chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Influenza like illness, Myalgia, Nasopharyngitis
Clinical narrative: This spontaneous case was reported by a  and describes the occurrence of ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold) and PAIN IN EXTREMITY (under arm was sore) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (under arm was sore) and MYALGIA (body hurt). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ALKA SELTZER PLUS AND FLU) at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (under arm was sore) and MYALGIA (body hurt) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided/unknown by the reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a  and describes the occurrence of ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold) and PAIN IN EXTREMITY (under arm was sore) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (under arm was sore) and MYALGIA (body hurt). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ALKA SELTZER PLUS AND FLU) at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (under arm was sore) and MYALGIA (body hurt) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided/unknown by the reporter.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, SARS-CoV-2 test
Clinical narrative: Vaccine given to the patient as she was 16 years old; A spontaneous report was received from a nurse, concerning a 16-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273)/product administered to patient of inappropriate age.   The patient's medical history as provided included COVID positive on 09 Feb 2021. Products known to have been used by the patient, within two weeks prior to the event included benzoyl peroxide 5% topical cleanser.  On 18 Feb 2021 at 03:30 pm, the patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection considered as product administered to patient of inappropriate age.   It was reported that the patient was doing well with no signs and symptoms.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event Moderna vaccine given to the patient when she was 16 years old/ product administered to patient of inappropriate age was considered as resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age, for mRNA-1273, lot #: 016M20A, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: assistant was out of the office for three to four days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (assistant was out of the office for three to four days after the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (assistant was out of the office for three to four days after the vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (assistant was out of the office for three to four days after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       From the first dose she just had a sore arm later in the evening
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Erythema, Fatigue
Clinical narrative: Arm is swollen and red under the armpit; Gland around her neck is swollen; Weakness; like she has the flu; Pain throughout her body; Arm is swollen and red under the armpit; fever is 100.9 ° F; Tired; Chills; Nausea in her stomach/nausea every time she eats; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Arm is swollen and red under the armpit), LYMPHADENOPATHY (Gland around her neck is swollen), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (like she has the flu) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN for Allergy.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced CHILLS (Chills) and NAUSEA (Nausea in her stomach/nausea every time she eats). On 24-Mar-2021, the patient experienced LYMPHADENOPATHY (Arm is swollen and red under the armpit), LYMPHADENOPATHY (Gland around her neck is swollen), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (like she has the flu), MYALGIA (Pain throughout her body), ERYTHEMA (Arm is swollen and red under the armpit), PYREXIA (fever is 100.9 ° F) and FATIGUE (Tired). At the time of the report, LYMPHADENOPATHY (Arm is swollen and red under the armpit), LYMPHADENOPATHY (Gland around her neck is swollen), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (like she has the flu), CHILLS (Chills), NAUSEA (Nausea in her stomach/nausea every time she eats), MYALGIA (Pain throughout her body), ERYTHEMA (Arm is swollen and red under the armpit), PYREXIA (fever is 100.9 ° F) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 100.9 ° f High.         Treatment information was not provided. /unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Myalgia, Nausea, Pyrexia
Clinical narrative: Arm is swollen and red under the armpit; Gland around her neck is swollen; Weakness; like she has the flu; Pain throughout her body; Arm is swollen and red under the armpit; fever is 100.9 ° F; Tired; Chills; Nausea in her stomach/nausea every time she eats; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Arm is swollen and red under the armpit), LYMPHADENOPATHY (Gland around her neck is swollen), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (like she has the flu) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN for Allergy.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced CHILLS (Chills) and NAUSEA (Nausea in her stomach/nausea every time she eats). On 24-Mar-2021, the patient experienced LYMPHADENOPATHY (Arm is swollen and red under the armpit), LYMPHADENOPATHY (Gland around her neck is swollen), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (like she has the flu), MYALGIA (Pain throughout her body), ERYTHEMA (Arm is swollen and red under the armpit), PYREXIA (fever is 100.9 ° F) and FATIGUE (Tired). At the time of the report, LYMPHADENOPATHY (Arm is swollen and red under the armpit), LYMPHADENOPATHY (Gland around her neck is swollen), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (like she has the flu), CHILLS (Chills), NAUSEA (Nausea in her stomach/nausea every time she eats), MYALGIA (Pain throughout her body), ERYTHEMA (Arm is swollen and red under the armpit), PYREXIA (fever is 100.9 ° F) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 100.9 ° f High.         Treatment information was not provided. /unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Brain fog; Loss appetite; Pain in injection site (right); Fatigue; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and CALCIPOTRIOL (DOVONEX) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-Mar-2021 at a dose of 2 doses. On 07-Mar-2021, FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had resolved. On 09-Mar-2021, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was recommended for second dose on 30 March 2021.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Added concomitant medication and amended narrative.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Brain fog; Loss appetite; Pain in injection site (right); Fatigue; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and CALCIPOTRIOL (DOVONEX) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-Mar-2021 at a dose of 2 doses. On 07-Mar-2021, FEELING ABNORMAL (Brain fog), DECREASED APPETITE (Loss appetite), VACCINATION SITE PAIN (Pain in injection site (right)), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had resolved. On 09-Mar-2021, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was recommended for second dose on 30 March 2021.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Added concomitant medication and amended narrative.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site warmth, Type IV hypersensitivity reaction
Clinical narrative: mark is hot and warm to the touch; mark is now spreading into a round red spot  / got the mark again after it cleared; Covid-arm; hard round lump in her arm; red dot at or near injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid-arm), INJECTION SITE MASS (hard round lump in her arm), INJECTION SITE DISCOLOURATION (red dot at or near injection site), INJECTION SITE WARMTH (mark is hot and warm to the touch) and INJECTION SITE ERYTHEMA (mark is now spreading into a round red spot  / got the mark again after it cleared) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid-arm) and INJECTION SITE DISCOLOURATION (red dot at or near injection site). 20-Mar-2021, the patient experienced INJECTION SITE MASS (hard round lump in her arm). On an unknown date, the patient experienced INJECTION SITE WARMTH (mark is hot and warm to the touch) and INJECTION SITE ERYTHEMA (mark is now spreading into a round red spot  / got the mark again after it cleared). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Covid-arm), INJECTION SITE WARMTH (mark is hot and warm to the touch) and INJECTION SITE ERYTHEMA (mark is now spreading into a round red spot  / got the mark again after it cleared) outcome was unknown and INJECTION SITE MASS (hard round lump in her arm) and INJECTION SITE DISCOLOURATION (red dot at or near injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Paraesthesia, Vertigo
Clinical narrative: stability problems; vertigo; tingling; chills; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (stability problems), VERTIGO (vertigo), PARAESTHESIA (tingling) and CHILLS (chills) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BALANCE DISORDER (stability problems), VERTIGO (vertigo), PARAESTHESIA (tingling) and CHILLS (chills). At the time of the report, BALANCE DISORDER (stability problems), VERTIGO (vertigo), PARAESTHESIA (tingling) and CHILLS (chills) 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 was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI, Per reporter - "You will have to make it easier to send back.  We couldn't return it". On 15-Jul-2021: Significant follow up received on 15-JUL-2021. Patient updated the outcome as resolved by stating 'No symptoms remain'.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema
Clinical narrative: it also feels warm; Arm turned really red on the injection site, the size of my hand; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (it also feels warm) and VACCINATION SITE ERYTHEMA (Arm turned really red on the injection site, the size of my hand) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. (1 or 0) 27A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FEELING HOT (it also feels warm) and VACCINATION SITE ERYTHEMA (Arm turned really red on the injection site, the size of my hand). At the time of the report, FEELING HOT (it also feels warm) and VACCINATION SITE ERYTHEMA (Arm turned really red on the injection site, the size of my hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  Treatment using  anti itch cream was reported
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received a third dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 20-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine). On 20-Mar-2021, EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of Extra dose administered for mRNA-1273 (Lot number: Unknown) with no associated AEs.; Sender's Comments: This report refers to a case of Extra dose administered for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: face was swollen on both side; swelling in her upper lip.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was swollen on both side) and LIP SWELLING (swelling in her upper lip.) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (face was swollen on both side) and LIP SWELLING (swelling in her upper lip.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SWELLING FACE (face was swollen on both side) and LIP SWELLING (swelling in her upper lip.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pruritus, Rash, Swelling face
Clinical narrative: Rash on her face got really bad; Swelling of her whole face after the second dose; Redness on her whole face after the second dose; Itching on her whole face after the second dose; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), SWELLING FACE (Swelling of her whole face after the second dose), ERYTHEMA (Redness on her whole face after the second dose), PRURITUS (Itching on her whole face after the second dose) and RASH (Rash on her face got really bad) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced SWELLING FACE (Swelling of her whole face after the second dose), ERYTHEMA (Redness on her whole face after the second dose) and PRURITUS (Itching on her whole face after the second dose). On 20-Mar-2021, the patient experienced RASH (Rash on her face got really bad). At the time of the report, FATIGUE (Fatigue), SWELLING FACE (Swelling of her whole face after the second dose), ERYTHEMA (Redness on her whole face after the second dose), PRURITUS (Itching on her whole face after the second dose) and RASH (Rash on her face got really bad) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    This case was linked to MOD21-061327, MOD-2021-062562 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: aches in her legs and arms; she has been experiencing fever; headache/severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in her legs and arms), PYREXIA (she has been experiencing fever) and HEADACHE (headache/severe headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Fibromyalgia.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (aches in her legs and arms), PYREXIA (she has been experiencing fever) and HEADACHE (headache/severe headache). At the time of the report, PAIN IN EXTREMITY (aches in her legs and arms), PYREXIA (she has been experiencing fever) and HEADACHE (headache/severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. Treatment included paracetamol.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: fever; Nausea; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), NAUSEA (Nausea) and CHILLS (chills) 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) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), NAUSEA (Nausea) and CHILLS (chills). At the time of the report, PYREXIA (fever), NAUSEA (Nausea) and CHILLS (chills) outcome was unknown. Not Provided          No Concomitant Medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A rash across her stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash across her stomach) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (A rash across her stomach). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (A rash across her stomach) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified high blood pressure medicine and diabetes medication.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection site reaction, cherry red circle size of a half dollar; Injection site reaction is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site reaction, cherry red circle size of a half dollar) and VACCINATION SITE PRURITUS (Injection site reaction is itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.    Co-suspect product included non-company product DIAZEPAM for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN and BACILLUS LICHENFORMIS (ENTERAC).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient started DIAZEPAM (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site reaction, cherry red circle size of a half dollar) and VACCINATION SITE PRURITUS (Injection site reaction is itchy). At the time of the report, VACCINATION SITE ERYTHEMA (injection site reaction, cherry red circle size of a half dollar) and VACCINATION SITE PRURITUS (Injection site reaction is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Sinus congestion
Clinical narrative: feel dizzy/having dizzy spells; Sinus congestion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy/having dizzy spells) and SINUS CONGESTION (Sinus congestion) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.  The patient's past medical history included Glaucoma. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (SUDAFED OM SINUS CONGESTION) for Sinus congestion, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MECLIZINE HCL, URSODEOXYCHOLIC ACID (URSODOL) and PANCREATIN (CREON) for an unknown indication.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (feel dizzy/having dizzy spells). On an unknown date, the patient experienced SINUS CONGESTION (Sinus congestion). At the time of the report, DIZZINESS (feel dizzy/having dizzy spells) and SINUS CONGESTION (Sinus congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Primary care gave him meclizine for dizziness. Sinus congestion was put on sudafed   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: date of birth of patient updated in followup
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Pain, Pyrexia, Rash
Clinical narrative: itchy rash that comes and goes; swelling underneath the armpit; Pain; fever; Rash generalised; Hives Generalised; Eryrhema generalised; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (itchy rash that comes and goes), URTICARIA (Hives Generalised), ERYTHEMA (Eryrhema generalised), SWELLING (swelling underneath the armpit) and PAIN (Pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (Yearly) and HEPATITIS B VACCIN (13 years ago). Concurrent medical conditions included Hypothyroidism since 2017 and Type 2 diabetes mellitus. Concomitant products included SEMAGLUTIDE (OZEMPIC) and LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced URTICARIA (Hives Generalised), ERYTHEMA (Eryrhema generalised) and RASH (Rash generalised). On 26-Feb-2021, the patient experienced SWELLING (swelling underneath the armpit), PAIN (Pain) and PYREXIA (fever). On 12-Mar-2021, the patient experienced RASH PRURITIC (itchy rash that comes and goes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 28-Feb-2021, SWELLING (swelling underneath the armpit), PAIN (Pain) and PYREXIA (fever) had resolved. On 06-Apr-2021, URTICARIA (Hives Generalised), ERYTHEMA (Eryrhema generalised) and RASH (Rash generalised) had resolved. At the time of the report, RASH PRURITIC (itchy rash that comes and goes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101 (High) 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include steroid cream.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Other relevant history and lab data added, Patient details added, AE Added. Outcome of event added.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Swelling, Urticaria
Clinical narrative: itchy rash that comes and goes; swelling underneath the armpit; Pain; fever; Rash generalised; Hives Generalised; Eryrhema generalised; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (itchy rash that comes and goes), URTICARIA (Hives Generalised), ERYTHEMA (Eryrhema generalised), SWELLING (swelling underneath the armpit) and PAIN (Pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (Yearly) and HEPATITIS B VACCIN (13 years ago). Concurrent medical conditions included Hypothyroidism since 2017 and Type 2 diabetes mellitus. Concomitant products included SEMAGLUTIDE (OZEMPIC) and LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced URTICARIA (Hives Generalised), ERYTHEMA (Eryrhema generalised) and RASH (Rash generalised). On 26-Feb-2021, the patient experienced SWELLING (swelling underneath the armpit), PAIN (Pain) and PYREXIA (fever). On 12-Mar-2021, the patient experienced RASH PRURITIC (itchy rash that comes and goes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 28-Feb-2021, SWELLING (swelling underneath the armpit), PAIN (Pain) and PYREXIA (fever) had resolved. On 06-Apr-2021, URTICARIA (Hives Generalised), ERYTHEMA (Eryrhema generalised) and RASH (Rash generalised) had resolved. At the time of the report, RASH PRURITIC (itchy rash that comes and goes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101 (High) 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include steroid cream.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Other relevant history and lab data added, Patient details added, AE Added. Outcome of event added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Headache, Hypertension
Clinical narrative: High Blood pressure 180/117 mm of Hg; Mild headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High Blood pressure 180/117 mm of Hg), HEADACHE (Mild headache) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included LANSOPRAZOLE (PREVACID), NITROFURANTOIN, ESCITALOPRAM OXALATE (LEXAPRO), ALPRAZOLAM, MELOXICAM, MONTELUKAST, ATORVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (Mild headache) and FATIGUE (Fatigue). On 08-Mar-2021, the patient experienced HYPERTENSION (High Blood pressure 180/117 mm of Hg). At the time of the report, HYPERTENSION (High Blood pressure 180/117 mm of Hg) was resolving and HEADACHE (Mild headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood pressure measurement: 180/117 mmHg (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included anti-hypertensive medicines.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness on same side, lasted longer for 12 hrs; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Facial numbness on same side, lasted longer for 12 hrs) in a 55-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 No adverse event. Concomitant product use was not reported by the reporter.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA (Facial numbness on same side, lasted longer for 12 hrs). On 03-Mar-2021, HYPOAESTHESIA (Facial numbness on same side, lasted longer for 12 hrs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Illness, Malaise, Rash, Vaccination site rash
Clinical narrative: rash all over body; feeling sick , not well; rash at injection site; fast heartbeat; feeling sick , not well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED, MALAISE, ILLNESS, VACCINATION SITE RASH, and RASH in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1030M20A and 003A21A) for an unknown indication.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced HEART RATE INCREASED, MALAISE, and VACCINATION SITE RASH. On 09-Mar-2021, the patient experienced ILLNESS. On 17-Mar-2021, the patient experienced RASH. On 11-Feb-2021, MALAISE and VACCINATION SITE RASH outcome was unknown. On 11-Mar-2021, ILLNESS outcome was unknown. At the time of the report, HEART RATE INCREASED and RASH outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable No concomitant was provided. Patient treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both legs) 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 20-Mar-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. On an unknown date, the patient experienced RASH (Rash on both legs). At the time of the report, RASH (Rash on both legs) had not resolved. Not Provided          Patient stated has taken allergy medication and no relief yet.  Patient stated has been visiting HCP.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed urticaria within an hour after; 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 URTICARIA (Developed urticaria within an hour after) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Developed urticaria within an hour after). At the time of the report, URTICARIA (Developed urticaria within an hour after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  NO treatment was provided for events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Mass, Vomiting
Clinical narrative: Sweating; Threw up; Chills; Painful lump on right collar bone; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Painful lump on right collar bone), HYPERHIDROSIS (Sweating), VOMITING (Threw up) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MASS (Painful lump on right collar bone). On 23-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), VOMITING (Threw up) and CHILLS (Chills). At the time of the report, MASS (Painful lump on right collar bone), HYPERHIDROSIS (Sweating), VOMITING (Threw up) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started to get sick), HEADACHE (Really bad headache), MYALGIA (Body ache) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031M20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced ILLNESS (Started to get sick), HEADACHE (Really bad headache), MYALGIA (Body ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (Started to get sick), HEADACHE (Really bad headache), MYALGIA (Body ache) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of maternal exposure during breast feeding (breastfeeding and received her 1st dose of the Moderna COVID-19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031A21A) for COVID-19 immunization. No medical history reported. On Mar 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced maternal exposure during breast feeding (breastfeeding and received her 1st dose of the Moderna COVID-19 vaccine). At the time of the report, maternal exposure during breast feeding (breastfeeding and received her 1st dose of the Moderna COVID-19 vaccine) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate, Inappropriate schedule of product administration
Clinical narrative: flu like symptoms with increased heart rate; Muscle ache (like coming down with bad flu); Fast heart beat (103-109); Caller >35 days from first vaccination; Fatigue; Chills; Body ache; Stuffy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), NASAL CONGESTION (Stuffy) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), NASAL CONGESTION (Stuffy), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller >35 days from first vaccination). On 12-Mar-2021, the patient experienced TACHYCARDIA (Fast heart beat (103-109)). On 15-Mar-2021, the patient experienced MYALGIA (Muscle ache (like coming down with bad flu)). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms with increased heart rate). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), NASAL CONGESTION (Stuffy), HEADACHE (Headache), MYALGIA (Muscle ache (like coming down with bad flu)) and TACHYCARDIA (Fast heart beat (103-109)) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: 103-109 (High) heart beating fast (103-109) for 20-30 minutes..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications reported by investigator  Water is the other treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14MAY2021, contains reporter details, additional events added Flu like symptoms and patient state that she didn't go back for 2nd dose and patient is due for 2nd dose i.e greater than 35days from first vaccination.