and FATIGUE (feels a little tired) had resolved.            Concomitant products also included Water pills. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Updated event outcome to Resolved and treatment medication taken.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: sneezing a lot; flu-like symptoms; runny nose; feels congested stuffy nose; her head feels congested; cough bringing up phlegm; feels a little tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose) and HEAD DISCOMFORT (her head feels congested) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, ATORVASTATIN and VITAMINS NOS for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose), HEAD DISCOMFORT (her head feels congested), PRODUCTIVE COUGH (cough bringing up phlegm) and FATIGUE (feels a little tired). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing a lot), INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), NASAL CONGESTION (feels congested stuffy nose), HEAD DISCOMFORT (her head feels congested), PRODUCTIVE COUGH (cough bringing up phlegm) and FATIGUE (feels a little tired) had resolved.            Concomitant products also included Water pills. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Updated event outcome to Resolved and treatment medication taken.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old got the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy; Pain; Red blotch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red blotch at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red blotch at injection site). On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (Pain). On 01-Mar-2021, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red blotch at injection site) was resolving.            No concomitant medication details was reported.  No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received TCR document  Patient declined further follow up and state that she is fine.; 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Pain in extremity
Clinical narrative: swollen/inflammation on hand started12 Feb 2021; headache started 12 Feb 2021; arms left and right so much pain felt like snake bite -11 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (swollen/inflammation on hand started12 Feb 2021), PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021) and HEADACHE (headache started 12 Feb 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021). On 12-Feb-2021, the patient experienced INFLAMMATION (swollen/inflammation on hand started12 Feb 2021) and HEADACHE (headache started 12 Feb 2021). At the time of the report, INFLAMMATION (swollen/inflammation on hand started12 Feb 2021), PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021) and HEADACHE (headache started 12 Feb 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment medication were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Muscular weakness
Clinical narrative: Weakness on both legs (she was taking small steps when she walked; Almost losing her balance; Feels tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked), BALANCE DISORDER (Almost losing her balance) and FATIGUE (Feels tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked), BALANCE DISORDER (Almost losing her balance) and FATIGUE (Feels tired). On 27-Feb-2021, MUSCULAR WEAKNESS (Weakness on both legs (she was taking small steps when she walked) and BALANCE DISORDER (Almost losing her balance) had resolved. At the time of the report, FATIGUE (Feels tired) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: hot to touch; pain; A spontaneous report was received from a consumer concerning a 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, hot to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 1900, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) pain at the injection site (pain scale level 5 -1 being no pain and 10 with, worst pain), hot to touch.  No treatments was taken.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain, hot to touch was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numbness in upper lip; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness in upper lip) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness in upper lip). At the time of the report, HYPOAESTHESIA ORAL (Numbness in upper lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up information was received on 22 Apr 2021, correct adverse event numbness of upper lip updated;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oropharyngeal pain
Clinical narrative: front of the tongue is sore; scratchy throat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (front of the tongue is sore) and OROPHARYNGEAL PAIN (scratchy throat) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M204) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced GLOSSODYNIA (front of the tongue is sore) and OROPHARYNGEAL PAIN (scratchy throat). At the time of the report, GLOSSODYNIA (front of the tongue is sore) and OROPHARYNGEAL PAIN (scratchy throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Mechanical urticaria, Rash, Throat tightness
Clinical narrative: dermatographism; trouble swallowing; throat closing up; rash all over the body; ear hot and red; Hives; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body) and ERYTHEMA (ear hot and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body), ERYTHEMA (ear hot and red) and URTICARIA (Hives). At the time of the report, MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body), ERYTHEMA (ear hot and red) and URTICARIA (Hives) outcome was unknown.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: dermatographism; trouble swallowing; throat closing up; rash all over the body; ear hot and red; Hives; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body) and ERYTHEMA (ear hot and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body), ERYTHEMA (ear hot and red) and URTICARIA (Hives). At the time of the report, MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body), ERYTHEMA (ear hot and red) and URTICARIA (Hives) outcome was unknown.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site pain
Clinical narrative: Fatty tumor is right where the shot went. Fatty tumor covers the muscle.; Burned like heck when went in; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced it burned like heck when it went in the fatty tumor where the shot went in.  The patient's medical history included acid reflux, hypothyroidism, high blood pressure and type-2 diabetes.  The Patient's Concomitant medications included Omeprazole, Synthroid, Beazepril and Rybelsus.  The patient is allergic to Percocet and motrin.  On 26-FEB-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:022M20A)  in the left arm for prophylaxis of COVID-19 infection.  On 26-FEB-2021, The patient experienced the event fatty tumor is right where the shot went.  Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   On unknown date, the outcome of the events fatty tumor is right where the shot went(Inappropriate route of vaccination). is recovered/resolved.  The reporter assessed the event fatty tumor is right where the shot went(Inappropriate route of vaccination) related to the study drug is unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 022M20A) with reported event of vaccination site pain.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Headache, Influenza like illness, Myalgia
Clinical narrative: feeling very weak; lower back aches which then resulted in her aching everywhere at night; body aches from her head to her toes; feels like it's the flu or as if she was hit by a truck; sinuses are messed up; face feels a bit swollen; tighter lump at the injection site; headaches; injection site very sore; fever of 101; achy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes) and INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes), INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck), SINUS DISORDER (sinuses are messed up), SWELLING FACE (face feels a bit swollen), HEADACHE (headaches), VACCINATION SITE INDURATION (tighter lump at the injection site), VACCINATION SITE PAIN (injection site very sore) and PYREXIA (fever of 101). At the time of the report, ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes), INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck), SINUS DISORDER (sinuses are messed up), SWELLING FACE (face feels a bit swollen), HEADACHE (headaches), VACCINATION SITE INDURATION (tighter lump at the injection site), VACCINATION SITE PAIN (injection site very sore) and PYREXIA (fever of 101) outcome was unknown.            Concomitant product information was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sinus disorder, Swelling face, Vaccination site induration
Clinical narrative: feeling very weak; lower back aches which then resulted in her aching everywhere at night; body aches from her head to her toes; feels like it's the flu or as if she was hit by a truck; sinuses are messed up; face feels a bit swollen; tighter lump at the injection site; headaches; injection site very sore; fever of 101; achy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes) and INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes), INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck), SINUS DISORDER (sinuses are messed up), SWELLING FACE (face feels a bit swollen), HEADACHE (headaches), VACCINATION SITE INDURATION (tighter lump at the injection site), VACCINATION SITE PAIN (injection site very sore) and PYREXIA (fever of 101). At the time of the report, ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes), INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck), SINUS DISORDER (sinuses are messed up), SWELLING FACE (face feels a bit swollen), HEADACHE (headaches), VACCINATION SITE INDURATION (tighter lump at the injection site), VACCINATION SITE PAIN (injection site very sore) and PYREXIA (fever of 101) outcome was unknown.            Concomitant product information was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feeling very weak; lower back aches which then resulted in her aching everywhere at night; body aches from her head to her toes; feels like it's the flu or as if she was hit by a truck; sinuses are messed up; face feels a bit swollen; tighter lump at the injection site; headaches; injection site very sore; fever of 101; achy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes) and INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes), INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck), SINUS DISORDER (sinuses are messed up), SWELLING FACE (face feels a bit swollen), HEADACHE (headaches), VACCINATION SITE INDURATION (tighter lump at the injection site), VACCINATION SITE PAIN (injection site very sore) and PYREXIA (fever of 101). At the time of the report, ASTHENIA (feeling very weak), MYALGIA (achy), BACK PAIN (lower back aches which then resulted in her aching everywhere at night), PAIN (body aches from her head to her toes), INFLUENZA LIKE ILLNESS (feels like it's the flu or as if she was hit by a truck), SINUS DISORDER (sinuses are messed up), SWELLING FACE (face feels a bit swollen), HEADACHE (headaches), VACCINATION SITE INDURATION (tighter lump at the injection site), VACCINATION SITE PAIN (injection site very sore) and PYREXIA (fever of 101) outcome was unknown.            Concomitant product information was not provided by the reporter.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: 4 inch in diameter/circular red itchy patch at injection site; 4 inch in diameter/circular red itchy patch at injection site; redness at the injection site; sore arm - 18 Feb 2021 , duration "a few days"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"). On 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site). On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site). At the time of the report, PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated events outcome to recovered/resolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: temperature was near 100°F; sore arm; chills at night, was very cold, woke up freezing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), CHILLS (chills at night, was very cold, woke up freezing) and PYREXIA (temperature was near 100°F) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 041L20A) for COVID-19 vaccination.     Concomitant products included TICAGRELOR (BRILINTA), MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and ROSUVASTATIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and CHILLS (chills at night, was very cold, woke up freezing). On 26-Feb-2021, the patient experienced PYREXIA (temperature was near 100°F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (sore arm), CHILLS (chills at night, was very cold, woke up freezing) and PYREXIA (temperature was near 100°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    This case was linked to MOD-2021-028494 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Could not raise the arm; Is still experiencing pains in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 32L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not raise the arm) and VACCINATION SITE PAIN (Is still experiencing pains in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Events outcome updated.