chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past the 42 days mark to receive the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past the 42 days mark to receive the second dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 days mark to receive the second dose). On 26-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Past the 42 days mark to receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no significant medical history and does not have any current medications. No concomitant medications were provided. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-Jul-2021 and does not contain any new information.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle swelling, Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of muscle swelling (swelling in the muscle area) and product/dose omission issue (wanted to know if he should restart or get second dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031A21A) for COVID-19 immunization. No medical history reported. On May 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced muscle swelling (swelling in the muscle area) and product/dose omission issue (wanted to know if he should restart or get second dose). At the time of the report, muscle swelling (swelling in the muscle area) and product/dose omission issue (wanted to know if he should restart or get second dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine that was drawn up on 2-Jul-2021 were given on 6-Jul-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that was drawn up on 2-Jul-2021 were given on 6-Jul-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that was drawn up on 2-Jul-2021 were given on 6-Jul-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine that was drawn up on 2-Jul-2021 were given on 6-Jul-2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-significant follow up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-251614:MOD21-118851, MOD21-118852, MOD21-118853
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash on chest and arms; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) and RASH (rash on chest and arms) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04013213a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles) and RASH (rash on chest and arms). At the time of the report, HERPES ZOSTER (shingles) had resolved and RASH (rash on chest and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: New AE added, Reporter details added. On 01-Oct-2021: Follow up received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strong Metallic Taste in the mouth right after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Strong Metallic Taste in the mouth right after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Strong Metallic Taste in the mouth right after vaccination). At the time of the report, DYSGEUSIA (Strong Metallic Taste in the mouth right after vaccination) 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.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: An unknown angry caller stated that he had a racing heart after taking moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (An unknown angry caller stated that he had a racing heart after taking moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PALPITATIONS (An unknown angry caller stated that he had a racing heart after taking moderna vaccine). At the time of the report, PALPITATIONS (An unknown angry caller stated that he had a racing heart after taking moderna vaccine) outcome was unknown.        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 relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Pruritus, Rash erythematous, Tenderness
Clinical narrative: Red rash; Swelling on arm; Hot to touch; Itching; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (Swelling on arm), FEELING HOT (Hot to touch), PRURITUS (Itching) and TENDERNESS (Tender to touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ZOSTER IMMUNOGLOBULIN (shingles shot). Concurrent medical conditions included Drug allergy (Naproxen). Concomitant products included RALOXIFENE HYDROCHLORIDE for Bone disorder NOS, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3) for Mineral supplementation, FISH OIL for Nutritional support, CYANOCOBALAMIN (B12 1000 SR) and BIOTIN for Vitamin supplementation.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (Swelling on arm), FEELING HOT (Hot to touch), PRURITUS (Itching) and TENDERNESS (Tender to touch). On 21-Mar-2021, RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (Swelling on arm), FEELING HOT (Hot to touch), PRURITUS (Itching) and TENDERNESS (Tender to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The events were treated with over the counter with cream.   This case was linked to MOD-2021-109657 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Lichenoid keratosis, Pruritus, Rash, Scratch, Urticaria
Clinical narrative: Lichenoid dermatitis/ got very intense; Scratching; Itching; Hives; Rashy looking; This spontaneous case was reported by a consumer and describes the occurrence of LICHENOID KERATOSIS (Lichenoid dermatitis/ got very intense), SCRATCH (Scratching), PRURITUS (Itching), URTICARIA (Hives) and RASH (Rashy looking) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Food allergy to peas and fenugreek. Allergy from birth) since February 1942 and Diabetes since 1995. Concomitant products included SIMVASTATIN from 1998 to an unknown date for Cholesterol, INSULIN LISPRO (HUMALOG) from 1999 to an unknown date for Diabetes, TAMSULOSIN from 2001 to an unknown date for Prostatic disorder, LEVOTHYROXINE from 2000 to an unknown date for Thyroid disorder, ACETYLSALICYLIC ACID (ASPRIN) from 1999 to an unknown date, VITAMIN D [VITAMIN D NOS] and COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-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 LICHENOID KERATOSIS (Lichenoid dermatitis/ got very intense), SCRATCH (Scratching), PRURITUS (Itching), URTICARIA (Hives) and RASH (Rashy looking). The patient was treated with Laser therapy for Lichenoid keratosis. At the time of the report, LICHENOID KERATOSIS (Lichenoid dermatitis/ got very intense) had not resolved and SCRATCH (Scratching), PRURITUS (Itching), URTICARIA (Hives) and RASH (Rashy looking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication include turmeric (1500 mg per day) No treatment medication information was provided Patient's dermatologist attempted a number of different things, everything has sort of helped.  Patient's doctor wrote "the process is not consistent with urticaria". Patient took light treatments at the 26 May 2021 at the rate of 4x per week. Reduced to 2x per week about 3 weeks ago. Results have been positive (only minor itching and not intense).   This case was linked to MOD-2021-251455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received and updated the reporter details, patient initials, medical history, concomitant drugs and treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache after injection; 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 HEADACHE (slight headache after injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight headache after injection). At the time of the report, HEADACHE (slight headache after injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine that were drawn up on 2Jul2021 were given on 6Jul2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that were drawn up on 2Jul2021 were given on 6Jul2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that were drawn up on 2Jul2021 were given on 6Jul2021). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (vaccine that were drawn up on 2Jul2021 were given on 6Jul2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drug details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Fallow-up received and contains no new information.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: stomach issues; diarrhea; nausea; lost 12 pounds; cannot eat; does not have an appetite; wakes up sick, sweating, and panic; has anxiety when he wakes up sweating; sweating; used to be able to lift but now he would have to stop lifting as he cannot breathe; feels bad/it bothers him; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds) and EATING DISORDER (cannot eat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-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 ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds), EATING DISORDER (cannot eat), DECREASED APPETITE (does not have an appetite), MALAISE (wakes up sick, sweating, and panic), ANXIETY (has anxiety when he wakes up sweating), HYPERHIDROSIS (sweating), DYSPNOEA (used to be able to lift but now he would have to stop lifting as he cannot breathe) and FEELING ABNORMAL (feels bad/it bothers him). The patient was treated with RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds), EATING DISORDER (cannot eat), DECREASED APPETITE (does not have an appetite), MALAISE (wakes up sick, sweating, and panic), ANXIETY (has anxiety when he wakes up sweating), HYPERHIDROSIS (sweating), DYSPNOEA (used to be able to lift but now he would have to stop lifting as he cannot breathe) and FEELING ABNORMAL (feels bad/it bothers him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Tried a new diet and ate more vegetables   This case was linked to MOD-2021-251774 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Eating disorder, Feeling abnormal, Hyperhidrosis, Malaise, Nausea
Clinical narrative: stomach issues; diarrhea; nausea; lost 12 pounds; cannot eat; does not have an appetite; wakes up sick, sweating, and panic; has anxiety when he wakes up sweating; sweating; used to be able to lift but now he would have to stop lifting as he cannot breathe; feels bad/it bothers him; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds) and EATING DISORDER (cannot eat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-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 ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds), EATING DISORDER (cannot eat), DECREASED APPETITE (does not have an appetite), MALAISE (wakes up sick, sweating, and panic), ANXIETY (has anxiety when he wakes up sweating), HYPERHIDROSIS (sweating), DYSPNOEA (used to be able to lift but now he would have to stop lifting as he cannot breathe) and FEELING ABNORMAL (feels bad/it bothers him). The patient was treated with RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds), EATING DISORDER (cannot eat), DECREASED APPETITE (does not have an appetite), MALAISE (wakes up sick, sweating, and panic), ANXIETY (has anxiety when he wakes up sweating), HYPERHIDROSIS (sweating), DYSPNOEA (used to be able to lift but now he would have to stop lifting as he cannot breathe) and FEELING ABNORMAL (feels bad/it bothers him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Tried a new diet and ate more vegetables   This case was linked to MOD-2021-251774 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: stomach issues; diarrhea; nausea; lost 12 pounds; cannot eat; does not have an appetite; wakes up sick, sweating, and panic; has anxiety when he wakes up sweating; sweating; used to be able to lift but now he would have to stop lifting as he cannot breathe; feels bad/it bothers him; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds) and EATING DISORDER (cannot eat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-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 ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds), EATING DISORDER (cannot eat), DECREASED APPETITE (does not have an appetite), MALAISE (wakes up sick, sweating, and panic), ANXIETY (has anxiety when he wakes up sweating), HYPERHIDROSIS (sweating), DYSPNOEA (used to be able to lift but now he would have to stop lifting as he cannot breathe) and FEELING ABNORMAL (feels bad/it bothers him). The patient was treated with RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds), EATING DISORDER (cannot eat), DECREASED APPETITE (does not have an appetite), MALAISE (wakes up sick, sweating, and panic), ANXIETY (has anxiety when he wakes up sweating), HYPERHIDROSIS (sweating), DYSPNOEA (used to be able to lift but now he would have to stop lifting as he cannot breathe) and FEELING ABNORMAL (feels bad/it bothers him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Tried a new diet and ate more vegetables   This case was linked to MOD-2021-251774 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Felt cold all of the sudden after working out; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold all of the sudden after working out) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pityriasis rosea (been using Steroid cream since then) since 04-May-2021.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced FEELING COLD (Felt cold all of the sudden after working out). At the time of the report, FEELING COLD (Felt cold all of the sudden after working out) outcome was unknown.            Concomitant medications included  multivitamins as supplement.  Treatment information included Steroid Cream for rashes, recommended by the dermatologist.   This case was linked to MOD-2021-251531 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Non-Significant follow-up received and included patient denies consent.
Sex: F
Vaccine: COVID19
Symptoms: Lichenoid keratosis, Pruritus, Scratch
Clinical narrative: itchy and scratching; scratching; lichenoid dermatitis; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (itchy and scratching), SCRATCH (scratching) and LICHENOID KERATOSIS (lichenoid dermatitis) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy and scratching), SCRATCH (scratching) and LICHENOID KERATOSIS (lichenoid dermatitis). At the time of the report, PRURITUS (itchy and scratching), SCRATCH (scratching) and LICHENOID KERATOSIS (lichenoid dermatitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 9 weeks since receiving 1st dose, has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (9 weeks since receiving 1st dose, has not received 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRODUCT DOSE OMISSION ISSUE (9 weeks since receiving 1st dose, has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (9 weeks since receiving 1st dose, has not received 2nd dose) had resolved.            No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Full blood count abnormal, Illness, Inflammation
Clinical narrative: Got Sick; Abdominal Pain; Inflammation all over body; Low Blood Counts; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got Sick), ABDOMINAL PAIN (Abdominal Pain), INFLAMMATION (Inflammation all over body) and BLOOD COUNT ABNORMAL (Low Blood Counts) 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 17-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced ILLNESS (Got Sick), ABDOMINAL PAIN (Abdominal Pain), INFLAMMATION (Inflammation all over body) and BLOOD COUNT ABNORMAL (Low Blood Counts). At the time of the report, ILLNESS (Got Sick), ABDOMINAL PAIN (Abdominal Pain), INFLAMMATION (Inflammation all over body) and BLOOD COUNT ABNORMAL (Low Blood Counts) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Concomitant medication use was unknown Treatment information use was unknown
Sex: U
Vaccine: COVID19
Symptoms: Conjunctivitis, Lymph node pain, Myalgia
Clinical narrative: discharge from the left eye which was described as conjunctivitis; soreness in the armpit which the patient thinks is the lymph node; left arm was sore/ soreness in the armpit which the patient thinks is the lymph node; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (discharge from the left eye which was described as conjunctivitis), LYMPH NODE PAIN (soreness in the armpit which the patient thinks is the lymph node) and MYALGIA (left arm was sore/ soreness in the armpit which the patient thinks is the lymph node) 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 CONJUNCTIVITIS (discharge from the left eye which was described as conjunctivitis), LYMPH NODE PAIN (soreness in the armpit which the patient thinks is the lymph node) and MYALGIA (left arm was sore/ soreness in the armpit which the patient thinks is the lymph node). At the time of the report, CONJUNCTIVITIS (discharge from the left eye which was described as conjunctivitis), LYMPH NODE PAIN (soreness in the armpit which the patient thinks is the lymph node) and MYALGIA (left arm was sore/ soreness in the armpit which the patient thinks is the lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Got weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Got weak) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Degenerative joint disease, Sulfonamide allergy, Tremor muscle (Leg tremor) and Primary progressive multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), BACLOFEN and TAMSULOSIN for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ASTHENIA (Got weak). At the time of the report, ASTHENIA (Got weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose > 35 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) 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.   No concomitant medications reported.  Treatment information not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after being drawn up more than 12 hours before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) 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.   No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up contains No new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-251523:MOD21-118851, MOD21-118852, MOD21-118853
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: Localised numbness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Localised numbness) and FATIGUE (Tiredness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jul-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 HYPOAESTHESIA (Localised numbness) and FATIGUE (Tiredness). At the time of the report, HYPOAESTHESIA (Localised numbness) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   This case was linked to MOD-2021-221132 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after being drawn up more than 12 hours before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) to be not applicable.    No concomitant drugs were reported . No treatment information was reported.  Per reporter the patient did not experience an adverse event just a medication error.    Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and does not contain new information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Felt like she was drowning; Fever; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Felt like she was drowning), PYREXIA (Fever) and MYALGIA (Sore arm) in a 38-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt like she was drowning), PYREXIA (Fever) and MYALGIA (Sore arm). At the time of the report, FEELING ABNORMAL (Felt like she was drowning), PYREXIA (Fever) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the vaccine; 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) 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 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A child received the Moderna vaccine at the age of 16; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child received the Moderna vaccine at the age of 16) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child received the Moderna vaccine at the age of 16). On 08-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A child received the Moderna vaccine at the age of 16) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pruritus, Swelling
Clinical narrative: Swelling; Itching; Muscle pain in both legs; Chills; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (Swelling), PRURITUS (Itching), MYALGIA (Muscle pain in both legs), CHILLS (Chills) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On 06-Jul-2021, the patient experienced SWELLING (Swelling), PRURITUS (Itching), MYALGIA (Muscle pain in both legs) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and CORTISOL [HYDROCORTISONE] (topical) ongoing since an unknown date at an unspecified dose and frequency. On 30-Jun-2021, FATIGUE (Fatigue) had resolved. At the time of the report, SWELLING (Swelling), MYALGIA (Muscle pain in both legs) and CHILLS (Chills) outcome was unknown and PRURITUS (Itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Lymphadenopathy, Mastication disorder
Clinical narrative: little bit of discomfort if I chewed or spoke; some inflammation of the gland in neck; little bit of swelling on the gland in his neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (little bit of swelling on the gland in his neck), MASTICATION DISORDER (little bit of discomfort if I chewed or spoke) and INFLAMMATION (some inflammation of the gland in neck) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (little bit of swelling on the gland in his neck), MASTICATION DISORDER (little bit of discomfort if I chewed or spoke) and INFLAMMATION (some inflammation of the gland in neck). At the time of the report, LYMPHADENOPATHY (little bit of swelling on the gland in his neck), MASTICATION DISORDER (little bit of discomfort if I chewed or spoke) and INFLAMMATION (some inflammation of the gland in neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Ear infection, Hypoacusis, Middle ear effusion
Clinical narrative: Hearing Issues ranging from Simple to Serious  after vaccination; Ear Infections ranging from Simple to Serious  after vaccination; Fluids in the Ear ranging from Simple to Serious  after vaccination; 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 HYPOACUSIS (Hearing Issues ranging from Simple to Serious  after vaccination), EAR INFECTION (Ear Infections ranging from Simple to Serious  after vaccination) and MIDDLE EAR EFFUSION (Fluids in the Ear ranging from Simple to Serious  after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HYPOACUSIS (Hearing Issues ranging from Simple to Serious  after vaccination), EAR INFECTION (Ear Infections ranging from Simple to Serious  after vaccination) and MIDDLE EAR EFFUSION (Fluids in the Ear ranging from Simple to Serious  after vaccination). At the time of the report, HYPOACUSIS (Hearing Issues ranging from Simple to Serious  after vaccination), EAR INFECTION (Ear Infections ranging from Simple to Serious  after vaccination) and MIDDLE EAR EFFUSION (Fluids in the Ear ranging from Simple to Serious  after vaccination) outcome was unknown.        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 relevant concomitant medications was reported.  Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose of Moderna COVID 19 vaccine on 13May2021 and she is having her 2nd shot tomorrow (9Jul2021); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID 19 vaccine on 13May2021 and she is having her 2nd shot tomorrow (9Jul2021)) 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 13-May-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 PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID 19 vaccine on 13May2021 and she is having her 2nd shot tomorrow (9Jul2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID 19 vaccine on 13May2021 and she is having her 2nd shot tomorrow (9Jul2021)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was  not provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Lymphadenopathy, Mobility decreased, Productive cough
Clinical narrative: could not lift his left arm elbow higher than his shoulder; soft cough; spitting out flem; headache; swollen lymph nodes on both the right and left side of neck; painful injection site left arm; swollen injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem), MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder), VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0748C21A E) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm). On 05-Jul-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on both the right and left side of neck). On 08-Jul-2021, the patient experienced COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem) and HEADACHE (headache). On an unknown date, the patient experienced MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder). On 04-Jul-2021, VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm) had resolved. On 07-Jul-2021, LYMPHADENOPATHY (swollen lymph nodes on both the right and left side of neck) had resolved. At the time of the report, COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem), MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  had received his Moderna Covid-19 vaccine at  Supermarket. Treatment information was not provided Concomitant medication were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Translation received on 09 Jul 2021 and does not contain any new information.