chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blister, Feeling abnormal, Illness, Influenza like illness
Clinical narrative: got really sick after both shots/ get too sick, and never get sick; Like get the flu; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick after both shots/ get too sick, and never get sick) and INFLUENZA LIKE ILLNESS (Like get the flu) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ILLNESS (got really sick after both shots/ get too sick, and never get sick) and INFLUENZA LIKE ILLNESS (Like get the flu). At the time of the report, ILLNESS (got really sick after both shots/ get too sick, and never get sick) and INFLUENZA LIKE ILLNESS (Like get the flu) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient not having any pre existing health condition.  Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-465262 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: little spots of hair, losing little spots of hair like alopecia/noticing some hair lost; notice some batches in his beard/getting bald spots on scalp,noticed 15 spots size of a penny; like get the flu; I get too sick; it was bad; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (little spots of hair, losing little spots of hair like alopecia/noticing some hair lost), BLISTER (notice some batches in his beard/getting bald spots on scalp,noticed 15 spots size of a penny), INFLUENZA LIKE ILLNESS (like get the flu), ILLNESS (I get too sick) and FEELING ABNORMAL (it was bad) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 006D21A) for COVID-19 vaccination.     It was reported that patient was not having any pre existing health condition.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ALOPECIA (little spots of hair, losing little spots of hair like alopecia/noticing some hair lost), BLISTER (notice some batches in his beard/getting bald spots on scalp,noticed 15 spots size of a penny), INFLUENZA LIKE ILLNESS (like get the flu), ILLNESS (I get too sick) and FEELING ABNORMAL (it was bad). At the time of the report, ALOPECIA (little spots of hair, losing little spots of hair like alopecia/noticing some hair lost), BLISTER (notice some batches in his beard/getting bald spots on scalp,noticed 15 spots size of a penny), INFLUENZA LIKE ILLNESS (like get the flu), ILLNESS (I get too sick) and FEELING ABNORMAL (it was bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.  It was reported that events occurred in November/December 2021. It was stated that patient would not take the booster shot.   This case was linked to MOD-2022-467203 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow up information received added additional reporter, patient demographics, medical history information, events and updated i-Narrative.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blister, Feeling abnormal, Illness, Influenza like illness
Clinical narrative: little spots of hair, losing little spots of hair like alopecia/noticing some hair lost; notice some batches in his beard/getting bald spots on scalp,noticed 15 spots size of a penny; like get the flu; I get too sick; it was bad; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (little spots of hair, losing little spots of hair like alopecia/noticing some hair lost), BLISTER (notice some batches in his beard/getting bald spots on scalp,noticed 15 spots size of a penny), INFLUENZA LIKE ILLNESS (like get the flu), ILLNESS (I get too sick) and FEELING ABNORMAL (it was bad) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 006D21A) for COVID-19 vaccination.     It was reported that patient was not having any pre existing health condition.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ALOPECIA (little spots of hair, losing little spots of hair like alopecia/noticing some hair lost), BLISTER (notice some batches in his beard/getting bald spots on scalp,noticed 15 spots size of a penny), INFLUENZA LIKE ILLNESS (like get the flu), ILLNESS (I get too sick) and FEELING ABNORMAL (it was bad). At the time of the report, ALOPECIA (little spots of hair, losing little spots of hair like alopecia/noticing some hair lost), BLISTER (notice some batches in his beard/getting bald spots on scalp,noticed 15 spots size of a penny), INFLUENZA LIKE ILLNESS (like get the flu), ILLNESS (I get too sick) and FEELING ABNORMAL (it was bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.  It was reported that events occurred in November/December 2021. It was stated that patient would not take the booster shot.   This case was linked to MOD-2022-467203 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow up information received added additional reporter, patient demographics, medical history information, events and updated i-Narrative.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had a few hours of fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Had a few hours of fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In May 2021, the patient experienced PYREXIA (Had a few hours of fever). In May 2021, PYREXIA (Had a few hours of fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The patient had no reactions after the 1st dose.   This case was linked to MOD-2022-467247 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis came back and got even worse than before; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis came back and got even worse than before) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Psoriasis.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (psoriasis came back and got even worse than before). At the time of the report, PSORIASIS (psoriasis came back and got even worse than before) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, Skin burning sensation, Vaccination site pain
Clinical narrative: Soreness in the right arm; Her skin felt like it was burning up; Could not go to sleep; A raging fever of 104F/the fever was not responsive to Tylenol & Aspirin; This spontaneous case was reported by a physician and describes the occurrence of SKIN BURNING SENSATION (Her skin felt like it was burning up), INSOMNIA (Could not go to sleep), PYREXIA (A raging fever of 104F/the fever was not responsive to Tylenol & Aspirin) and VACCINATION SITE PAIN (Soreness in the right arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 022C21A and 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, the patient experienced SKIN BURNING SENSATION (Her skin felt like it was burning up), INSOMNIA (Could not go to sleep) and PYREXIA (A raging fever of 104F/the fever was not responsive to Tylenol & Aspirin). On 28-Jan-2022, the patient experienced VACCINATION SITE PAIN (Soreness in the right arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN BURNING SENSATION (Her skin felt like it was burning up), INSOMNIA (Could not go to sleep) and PYREXIA (A raging fever of 104F/the fever was not responsive to Tylenol & Aspirin) was resolving and VACCINATION SITE PAIN (Soreness in the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   This case was linked to MOD-2022-467238 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-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 (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment drugs were reported.  No treatment information was reported.  Reporter stated that his wife got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months details included Booster dose on 08Jan2022 ,Lot - 033H21A.    This case was linked to MOD-2022-467313, MOD-2022-467315 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2022-467290, MOD-2022-467315 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 037F21A and 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months). On 08-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the booster dose too early, because of the negligence of the pharmacist. It was 24 days before the 5 months) had resolved.            No concomitant medications were reported. No treatment medications were reported. The reporter denied side effects. It was reported that there was no product complaint associated with this case.   This case was linked to MOD-2022-467290, MOD-2022-467313 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: gave me only .25 ml for my second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (gave me only .25 ml for my second dose) 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (gave me only .25 ml for my second dose). At the time of the report, UNDERDOSE (gave me only .25 ml for my second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the patient received only .25 ml for their second dose.   No treatment information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder, Inflammation, Blood pressure abnormal and Insulin resistance. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Autoimmune disorder, LISINOPRIL for Blood pressure abnormal, CELECOXIB for Inflammation, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Insulin resistance.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Felt tired). On 25-Mar-2021, FATIGUE (Felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received first dose of Moderna COVID-19 Vaccine on 18-Mar-2021. After receiving the 1st shot, patient just felt tired for around 1 week..  No treatment information was provided by the reporter.   This case was linked to MOD-2022-467362 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Aches; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Aches), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). In April 2021, PAIN (Aches), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. The patient stated that, she used to be active and pretty healthy.   This case was linked to MOD-2022-466170 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Pruritus, Rash
Clinical narrative: Skin Rashes 2 weeks after booster; Little bubbles / pimples on the skin 2 weeks after booster Similar to mosquito bites on the skin 2 weeks after booster; Itching skin 2 weeks after booster; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin Rashes 2 weeks after booster), ACNE (Little bubbles / pimples on the skin 2 weeks after booster Similar to mosquito bites on the skin 2 weeks after booster) and PRURITUS (Itching skin 2 weeks after booster) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A, 004C21A and 003321-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, the patient experienced RASH (Skin Rashes 2 weeks after booster), ACNE (Little bubbles / pimples on the skin 2 weeks after booster Similar to mosquito bites on the skin 2 weeks after booster) and PRURITUS (Itching skin 2 weeks after booster). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and COCONUT OIL ongoing since an unknown date for Itch, at an unspecified dose and frequency. At the time of the report, RASH (Skin Rashes 2 weeks after booster) and ACNE (Little bubbles / pimples on the skin 2 weeks after booster Similar to mosquito bites on the skin 2 weeks after booster) outcome was unknown and PRURITUS (Itching skin 2 weeks after booster) had resolved.            No concomitant medication was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired for 12 hours) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt tired for 12 hours). In January 2021, FATIGUE (felt tired for 12 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2022-467416 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow up received on 31-Jan-2022 contains no new information.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Inflammation, Pyrexia, Tooth fracture, Vaccination site pain
Clinical narrative: she had an accident; she broke a tooth; inflammation; I had pain in the arm; I had a slight fever; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT (she had an accident), TOOTH FRACTURE (she broke a tooth), INFLAMMATION (inflammation), VACCINATION SITE PAIN (I had pain in the arm) and PYREXIA (I had a slight fever) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016CK1A and 042B21-2A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PRAVASTATIN, LISINOPRIL and METFORMIN HYDROCHLORIDE (CETAPIN) for an unknown indication.   On 14-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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENT (she had an accident), TOOTH FRACTURE (she broke a tooth), INFLAMMATION (inflammation), VACCINATION SITE PAIN (I had pain in the arm) and PYREXIA (I had a slight fever). At the time of the report, ACCIDENT (she had an accident), TOOTH FRACTURE (she broke a tooth) and INFLAMMATION (inflammation) outcome was unknown and VACCINATION SITE PAIN (I had pain in the arm) and PYREXIA (I had a slight fever) had resolved.            It was reported that patient had called to change her booster shot appointment which was on 04-FEB-2022, because she had an accident, she broke a tooth and because of the inflammation she was advised not to get the Moderna COVID-19 vaccine until it resolves.  No treatment medication details was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Body aches; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), PYREXIA (Slight fever) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03212A, 039K20-2A and 071R21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (Body aches), PYREXIA (Slight fever) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.  The patient had no adverse reactions after booster shot.   This case was linked to MOD-2022-467403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow-up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash after receiving Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash after receiving Moderna COVID-19 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash after receiving Moderna COVID-19 vaccine). At the time of the report, RASH (Rash after receiving Moderna COVID-19 vaccine) outcome was unknown.            Patient details was mentioned as Unknown group. Concomitant and treatment medication was not reported.   This case was linked to MOD22-005566 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Person administering the shot gave me wrong dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Person administering the shot gave me wrong dose) 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. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Person administering the shot gave me wrong dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Person administering the shot gave me wrong dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 044A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Additional information was reported as follows: Date the vial was initially stored in the refrigerator was on 26Jan2022 at 8 am. It was reported that vial had not undergone any temperature excursions.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cough, Fatigue, Nasal congestion, Nasopharyngitis
Clinical narrative: Severe Congestion; Coughing; Fatigue; Runny Nose; Sneezing; Not sick but has Colds/Slight Colds; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), NASAL CONGESTION (Severe Congestion), COUGH (Coughing) and NASOPHARYNGITIS (Not sick but has Colds/Slight Colds) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0035252A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Pfizer (second dose) in April 2021 and Pfizer (first dose) in April 2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced NASOPHARYNGITIS (Not sick but has Colds/Slight Colds). On 21-Jan-2022, the patient experienced RHINORRHOEA (Runny Nose) and SNEEZING (Sneezing). On 25-Jan-2022, the patient experienced NASAL CONGESTION (Severe Congestion), COUGH (Coughing) and FATIGUE (Fatigue). The patient was treated with PHENYLEPHRINE HYDROCHLORIDE (SUDAFED PE) at a dose of 2tabs 4x a day every 6hrs and IBUPROFEN at a dose of 400 milligram twice a day. On 28-Jan-2022, NASAL CONGESTION (Severe Congestion), COUGH (Coughing), NASOPHARYNGITIS (Not sick but has Colds/Slight Colds) and FATIGUE (Fatigue) had resolved. At the time of the report, RHINORRHOEA (Runny Nose) had not resolved and SNEEZING (Sneezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2022, Blood pressure measurement: normal (normal) Normal. On 23-Jan-2022, Vital signs measurement: normal (normal) Normal.         No concomitant medication, no vitamins and no allergies were reported. Reported to physician on the 23rd Monday for normal check-up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Vital signs measurement
Clinical narrative: Severe Congestion; Coughing; Fatigue; Runny Nose; Sneezing; Not sick but has Colds/Slight Colds; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), NASAL CONGESTION (Severe Congestion), COUGH (Coughing) and NASOPHARYNGITIS (Not sick but has Colds/Slight Colds) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0035252A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Pfizer (second dose) in April 2021 and Pfizer (first dose) in April 2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced NASOPHARYNGITIS (Not sick but has Colds/Slight Colds). On 21-Jan-2022, the patient experienced RHINORRHOEA (Runny Nose) and SNEEZING (Sneezing). On 25-Jan-2022, the patient experienced NASAL CONGESTION (Severe Congestion), COUGH (Coughing) and FATIGUE (Fatigue). The patient was treated with PHENYLEPHRINE HYDROCHLORIDE (SUDAFED PE) at a dose of 2tabs 4x a day every 6hrs and IBUPROFEN at a dose of 400 milligram twice a day. On 28-Jan-2022, NASAL CONGESTION (Severe Congestion), COUGH (Coughing), NASOPHARYNGITIS (Not sick but has Colds/Slight Colds) and FATIGUE (Fatigue) had resolved. At the time of the report, RHINORRHOEA (Runny Nose) had not resolved and SNEEZING (Sneezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2022, Blood pressure measurement: normal (normal) Normal. On 23-Jan-2022, Vital signs measurement: normal (normal) Normal.         No concomitant medication, no vitamins and no allergies were reported. Reported to physician on the 23rd Monday for normal check-up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenitis, Product administered to patient of inappropriate age
Clinical narrative: The recipient of this vaccine is 12 years old.; Inflamed lymph nodes under his arm; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENITIS (Inflamed lymph nodes under his arm), CHILLS (Chills) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (The recipient of this vaccine is 12 years old.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Patient received 2 primary doses of the Pfizer COVID-19 vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In January 2022, the patient experienced LYMPHADENITIS (Inflamed lymph nodes under his arm) and CHILLS (Chills). On 29-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (The recipient of this vaccine is 12 years old.). The patient was treated with IBUPROFEN in January 2022 for Chills and Lymph node inflammation, at an unspecified dose and frequency. On 29-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (The recipient of this vaccine is 12 years old.) had resolved. At the time of the report, LYMPHADENITIS (Inflamed lymph nodes under his arm) and CHILLS (Chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were provided. It was reported that since receiving the booster dose of the vaccine the patient experienced the event and was ongoing at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Got symptoms worse and longer lasting than her own; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Got symptoms worse and longer lasting than her own) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got symptoms worse and longer lasting than her own). At the time of the report, VACCINATION COMPLICATION (Got symptoms worse and longer lasting than her own) 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 are provided. No treatment medications are provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: dermographia with welts & hives; dermographia with welts & hives; This spontaneous case was reported by an other health care professional and describes the occurrence of MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK UNK, qd. At the time of the report, MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD22-005475 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a non-health professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They gave a patient the Moderna booster after the 30-day Use by Date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave a patient the Moderna booster after the 30-day Use by Date.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave a patient the Moderna booster after the 30-day Use by Date.). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (They gave a patient the Moderna booster after the 30-day Use by Date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.  On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-467668, MOD-2021-435280 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Myalgia, Vaccination complication
Clinical narrative: Sicker than a dog; Laid in bed for 36 hours; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Laid in bed for 36 hours), ILLNESS (Sicker than a dog) and MYALGIA (Arm was sore) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concomitant products included MELATONIN and ALLOPURINOL for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION COMPLICATION (Laid in bed for 36 hours). In April 2021, the patient experienced MYALGIA (Arm was sore). On an unknown date, the patient experienced ILLNESS (Sicker than a dog). In April 2021, VACCINATION COMPLICATION (Laid in bed for 36 hours), ILLNESS (Sicker than a dog) and MYALGIA (Arm was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.  On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.  Concomitant medication of the patient was not reported.  The patient did not remember on which arm he received his Moderna COVID-19 vaccine.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-467633, MOD-2021-435280 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: laid in bed for 36 hours; sicker than a dog; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (laid in bed for 36 hours), ILLNESS (sicker than a dog) and PAIN IN EXTREMITY (arm was sore) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Broken bones (Patient fell off the roof and had broken multiple bone about 30 years ago). Concomitant products included MELATONIN and ALLOPURINOL for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION COMPLICATION (laid in bed for 36 hours). In March 2021, the patient experienced ILLNESS (sicker than a dog) and PAIN IN EXTREMITY (arm was sore). On 09-Mar-2021, VACCINATION COMPLICATION (laid in bed for 36 hours) had resolved. In March 2021, ILLNESS (sicker than a dog) and PAIN IN EXTREMITY (arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication use was reported.   This case was linked to MOD-2022-467651, MOD-2022-467677 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Pain in extremity, Vaccination complication
Clinical narrative: laid in bed for 36 hours; sicker than a dog; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (laid in bed for 36 hours), ILLNESS (sicker than a dog) and PAIN IN EXTREMITY (arm was sore) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Broken bones (Patient fell off the roof and had broken multiple bone about 30 years ago). Concomitant products included MELATONIN and ALLOPURINOL for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION COMPLICATION (laid in bed for 36 hours). In March 2021, the patient experienced ILLNESS (sicker than a dog) and PAIN IN EXTREMITY (arm was sore). On 09-Mar-2021, VACCINATION COMPLICATION (laid in bed for 36 hours) had resolved. In March 2021, ILLNESS (sicker than a dog) and PAIN IN EXTREMITY (arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication use was reported.   This case was linked to MOD-2022-467651, MOD-2022-467677 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Disseminated varicella zoster virus infection
Clinical narrative: disseminated varicella-zoster virus infection; This literature-non-study case was reported in a literature article and describes the occurrence of DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated varicella-zoster virus infection) in a 70-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 DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated varicella-zoster virus infection) (seriousness criteria hospitalization and medically significant). At the time of the report, DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated varicella-zoster virus infection) 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 considered DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated varicella-zoster virus infection) to be related.    No concomitant medications were reported. No treatment information was provided.  Company comment: This case concerns a 70-year-old female patient with no medical history provided who experienced serious unexpected event of Disseminated varicella zoster virus infection which required hospitalization. The event occurred after the first dose of mRNA-1273. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event nor hospitalization details was provided. Causality is confounded with patient's advanced age. The Reporter assessed the event as related to the Company product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 70-year-old female patient with no medical history provided who experienced serious unexpected event of Disseminated varicella zoster virus infection which required hospitalization. The event occurred after the first dose of mRNA-1273. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event nor hospitalization details was provided. Causality is confounded with patient's advanced age. The Reporter assessed the event as related to the Company product. The benefit-risk relationship of mRNA-1273 is not affected by this report.