chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia, Tinnitus
Clinical narrative: Cough; Hyperosmia (cannot bare the smell of cooking); Tinnitus (wind whisper in his ear); Not sure if he has developed asthma because sometimes he feels like he is choking; Worried these symptoms are changing his life; fever of 103; Body aches; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Cough), PAROSMIA (Hyperosmia (cannot bare the smell of cooking)), TINNITUS (Tinnitus (wind whisper in his ear)), CHOKING SENSATION (Not sure if he has developed asthma because sometimes he feels like he is choking) and ANXIETY (Worried these symptoms are changing his life) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 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 an unknown date, the patient experienced COUGH (Cough), PAROSMIA (Hyperosmia (cannot bare the smell of cooking)), TINNITUS (Tinnitus (wind whisper in his ear)), CHOKING SENSATION (Not sure if he has developed asthma because sometimes he feels like he is choking), ANXIETY (Worried these symptoms are changing his life), PYREXIA (fever of 103) and MYALGIA (Body aches). At the time of the report, COUGH (Cough), PAROSMIA (Hyperosmia (cannot bare the smell of cooking)), TINNITUS (Tinnitus (wind whisper in his ear)), CHOKING SENSATION (Not sure if he has developed asthma because sometimes he feels like he is choking), ANXIETY (Worried these symptoms are changing his life), PYREXIA (fever of 103) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 103 (High) Fever of 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to he events were not applicable.   This case was linked to MOD-2021-023851 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gingival swelling, Pruritus, Rash erythematous, Rhinalgia
Clinical narrative: nose pain; gum area swollen on right side; larger 2.5 inch x 4 inch, itching, red; larger 2.5 inch x 4 inch, itching; large area red ,2 to 3 inches; large area red, hot, 2 to 3 inches; Red rash; Itching at injection site; red rash / like mosquito bite / protruded / 3 or 4 round; swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GINGIVAL SWELLING (gum area swollen on right side), VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches), RHINALGIA (nose pain), ERYTHEMA (larger 2.5 inch x 4 inch, itching, red) and PRURITUS (larger 2.5 inch x 4 inch, itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (Pharmacist had given a shot for shingles in the past).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (red rash / like mosquito bite / protruded / 3 or 4 round) and VACCINATION SITE SWELLING (swollen). On 24-Apr-2021, the patient experienced VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches) and ERYTHEMA (large area red ,2 to 3 inches). On 25-Apr-2021, the patient experienced ERYTHEMA (larger 2.5 inch x 4 inch, itching, red) and PRURITUS (larger 2.5 inch x 4 inch, itching). On 26-Apr-2021, the patient experienced GINGIVAL SWELLING (gum area swollen on right side) and RHINALGIA (nose pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, GINGIVAL SWELLING (gum area swollen on right side), VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches), RHINALGIA (nose pain), ERYTHEMA (larger 2.5 inch x 4 inch, itching, red), PRURITUS (larger 2.5 inch x 4 inch, itching), ERYTHEMA (large area red ,2 to 3 inches), RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (red rash / like mosquito bite / protruded / 3 or 4 round) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The treatment involved anti-itch cream for itching.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received on 09-Aug-2021 and contains no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: nose pain; gum area swollen on right side; larger 2.5 inch x 4 inch, itching, red; larger 2.5 inch x 4 inch, itching; large area red ,2 to 3 inches; large area red, hot, 2 to 3 inches; Red rash; Itching at injection site; red rash / like mosquito bite / protruded / 3 or 4 round; swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GINGIVAL SWELLING (gum area swollen on right side), VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches), RHINALGIA (nose pain), ERYTHEMA (larger 2.5 inch x 4 inch, itching, red) and PRURITUS (larger 2.5 inch x 4 inch, itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (Pharmacist had given a shot for shingles in the past).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (red rash / like mosquito bite / protruded / 3 or 4 round) and VACCINATION SITE SWELLING (swollen). On 24-Apr-2021, the patient experienced VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches) and ERYTHEMA (large area red ,2 to 3 inches). On 25-Apr-2021, the patient experienced ERYTHEMA (larger 2.5 inch x 4 inch, itching, red) and PRURITUS (larger 2.5 inch x 4 inch, itching). On 26-Apr-2021, the patient experienced GINGIVAL SWELLING (gum area swollen on right side) and RHINALGIA (nose pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, GINGIVAL SWELLING (gum area swollen on right side), VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches), RHINALGIA (nose pain), ERYTHEMA (larger 2.5 inch x 4 inch, itching, red), PRURITUS (larger 2.5 inch x 4 inch, itching), ERYTHEMA (large area red ,2 to 3 inches), RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (red rash / like mosquito bite / protruded / 3 or 4 round) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The treatment involved anti-itch cream for itching.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received on 09-Aug-2021 and contains no new information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Vomiting
Clinical narrative: feeling cold; vomiting; she was tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), FATIGUE (she was tired) and VOMITING (vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke. Previously administered products included for an unreported indication: BABY ASPIRIN.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced FATIGUE (she was tired). On 27-Apr-2021, the patient experienced FEELING COLD (feeling cold) and VOMITING (vomiting). On 26-Apr-2021, FATIGUE (she was tired) had resolved. On 27-Apr-2021, VOMITING (vomiting) had resolved. At the time of the report, FEELING COLD (feeling cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Medical history included stroke. Treatment information provided was Baby Aspirin
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling, Oropharyngeal pain, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Tingling lips; tingling throat; pain in lips; pain in throat; bottom lip is swollen; looks like she got Botox in her lower lip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling lips), PHARYNGEAL PARAESTHESIA (tingling throat), LIP PAIN (pain in lips), OROPHARYNGEAL PAIN (pain in throat) and LIP SWELLING (bottom lip is swollen) in a 55-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.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PARAESTHESIA ORAL (Tingling lips), PHARYNGEAL PARAESTHESIA (tingling throat), LIP PAIN (pain in lips), OROPHARYNGEAL PAIN (pain in throat), LIP SWELLING (bottom lip is swollen) and LIP SWELLING (looks like she got Botox in her lower lip). At the time of the report, PARAESTHESIA ORAL (Tingling lips), PHARYNGEAL PARAESTHESIA (tingling throat), LIP PAIN (pain in lips), OROPHARYNGEAL PAIN (pain in throat), LIP SWELLING (bottom lip is swollen) and LIP SWELLING (looks like she got Botox in her lower lip) outcome was unknown. Not Provided          Treatment He stated she took a vitamin supplement last night for the painful, swollen lip. No concomitant medications were reported.   This case was linked to MOD21-082154, US-MODERNATX, INC.-MOD-2021-090569, US-MODERNATX, INC.-MOD-2021-090584 (E2B Linked Report). This case was linked to MOD-2021-090547 (Patient Link).; Sender's Comments:  MOD21-082154: US-MODERNATX, INC.-MOD-2021-090569:Wife dose 2 case US-MODERNATX, INC.-MOD-2021-090584:wife dose 2 case
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Ear swelling, Fatigue, Headache, Pharyngeal swelling
Clinical narrative: Swelling the size of a softball under the left armpit; Swelling behind left ear; Swelling of left jaw; Trouble swallowing food; Feeling like throat was swelling; Sensation of throat closing; Really bad headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling the size of a softball under the left armpit), EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food) and PHARYNGEAL SWELLING (Feeling like throat was swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetes since 01-Jan-2011 and Blood pressure abnormal since 05-Jan-2018. Concomitant products included LOSARTAN from 05-Jan-2018 to an unknown date for Blood pressure abnormal, METFORMIN HYDROCHLORIDE (GLUCOPHAGE) from 01-Jan-2003 to an unknown date for Blood sugar abnormal.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling the size of a softball under the left armpit), EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food), PHARYNGEAL SWELLING (Feeling like throat was swelling), THROAT TIGHTNESS (Sensation of throat closing), HEADACHE (Really bad headache) and FATIGUE (Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling the size of a softball under the left armpit) was resolving, EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food), PHARYNGEAL SWELLING (Feeling like throat was swelling), HEADACHE (Really bad headache) and FATIGUE (Fatigue) had resolved and THROAT TIGHTNESS (Sensation of throat closing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Lot number of dose 1 and dose 2 were added. On 19-Jul-2021: Adverse event throat constriction, current conditions, concomitant medications all were added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Throat tightness
Clinical narrative: Swelling the size of a softball under the left armpit; Swelling behind left ear; Swelling of left jaw; Trouble swallowing food; Feeling like throat was swelling; Sensation of throat closing; Really bad headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling the size of a softball under the left armpit), EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food) and PHARYNGEAL SWELLING (Feeling like throat was swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetes since 01-Jan-2011 and Blood pressure abnormal since 05-Jan-2018. Concomitant products included LOSARTAN from 05-Jan-2018 to an unknown date for Blood pressure abnormal, METFORMIN HYDROCHLORIDE (GLUCOPHAGE) from 01-Jan-2003 to an unknown date for Blood sugar abnormal.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling the size of a softball under the left armpit), EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food), PHARYNGEAL SWELLING (Feeling like throat was swelling), THROAT TIGHTNESS (Sensation of throat closing), HEADACHE (Really bad headache) and FATIGUE (Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling the size of a softball under the left armpit) was resolving, EAR SWELLING (Swelling behind left ear), SWELLING FACE (Swelling of left jaw), DYSPHAGIA (Trouble swallowing food), PHARYNGEAL SWELLING (Feeling like throat was swelling), HEADACHE (Really bad headache) and FATIGUE (Fatigue) had resolved and THROAT TIGHTNESS (Sensation of throat closing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Lot number of dose 1 and dose 2 were added. On 19-Jul-2021: Adverse event throat constriction, current conditions, concomitant medications all were added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anger, Anxiety, Asthenia, Back pain
Clinical narrative: flu like symptoms; cold; pain in arm; stomach upset; depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19; depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19; has no strength; sleeping a lot; lower back is in pain; crying a lot; feel like I can not function, haven't showered since 19Apr2021; "I am very short, yelling and screaming, wasn't like this before"; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset) and DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth infection (Mouth infection from 09 Mar 2021 to 14 Apr 2021-four cycles of antibiotics and pain killers) on 09-Mar-2021. Concurrent medical conditions included Depression and Anxiety.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset), DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ANXIETY (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ASTHENIA (has no strength), SOMNOLENCE (sleeping a lot), BACK PAIN (lower back is in pain), CRYING (crying a lot), FEELING ABNORMAL (feel like I can not function, haven't showered since 19Apr2021), ANGER ("I am very short, yelling and screaming, wasn't like this before"), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Apr-2021, FEELING ABNORMAL (feel like I can not function, haven't showered since 19Apr2021) had resolved. On 22-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset), NAUSEA (nausea) and PYREXIA (fever) had resolved. At the time of the report, DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ANXIETY (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ASTHENIA (has no strength), SOMNOLENCE (sleeping a lot), BACK PAIN (lower back is in pain), CRYING (crying a lot) and ANGER ("I am very short, yelling and screaming, wasn't like this before") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Depression, Feeling abnormal, Influenza like illness, Nasopharyngitis
Clinical narrative: flu like symptoms; cold; pain in arm; stomach upset; depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19; depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19; has no strength; sleeping a lot; lower back is in pain; crying a lot; feel like I can not function, haven't showered since 19Apr2021; "I am very short, yelling and screaming, wasn't like this before"; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset) and DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth infection (Mouth infection from 09 Mar 2021 to 14 Apr 2021-four cycles of antibiotics and pain killers) on 09-Mar-2021. Concurrent medical conditions included Depression and Anxiety.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset), DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ANXIETY (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ASTHENIA (has no strength), SOMNOLENCE (sleeping a lot), BACK PAIN (lower back is in pain), CRYING (crying a lot), FEELING ABNORMAL (feel like I can not function, haven't showered since 19Apr2021), ANGER ("I am very short, yelling and screaming, wasn't like this before"), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Apr-2021, FEELING ABNORMAL (feel like I can not function, haven't showered since 19Apr2021) had resolved. On 22-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset), NAUSEA (nausea) and PYREXIA (fever) had resolved. At the time of the report, DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ANXIETY (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ASTHENIA (has no strength), SOMNOLENCE (sleeping a lot), BACK PAIN (lower back is in pain), CRYING (crying a lot) and ANGER ("I am very short, yelling and screaming, wasn't like this before") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: flu like symptoms; cold; pain in arm; stomach upset; depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19; depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19; has no strength; sleeping a lot; lower back is in pain; crying a lot; feel like I can not function, haven't showered since 19Apr2021; "I am very short, yelling and screaming, wasn't like this before"; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset) and DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth infection (Mouth infection from 09 Mar 2021 to 14 Apr 2021-four cycles of antibiotics and pain killers) on 09-Mar-2021. Concurrent medical conditions included Depression and Anxiety.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset), DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ANXIETY (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ASTHENIA (has no strength), SOMNOLENCE (sleeping a lot), BACK PAIN (lower back is in pain), CRYING (crying a lot), FEELING ABNORMAL (feel like I can not function, haven't showered since 19Apr2021), ANGER ("I am very short, yelling and screaming, wasn't like this before"), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Apr-2021, FEELING ABNORMAL (feel like I can not function, haven't showered since 19Apr2021) had resolved. On 22-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in arm), ABDOMINAL DISCOMFORT (stomach upset), NAUSEA (nausea) and PYREXIA (fever) had resolved. At the time of the report, DEPRESSION (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ANXIETY (depression and anxiety symptoms have worsened since receiving 1st dose of Moderna COVID 19), ASTHENIA (has no strength), SOMNOLENCE (sleeping a lot), BACK PAIN (lower back is in pain), CRYING (crying a lot) and ANGER ("I am very short, yelling and screaming, wasn't like this before") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching a lot at injection site; arm is sore; arm is swollen; red/big round circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching a lot at injection site), VACCINATION SITE PAIN (arm is sore), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE ERYTHEMA (red/big round circle) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ZINC and DAPAGLIFLOZIN for an unknown indication.    On 04-Apr-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 PRURITUS (itching a lot at injection site), VACCINATION SITE PAIN (arm is sore), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE ERYTHEMA (red/big round circle). At the time of the report, VACCINATION SITE PRURITUS (itching a lot at injection site) and VACCINATION SITE PAIN (arm is sore) outcome was unknown, VACCINATION SITE SWELLING (arm is swollen) had not resolved and VACCINATION SITE ERYTHEMA (red/big round circle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include, blood pressure medications, and pill for swelling in the legs. Treatment information included application of alcohol to affected area.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired) outcome was unknown.            No Concomitant medications were provided No Treatment information provided   This case was linked to MOD-2021-009215 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Nine patients were administered the vaccine that was not prepared properly/took the vaccine vials out of the freezer and thawed it in their hands for 15 minutes to turn it into the liquid state quicker; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Nine patients were administered the vaccine that was not prepared properly/took the vaccine vials out of the freezer and thawed it in their hands for 15 minutes to turn it into the liquid state quicker) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Nine patients were administered the vaccine that was not prepared properly/took the vaccine vials out of the freezer and thawed it in their hands for 15 minutes to turn it into the liquid state quicker). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Nine patients were administered the vaccine that was not prepared properly/took the vaccine vials out of the freezer and thawed it in their hands for 15 minutes to turn it into the liquid state quicker) 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.   Concomitant product use was not provided. Treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling as if she "hit a massive wall" with extreme fatigue/can't sit up after 12 or 1 pm as she feels really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling as if she "hit a massive wall" with extreme fatigue/can't sit up after 12 or 1 pm as she feels really tired) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced FATIGUE (feeling as if she "hit a massive wall" with extreme fatigue/can't sit up after 12 or 1 pm as she feels really tired). At the time of the report, FATIGUE (feeling as if she "hit a massive wall" with extreme fatigue/can't sit up after 12 or 1 pm as she feels really tired) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment details were provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus
Clinical narrative: Immediate reaction of flushing; Itchiness on right shoulders; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Immediate reaction of flushing) and PRURITUS (Itchiness on right shoulders) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced FLUSHING (Immediate reaction of flushing) and PRURITUS (Itchiness on right shoulders). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FLUSHING (Immediate reaction of flushing) and PRURITUS (Itchiness on right shoulders) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-016712 (E2B Linked Report).; Sender's Comments:  MOD-2021-016712:First dose case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I got a case of shingles: blistering below my waist, on my abdomen, and top of my buttock area.; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (I got a case of shingles: blistering below my waist, on my abdomen, and top of my buttock area.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HERPES ZOSTER (I got a case of shingles: blistering below my waist, on my abdomen, and top of my buttock area.). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at an unspecified dose and frequency and PREGABALIN (LYRICA) for Pain, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (I got a case of shingles: blistering below my waist, on my abdomen, and top of my buttock area.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea after she eats food; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea after she eats food) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included NIFEDIPINE (PROCARDIA [NIFEDIPINE]) and ANASTROZOLE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (diarrhea after she eats food). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea after she eats food) outcome was unknown. Not Provided          Patient experienced diarrhea after she eats food, she did not have a particular date but stated after she received the 1st dose and has continued even after she received her 2nd dose for which she has taken Imodium. Action taken with RNA-1273 in response to the events were not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Headache, Illness
Clinical narrative: very sick; experiencing all the symptoms of COVID; every bone in her body is aching; headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021. The most recent information was received on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), COVID-19 (experiencing all the symptoms of COVID), BONE PAIN (every bone in her body is aching) and HEADACHE (headache) in a 73-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (very sick), COVID-19 (experiencing all the symptoms of COVID), BONE PAIN (every bone in her body is aching) and HEADACHE (headache). At the time of the report, ILLNESS (very sick), COVID-19 (experiencing all the symptoms of COVID), BONE PAIN (every bone in her body is aching) and HEADACHE (headache) had resolved.            The patient took second dose 25 days after first dose. The patient recovered but still feels tired. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was Not Applicable. Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: TCR : AE outcome
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: it has been 42 days since her first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been 42 days since her first dose of the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus, Scleroderma and Autoimmune disorder.    On 08-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been 42 days since her first dose of the vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been 42 days since her first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she is on a lot of medication. Concomitant product use was not provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a few days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a few days). On 21-Mar-2021, PAIN IN EXTREMITY (sore arm for a few days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090547, US-MODERNATX, INC.-MOD-2021-090554 (E2B Linked Report). This case was linked to MOD-2021-090584 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090547:Wife dose 1 case US-MODERNATX, INC.-MOD-2021-090554:Wife dose 2 case
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: having trouble staying awake,he sits down and falls asleep, can't stay awake; still tired,Exhausted,; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE and FATIGUE in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PLAVIX, ASPIRIN, CRESTOR, and FIORICET for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced SOMNOLENCE and FATIGUE. At the time of the report, SOMNOLENCE and FATIGUE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No treatment medicines were reported. Patient got second dose on 28-MAY-2021 with batch no 033C21A on Left arm.   Most recent FOLLOW-UP information incorporated above included, on 29-Jul-2021, No Significant Follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Rash, Somnolence, Vaccination site pain
Clinical narrative: low grade fever; body ached; slept all day; the injection site feels like there is a pinch in the booth arm; break out on torso with a cluster of pimples; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), MYALGIA (body ached), SOMNOLENCE (slept all day), VACCINATION SITE PAIN (the injection site feels like there is a pinch in the booth arm) and RASH (break out on torso with a cluster of pimples) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever), MYALGIA (body ached), SOMNOLENCE (slept all day), VACCINATION SITE PAIN (the injection site feels like there is a pinch in the booth arm) and RASH (break out on torso with a cluster of pimples). At the time of the report, PYREXIA (low grade fever), MYALGIA (body ached), SOMNOLENCE (slept all day), VACCINATION SITE PAIN (the injection site feels like there is a pinch in the booth arm) and RASH (break out on torso with a cluster of pimples) outcome was unknown. Not Provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Laziness, Myalgia, Pain in extremity
Clinical narrative: Hardness at the injection site; Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site; Feeling really tired; Body aching; Chills; Feeling lazy; Arm hurt, arm sore; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (Feeling lazy), PAIN IN EXTREMITY (Arm hurt, arm sore), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site) and FATIGUE (Feeling really tired) in a 49-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.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 22-Apr-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 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt, arm sore). On 23-Apr-2021, the patient experienced LAZINESS (Feeling lazy), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site), FATIGUE (Feeling really tired), MYALGIA (Body aching) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) on 23-Apr-2021 at an unspecified dose and frequency. On 25-Apr-2021, LAZINESS (Feeling lazy) and FATIGUE (Feeling really tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt, arm sore) and CHILLS (Chills) had resolved and VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site) and MYALGIA (Body aching) was resolving.            Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-090145, MOD21-082104 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Hardness at the injection site; Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site; Feeling really tired; Body aching; Chills; Feeling lazy; Arm hurt, arm sore; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (Feeling lazy), PAIN IN EXTREMITY (Arm hurt, arm sore), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site) and FATIGUE (Feeling really tired) in a 49-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.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 22-Apr-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 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt, arm sore). On 23-Apr-2021, the patient experienced LAZINESS (Feeling lazy), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site), FATIGUE (Feeling really tired), MYALGIA (Body aching) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) on 23-Apr-2021 at an unspecified dose and frequency. On 25-Apr-2021, LAZINESS (Feeling lazy) and FATIGUE (Feeling really tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt, arm sore) and CHILLS (Chills) had resolved and VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site) and MYALGIA (Body aching) was resolving.            Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-090145, MOD21-082104 (Patient Link).