chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Malaise
Clinical narrative: Horribly sick; Diarrhea; Still not feeling particularly well; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Horribly sick), DIARRHOEA (Diarrhea) and MALAISE (Still not feeling particularly well) in an 81-year-old male patient who received mRNA-1273 (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol (patient did not report any historical medical condition, but is on unspecified blood pressure, blood thinner and cholesterol medication.s) and Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and PANTOPRAZOLE for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ILLNESS (Horribly sick), DIARRHOEA (Diarrhea) and MALAISE (Still not feeling particularly well). At the time of the report, ILLNESS (Horribly sick), DIARRHOEA (Diarrhea) and MALAISE (Still not feeling particularly well) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications taken by the patient include baby aspirin, pantoprazole, Blood Thinner Medication, Cholesterol Medication, Blood Pressure Medication   This case was linked to US-MODERNATX, INC.-MOD-2021-100410 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100410:Wife case
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: fever; Body ache; chills; Felt tired; diarrhea; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired) and DIARRHOEA (diarrhea) in a 40-year-old male 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 reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 09-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 PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired), DIARRHOEA (diarrhea) and NAUSEA (nausea). On 21-Apr-2021, PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired) and NAUSEA (nausea) had resolved. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, COVID-19: Positive.     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.   Caller advised patient also taking Berry Syrup.    This case was linked INC.-MOD-2021-100778 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-100778:wife's case crosslinked
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; Body ache; chills; Felt tired; diarrhea; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired) and DIARRHOEA (diarrhea) in a 40-year-old male 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 reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 09-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 PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired), DIARRHOEA (diarrhea) and NAUSEA (nausea). On 21-Apr-2021, PYREXIA (fever), PAIN (Body ache), CHILLS (chills), FATIGUE (Felt tired) and NAUSEA (nausea) had resolved. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, COVID-19: Positive.     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.   Caller advised patient also taking Berry Syrup.    This case was linked INC.-MOD-2021-100778 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-100778:wife's case crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Erythema, Fatigue, Pruritus
Clinical narrative: Hives at the injection site; Dry-cough; Dry heaving; Light-headedness; Itching; swelling redness of face; began feeling exhausted; Hives; redness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 01-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and HISTAMINE for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness), PRURITUS (Itching), ERYTHEMA (swelling redness of face), FATIGUE (began feeling exhausted), URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness), PRURITUS (Itching), ERYTHEMA (swelling redness of face), FATIGUE (began feeling exhausted), URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (redness at the injection site) was resolving.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment product information was provided
Sex: F
Vaccine: COVID19
Symptoms: Retching, Urticaria, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Hives at the injection site; Dry-cough; Dry heaving; Light-headedness; Itching; swelling redness of face; began feeling exhausted; Hives; redness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 01-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and HISTAMINE for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness), PRURITUS (Itching), ERYTHEMA (swelling redness of face), FATIGUE (began feeling exhausted), URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness), PRURITUS (Itching), ERYTHEMA (swelling redness of face), FATIGUE (began feeling exhausted), URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (redness at the injection site) was resolving.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment product information was provided
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: burning bump in her left arm where she got the vaccine; fever of 100.7; muscle pain; nausea; can't control her head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (burning bump in her left arm where she got the vaccine), PYREXIA (fever of 100.7), MYALGIA (muscle pain), NAUSEA (nausea) and HEADACHE (can't control her head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00AC21A and 8016B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Watering eyes.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (burning bump in her left arm where she got the vaccine), PYREXIA (fever of 100.7), MYALGIA (muscle pain), NAUSEA (nausea) and HEADACHE (can't control her head). At the time of the report, VACCINATION SITE PAIN (burning bump in her left arm where she got the vaccine), PYREXIA (fever of 100.7), MYALGIA (muscle pain), NAUSEA (nausea) and HEADACHE (can't control her head) outcome was unknown.            The caller had her second dose yesterday. She noticed a burning red bump in her left arm where she got the vaccine. she also has fever of 100.7, muscle pain, nausea, and can't control her head.  After the first dose she also had fever of 103.8 degrees, nausea, and vomiting for 3 days. She also notified us that she is immunocompromised and is on immunosuppressants. She also took Zyrtec because she has watery eyes. The first dose lot number 8016B21A and the lot number for the second dose is 00AC21A. The caller is okay with safety department reaching out via phone.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Headache, Joint stiffness, Muscular weakness
Clinical narrative: weakness in the left hand; pins and needles in the face and hands; stiff and achy joints; headache; fever; stiff and achy joints; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache) and ARTHRALGIA (stiff and achy joints). 29-Apr-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (stiff and achy joints) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, COVID-19: positive She had a diagnosis of COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  Concomitant medications were provided
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: weakness in the left hand; pins and needles in the face and hands; stiff and achy joints; headache; fever; stiff and achy joints; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache) and ARTHRALGIA (stiff and achy joints). 29-Apr-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MUSCULAR WEAKNESS (weakness in the left hand), PARAESTHESIA (pins and needles in the face and hands), JOINT STIFFNESS (stiff and achy joints), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (stiff and achy joints) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, COVID-19: positive She had a diagnosis of COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  Concomitant medications were provided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Influenza like illness, Rash
Clinical narrative: when goes outside, the rash gets worse; joints are angry; what felt like the flu; there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse; sort of looks like ringworm, edges are super raised and bumps are in there; a big knot under skin and now it's soft and looks gross; a discoloration in the skin; her arthritis is affected; pure exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (what felt like the flu), RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), RASH (when goes outside, the rash gets worse) and SWELLING (a big knot under skin and now it's soft and looks gross) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriatic arthritis and Rheumatoid arthritis.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (what felt like the flu), RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), SWELLING (a big knot under skin and now it's soft and looks gross), SKIN DISCOLOURATION (a discoloration in the skin), ARTHRITIS (her arthritis is affected) and FATIGUE (pure exhaustion). On an unknown date, the patient experienced RASH (when goes outside, the rash gets worse) and ARTHRALGIA (joints are angry). On 16-Apr-2021, INFLUENZA LIKE ILLNESS (what felt like the flu) and FATIGUE (pure exhaustion) had resolved. At the time of the report, RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), RASH (when goes outside, the rash gets worse), SWELLING (a big knot under skin and now it's soft and looks gross), SKIN DISCOLOURATION (a discoloration in the skin), ARTHRITIS (her arthritis is affected) and ARTHRALGIA (joints are angry) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Prior medical history includes neck and back surgery. Her HCP suggested OTC allergy medication and ibuprofen which she has been taking but does not affect it.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Skin discolouration, Swelling
Clinical narrative: when goes outside, the rash gets worse; joints are angry; what felt like the flu; there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse; sort of looks like ringworm, edges are super raised and bumps are in there; a big knot under skin and now it's soft and looks gross; a discoloration in the skin; her arthritis is affected; pure exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (what felt like the flu), RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), RASH (when goes outside, the rash gets worse) and SWELLING (a big knot under skin and now it's soft and looks gross) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriatic arthritis and Rheumatoid arthritis.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (what felt like the flu), RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), SWELLING (a big knot under skin and now it's soft and looks gross), SKIN DISCOLOURATION (a discoloration in the skin), ARTHRITIS (her arthritis is affected) and FATIGUE (pure exhaustion). On an unknown date, the patient experienced RASH (when goes outside, the rash gets worse) and ARTHRALGIA (joints are angry). On 16-Apr-2021, INFLUENZA LIKE ILLNESS (what felt like the flu) and FATIGUE (pure exhaustion) had resolved. At the time of the report, RASH ERYTHEMATOUS (there is a very large red raised circle with heat in it which is not an infection, she goes outside, the rash gets worse), RASH PAPULAR (sort of looks like ringworm, edges are super raised and bumps are in there), RASH (when goes outside, the rash gets worse), SWELLING (a big knot under skin and now it's soft and looks gross), SKIN DISCOLOURATION (a discoloration in the skin), ARTHRITIS (her arthritis is affected) and ARTHRALGIA (joints are angry) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Prior medical history includes neck and back surgery. Her HCP suggested OTC allergy medication and ibuprofen which she has been taking but does not affect it.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: strong pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (strong pain in the arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 03-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 PAIN IN EXTREMITY (strong pain in the arm). At the time of the report, PAIN IN EXTREMITY (strong pain in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Somnolence
Clinical narrative: felt very low on energy; sleepiness; second dose administered less than 26 days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt very low on energy), SOMNOLENCE (sleepiness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered less than 26 days) 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 06-Apr-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 FATIGUE (felt very low on energy), SOMNOLENCE (sleepiness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered less than 26 days). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-103227 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 101.4; Soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the left arm) and PYREXIA (Fever 101.4) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ETHINYLESTRADIOL, NORGESTIMATE (ORTHO TRI-CYCLEN) and CICLOSPORIN (RESTASIS) for an unknown indication.   On 03-May-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the left arm). On 04-May-2021, the patient experienced PYREXIA (Fever 101.4). At the time of the report, PAIN IN EXTREMITY (Soreness of the left arm) and PYREXIA (Fever 101.4) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not provided
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer, Non-Moderna COVID-19 vaccine as first dose and Moderna Covid19 Vaccine as second dose; This spontaneous case was reported by a non-health professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer, Non-Moderna COVID-19 vaccine as first dose and Moderna Covid19 Vaccine as second dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer, Non-Moderna COVID-19 vaccine as first dose and Moderna Covid19 Vaccine as second dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer, Non-Moderna COVID-19 vaccine as first dose and Moderna Covid19 Vaccine as second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-026389 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026389:Wife's case
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 07-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tiredness) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Crohn's disease.    No relevant Past Medical History was provided.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In April 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: aches; Fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, ROSUVASTATIN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-May-2021, the patient experienced MYALGIA (aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache). On 07-May-2021, MYALGIA (aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Felt more tired than usual; Soreness on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt more tired than usual) and VACCINATION SITE PAIN (Soreness on arm of injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included Hiatal hernia. Concurrent medical conditions included Constipation and Diarrhoea. Concomitant products included CITALOPRAM, LOPERAMIDE HYDROCHLORIDE (IMODIUM) and LEVOTHYROXINE for an unknown indication.    On 03-Apr-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 FATIGUE (Felt more tired than usual) and VACCINATION SITE PAIN (Soreness on arm of injection). At the time of the report, FATIGUE (Felt more tired than usual) and VACCINATION SITE PAIN (Soreness on arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient reports that she underwent surgery for hiatal hernia "back in February", has since often experienced constipation and diarrhea. Patient received first dose of Moderna COVID-19 vaccine on "1st Saturday in April" (3Apr2021). Lot #016B21A (or 016BZ1A). Administered on left shoulder (nondominant side). At that time she experienced soreness on her left arm, and felt "a bit more tired than usual".   This case was linked to US-MODERNATX, INC.-MOD-2021-114597 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114597:dose 2
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Sore of throat for for 2 months, i still have throat problems; swelling of throat for 2 months, I still have throat problems; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore of throat for for 2 months, i still have throat problems) and PHARYNGEAL SWELLING (swelling of throat for 2 months, I still have throat problems) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore of throat for for 2 months, i still have throat problems) and PHARYNGEAL SWELLING (swelling of throat for 2 months, I still have throat problems). At the time of the report, OROPHARYNGEAL PAIN (Sore of throat for for 2 months, i still have throat problems) and PHARYNGEAL SWELLING (swelling of throat for 2 months, I still have throat problems) had not resolved. Not Provided          Treatment Information was not reported. Concomitant product information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Herpes zoster, Hyperhidrosis
Clinical narrative: It was like shingles on right leg; Pain in the knee in right leg; Rash right leg  from the knee to ankle to feet; Sweating; Dizziness; Weakness; It was like hives on right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness) and URTICARIA (It was like hives on right leg) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 037A21B and 046b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient has no known Allergies.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, HYDROCHLOROTHIAZIDE and LISINOPRIL for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness), URTICARIA (It was like hives on right leg) and ARTHRALGIA (Pain in the knee in right leg). On an unknown date, the patient experienced HERPES ZOSTER (It was like shingles on right leg). At the time of the report, RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness), URTICARIA (It was like hives on right leg), HERPES ZOSTER (It was like shingles on right leg) and ARTHRALGIA (Pain in the knee in right leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: no blood clot.         No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Ultrasound scan, Urticaria
Clinical narrative: It was like shingles on right leg; Pain in the knee in right leg; Rash right leg  from the knee to ankle to feet; Sweating; Dizziness; Weakness; It was like hives on right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness) and URTICARIA (It was like hives on right leg) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 037A21B and 046b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient has no known Allergies.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, HYDROCHLOROTHIAZIDE and LISINOPRIL for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness), URTICARIA (It was like hives on right leg) and ARTHRALGIA (Pain in the knee in right leg). On an unknown date, the patient experienced HERPES ZOSTER (It was like shingles on right leg). At the time of the report, RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness), URTICARIA (It was like hives on right leg), HERPES ZOSTER (It was like shingles on right leg) and ARTHRALGIA (Pain in the knee in right leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: no blood clot.         No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: myalgia; Not Hungry; slept a lot; thirst; tiredness; headache; chills; light fever; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst) and FATIGUE (tiredness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date and Heart rate variability increased since an unknown date. Concomitant products included ATORVASTATIN, METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN ACTIVE WOMAN for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-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 MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst), FATIGUE (tiredness), HEADACHE (headache), CHILLS (chills), PYREXIA (light fever) and VACCINATION SITE PAIN (vaccination site pain). On 09-May-2021, MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst), FATIGUE (tiredness), HEADACHE (headache), CHILLS (chills), PYREXIA (light fever) and VACCINATION SITE PAIN (vaccination site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: not provided (High) High Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.   This case was linked to MOD-2021-073059, MOD-2021-125294, MOD-2021-073059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: ADR: reporter info, pt info, hcp info, vaccine info, AE progress, etc.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Somnolence, Thirst, Vaccination site pain
Clinical narrative: myalgia; Not Hungry; slept a lot; thirst; tiredness; headache; chills; light fever; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst) and FATIGUE (tiredness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date and Heart rate variability increased since an unknown date. Concomitant products included ATORVASTATIN, METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN ACTIVE WOMAN for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-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 MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst), FATIGUE (tiredness), HEADACHE (headache), CHILLS (chills), PYREXIA (light fever) and VACCINATION SITE PAIN (vaccination site pain). On 09-May-2021, MYALGIA (myalgia), DECREASED APPETITE (Not Hungry), SOMNOLENCE (slept a lot), THIRST (thirst), FATIGUE (tiredness), HEADACHE (headache), CHILLS (chills), PYREXIA (light fever) and VACCINATION SITE PAIN (vaccination site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: not provided (High) High Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.   This case was linked to MOD-2021-073059, MOD-2021-125294, MOD-2021-073059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: ADR: reporter info, pt info, hcp info, vaccine info, AE progress, etc.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong technique in product usage process
Clinical narrative: pulled the needle out of my arm too soon and the vaccine ran down the outside of my arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (pulled the needle out of my arm too soon and the vaccine ran down the outside of my arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L2OA and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tremor. Concomitant products included PRIMIDONE for Tremor.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (pulled the needle out of my arm too soon and the vaccine ran down the outside of my arm). At the time of the report, PAIN IN EXTREMITY (sore arm) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (pulled the needle out of my arm too soon and the vaccine ran down the outside of my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-033933 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 26-May-2021 added event.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gastrooesophageal reflux disease, Myalgia, Nausea
Clinical narrative: Acid reflux with second vaccine; pain in right foot; pain in right ankle; nausea; Chills; body aches; did not get a full night sleep; shaking; This spontaneous case was reported by a patient and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux with second vaccine), PAIN IN EXTREMITY (pain in right foot), SLEEP DISORDER (did not get a full night sleep), TREMOR (shaking) and ARTHRALGIA (pain in right ankle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 026CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.  Concomitant products included PRAZOSIN, OLANZAPINE and MIRTAZAPINE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced SLEEP DISORDER (did not get a full night sleep), TREMOR (shaking), CHILLS (Chills) and MYALGIA (body aches). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux with second vaccine), PAIN IN EXTREMITY (pain in right foot), ARTHRALGIA (pain in right ankle) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux with second vaccine), PAIN IN EXTREMITY (pain in right foot), SLEEP DISORDER (did not get a full night sleep), TREMOR (shaking), ARTHRALGIA (pain in right ankle), CHILLS (Chills), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-083083 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder, Tremor
Clinical narrative: Acid reflux with second vaccine; pain in right foot; pain in right ankle; nausea; Chills; body aches; did not get a full night sleep; shaking; This spontaneous case was reported by a patient and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux with second vaccine), PAIN IN EXTREMITY (pain in right foot), SLEEP DISORDER (did not get a full night sleep), TREMOR (shaking) and ARTHRALGIA (pain in right ankle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 026CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.  Concomitant products included PRAZOSIN, OLANZAPINE and MIRTAZAPINE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced SLEEP DISORDER (did not get a full night sleep), TREMOR (shaking), CHILLS (Chills) and MYALGIA (body aches). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux with second vaccine), PAIN IN EXTREMITY (pain in right foot), ARTHRALGIA (pain in right ankle) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux with second vaccine), PAIN IN EXTREMITY (pain in right foot), SLEEP DISORDER (did not get a full night sleep), TREMOR (shaking), ARTHRALGIA (pain in right ankle), CHILLS (Chills), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-083083 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: reschedule dose 2 and have not been able to achedule; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (reschedule dose 2 and have not been able to achedule) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (reschedule dose 2 and have not been able to achedule). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (reschedule dose 2 and have not been able to achedule) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: "flu like symtoms"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS ("flu like symtoms") 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS ("flu like symtoms"). At the time of the report, INFLUENZA LIKE ILLNESS ("flu like symtoms") outcome was unknown.          AE: "got my second shot and now have flu like symptoms. Can my wife catch these symptoms from if she hasn't had her shots