chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Area has Very hard lump; Area is being black and blue; itches at the area of injection; Sorenessat the area, hurts; Area is being Red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches) in a 61-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 26-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 INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches). At the time of the report, INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: new events coded
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Myalgia, Pain in extremity, Swelling
Clinical narrative: swelling; Pain in the arm; axillary pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm). At the time of the report, SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: fever of 99.6°F; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.6°F) and VACCINATION SITE PAIN (pain in the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (10 days in the hospital) in April 2020. Previously administered products included for an unreported indication: SHINGRIX (Shingles shot) in January 2021. Concurrent medical conditions included Back pain (fall from horse). Concomitant products included OXYCODONE for Back pain.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (fever of 99.6°F) and VACCINATION SITE PAIN (pain in the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 99.6°F) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 108 DF (High) fever of 99.6 DF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) in a female 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 reported medical history).    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, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Lymph node pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of LYMPH NODE PAIN (Lymph node pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain). At the time of the report, LYMPH NODE PAIN (Lymph node pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  The physician told her that before receiving the second vaccine, she should take 1 tylenol, 1 pepcid, and 1 benadadryl day before the vaccination, the night of the vaccination, and the day after the vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sight tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sight tenderness at injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (sight tenderness at injection site). At the time of the report, VACCINATION SITE PAIN (sight tenderness at injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN for Chills and Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Chills and Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient woke up to chills and fever after 10 days. Concomitant medications were not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: fever of 102; Slight soreness at injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight soreness at injection site (right arm)) and PYREXIA (fever of 102) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-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 PAIN (Slight soreness at injection site (right arm)). On 02-Feb-2021, the patient experienced PYREXIA (fever of 102). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Slight soreness at injection site (right arm)) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 102 (High) Fever of 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.; 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: bump; itching; Red spot 2 inch diameter; Left arm sore with bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter) and VACCINATION SITE PAIN (Left arm sore with bump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Left arm sore with bump). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter). At the time of the report, VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter) and VACCINATION SITE PAIN (Left arm sore with bump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment reported was Tylenol #3.; 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Influenza like illness
Clinical narrative: Flu-like symptoms; Feeling tired; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), COVID-19 (Tested positive for COVID) and FATIGUE (Feeling tired) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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 COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and FATIGUE (Feeling tired). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; COLECALCIFEROL (VITAMIN D 3) at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and COVID-19 (Tested positive for COVID) had resolved and FATIGUE (Feeling tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, COVID-19: positive (Positive) tested positive for COVID.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.; Sender's Comments: This case concerns a 76-year-old, male patient, who experienced Covid-19, fatigue and influenza like illness. Even thought fatigue and influenza like illness can be experienced with Covid-19, the causal relationship with mRNA-1273 cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 , is assessed as unlikely related.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Top lip swelled up; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Top lip swelled up) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 31-Jan-2021, the patient experienced LIP SWELLING (Top lip swelled up). The patient was treated with IBUPROFEN for Lip swelling, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Top lip swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: rash; Enlargement of the lymph nodes on the same arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same 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 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 RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same arm). At the time of the report, RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Case crosslinked with MOD21-019884. Concomitant medications were not provided. Treatment information was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Vaccination site pain
Clinical narrative: Frequent urination; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination) and VACCINATION SITE PAIN (soreness at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 02-Feb-2021, the patient experienced POLLAKIURIA (Frequent urination). At the time of the report, POLLAKIURIA (Frequent urination) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Top lip swelled up; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Top lip swelled up) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 31-Jan-2021, the patient experienced LIP SWELLING (Top lip swelled up). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Top lip swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Covid
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SLIGHT HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (SLIGHT HEADACHE) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine headache. Concomitant products included RIZATRIPTAN for Migraine headache.    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 HEADACHE (SLIGHT HEADACHE). At the time of the report, HEADACHE (SLIGHT HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling under his left armpit; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (Swelling under his left armpit) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling under his left armpit). The patient was treated with IBUPROFEN on 14-Jan-2021 at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling under his left armpit) had not 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.   No relevant concomitant medications were reported. The swelling was half the size it was, but still swollen at the time of report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No new information reported
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: On 01-Feb-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 PAIN (few hours after the injection she had a sore arm). At the time of the report, VACCINATION SITE PAIN (few hours after the injection she had a sore arm) had not resolved. 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: Fatigue, Lethargy, Thinking abnormal
Clinical narrative: Feeling lethargic; His mind is not working very well; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Feeling lethargic), THINKING ABNORMAL (His mind is not working very well) and FATIGUE (Feeling very tired) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 02-Feb-2021, the patient experienced LETHARGY (Feeling lethargic), THINKING ABNORMAL (His mind is not working very well) and FATIGUE (Feeling very tired). At the time of the report, LETHARGY (Feeling lethargic), THINKING ABNORMAL (His mind is not working very well) and FATIGUE (Feeling very tired) 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site is warm to the touch; Injection site itching; injection site reddness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling) in a 52-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) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is experiencing redness swelling itching and injection site is warm to the touch 2 weeks after initial injection. Concomitant and treatment information not provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tenderness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness in the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.    On 28-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 PAIN (tenderness in the arm). At the time of the report, VACCINATION SITE PAIN (tenderness in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Hip pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Hip pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Hip pain). At the time of the report, ARTHRALGIA (Hip pain) 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.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Red arm; Fever; Swollen arm; Itching; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching), PYREXIA (Fever) and ERYTHEMA (Red 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching) and PYREXIA (Fever). On an unknown date, the patient experienced ERYTHEMA (Red arm). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) ongoing since an unknown date for Cellulitis, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching), PYREXIA (Fever) and ERYTHEMA (Red arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, COVID-19: negative (Negative) Covid-19 test was negative.. On 25-Jan-2021, Pyrexia: 100.5 (Inconclusive) 100.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were cortisone, antibiotics.  No concomitant medication was reported.   This case was linked to MOD-2021-021941 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Myalgia, Nasal congestion, SARS-CoV-2 test
Clinical narrative: congestion; achy feeling in body; Bad Headache; Got COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID after first dose), NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Got COVID after first dose). On an unknown date, the patient experienced NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache). At the time of the report, COVID-19 (Got COVID after first dose), NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (abnormal) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was diagnosed with Covid-19 a week after receiving first dose of the vaccine. Concomitant medications were not provided. Treatment information was not reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain, Vertigo, Vomiting
Clinical narrative: Vertigo; Arm pain; Vomiting; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), VACCINATION SITE PAIN (Arm pain), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FATIGUE (Fatigue). On 15-Jan-2021, the patient experienced VERTIGO (Vertigo), VACCINATION SITE PAIN (Arm pain), VOMITING (Vomiting) and NAUSEA (Nausea). The patient was treated with HYDROCHLOROTHIAZIDE (MICROZIDE [HYDROCHLOROTHIAZIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), VACCINATION SITE PAIN (Arm pain), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Consumer reported he visited an urgent care on unspecified date. He received unspecified medication to treat vertigo and nausea, and was instructed to hydrate.  Consumer visited his primary care physician on 19-Jan-2021 and was again treated with unspecified medication for vertigo.   Consumer reported the events fully recovered before receiving the second dose of the vaccine.   This case was linked to MOD-2021-237299.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021 included new information- patient's demographics, Events of first dose recovered prior to second dose. Additional treatment information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching; red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, EZETIMIBE, LISINOPRIL, RIVAROXABAN (XARELTO) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red). The patient was treated with CORTISONE for Vaccination site pruritus and Vaccination site erythema, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Vaccination site pruritus and Vaccination site erythema, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Heart rate, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swollen red spot 1 inch from vaccination site; Swollen red spot size of 50 cent piece; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical history reported.  Concomitant products included INSULIN for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece). At the time of the report, VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Heart rate: increased (High) Increased. On an unknown date, Blood glucose: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. Concomitant medications reported were Insulin, medication for blood pressure, eye drops for glaucoma, medication for diabetes.; Reporter'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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Hypoaesthesia oral, Myalgia
Clinical narrative: Chest tightness; small difficulty breathing; Nausea; Muscle aches; Brain fog; Tingling in lips, mouth, tongue; Mouth felt like numb; all her arm felt cold, like a funny sensation.; tingling's in mouth and tongue which also appeared and reappeared; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest tightness), FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling in lips, mouth, tongue), HYPOAESTHESIA ORAL (Mouth felt like numb) and PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling in lips, mouth, tongue), HYPOAESTHESIA ORAL (Mouth felt like numb), PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.), SYMPTOM RECURRENCE (tingling's in mouth and tongue which also appeared and reappeared) and MYALGIA (Muscle aches). On 23-Jan-2021, the patient experienced NAUSEA (Nausea). On 24-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (small difficulty breathing). On 22-Jan-2021, FEELING ABNORMAL (Brain fog) and PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.) had resolved. On 23-Jan-2021, NAUSEA (Nausea) had resolved. On 24-Jan-2021, CHEST DISCOMFORT (Chest tightness), SYMPTOM RECURRENCE (tingling's in mouth and tongue which also appeared and reappeared), DYSPNOEA (small difficulty breathing) and MYALGIA (Muscle aches) had resolved. At the time of the report, PARAESTHESIA (Tingling in lips, mouth, tongue) and HYPOAESTHESIA ORAL (Mouth felt like numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medication includes inhaler for shortness of breath
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Peripheral coldness, Symptom recurrence
Clinical narrative: Chest tightness; small difficulty breathing; Nausea; Muscle aches; Brain fog; Tingling in lips, mouth, tongue; Mouth felt like numb; all her arm felt cold, like a funny sensation.; tingling's in mouth and tongue which also appeared and reappeared; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest tightness), FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling in lips, mouth, tongue), HYPOAESTHESIA ORAL (Mouth felt like numb) and PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling in lips, mouth, tongue), HYPOAESTHESIA ORAL (Mouth felt like numb), PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.), SYMPTOM RECURRENCE (tingling's in mouth and tongue which also appeared and reappeared) and MYALGIA (Muscle aches). On 23-Jan-2021, the patient experienced NAUSEA (Nausea). On 24-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (small difficulty breathing). On 22-Jan-2021, FEELING ABNORMAL (Brain fog) and PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.) had resolved. On 23-Jan-2021, NAUSEA (Nausea) had resolved. On 24-Jan-2021, CHEST DISCOMFORT (Chest tightness), SYMPTOM RECURRENCE (tingling's in mouth and tongue which also appeared and reappeared), DYSPNOEA (small difficulty breathing) and MYALGIA (Muscle aches) had resolved. At the time of the report, PARAESTHESIA (Tingling in lips, mouth, tongue) and HYPOAESTHESIA ORAL (Mouth felt like numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medication includes inhaler for shortness of breath
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: aches; arm sore; fever; gums in mouth were swollen; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL SWELLING (gums in mouth were swollen), PAIN (aches), PAIN IN EXTREMITY (arm sore) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced GINGIVAL SWELLING (gums in mouth were swollen). On an unknown date, the patient experienced PAIN (aches), PAIN IN EXTREMITY (arm sore) and PYREXIA (fever). At the time of the report, GINGIVAL SWELLING (gums in mouth were swollen), PAIN (aches), PAIN IN EXTREMITY (arm sore) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm to touch; Angry red ring (3 by 2.5 inches); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)) 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.   Treatment details included ice and antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up information  received  on 01-JUL-2021 and it  contains no new information.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Vaccination site erythema is consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Mild dizziness; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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 29-Jan-2021, the patient experienced DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Dizziness, Nausea and Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, Nausea and Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness on his arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (little soreness on his arm). At the time of the report, PAIN IN EXTREMITY (little soreness on his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-215664 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; fever; Severe headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (fever) and HEADACHE (Severe headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions reported).    On 22-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 CHILLS (Chills), PYREXIA (fever) and HEADACHE (Severe headache). At the time of the report, CHILLS (Chills), PYREXIA (fever) and HEADACHE (Severe headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded