chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: rapid heart beat; left arm soreness; body ache; chills; fever of 101.5F; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (rapid heart beat), PAIN IN EXTREMITY (left arm soreness), MYALGIA (body ache), CHILLS (chills) and PYREXIA (fever of 101.5F) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HEART RATE INCREASED (rapid heart beat), MYALGIA (body ache) and PYREXIA (fever of 101.5F). 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm soreness) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (rapid heart beat), PAIN IN EXTREMITY (left arm soreness), MYALGIA (body ache), CHILLS (chills) and PYREXIA (fever of 101.5F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Fatigue, Pruritus, Rash, Rash erythematous
Clinical narrative: Forehead broke out; On right cheek two small lumps; Top of head itching like crazy; Top of chest down to my boobs broke out; My back is starting to itch, like creepy ants crawling all over; Pin point red dots on stomach and legs but not itching; One arm is a little broke out; Real tired; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out) and PRURITUS (My back is starting to itch, like creepy ants crawling all over) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attacks and Thyroid disorder NOS (Thyroid). Concomitant products included LEVOTHYROXINE and CLONAZEPAM for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out), PRURITUS (My back is starting to itch, like creepy ants crawling all over), RASH ERYTHEMATOUS (Pin point red dots on stomach and legs but not itching), RASH (One arm is a little broke out) and FATIGUE (Real tired). At the time of the report, ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out), PRURITUS (My back is starting to itch, like creepy ants crawling all over), RASH ERYTHEMATOUS (Pin point red dots on stomach and legs but not itching), RASH (One arm is a little broke out) and FATIGUE (Real tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Forehead broke out; On right cheek two small lumps; Top of head itching like crazy; Top of chest down to my boobs broke out; My back is starting to itch, like creepy ants crawling all over; Pin point red dots on stomach and legs but not itching; One arm is a little broke out; Real tired; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out) and PRURITUS (My back is starting to itch, like creepy ants crawling all over) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attacks and Thyroid disorder NOS (Thyroid). Concomitant products included LEVOTHYROXINE and CLONAZEPAM for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out), PRURITUS (My back is starting to itch, like creepy ants crawling all over), RASH ERYTHEMATOUS (Pin point red dots on stomach and legs but not itching), RASH (One arm is a little broke out) and FATIGUE (Real tired). At the time of the report, ACNE (Forehead broke out), SWELLING FACE (On right cheek two small lumps), PRURITUS (Top of head itching like crazy), ACNE (Top of chest down to my boobs broke out), PRURITUS (My back is starting to itch, like creepy ants crawling all over), RASH ERYTHEMATOUS (Pin point red dots on stomach and legs but not itching), RASH (One arm is a little broke out) and FATIGUE (Real tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Headache, Pain, Pyrexia
Clinical narrative: headache; fever; tired; hot and cold; bone and joint ache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), PYREXIA (fever), FATIGUE (tired), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and PAIN (bone and joint ache) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache), PYREXIA (fever), FATIGUE (tired), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and PAIN (bone and joint ache).            Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection
Clinical narrative: Bacterial infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACTERIAL INFECTION (Bacterial infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACTERIAL INFECTION (Bacterial infection). The patient was treated with CEFALEXIN (CEPHALEXINE) (oral) at a dose of 500 milligram three times a day. At the time of the report, BACTERIAL INFECTION (Bacterial infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient started with oral medication, cephalexin 500mg, 3 times a day for ten days for a bacterial infection.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Intentional product use issue, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose; Fever; Fatigue; Sore arm and red rash at the injection site; Sore arm and red rash at the injection site; Sore arm and red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site) and VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history 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, 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 INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site), VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) and VACCINATION SITE RASH (Sore arm and red rash at the injection site). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose) outcome was unknown and PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site), VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) and VACCINATION SITE RASH (Sore arm and red rash at the injection site) had resolved.            No concomitant medications provided. No treatment information was provided.   This case was linked to MOD-2021-017852 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose; Fever; Fatigue; Sore arm and red rash at the injection site; Sore arm and red rash at the injection site; Sore arm and red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site) and VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history 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, 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 INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site), VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) and VACCINATION SITE RASH (Sore arm and red rash at the injection site). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose) outcome was unknown and PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site), VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) and VACCINATION SITE RASH (Sore arm and red rash at the injection site) had resolved.            No concomitant medications provided. No treatment information was provided.   This case was linked to MOD-2021-017852 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis. Concomitant products included DICLOFENAC for Osteoarthritis.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was advised from her doctor to stop taking her Diclofenac for her osteoarthritis and not to take Tylenol before her vaccine. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Outcome of event updated
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Injection site erythema
Clinical narrative: Weakness; Chills; Redness at injection site; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included GERD and Short-bowel syndrome. Concurrent medical conditions included Hypertension. Concomitant products included FISH OIL for Cholesterol, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from an unknown date to 20-May-2021 for GERD, LISINOPRIL for Hypertension, TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for Non-alcoholic steatohepatitis, VITAMIN D3 for Vitamin D deficiency.   On 12-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site). On 18-Feb-2021, ASTHENIA (Weakness), CHILLS (Chills) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-011287 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 210521 and updated patient information,  added medical History, concomitant medications, new event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011287:First dose
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Pain, Paraesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 021B21A and 030A21A) for COVID-19 immunization. Concurrent medical conditions included blood pressure, high cholesterol, diabetes, heart disorder and iodine allergy. On Mar 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 8, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 9, 2021, patient experienced hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm). At the time of the report, hyperhidrosis (feet sweating), paresthesia (hands are tingling/tingling; also went from shoulders down to hand), feeling hot (hot hands) and pain (feels like a sting down entire arm) resolved. Reporter did not allow further contact. Most recent follow-up information incorporated: On May 19, 2021: Follow-up received on May 19, 2021 contained information regarding outcome of the events.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Injection site rash, Pyrexia
Clinical narrative: rash on my injected arm; joint pains; fever; This spontaneous case was reported by an other and describes the occurrence of PYREXIA (fever), INJECTION SITE RASH (rash on my injected arm) and ARTHRALGIA (joint pains) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), INJECTION SITE RASH (rash on my injected arm) and ARTHRALGIA (joint pains). At the time of the report, PYREXIA (fever) had resolved, INJECTION SITE RASH (rash on my injected arm) outcome was unknown and ARTHRALGIA (joint pains) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.7.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant drugs and treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: A little soreness; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little soreness) and HEADACHE (Mild headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 PAIN (A little soreness) and HEADACHE (Mild headache). At the time of the report, PAIN (A little soreness) and HEADACHE (Mild headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination complication; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination complication) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination complication). At the time of the report, VACCINATION COMPLICATION (Vaccination complication) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is reporting an interaction with their Warfarin medication after receiving the Moderna COVID-19 shot (did not indicate if 1st or 2nd).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: Fever reached 101F; flu like symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (Fever reached 101F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product AZTREONAM LYSINE inhalation vapour, liquid for Cystic fibrosis.    Concurrent medical conditions included Cystic fibrosis. Concomitant products included DORNASE ALFA (PULMOZYME) and ELEXACAFTOR, IVACAFTOR, TEZACAFTOR (TRIKAFTA) for an unknown indication.   In 2018, the patient started AZTREONAM LYSINE (unknown route) 75 milligram. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced PYREXIA (Fever reached 101F). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and PYREXIA (Fever reached 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101 (High) 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Odynophagia, Oropharyngeal pain, Pruritus, Vaccination site induration
Clinical narrative: throat pain at night; swallowing pain at night; a swollen red hard patch in the arm; dry throat; whole body itchiness (mostly back and arm); This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat), PRURITUS (whole body itchiness (mostly back and arm)), OROPHARYNGEAL PAIN (throat pain at night), ODYNOPHAGIA (swallowing pain at night) and VACCINATION SITE INDURATION (a swollen red hard patch in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DRY THROAT (dry throat), PRURITUS (whole body itchiness (mostly back and arm)) and VACCINATION SITE INDURATION (a swollen red hard patch in the arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain at night) and ODYNOPHAGIA (swallowing pain at night). On 11-Apr-2021, DRY THROAT (dry throat), PRURITUS (whole body itchiness (mostly back and arm)) and VACCINATION SITE INDURATION (a swollen red hard patch in the arm) had resolved. At the time of the report, OROPHARYNGEAL PAIN (throat pain at night) and ODYNOPHAGIA (swallowing pain at night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.   This case was linked to MOD-2021-079688   See case MOD-2021-079688
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Influenza like illness
Clinical narrative: flu-like symptoms; Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a  patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (Medical history not reported ).    On 09-Apr-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Apr-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). On an unknown date, the patient was diagnosed with INFLUENZA LIKE ILLNESS (flu-like symptoms). On 09-Apr-2021, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.   This case was linked to MOD-2021-079681 (Parent-Child Link).   See case MOD-2021-079681 for details regarding the Parent case.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Limb injury, Oropharyngeal pain, Pain
Clinical narrative: Aches and it was still sore the next day; Burning lungs; hit feet; Sore throat; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and it was still sore the next day), PNEUMONITIS (Burning lungs), LIMB INJURY (hit feet), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) in a patient of an unknown age and gender 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 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 PAIN (Aches and it was still sore the next day), PNEUMONITIS (Burning lungs), LIMB INJURY (hit feet), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Aches and it was still sore the next day), PNEUMONITIS (Burning lungs), LIMB INJURY (hit feet), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Treatment medication was not provided  The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-117026 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25-May-2021 contains information regarding additional events (Fever, chills, and  burning lungs) On 31-May-2021: Follow-up information was received on 31-May-2021 contains information regarding additional event aches and hit feet two days. On 01-Jun-2021: Follow-up information received on 01-Jun-2021 contains information regarding the additional events sore throat and headache. On 06-Aug-2021: Follow up received on 06-AUG-2021 included no new information
Sex: U
Vaccine: COVID19
Symptoms: Pneumonitis, Pyrexia
Clinical narrative: Aches and it was still sore the next day; Burning lungs; hit feet; Sore throat; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and it was still sore the next day), PNEUMONITIS (Burning lungs), LIMB INJURY (hit feet), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) in a patient of an unknown age and gender 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 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 PAIN (Aches and it was still sore the next day), PNEUMONITIS (Burning lungs), LIMB INJURY (hit feet), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Aches and it was still sore the next day), PNEUMONITIS (Burning lungs), LIMB INJURY (hit feet), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Treatment medication was not provided  The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-117026 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25-May-2021 contains information regarding additional events (Fever, chills, and  burning lungs) On 31-May-2021: Follow-up information was received on 31-May-2021 contains information regarding additional event aches and hit feet two days. On 01-Jun-2021: Follow-up information received on 01-Jun-2021 contains information regarding the additional events sore throat and headache. On 06-Aug-2021: Follow up received on 06-AUG-2021 included no new information
Sex: M
Vaccine: COVID19
Symptoms: Effusion, Headache, Vaccination site pain
Clinical narrative: pretty bad eye effusion on the left eye; mild pain in the arm of the injection ( left arm); Headache; This spontaneous case was reported by a consumer and describes the occurrence of EFFUSION (pretty bad eye effusion on the left eye), VACCINATION SITE PAIN (mild pain in the arm of the injection ( left arm)) and HEADACHE (Headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical history was reported.).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild pain in the arm of the injection ( left arm)) and HEADACHE (Headache). On an unknown date, the patient experienced EFFUSION (pretty bad eye effusion on the left eye). At the time of the report, EFFUSION (pretty bad eye effusion on the left eye), VACCINATION SITE PAIN (mild pain in the arm of the injection ( left arm)) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported Took Tylenol for headache and vaccination site pain
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dizziness, Headache, Hypoacusis
Clinical narrative: she felt like she had "air in her left ear" could not hear well/right ear is starting to feel the same; dizzy; Fever; headache; chills; pain in bones; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (pain in bones), HYPOACUSIS (she felt like she had "air in her left ear" could not hear well/right ear is starting to feel the same), DIZZINESS (dizzy), PYREXIA (Fever) and HEADACHE (headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive). Concurrent medical conditions included Food allergy (pork).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (pain in bones), DIZZINESS (dizzy), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills). On 15-Apr-2021, the patient experienced HYPOACUSIS (she felt like she had "air in her left ear" could not hear well/right ear is starting to feel the same). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BONE PAIN (pain in bones), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills) had resolved and HYPOACUSIS (she felt like she had "air in her left ear" could not hear well/right ear is starting to feel the same) and DIZZINESS (dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test-POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller gave consent to follow up with her.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-079209 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: she felt like she had "air in her left ear" could not hear well/right ear is starting to feel the same; dizzy; Fever; headache; chills; pain in bones; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (pain in bones), HYPOACUSIS (she felt like she had "air in her left ear" could not hear well/right ear is starting to feel the same), DIZZINESS (dizzy), PYREXIA (Fever) and HEADACHE (headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive). Concurrent medical conditions included Food allergy (pork).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (pain in bones), DIZZINESS (dizzy), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills). On 15-Apr-2021, the patient experienced HYPOACUSIS (she felt like she had "air in her left ear" could not hear well/right ear is starting to feel the same). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BONE PAIN (pain in bones), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills) had resolved and HYPOACUSIS (she felt like she had "air in her left ear" could not hear well/right ear is starting to feel the same) and DIZZINESS (dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test-POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller gave consent to follow up with her.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-079209 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   This case was linked to MOD-2021-079722 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling and hot to touch; allergic reaction; itching around the injection site; redness around the injection site; swelling and hot to touch; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling and hot to touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Grass allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid adenoma, VITAMIN D NOS, METFORMIN HCL, CARVEDILOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM and ATORVASTATIN CALCIUM for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced FATIGUE (very tired). On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling and hot to touch). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE SWELLING (swelling and hot to touch) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient applied tekno calamine lotion on the injection site for vaccination site erythema, vaccination site pruritus, vaccination site swelling and vaccination site warmth.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-significant follow up; 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: swelling and hot to touch; allergic reaction; itching around the injection site; redness around the injection site; swelling and hot to touch; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling and hot to touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Grass allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid adenoma, VITAMIN D NOS, METFORMIN HCL, CARVEDILOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM and ATORVASTATIN CALCIUM for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced FATIGUE (very tired). On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling and hot to touch). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE SWELLING (swelling and hot to touch) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient applied tekno calamine lotion on the injection site for vaccination site erythema, vaccination site pruritus, vaccination site swelling and vaccination site warmth.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-significant follow up; 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.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Peripheral coldness
Clinical narrative: Cold feet; Burning feet; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL COLDNESS (Cold feet) and BURNING SENSATION (Burning feet) 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 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (Cold feet) and BURNING SENSATION (Burning feet). At the time of the report, PERIPHERAL COLDNESS (Cold feet) and BURNING SENSATION (Burning feet) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient got the first one, the patient started with cold/burning feet/ face a crossed the bridge of the nose. The patient had received second dose of Moderna vaccine in Jan-2021.  Treatment details were not reported by the reporter. Concomitant medications were not reported by the reporter.   This case was linked to MOD-2021-079708 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-May-2021 contains information regarding the outcome of the events. On 18-May-2021: Follow-up Received on 18-May-2021 does not any new information.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 (Medical history was not provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter had experienced headaches after she got home from the hospital that Friday the 26th, and the 27th and 28th. For two solid days, it was really unusual, unlike any headaches she had before. It was not severe and she did not need Advil (case MOD-2021-079714). The reporter mentioned that her daughter reported something similar after the Moderna shot. Concomitant drugs were not reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Feeling hot
Clinical narrative: Burning hand/burning feet; It has progressed since the second one, moved into my hands; Hot feeling in my back; This spontaneous case was reported by a nurse and describes the occurrence of BURNING SENSATION (Burning hand/burning feet), CONDITION AGGRAVATED (It has progressed since the second one, moved into my hands) and FEELING HOT (Hot feeling in my back) 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 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning hand/burning feet), CONDITION AGGRAVATED (It has progressed since the second one, moved into my hands) and FEELING HOT (Hot feeling in my back). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning hand/burning feet), CONDITION AGGRAVATED (It has progressed since the second one, moved into my hands) and FEELING HOT (Hot feeling in my back) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-079703 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17 May 2021: Updated Reporter contact details( Address) and Event outcome. On 19-Jul-2021: Follow up received on 19 JUL 2021: No new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Arthritis, SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore). At the time of the report, PAIN IN EXTREMITY (Arm is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.