chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. 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 ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature), HEADACHE (headache) and NAUSEA (feeling of wanting to vomit). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature), HEADACHE (headache) and NAUSEA (feeling of wanting to vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade temperature (abnormal) low grade temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  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.   Reporter did not allow further contact; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: vaccination site warmth; vaccination site pruritis; vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site pruritis) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site pruritis) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site pruritis) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; felt like she caught a really bad cold; was very congested; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt like she caught a really bad cold), NASAL CONGESTION (was very congested) and SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Cholesterol, Blood pressure and Asthma.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced NASOPHARYNGITIS (felt like she caught a really bad cold) and NASAL CONGESTION (was very congested). On 21-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (felt like she caught a really bad cold), NASAL CONGESTION (was very congested) and SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication includes unspecified treatment for Asthma, thyroid, cholesterol and blood pressure.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at the injection site; A spontaneous report was received from a nurse concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cellulitis at the injection (Vaccination site cellulitis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date, after vaccination the patient diagnosed with possible cellulitis at the injection site since it was swollen, red, and had a temperature of 99.8 F. Treatment details included Keflex for 10 days  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of event, cellulitis at the injection site was considered as unknown .; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Ear discomfort, Headache, Oropharyngeal discomfort
Clinical narrative: Scratchy throat; Trouble swallowing; Clogged ears; Chills; Headache; A spontaneous report was received from a Healthcare Professional concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events scratchy throat, trouble swallowing, clogged ears, chills and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient experienced the events scratchy throat, trouble swallowing, clogged ears, chills, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, scratchy throat, trouble swallowing and clogged ears, was considered resolved on 08 Jan 2021. The event, chill, was considered resolved on 09 Jan 2021. The event, headache, was considered resolved on 10 Jan 2021.; 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pruritus
Clinical narrative: Injection site is itchy; Has turned very red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Injection site is itchy) and ERYTHEMA (Has turned very red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), AMLODIPINE;OLMESARTAN, ATORVASTATIN, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) and BIOTIN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site is itchy) and ERYTHEMA (Has turned very red). At the time of the report, VACCINATION SITE PRURITUS (Injection site is itchy) and ERYTHEMA (Has turned very red) outcome was unknown.        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.   On 01-Feb-2021, the patient received her allergy shot and her allergist said she could take diphenhydramine.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: swelling; redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (redness) and PRURITUS (itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SWELLING (swelling), ERYTHEMA (redness) and PRURITUS (itching). At the time of the report, SWELLING (swelling), ERYTHEMA (redness) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Further information has been requested.   Reporter did not allow further contact; 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. Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache; Fever of 99; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever of 99) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever of 99). On 29-Jan-2021, HEADACHE (Headache) and PYREXIA (Fever of 99) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 99. On 29-Jan-2021, Body temperature: 97.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore) and PRURITUS (Arm is Itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2019) for COVID-19 vaccination.    No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and PRURITUS (Arm is Itchy). At the time of the report, PAIN IN EXTREMITY (Arm is sore) and PRURITUS (Arm is Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling cold
Clinical narrative: Felt like having a cold around 25 or 26 Jan; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt like having a cold around 25 or 26 Jan) and COVID-19 (Tested positive for Covid) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J2oA) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced FEELING COLD (Felt like having a cold around 25 or 26 Jan). At the time of the report, FEELING COLD (Felt like having a cold around 25 or 26 Jan) and COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, COVID-19: positive (Positive) tested positive for Covid on 28 Jan 2021.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment was given.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event- feeling cold , a causal relationship cannot be excluded. Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore to the touch on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore to the touch on the injection site) 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 31-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore to the touch on the injection site). At the time of the report, VACCINATION SITE PAIN (Sore to the touch on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: very itchy; Rash around injection site; It's not extreme red as like yesterday; A spontaneous report was received from a Consumer, concerning a 43-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash around injection site, very itchy, it's not extreme red as like yesterday.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced rash around injection site, very itchy, it's not extreme red as like yesterday.  Treatment details included Cortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of events, rash around injection site, very itchy and it's not extreme red as like yesterday was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ARTHRALGIA (joint pains) and MYALGIA (body ache all over) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 30-Jan-2021, the patient experienced ARTHRALGIA (joint pains) and MYALGIA (body ache all over). The patient was treated with MELOXICAM on 30-Jan-2021 for Joint pain and General body pain, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) 01-Feb-2021 for Diarrhoea, at an unspecified dose and frequency. On 01-Feb-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, ARTHRALGIA (joint pains) and MYALGIA (body ache all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Acne, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Pimple outside of lip) and VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ACNE (Pimple outside of lip) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, ACNE (Pimple outside of lip) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site joint warmth, Injection site pain, Injection site swelling, Nausea
Clinical narrative: nausea; warm to touch; soreness at the injection site; swelling at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE JOINT WARMTH (warm to touch), INJECTION SITE PAIN (soreness at the injection site), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and NAUSEA (nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE JOINT WARMTH (warm to touch), INJECTION SITE PAIN (soreness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). On 19-Jan-2021, the patient experienced NAUSEA (nausea). On 23-Jan-2021, NAUSEA (nausea) had resolved. At the time of the report, INJECTION SITE JOINT WARMTH (warm to touch), INJECTION SITE PAIN (soreness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Side effects after Moderna's second dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effects after Moderna's second dose) 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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side effects after Moderna's second dose). At the time of the report, ADVERSE REACTION (Side effects after Moderna's second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Right eye swollen underneath then on 28Jan2021 both eyes were affected; This spontaneous case was reported by a nurse and describes the occurrence of EYE SWELLING (Right eye swollen underneath then on 28Jan2021 both eyes were affected) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced EYE SWELLING (Right eye swollen underneath then on 28Jan2021 both eyes were affected). At the time of the report, EYE SWELLING (Right eye swollen underneath then on 28Jan2021 both eyes were affected) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was also taking antidepressants. The patient wanted to specify that she has dermatological fillers.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: reaction around the site where I had the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction around the site where I had the shot) 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 27-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 VACCINATION SITE REACTION (reaction around the site where I had the shot). At the time of the report, VACCINATION SITE REACTION (reaction around the site where I had the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking unspecified medications. Treatment information was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching at the injection site; Swelling at the injection site; Redness at the injection site; A spontaneous report  was received from a consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling, redness and itching at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, approximately ten days prior to the onset of the events swelling, redness and itching at the injection site, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 013620A) in the left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced swelling, redness and itching at the injection site. The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events swelling, redness and itching at the injection site was not reported.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extremely sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extremely sore arm) 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 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Extremely sore arm). At the time of the report, PAIN IN EXTREMITY (Extremely sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Tingling sensation for sometime; Numbness and soreness on her right arm; Numbness and soreness on her right arm, heavy; A spontaneous report was received from a non healthcare professional concerning a 40-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling sensation for a sometime, numbness and soreness on her right arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced tingling sensation for a sometime, numbness and soreness on her right arm. Still her arm is feeling numb and heavy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  On an unknown date the outcome of tingling sensation, soreness on her right arm were unknown and for numbness not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), MYALGIA (muscle ache) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L2OA) for COVID-19 vaccination.    No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (muscle ache) and HEADACHE (headache). On 23-Jan-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, FEELING ABNORMAL (brain fog), MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse event.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed adverse event.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, adverse event was unknown.; Reporter's Comments: This is a case of a consumer who experienced 'adverse event' event. No specific S/AE was reported. This case is being returned to provide a named event, otherwise this will be an invalid case.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after recieving vaccine; A spontaneous report (United States) was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  side effects .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection and experienced side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered as unknown. .; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Fever 102Fto 105F on same day; extremely fatigue; sore shoulder.; A spontaneous report was received from a consumer concerning a 56-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever 102F to 105F on same day, extremely fatigue, and sore shoulder.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events fever 102c to 105c and extremely fatigue, and sore shoulder  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events fever 102F to 105F, extremely fatigue, and sore shoulder 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. Further information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: large hardness at the injection site; Injection site warm to the touch; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (large hardness at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch) and VACCINATION SITE ERYTHEMA (Injection site red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE MASS (large hardness at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch) and VACCINATION SITE ERYTHEMA (Injection site red). The patient was treated with IBUPROFEN for Vaccination site lump, Vaccination site erythema and Vaccination site warmth, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MASS (large hardness at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch) and VACCINATION SITE ERYTHEMA (Injection site red) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient treated symptoms with ice.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Dyspnoea, Fatigue
Clinical narrative: A spontaneous report (United States) was received from a Consumer concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events could not sleep, difficulty breathing, pain at the injection site, arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea. The patient's medical history was not provided. Concomitant medications reported were vitamins for drug use for unknown indication. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) in left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events could not sleep. difficulty breathing. On 27 Jan 2021, the patient experienced the events pain at the injection site. arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea.  No treatment information was provided.  On 27-Jan-2021, the patient's body temperature was 102.2.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, could not sleep, difficulty breathing, pain at the injection site, arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: A spontaneous report (United States) was received from a Consumer concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events could not sleep, difficulty breathing, pain at the injection site, arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea. The patient's medical history was not provided. Concomitant medications reported were vitamins for drug use for unknown indication. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) in left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events could not sleep. difficulty breathing. On 27 Jan 2021, the patient experienced the events pain at the injection site. arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea.  No treatment information was provided.  On 27-Jan-2021, the patient's body temperature was 102.2.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, could not sleep, difficulty breathing, pain at the injection site, arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A spontaneous report (United States) was received from a Consumer concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events could not sleep, difficulty breathing, pain at the injection site, arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea. The patient's medical history was not provided. Concomitant medications reported were vitamins for drug use for unknown indication. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) in left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events could not sleep. difficulty breathing. On 27 Jan 2021, the patient experienced the events pain at the injection site. arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea.  No treatment information was provided.  On 27-Jan-2021, the patient's body temperature was 102.2.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, could not sleep, difficulty breathing, pain at the injection site, arm hurts when she moves it, fever of 102.2, headache, chills, bone pains, feels tired, nausea 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID diagnosis after vaccination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 COVID-19 (COVID diagnosis after vaccination). At the time of the report, COVID-19 (COVID diagnosis after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, Vaccination site pruritus
Clinical narrative: Achy arms; Aches all over; Her shoulders hurts; Injection site itches; Fatigue; A spontaneous report was received from a consumer concerning a 77 years old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events aches all over, her shoulders hurts, injection site itches, fatigue, achy arms.  The patient's medical history provided was cancer in her ovaries and stent in place. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.  on an unknown date, the patient developed aches all over, her shoulders hurts, injection site itches, fatigue, achy arms.  Treatment details included Acetaminophen  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, aches all over, her shoulders hurts, injection site itches, fatigue, achy arms was not reported.; 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: Asthenia, Fatigue, Pain in extremity, Rash, Rash pruritic
Clinical narrative: rash which is slowly getting bigger and really itches; rash which is slowly getting bigger and really itches; feeling tired; sore arm; weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), RASH PRURITIC (rash which is slowly getting bigger and really itches), PAIN IN EXTREMITY (sore arm), RASH (rash which is slowly getting bigger and really itches) and FATIGUE (feeling tired) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ASTHENIA (weak), PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired). On an unknown date, the patient experienced RASH PRURITIC (rash which is slowly getting bigger and really itches) and RASH (rash which is slowly getting bigger and really itches). On 24-Jan-2021, ASTHENIA (weak), PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired) had resolved. At the time of the report, RASH PRURITIC (rash which is slowly getting bigger and really itches) and RASH (rash which is slowly getting bigger and really itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: arm pain; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and VACCINATION SITE SWELLING (swelling at injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, PAIN IN EXTREMITY (arm pain) had resolved and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included ibuprofen.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Pain in extremity
Clinical narrative: diarrhea; achy; Tired; sore shot arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore shot arms), DIARRHOEA (diarrhea), MYALGIA (achy) and FATIGUE (Tired) 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 Diverticulitis (three one feet sections of his intestines removed and wore an ostomy bag for one and one-half years), Heart attack in 2015, Hartmann's pouch procedure in 2016 and Arterial stent insertion. Concurrent medical conditions included Type 2 diabetes mellitus.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore shot arms), MYALGIA (achy) and FATIGUE (Tired). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, PAIN IN EXTREMITY (sore shot arms), DIARRHOEA (diarrhea), MYALGIA (achy) and FATIGUE (Tired) outcome was unknown.            The patient had sensitive stomach and got diarrhea from eating too much beef, fish, dairy products. His diarrhea has been yellow and smelly and severe. Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-043706.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site infection
Clinical narrative: Rash all over body; Itchy; Injection site got infected; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site got infected, rash all over  body, itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, 1 week after vaccination, the patient experienced Injection site got infected and 2 1/2 weeks after vaccination, the patient experienced  rash all over my body and itchy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, injection site got infected, rash all over my body,  itchy was not reported.; 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. Further information has been requested.