chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient stated that she received the 3 doses on the Moderna vaccine; A spontaneous report was received from a pharmacist concerning a elderly (patient age :unknown) female patient, who received three doses of Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not reported by the reporter. Concomitant medications were not provided by the reporter.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown). On an unknown date, the patient received their second  to two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection   On an unknown date, the elderly patient had received three doses of Moderna vaccine.    Treatment activities was not reported by the reporter.   Action taken with mRNA-1273 in response to the events was not applicable    The outcome of events, received three doses of Moderna vaccine was considered resolved.; Reporter's Comments: This report refers to an elderly (patient age: unknown) female patient who experienced who received three doses (Extra dose administered) for mRNA-1273 (Lot number: unknown). There were no reported AEs associated with this case of extra dose administered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Doctor advised that these reactions were because dose was given to her improperly; Rash at injection site; Pain at injection site; Oval outline (COVID arm) at injections; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Doctor advised that these reactions were because dose was given to her improperly), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Oval outline (COVID arm) at injections) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Oval outline (COVID arm) at injections). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Doctor advised that these reactions were because dose was given to her improperly). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INCORRECT DOSE ADMINISTERED (Doctor advised that these reactions were because dose was given to her improperly), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Oval outline (COVID arm) at injections) had resolved.            Concomitant product use was not provided by the reporter.  Additional treatment medication was antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added dose 2. Added event (incorrect dose administered) and added event outcome was recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Decreased appetite, Fatigue
Clinical narrative: tested positive for Covid19; Loss of appetite; Aching in her neck which got to the other side; Couldn't smell anything; Couldn't taste anything; LIttle bit of headache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid19), DECREASED APPETITE (Loss of appetite), NECK PAIN (Aching in her neck which got to the other side), ANOSMIA (Couldn't smell anything) and AGEUSIA (Couldn't taste anything) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (In her right knee.) and Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), NECK PAIN (Aching in her neck which got to the other side), ANOSMIA (Couldn't smell anything), AGEUSIA (Couldn't taste anything), HEADACHE (LIttle bit of headache), FATIGUE (Fatigue) and PYREXIA (Fever). On 03-Mar-2021, the patient experienced COVID-19 (tested positive for Covid19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid19), DECREASED APPETITE (Loss of appetite), NECK PAIN (Aching in her neck which got to the other side), HEADACHE (LIttle bit of headache), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown and ANOSMIA (Couldn't smell anything) and AGEUSIA (Couldn't taste anything) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Oxygen saturation: 95 % (Low) pulse oxygen went down to about 95% but didn't go any lower..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports that after the first dose her pulse oxygen was 95%..    This case was linked to MOD-2021-244666 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant Follow-up received on 01-JUL-2021, Added other events and lab data. On 16-Jul-2021: Follow up received on 16-JUL-2021 contains No New Information. On 28-Jul-2021: Non-significant follow-up case booked in; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This is also a case with an adverse event of COVID-19. Based on the mechanism of action of mRNA-1273 the event COVID-19 is unlikely related to the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Oxygen saturation, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for Covid19; Loss of appetite; Aching in her neck which got to the other side; Couldn't smell anything; Couldn't taste anything; LIttle bit of headache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid19), DECREASED APPETITE (Loss of appetite), NECK PAIN (Aching in her neck which got to the other side), ANOSMIA (Couldn't smell anything) and AGEUSIA (Couldn't taste anything) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (In her right knee.) and Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), NECK PAIN (Aching in her neck which got to the other side), ANOSMIA (Couldn't smell anything), AGEUSIA (Couldn't taste anything), HEADACHE (LIttle bit of headache), FATIGUE (Fatigue) and PYREXIA (Fever). On 03-Mar-2021, the patient experienced COVID-19 (tested positive for Covid19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid19), DECREASED APPETITE (Loss of appetite), NECK PAIN (Aching in her neck which got to the other side), HEADACHE (LIttle bit of headache), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown and ANOSMIA (Couldn't smell anything) and AGEUSIA (Couldn't taste anything) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Oxygen saturation: 95 % (Low) pulse oxygen went down to about 95% but didn't go any lower..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports that after the first dose her pulse oxygen was 95%..    This case was linked to MOD-2021-244666 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant Follow-up received on 01-JUL-2021, Added other events and lab data. On 16-Jul-2021: Follow up received on 16-JUL-2021 contains No New Information. On 28-Jul-2021: Non-significant follow-up case booked in; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This is also a case with an adverse event of COVID-19. Based on the mechanism of action of mRNA-1273 the event COVID-19 is unlikely related to the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Ear pain, Headache, Lacrimation increased, Reduced facial expression
Clinical narrative: left side of face tight; Bone pain around eye and cheek bone; headache; left eye watering; Face tightness; Ear ache; This spontaneous case was reported by a consumer and describes the occurrence of REDUCED FACIAL EXPRESSION (left side of face tight), BONE PAIN (Bone pain around eye and cheek bone), HEADACHE (headache), LACRIMATION INCREASED (left eye watering) and REDUCED FACIAL EXPRESSION (Face tightness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced REDUCED FACIAL EXPRESSION (left side of face tight), BONE PAIN (Bone pain around eye and cheek bone), HEADACHE (headache), LACRIMATION INCREASED (left eye watering), REDUCED FACIAL EXPRESSION (Face tightness) and EAR PAIN (Ear ache). On 26-Feb-2021, HEADACHE (headache) had resolved. On 27-Feb-2021, LACRIMATION INCREASED (left eye watering) had resolved. On 03-Mar-2021, BONE PAIN (Bone pain around eye and cheek bone) had resolved. At the time of the report, REDUCED FACIAL EXPRESSION (left side of face tight), REDUCED FACIAL EXPRESSION (Face tightness) and EAR PAIN (Ear ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Illness
Clinical narrative: Felt sick all day; Couldn't ate; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick all day) and DECREASED APPETITE (Couldn't ate) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included COPD since an unknown date. Concurrent medical conditions included Asthma and Hypertension.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Felt sick all day) and DECREASED APPETITE (Couldn't ate). At the time of the report, ILLNESS (Felt sick all day) and DECREASED APPETITE (Couldn't ate) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my wife had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my wife had a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) 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) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (my wife had a sore arm). At the time of the report, VACCINATION SITE PAIN (my wife had a sore arm) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD21-046688 (Linked Report).; Sender's Comments:  MOD21-046688:Cross linked
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered vaccination to a patient that was 17 years old; A spontaneous report () was received from a healthcare professional concerning a 17-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) (Product administered to patient of inappropriate age) .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The nurse was aware that the patient was recommended to be 18 years of age (Product administered to patient of inappropriate age).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 014M20A) with no associated AEs reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Headache, Lymphadenopathy
Clinical narrative: swollen glands/(swollen glands) hurt; it hurts to swallow/affecting her whole neck; headache/headache (on and off); tired/fatigue/tired(on and off)/fatigue (on and off); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen glands/(swollen glands) hurt), HEADACHE (headache/headache (on and off)), FATIGUE (tired/fatigue/tired(on and off)/fatigue (on and off)) and DYSPHAGIA (it hurts to swallow/affecting her whole neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M209) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (headache/headache (on and off)) and FATIGUE (tired/fatigue/tired(on and off)/fatigue (on and off)). On 03-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen glands/(swollen glands) hurt) and DYSPHAGIA (it hurts to swallow/affecting her whole neck). On 19-Feb-2021, HEADACHE (headache/headache (on and off)) and FATIGUE (tired/fatigue/tired(on and off)/fatigue (on and off)) had resolved. At the time of the report, LYMPHADENOPATHY (swollen glands/(swollen glands) hurt) and DYSPHAGIA (it hurts to swallow/affecting her whole neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Night sweats, Sluggishness
Clinical narrative: woke up with night sweats only not as severe as before; still felt a bit sluggish; chills; body aches; This spontaneous case was reported by a  and describes the occurrence of NIGHT SWEATS (woke up with night sweats only not as severe as before), SLUGGISHNESS (still felt a bit sluggish), CHILLS (chills) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date and Anxiety since an unknown date. Concomitant products included OLMESARTAN for Hypertension, SODIUM CITRATE ACID (ALBACIT), CLONAZEPAM and TRAZODONE HYDROCHLORIDE (TRAZODONE ACTAVIS).   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NIGHT SWEATS (woke up with night sweats only not as severe as before), SLUGGISHNESS (still felt a bit sluggish), CHILLS (chills) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (woke up with night sweats only not as severe as before), SLUGGISHNESS (still felt a bit sluggish), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.            This case was linked to MOD-2021-035731, MOD-2021-035745 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Shaking; Very Nauseated out of deep sleep; Feverish; A spontaneous report (United Sates) was received from a consumer, concerning an 77 years-old male, who received Moderna's COVID-19 vaccine (mRNA-1273), which patient received the second dose on 04 Mar 2021 an experienced being very nauseated, out of deep sleep shaking, and feverish.   The patient's medical history was not reported. The concomitant medications were Metoprolol and Eliquis.  04 Mar 2021 The 2nd dose of the vaccine prior to the onset event the patient (batch- lot 003A21A), was given intramuscularly in the arm for the prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced being very nauseated out of deep sleep, shaking and feverish  Action taken with second dose of mRNA-1273 was not applicable.  The outcome of the all events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches). At the time of the report, CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia, Vaccination complication
Clinical narrative: felt bad; side effects were worse after the second dose; fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), VACCINATION COMPLICATION (side effects were worse after the second dose) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad), VACCINATION COMPLICATION (side effects were worse after the second dose) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (felt bad), VACCINATION COMPLICATION (side effects were worse after the second dose) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.         No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received  updated event outcome to "Recovered" for all events.
Sex: U
Vaccine: COVID19
Symptoms: Device malfunction, Underdose
Clinical narrative: Vaccine leaked onto patient/syringe malfunctioned; Vaccine leaked onto patient; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE MALFUNCTION (Vaccine leaked onto patient/syringe malfunctioned) and UNDERDOSE (Vaccine leaked onto patient) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On 05-Mar-2021, the patient experienced DEVICE MALFUNCTION (Vaccine leaked onto patient/syringe malfunctioned) and UNDERDOSE (Vaccine leaked onto patient). On 05-Mar-2021, DEVICE MALFUNCTION (Vaccine leaked onto patient/syringe malfunctioned) and UNDERDOSE (Vaccine leaked onto patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.; Sender's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot # unknown), reporting (device malfunction and underdose) without any associated adverse events. The outcome of the events is reported as resolved.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Myalgia, Restlessness
Clinical narrative: Muscle pain; Restlessness on the night; Flu like symptoms; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restlessness on the night), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RESTLESSNESS (Restlessness on the night), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, RESTLESSNESS (Restlessness on the night), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-036335 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Whole day in bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Whole day in bed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Whole day in bed). At the time of the report, FEELING ABNORMAL (Whole day in bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications included. No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Diarrhea; Upset Stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset Stomach) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 04-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 DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset Stomach). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset Stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was reported as blood pressure medications.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant woman comes for the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant woman comes for the Moderna vaccine) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant woman comes for the Moderna vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant woman comes for the Moderna vaccine) 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 considered EXPOSURE DURING PREGNANCY (pregnant woman comes for the Moderna vaccine) to be not applicable.    No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Injection site pruritus, Myalgia, Pain
Clinical narrative: Fuzzy-headed feeling; Fatigue; Body aches; Just below the injection site that was a large raised area that was intensely itchy.; Arm Soreness; Extreme Pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy-headed feeling), VACCINATION SITE PAIN (Arm Soreness), PAIN (Extreme Pain), FATIGUE (Fatigue) and MYALGIA (Body aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Soreness) and PAIN (Extreme Pain). On 10-Feb-2021, the patient experienced FEELING ABNORMAL (Fuzzy-headed feeling), FATIGUE (Fatigue), MYALGIA (Body aches) and INJECTION SITE PRURITUS (Just below the injection site that was a large raised area that was intensely itchy.). At the time of the report, FEELING ABNORMAL (Fuzzy-headed feeling), VACCINATION SITE PAIN (Arm Soreness), PAIN (Extreme Pain), FATIGUE (Fatigue), MYALGIA (Body aches) and INJECTION SITE PRURITUS (Just below the injection site that was a large raised area that was intensely itchy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fuzzy-headed feeling; Fatigue; Body aches; Just below the injection site that was a large raised area that was intensely itchy.; Arm Soreness; Extreme Pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Fuzzy-headed feeling), VACCINATION SITE PAIN (Arm Soreness), PAIN (Extreme Pain), FATIGUE (Fatigue) and MYALGIA (Body aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Soreness) and PAIN (Extreme Pain). On 10-Feb-2021, the patient experienced FEELING ABNORMAL (Fuzzy-headed feeling), FATIGUE (Fatigue), MYALGIA (Body aches) and INJECTION SITE PRURITUS (Just below the injection site that was a large raised area that was intensely itchy.). At the time of the report, FEELING ABNORMAL (Fuzzy-headed feeling), VACCINATION SITE PAIN (Arm Soreness), PAIN (Extreme Pain), FATIGUE (Fatigue), MYALGIA (Body aches) and INJECTION SITE PRURITUS (Just below the injection site that was a large raised area that was intensely itchy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered 1ml of the vaccine instead of just 0.5ml; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1ml of the vaccine instead of just 0.5ml) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Mar-2021 at 11:15 AM, the patient experienced ACCIDENTAL OVERDOSE (administered 1ml of the vaccine instead of just 0.5ml). On 06-Mar-2021 at 11:15 AM, ACCIDENTAL OVERDOSE (administered 1ml of the vaccine instead of just 0.5ml) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-035792, US-MODERNATX, INC.-MOD-2021-035848, US-MODERNATX, INC.-MOD-2021-035866 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035792: US-MODERNATX, INC.-MOD-2021-035848: US-MODERNATX, INC.-MOD-2021-035866:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Vaccination site reaction
Clinical narrative: redness; covid arm; hypersensitivity reaction; itching all day; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (hypersensitivity reaction), PRURITUS (itching all day), ERYTHEMA (redness) and VACCINATION SITE REACTION (covid arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012l20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction (hypersensitivity reactions to vaccine - small pox ( 1976) it was itchy on the left arm for 12 months.) and Hypersensitivity reaction (hypersensitivity reactions to medications -penicillin ( rash after 10 days )). Concurrent medical conditions included Hypersensitivity reaction (codeine ( red cheeks )), Hives and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and TIOTROPIUM BROMIDE (SPIRIVA) for Asthma, ATORVASTATIN CALCIUM (LIPITOR) for Blood cholesterol abnormal, DENOSUMAB (PROLIA) for an unknown indication.   On 19-Jan-2021 at 6:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 6:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced HYPERSENSITIVITY (hypersensitivity reaction). 28-Jan-2021, the patient experienced PRURITUS (itching all day) and VACCINATION SITE REACTION (covid arm). On an unknown date, the patient experienced ERYTHEMA (redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) on 28-Jan-2021 for Hypersensitivity reaction, at a dose of 10 mg once a day and CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) (topical) from 28-Jan-2021 to 05-Feb-2021 for Hypersensitivity reaction, at a dose of UNK dosage form. On 02-May-2021, HYPERSENSITIVITY (hypersensitivity reaction) had resolved. At the time of the report, PRURITUS (itching all day) and VACCINATION SITE REACTION (covid arm) had resolved and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-041232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Added vaccines' batch numbers, patient demographics, medical history, concomitant drug indications and dosage information and treatment drugs.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HCTZ, OMEPRAZOLE and LATANOPROST for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-035804 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Throat irritation
Clinical narrative: raw throat; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (raw throat), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (raw throat), PYREXIA (fever) and CHILLS (chills). At the time of the report, THROAT IRRITATION (raw throat), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received on 01-MAY-2021: Contain No new information. patient to follow up through regular mail. On 09-Jul-2021: Follow Up was received on 09-JUL-2021 Contain no new information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: I gave 1ml of the vaccine instead of just 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (I gave 1ml of the vaccine instead of just 0.5ml) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunization.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 06-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (I gave 1ml of the vaccine instead of just 0.5ml). On 06-Mar-2021, ACCIDENTAL OVERDOSE (I gave 1ml of the vaccine instead of just 0.5ml) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to INC.-MOD-2021-035775 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-035775:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: itchy; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and SWELLING (swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (itchy) and SWELLING (swollen). On 20-Feb-2021, PRURITUS (itchy) and SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-035817 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain, Pruritus, Rash
Clinical narrative: blisters where the rash was but they were "separate" and on top of the rash; painful; itchy; "COVID arm" along with rashes on her chest, midriff, both legs, and both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters where the rash was but they were "separate" and on top of the rash), PAIN (painful), PRURITUS (itchy) and RASH ("COVID arm" along with rashes on her chest, midriff, both legs, and both arms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history was not reported .    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced BLISTER (blisters where the rash was but they were "separate" and on top of the rash), PAIN (painful), PRURITUS (itchy) and RASH ("COVID arm" along with rashes on her chest, midriff, both legs, and both arms). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ALOE VERA at an unspecified dose and frequency. On 01-Mar-2021, BLISTER (blisters where the rash was but they were "separate" and on top of the rash), PRURITUS (itchy) and RASH ("COVID arm" along with rashes on her chest, midriff, both legs, and both arms) had resolved and PAIN (painful) outcome was unknown.            No Concomitant medications were provided Treatment medication also includes Anti-itch medicines.    This case was linked to PT-MODERNATX, INC.-MOD-2021-045860 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Non-significant information, Patient's email address, case linking added.; Sender's Comments:  PT-MODERNATX, INC.-MOD-2021-045860:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Headache, Inhibiting antibodies, Lymphadenopathy
Clinical narrative: Redness; Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised; Fever 100F; Body aches; Headache; Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised), PYREXIA (Fever 100F), MYALGIA (Body aches) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Previously around one year ago, he was exposed to COVID.) in April 2020.    On 04-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (Redness), LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised), PYREXIA (Fever 100F), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PYREXIA (Fever 100F), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown and LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: (High) 100 F. On 17-Mar-2021, Inhibiting antibodies: (High) He did his test IGG antibody before first vaccine shot and result were under threshold. He did the second test 12 days after first shot and antibody tested at high level after it..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow-up information received on 02 Apr 2021.Added laboratory details, medical history and updated outcome of event.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Redness; Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised; Fever 100F; Body aches; Headache; Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised), PYREXIA (Fever 100F), MYALGIA (Body aches) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Previously around one year ago, he was exposed to COVID.) in April 2020.    On 04-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (Redness), LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised), PYREXIA (Fever 100F), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PYREXIA (Fever 100F), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown and LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: (High) 100 F. On 17-Mar-2021, Inhibiting antibodies: (High) He did his test IGG antibody before first vaccine shot and result were under threshold. He did the second test 12 days after first shot and antibody tested at high level after it..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow-up information received on 02 Apr 2021.Added laboratory details, medical history and updated outcome of event.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination site pruritus
Clinical narrative: Itchy rash on the arm; Rash is all over her front body; Spot of the injection is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on the arm), RASH (Rash is all over her front body) and VACCINATION SITE PRURITUS (Spot of the injection is itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (allergic to aspirin,codeine and sulfa drugs.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on the arm), RASH (Rash is all over her front body) and VACCINATION SITE PRURITUS (Spot of the injection is itchy). At the time of the report, RASH PRURITIC (Itchy rash on the arm), RASH (Rash is all over her front body) and VACCINATION SITE PRURITUS (Spot of the injection is itchy) outcome was unknown.            No Treatment information provided