chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: Jaw was swollen on one side; Arm  itching; A spontaneous report was received from a consumer concerning a 82-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  swollen jaw on one side, and arm itching.   The patient's medical history and concomitant medications was not provided.   On 27-dec-2020 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly  for prophylaxis of COVID-19 infection.  On 10 Jan 2021, 2 weeks after of vaccination, the patient experienced arm itching, that resolved. On 18 Jan 2021, the patients jaw became swollen on one side. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, swollen jaw on one side and arm itching, was considered recovered/ resolved on 20 Jan 2021.; Reporter's Comments: This case concerns an 82-year-old female who experienced nonserious unexpected events of pruritus and face swelling.  Events onset occurred 15 days after the first dose of mRNA-1273. Treatment not reported. Event outcome reported as resolved. Based on 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Pain; Dizziness; Fever; Joint pains; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional information received: Non-significant follow up information.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Pain; Dizziness; Fever; Joint pains; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional information received: Non-significant follow up information.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; itchy at injection site; A spontaneous case report was received from a Consumer/Non-Health Professional on 20-JAN-2021, concerning an 80 year old, female patient who received Moderna COVID-19 Vaccine and experienced redness at injection site, swelling at injection site and itch at injection site.  On 11-JAN-2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 012220A), in the left arm for the prophylaxis COVID-19 infection.   On an unknown date, a week after vaccination, the patient experienced redness at injection site, swelling at injection site and itch at injection site.  The patients past medical history included: No adverse event.  The patient did not experience any serious criteria.  Patient gave consent for follow up.  No relevant laboratory tests and results were provided.   The action taken for Moderna COVID-19 Vaccine was Unknown. No information was provided on treatment given.  No concomitant medications were reported.  The outcome of the events, redness at injection site, swelling at injection site and itch at injection site was Unknown.  Additional information reported was: Patient received her vaccine in one state but spends winters in another state trying to get on a list in second state for 2nd dose due 08-FEB-2021.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: After 2 hours had severe pain on left side; Threw up no less than 6 separate times; A spontaneous report was received from a consumer concerning a 70 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain and vomiting.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 19-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) route of administration unknown and anatomical location unknown for prophylaxis of COVID-19 infection.  On 19-JAN-2021, the patient experienced pain on the left side and vomiting. No lab or treatment details provided. Patient is enquiring about taking the 2nd dose safe or not. Agent called back reporter on 27Jan2021 at 11:02am EST and was unable to reach. Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event (pain and vomiting) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Vaccination site erythema
Clinical narrative: A spontaneous report was received from a consumer concerning a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash spreading near injection site, dizziness, headache, body aches in upper arm and legs, feeling very tired, left arm hurting near injection site and left arm being red and itchy at the injection site.  The patient's medical history report were not included. No relevant Concomitant medications reported included.   On 12 Jan 2021 , approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot no# 012L20A) for prophylaxis of COVID-19 infection.     On 13 Jan 2021, she experienced rash spreading near the injection site and it got worse. She also felt dizzy, had headache, had body ache in upper arm and legs and was feeling very tired. On 19 jan 2021her left arm was hurting and was red and itchy. On 20 Jan 2021 it got worse.    Treatment for the events included Hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome for the events headache and dizziness were reported to be recovered/resolved around 15 Jan 2021. The outcome for the events rash spreading near injection site, body aches in upper arm and legs, feeling very tired, left arm hurting near injection site and left arm being red and itchy at the injection site were unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: A spontaneous report was received from a consumer concerning a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash spreading near injection site, dizziness, headache, body aches in upper arm and legs, feeling very tired, left arm hurting near injection site and left arm being red and itchy at the injection site.  The patient's medical history report were not included. No relevant Concomitant medications reported included.   On 12 Jan 2021 , approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot no# 012L20A) for prophylaxis of COVID-19 infection.     On 13 Jan 2021, she experienced rash spreading near the injection site and it got worse. She also felt dizzy, had headache, had body ache in upper arm and legs and was feeling very tired. On 19 jan 2021her left arm was hurting and was red and itchy. On 20 Jan 2021 it got worse.    Treatment for the events included Hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome for the events headache and dizziness were reported to be recovered/resolved around 15 Jan 2021. The outcome for the events rash spreading near injection site, body aches in upper arm and legs, feeling very tired, left arm hurting near injection site and left arm being red and itchy at the injection site were unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: pain in arm; Stiff Neck; Pain down arm to wrist; stiff neck; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff Neck), PAIN IN EXTREMITY (Pain down arm to wrist), MUSCULOSKELETAL STIFFNESS (stiff neck) and PAIN IN EXTREMITY (pain in arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 02bL20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff Neck), PAIN IN EXTREMITY (Pain down arm to wrist) and MUSCULOSKELETAL STIFFNESS (stiff neck). On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 20-Jan-2021, MUSCULOSKELETAL STIFFNESS (Stiff Neck), PAIN IN EXTREMITY (Pain down arm to wrist) and MUSCULOSKELETAL STIFFNESS (stiff neck) had resolved. On 18-Feb-2021, PAIN IN EXTREMITY (pain in arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCULOSKELETAL STIFFNESS (Stiff Neck) and PAIN IN EXTREMITY (Pain down arm to wrist) to be possibly related. No further causality assessments were provided for MUSCULOSKELETAL STIFFNESS (stiff neck) and PAIN IN EXTREMITY (pain in arm).    No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to MOD-2021-090696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate increased
Clinical narrative: weak; dizzy; had a fast heart beat over 125 BPM; A spontaneous report was received from a Consumer concerning a 75 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy, weakness and increased heartbeat.  The patient's medical history included High blood pressure and High Cholesterol. Concomitant medications included are Tenormin and Laptor.  On Monday 18Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-  (lot/batch: 041620A) on her right Arm.  On 19Jan2021, The patient experienced dizzy, weakness and increased heartbeat.  The patient did not took any medicinal product to treat the symptoms. Action taken with mRNA-1273 in response to the events was not reported.   On 19Jan2021, the outcome of the event- increased heartbeat was resolved. On unknown date dizzy- unknown, weakness-unknown. The reporter assessed the event(s), [dizzy, weakness and increased heartbeat], as related/not related to study drug. {Duplicate causality assessment for each combination of drug and event having different reported causality}. There is no product complaint associated with this case
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Coronavirus infection, Dyspnoea, Fatigue, Pain
Clinical narrative: hard to breathe; feels like he had COVID-19 all over again; body aches; fever; chills; feels tired and does not want to get up; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 28-Jan-2021, the patient experienced DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels tired and does not want to get up). At the time of the report, DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels tired and does not want to get up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication. No treatment information was provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: hard to breathe; feels like he had COVID-19 all over again; body aches; fever; chills; feels tired and does not want to get up; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 28-Jan-2021, the patient experienced DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels tired and does not want to get up). At the time of the report, DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels tired and does not want to get up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site induration, Vaccination site pruritus
Clinical narrative: site got itchy; pink; site got kind of hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site got itchy), RASH (pink) and VACCINATION SITE INDURATION (site got kind of hard) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (site got itchy), RASH (pink) and VACCINATION SITE INDURATION (site got kind of hard).        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 event, a causal relationship cannot be excluded.; 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: Adverse drug reaction
Clinical narrative: adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (adverse reactions) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced ADVERSE DRUG REACTION (adverse reactions). At the time of the report, ADVERSE DRUG REACTION (adverse reactions) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: INFLAMMATION WAS SPREADING; Arm was heavy; Arm was hard; Arm was red; injection site has gotten itchy; injection site has gotten swollen; it is warm to the touch; Bruising; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site has gotten itchy), INJECTION SITE SWELLING (injection site has gotten swollen), INJECTION SITE WARMTH (it is warm to the touch), CONTUSION (Bruising) and LIMB DISCOMFORT (Arm was heavy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).    On 14-Jan-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced CONTUSION (Bruising). On 19-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection site has gotten itchy), INJECTION SITE SWELLING (injection site has gotten swollen), INJECTION SITE WARMTH (it is warm to the touch), LIMB DISCOMFORT (Arm was heavy), PERIPHERAL SWELLING (Arm was hard) and ERYTHEMA (Arm was red). On 20-Jan-2021, the patient experienced INFLAMMATION (INFLAMMATION WAS SPREADING). On 17-Jan-2021, CONTUSION (Bruising) outcome was unknown. At the time of the report, INJECTION SITE PRURITUS (injection site has gotten itchy), INJECTION SITE SWELLING (injection site has gotten swollen), INJECTION SITE WARMTH (it is warm to the touch), LIMB DISCOMFORT (Arm was heavy), PERIPHERAL SWELLING (Arm was hard), ERYTHEMA (Arm was red) and INFLAMMATION (INFLAMMATION WAS SPREADING) 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded. On 21-Jan-2021: No specific follow-up information recorded. On 27-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Limb discomfort, Peripheral swelling
Clinical narrative: INFLAMMATION WAS SPREADING; Arm was heavy; Arm was hard; Arm was red; injection site has gotten itchy; injection site has gotten swollen; it is warm to the touch; Bruising; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site has gotten itchy), INJECTION SITE SWELLING (injection site has gotten swollen), INJECTION SITE WARMTH (it is warm to the touch), CONTUSION (Bruising) and LIMB DISCOMFORT (Arm was heavy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).    On 14-Jan-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced CONTUSION (Bruising). On 19-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection site has gotten itchy), INJECTION SITE SWELLING (injection site has gotten swollen), INJECTION SITE WARMTH (it is warm to the touch), LIMB DISCOMFORT (Arm was heavy), PERIPHERAL SWELLING (Arm was hard) and ERYTHEMA (Arm was red). On 20-Jan-2021, the patient experienced INFLAMMATION (INFLAMMATION WAS SPREADING). On 17-Jan-2021, CONTUSION (Bruising) outcome was unknown. At the time of the report, INJECTION SITE PRURITUS (injection site has gotten itchy), INJECTION SITE SWELLING (injection site has gotten swollen), INJECTION SITE WARMTH (it is warm to the touch), LIMB DISCOMFORT (Arm was heavy), PERIPHERAL SWELLING (Arm was hard), ERYTHEMA (Arm was red) and INFLAMMATION (INFLAMMATION WAS SPREADING) 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded. On 21-Jan-2021: No specific follow-up information recorded. On 27-Jan-2021: No specific follow-up information recorded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dyspnoea, Fatigue
Clinical narrative: Difficulty breathing; Warm to touch in area of injection; Fatigue moderate to severe; Chills/Occasional chills; Hardness; Redness; Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Difficulty breathing), VACCINATION SITE WARMTH (Warm to touch in area of injection), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia since 01-Jan-1995. Concomitant products included LOSARTAN from 01-Jan-2014 to an unknown date and ROSUVASTATIN CALCIUM (CRESTOR) from 01-Jan-2021 to an unknown date for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch in area of injection), FATIGUE (Fatigue moderate to severe) and CHILLS (Chills/Occasional chills). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). On 02-Feb-2021, VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown and VACCINATION SITE WARMTH (Warm to touch in area of injection), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swelling), FATIGUE (Fatigue moderate to severe) and CHILLS (Chills/Occasional chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 165/135 mmHg 165/135. On an unknown date, Body temperature: 102 102. On an unknown date, SARS-CoV-2 test: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-079715 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: follow up received on 18-apr-2021,height and weight ,race updated, medical history updated, lab data updated,2nd dose of vaccination include batch no,  s tart date updated, concomitant medication  updated, events include chills,fatigue ,difficulty breathing updated
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Difficulty breathing; Warm to touch in area of injection; Fatigue moderate to severe; Chills/Occasional chills; Hardness; Redness; Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Difficulty breathing), VACCINATION SITE WARMTH (Warm to touch in area of injection), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia since 01-Jan-1995. Concomitant products included LOSARTAN from 01-Jan-2014 to an unknown date and ROSUVASTATIN CALCIUM (CRESTOR) from 01-Jan-2021 to an unknown date for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch in area of injection), FATIGUE (Fatigue moderate to severe) and CHILLS (Chills/Occasional chills). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). On 02-Feb-2021, VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown and VACCINATION SITE WARMTH (Warm to touch in area of injection), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swelling), FATIGUE (Fatigue moderate to severe) and CHILLS (Chills/Occasional chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 165/135 mmHg 165/135. On an unknown date, Body temperature: 102 102. On an unknown date, SARS-CoV-2 test: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-079715 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: follow up received on 18-apr-2021,height and weight ,race updated, medical history updated, lab data updated,2nd dose of vaccination include batch no,  s tart date updated, concomitant medication  updated, events include chills,fatigue ,difficulty breathing updated
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Sleeping a lot; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping a lot) and PAIN IN EXTREMITY (Sore Arm) in an 83-year-old male 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, LOSARTAN, GABAPENTIN, METFORMIN, ZOLPIDEM and APIXABAN (ELIQUIS) for an unknown indication.    On 26-Jan-2021 at 4:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SOMNOLENCE (Sleeping a lot) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, SOMNOLENCE (Sleeping a lot) and PAIN IN EXTREMITY (Sore Arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash all over his body) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02GL20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced RASH PRURITIC (rash all over his body). At the time of the report, RASH PRURITIC (rash all over his body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 48-year-old male patient 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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 26-Jan-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. Not Provided          No concomitant medication use was provided by the reporter. Treatment of events was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: AE contact Information Updated
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Sore arm; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE RASH (rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported.).    On 13-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 PAIN (Sore arm) and VACCINATION SITE RASH (rash). At the time of the report, VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI - TCR
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain in extremity
Clinical narrative: sore arm; diarrhea; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 66-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 (no relevant medical history provided).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). At the time of the report, CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Pain, Pain of skin
Clinical narrative: Diarrhea; Body aches; Fatigue; Slight fever 100.6; Red spot was about 4 inches at it largest; Red spot was warm; Red spot was painful; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm), PAIN OF SKIN (Red spot was painful), DIARRHOEA (Diarrhea) and PAIN (Body aches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 30-Dec-2020 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm) and PAIN OF SKIN (Red spot was painful). On 31-Dec-2020, the patient experienced PYREXIA (Slight fever 100.6). On 01-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Body aches) and FATIGUE (Fatigue). On 01-Jan-2021, DIARRHOEA (Diarrhea) and PYREXIA (Slight fever 100.6) had resolved. On 02-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm), PAIN OF SKIN (Red spot was painful) and PAIN (Body aches) 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.   Additional concomitant product used was birth control. Treatment information was not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: Diarrhea; Body aches; Fatigue; Slight fever 100.6; Red spot was about 4 inches at it largest; Red spot was warm; Red spot was painful; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm), PAIN OF SKIN (Red spot was painful), DIARRHOEA (Diarrhea) and PAIN (Body aches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 30-Dec-2020 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm) and PAIN OF SKIN (Red spot was painful). On 31-Dec-2020, the patient experienced PYREXIA (Slight fever 100.6). On 01-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Body aches) and FATIGUE (Fatigue). On 01-Jan-2021, DIARRHOEA (Diarrhea) and PYREXIA (Slight fever 100.6) had resolved. On 02-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm), PAIN OF SKIN (Red spot was painful) and PAIN (Body aches) 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.   Additional concomitant product used was birth control. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Sore throat; Extreme tiredness; Bone and body aches; Headache; Back pain; Cough; Tested Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches) and HEADACHE (Headache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches), HEADACHE (Headache), BACK PAIN (Back pain) and COUGH (Cough). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches), HEADACHE (Headache), BACK PAIN (Back pain) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test positive
Clinical narrative: Sore throat; Extreme tiredness; Bone and body aches; Headache; Back pain; Cough; Tested Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches) and HEADACHE (Headache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches), HEADACHE (Headache), BACK PAIN (Back pain) and COUGH (Cough). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Extreme tiredness), PAIN (Bone and body aches), HEADACHE (Headache), BACK PAIN (Back pain) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain and soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain and soreness at injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient denies allergies and PMH.   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 PAIN (Pain and soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Pain and soreness at injection site) had not resolved.      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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itching at injection site; redness at injection site; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site). At the time of the report, INJECTION SITE PRURITUS (itching at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE SWELLING (swelling at injection site) 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 concomitants or treatment medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation
Clinical narrative: Inflamed Left Forearm, Left Hand, and Left foot; Redness of left forearm, left hand, and left foot; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflamed Left Forearm, Left Hand, and Left foot) and ERYTHEMA (Redness of left forearm, left hand, and left foot) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INFLAMMATION (Inflamed Left Forearm, Left Hand, and Left foot) and ERYTHEMA (Redness of left forearm, left hand, and left foot). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Inflamed Left Forearm, Left Hand, and Left foot) and ERYTHEMA (Redness of left forearm, left hand, and left foot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up contains no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.