chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: I have numbness from my elbows down to my hands, numbness from my knees down to my feet; Feels strange; Rapid heartbeat; shortness of breath; Joint aches; A massive headache; Fever (unknown temp); Nausea; Felt super super tired; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet), FEELING ABNORMAL (Feels strange), PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath) and ARTHRALGIA (Joint aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 023D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet), FEELING ABNORMAL (Feels strange), PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath), ARTHRALGIA (Joint aches), HEADACHE (A massive headache), PYREXIA (Fever (unknown temp)), NAUSEA (Nausea), FATIGUE (Felt super super tired) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet) and FEELING ABNORMAL (Feels strange) had not resolved and PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath), ARTHRALGIA (Joint aches), HEADACHE (A massive headache), PYREXIA (Fever (unknown temp)), NAUSEA (Nausea), FATIGUE (Felt super super tired) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.            No Concomitant medications were reported. No Treatment details were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Palpitations, Pyrexia, Vaccination site pain
Clinical narrative: I have numbness from my elbows down to my hands, numbness from my knees down to my feet; Feels strange; Rapid heartbeat; shortness of breath; Joint aches; A massive headache; Fever (unknown temp); Nausea; Felt super super tired; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet), FEELING ABNORMAL (Feels strange), PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath) and ARTHRALGIA (Joint aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 023D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet), FEELING ABNORMAL (Feels strange), PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath), ARTHRALGIA (Joint aches), HEADACHE (A massive headache), PYREXIA (Fever (unknown temp)), NAUSEA (Nausea), FATIGUE (Felt super super tired) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet) and FEELING ABNORMAL (Feels strange) had not resolved and PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath), ARTHRALGIA (Joint aches), HEADACHE (A massive headache), PYREXIA (Fever (unknown temp)), NAUSEA (Nausea), FATIGUE (Felt super super tired) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.            No Concomitant medications were reported. No Treatment details were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Taste disorder
Clinical narrative: Taste is slightly off; Constant face, nose, and upper jaw numbness; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Taste is slightly off) and HYPOAESTHESIA (Constant face, nose, and upper jaw numbness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced TASTE DISORDER (Taste is slightly off) and HYPOAESTHESIA (Constant face, nose, and upper jaw numbness). At the time of the report, TASTE DISORDER (Taste is slightly off) and HYPOAESTHESIA (Constant face, nose, and upper jaw numbness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient declined to provide concomitant medications name, the patient takes the same medications for years.  No treatment information was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Influenza like illness, Injection site pain, Malaise
Clinical narrative: Pain in her spleen; chest pain/feels like she had chest inflammation; vomiting; Right arm injection site pain; Patient felt feverish; Felt like she had the flu; Did not feel well/patient feels like she has chest inflamation; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), ABDOMINAL PAIN (Pain in her spleen), CHEST PAIN (chest pain/feels like she had chest inflammation) and VOMITING (vomiting) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spleen pain (after a tetanus shot 10 years ago) and COVID-19 (patient experienced chest pain at this time) on 13-Mar-2020.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), INJECTION SITE PAIN (Right arm injection site pain) and PYREXIA (Patient felt feverish). On 15-Aug-2021, the patient experienced VOMITING (vomiting). On 17-Aug-2021, the patient experienced CHEST PAIN (chest pain/feels like she had chest inflammation). On an unknown date, the patient experienced ABDOMINAL PAIN (Pain in her spleen). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) on 15-Aug-2021 for Vomiting, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), ABDOMINAL PAIN (Pain in her spleen), CHEST PAIN (chest pain/feels like she had chest inflammation), VOMITING (vomiting), INJECTION SITE PAIN (Right arm injection site pain) and PYREXIA (Patient felt feverish) was resolving.            Concomitant medications also include: antibiotic and steam compresses.    This case was linked to MOD-2021-330758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up received contained Non significant information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pain in her spleen; chest pain/feels like she had chest inflammation; vomiting; Right arm injection site pain; Patient felt feverish; Felt like she had the flu; Did not feel well/patient feels like she has chest inflamation; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), ABDOMINAL PAIN (Pain in her spleen), CHEST PAIN (chest pain/feels like she had chest inflammation) and VOMITING (vomiting) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spleen pain (after a tetanus shot 10 years ago) and COVID-19 (patient experienced chest pain at this time) on 13-Mar-2020.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), INJECTION SITE PAIN (Right arm injection site pain) and PYREXIA (Patient felt feverish). On 15-Aug-2021, the patient experienced VOMITING (vomiting). On 17-Aug-2021, the patient experienced CHEST PAIN (chest pain/feels like she had chest inflammation). On an unknown date, the patient experienced ABDOMINAL PAIN (Pain in her spleen). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) on 15-Aug-2021 for Vomiting, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), ABDOMINAL PAIN (Pain in her spleen), CHEST PAIN (chest pain/feels like she had chest inflammation), VOMITING (vomiting), INJECTION SITE PAIN (Right arm injection site pain) and PYREXIA (Patient felt feverish) was resolving.            Concomitant medications also include: antibiotic and steam compresses.    This case was linked to MOD-2021-330758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up received contained Non significant information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Fatigue
Clinical narrative: after both vaccine they notices that they were very tired and low blood pressure; very tired after first dose; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (very tired after first dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     Concurrent medical conditions included Coronary disease, Hypertension and Overweight. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), AMINOPHYLLINE, LOSARTAN, METOPROLOL, MULTIVITAMIN [VITAMINS NOS] and AMLODIPINE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (very tired after first dose). At the time of the report, BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (very tired after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-330514, MOD-2021-330881.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up contains Concomitant medication and their frequency and new event
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Ankle injury (Bad ankles), Knee replacement and Shoulder replacement. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-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 ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) had resolved.            No treatment medication details was reported.   This case was linked to MOD-2021-006473 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 2 patients were administered the Moderna vaccine from vials that experienced a temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2 patients were administered the Moderna vaccine from vials that experienced a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2 patients were administered the Moderna vaccine from vials that experienced a temperature excursion). On 24-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (2 patients were administered the Moderna vaccine from vials that experienced a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Reported said that 20 doses of Moderna (two 10-dose vials) were administered to patients following the brief temperature excursion. The vaccine vials were stored in the refrigerator where the temperature range normally was 36 - 46 degrees Fahrenheit. The temperature excursion occurred when was door was kept open for cleaning the refrigerator. The temperature range of the excursion was 46.02 - 46.77 degrees Fahrenheit for a total of 14 minutes out of range. She says that the Moderna vaccine was administered from these vials to 2 patients on the same day of the excursion.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains Non-significant information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Vaccination site pain
Clinical narrative: Chest pain; Left arm injection site soreness; Pain in spleen; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), ABDOMINAL PAIN (Pain in spleen) and VACCINATION SITE PAIN (Left arm injection site soreness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (experienced chest pain at that time) on 13-Mar-2020. Previously administered products included for an unreported indication: TETANUSVACCIN (Patient did not experience inflammation of spleen after vaccination.) in 2011. Concomitant products included ONDANSETRON for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ABDOMINAL PAIN (Pain in spleen). On 15-Jul-2021, the patient experienced CHEST PAIN (Chest pain) and VACCINATION SITE PAIN (Left arm injection site soreness). At the time of the report, CHEST PAIN (Chest pain), ABDOMINAL PAIN (Pain in spleen) and VACCINATION SITE PAIN (Left arm injection site soreness) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received an antibiotic, steam compresses and  The patient had spleen pain after a tetanus shot 10 years ago. The patient had no history of myocarditis or pericarditis or heart pain.  On 15-Jul-2021, the patient had left arm injection site soreness and chest pain.  After the first and second shots the patient noticed chest pain and pain in spleen.   This case was linked to MOD-2021-330668 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Body temperature, Pain in extremity
Clinical narrative: Pain in the arm; Feeling agitated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and AGITATION (Feeling agitated) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability (takes the following medication: Sertraline 100 mg and Latuda 80 mg.). Concomitant products included LURASIDONE HYDROCHLORIDE (LATUDA) and SERTRALINE for Disability.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and AGITATION (Feeling agitated). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and AGITATION (Feeling agitated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2021, Body temperature: 101.2 (High) Temperature of 101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of psoriasis (broke-out in a psoriatic skin eruption) and rash (had a rash ever since) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included psoriasis. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced psoriasis (broke-out in a psoriatic skin eruption) and rash (had a rash ever since). At the time of the report, psoriasis (broke-out in a psoriatic skin eruption) and rash (had a rash ever since) outcome: unknown. No concomitant medication or treatment information provided. Patient had her 1st Moderna dose mid-March and her 2nd dose about a month later.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 16Jun2021: I got the 2nd dose of the Moderna Covid-19 vaccine./6 month span between 1st & 2nd doses.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16Jun2021: I got the 2nd dose of the Moderna Covid-19 vaccine./6 month span between 1st & 2nd doses.) 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 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16Jun2021: I got the 2nd dose of the Moderna Covid-19 vaccine./6 month span between 1st & 2nd doses.). On 24-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (16Jun2021: I got the 2nd dose of the Moderna Covid-19 vaccine./6 month span between 1st & 2nd doses.) had resolved.            No concomitant medication was provided. No treatment medication was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vitreous detachment, Vitreous floaters
Clinical narrative: Posterior vitelline detachment - Right eye; Eye floaters in right eye; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VITREOUS DETACHMENT (Posterior vitelline detachment - Right eye) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INDOMETHACIN [INDOMETACIN], VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced VITREOUS DETACHMENT (Posterior vitelline detachment - Right eye) (seriousness criterion medically significant). In August 2021, the patient experienced VITREOUS FLOATERS (Eye floaters in right eye). At the time of the report, VITREOUS DETACHMENT (Posterior vitelline detachment - Right eye) and VITREOUS FLOATERS (Eye floaters in right eye) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.   Patient reports Posterior Vitelline Detachment 4 days later (after second dose). Symptoms included eye floaters in right eye. Ophthalmologist diagnosed condition on 08-Sep-t2021.  Company Comment - This case concerns a 60 year old male with no relevant medical history who experienced serious unexpected event of vitreous detachment 4 days after receiving the first dose of Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 60 year old male with no relevant medical history who experienced serious unexpected event of vitreous detachment 4 days after receiving the first dose of Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Pain in extremity
Clinical narrative: hurt his leg; didn't feel well; had COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had COVID-19), PAIN IN EXTREMITY (hurt his leg) and MALAISE (didn't feel well) 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 COVID-19 (had COVID-19) (seriousness criterion death), PAIN IN EXTREMITY (hurt his leg) (seriousness criteria death and hospitalization) and MALAISE (didn't feel well) (seriousness criterion death). The patient died on 23-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed.     No relevant concomitant and treatment medications were reported.  Company Comment - This case concerns an unknown age male with no medical history provided. Limited information regarding this case is provided. The patient experienced Covid-19, Pain in Extremity, and Malaise. He died on on 23-Sep-2021. No date for which the vaccination is provided, nor is the date of any of the events provided.The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.; Sender's Comments: This case concerns an unknown age male with no medical history provided. Limited information regarding this case is provided. The patient experienced Covid-19, Pain in Extremity, and Malaise. He died on on 23-Sep-2021. No date for which the vaccination is provided, nor is the date of any of the events provided.The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Wheezing
Clinical narrative: down for a couple of days; A little wheezy; Flu like symtpoms; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (down for a couple of days), WHEEZING (A little wheezy) and INFLUENZA LIKE ILLNESS (Flu like symtpoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery in December 2020.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MALAISE (down for a couple of days), WHEEZING (A little wheezy) and INFLUENZA LIKE ILLNESS (Flu like symtpoms). In April 2021, MALAISE (down for a couple of days), WHEEZING (A little wheezy) and INFLUENZA LIKE ILLNESS (Flu like symtpoms) had resolved.            Patient had surgery to remove polyps after receiving the vaccines in April. No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritic rash (itchy) and rash (rash on her back, arms and legs) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 23, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 24, 2021, patient experienced pruritic rash (itchy) and rash (rash on her back, arms and legs). At the time of the report, pruritic rash (itchy) and rash (rash on her back, arms and legs) outcome: unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-330419, MOD-2021-330408 (patient link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: headache for two moths after getting their Moderna covid19 vaccine; swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache for two moths after getting their Moderna covid19 vaccine) and LYMPHADENOPATHY (swollen lymph nodes) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Asthma.    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 HEADACHE (headache for two moths after getting their Moderna covid19 vaccine) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, HEADACHE (headache for two moths after getting their Moderna covid19 vaccine) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-330514, MOD-2021-330698 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I was diagnose positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I was diagnose positive for Covid-19) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced COVID-19 (I was diagnose positive for Covid-19). At the time of the report, COVID-19 (I was diagnose positive for Covid-19) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.; Sender's Comments: This case concerns a 49-year-old male patient with no relevant medical history reported who experienced  non serious unexpected event of COVID-19. The event occurred approximately 5 days after the first dose of Spikevax. Rechallenge was unknown since no information regarding the second dose was disclosed. The benefit-risk relationship of drug is not affected by this report
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dysstasia, Pyrexia
Clinical narrative: Could not stand up after 3rd shot; Humongous Knot on the left arm injection site after 3rd shot; Chills after 3rd shot; fever 99 Fahrenheit/Increased Fever 102.8 F after 3rd shot; Felt dizzy after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy after 3rd shot), DYSSTASIA (Could not stand up after 3rd shot), VACCINATION SITE MASS (Humongous Knot on the left arm injection site after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (fever 99 Fahrenheit/Increased Fever 102.8 F after 3rd shot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 043L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced DIZZINESS (Felt dizzy after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (fever 99 Fahrenheit/Increased Fever 102.8 F after 3rd shot). On 18-Sep-2021, the patient experienced DYSSTASIA (Could not stand up after 3rd shot) and VACCINATION SITE MASS (Humongous Knot on the left arm injection site after 3rd shot). At the time of the report, DIZZINESS (Felt dizzy after 3rd shot), DYSSTASIA (Could not stand up after 3rd shot), VACCINATION SITE MASS (Humongous Knot on the left arm injection site after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (fever 99 Fahrenheit/Increased Fever 102.8 F after 3rd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, Body temperature: 99 f (High) Fever of 99 F. On 18-Sep-2021, Body temperature: 102.8 f (High) fever of 102.8 F.         Concomitant medications were not provided. Treatment medications were not provided. The patient  could not shower.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Could not stand up after 3rd shot; Humongous Knot on the left arm injection site after 3rd shot; Chills after 3rd shot; fever 99 Fahrenheit/Increased Fever 102.8 F after 3rd shot; Felt dizzy after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy after 3rd shot), DYSSTASIA (Could not stand up after 3rd shot), VACCINATION SITE MASS (Humongous Knot on the left arm injection site after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (fever 99 Fahrenheit/Increased Fever 102.8 F after 3rd shot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 043L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced DIZZINESS (Felt dizzy after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (fever 99 Fahrenheit/Increased Fever 102.8 F after 3rd shot). On 18-Sep-2021, the patient experienced DYSSTASIA (Could not stand up after 3rd shot) and VACCINATION SITE MASS (Humongous Knot on the left arm injection site after 3rd shot). At the time of the report, DIZZINESS (Felt dizzy after 3rd shot), DYSSTASIA (Could not stand up after 3rd shot), VACCINATION SITE MASS (Humongous Knot on the left arm injection site after 3rd shot), CHILLS (Chills after 3rd shot) and PYREXIA (fever 99 Fahrenheit/Increased Fever 102.8 F after 3rd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, Body temperature: 99 f (High) Fever of 99 F. On 18-Sep-2021, Body temperature: 102.8 f (High) fever of 102.8 F.         Concomitant medications were not provided. Treatment medications were not provided. The patient  could not shower.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: The first time her arm was red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (The first time her arm was red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, ATORVASTATIN, MESALAZINE (LIALDA) and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced ERYTHEMA (The first time her arm was red). In January 2021, ERYTHEMA (The first time her arm was red) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-330737 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Therapeutic response unexpected
Clinical narrative: sudden attack of pain in the same evening I received the vaccine; at night got a strong pain down into right hand; Very good side effect, Since the day after vaccination patient never had knuckle pains anymore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sudden attack of pain in the same evening I received the vaccine), PAIN IN EXTREMITY (at night got a strong pain down into right hand) and THERAPEUTIC RESPONSE UNEXPECTED (Very good side effect, Since the day after vaccination patient never had knuckle pains anymore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     The patient's past medical history included Pain. Concomitant products included LEVOTHYROXINE, RIVAROXABAN (XARELTO) and VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (sudden attack of pain in the same evening I received the vaccine), PAIN IN EXTREMITY (at night got a strong pain down into right hand) and THERAPEUTIC RESPONSE UNEXPECTED (Very good side effect, Since the day after vaccination patient never had knuckle pains anymore). At the time of the report, PAIN (sudden attack of pain in the same evening I received the vaccine), PAIN IN EXTREMITY (at night got a strong pain down into right hand) and THERAPEUTIC RESPONSE UNEXPECTED (Very good side effect, Since the day after vaccination patient never had knuckle pains anymore) outcome was unknown.            No treatment information provided.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: The 1st dose was  COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was  COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of COVID-19 VACCINE (unknown route) at an unspecified dose. On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was  COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mydriasis, Nervous system disorder, Photophobia, Product dose omission issue
Clinical narrative: Neurological damage; Left pupil is permanently dilated; have blurry vision; Extreme sensitivity to light; Trouble sleeping/insomnia; Have not received the 2nd dose, because got neurological damage.; This spontaneous case was reported by a nurse and describes the occurrence of NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light) and INSOMNIA (Trouble sleeping/insomnia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Allergy, ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (FIORINAL [ACETYLSALICYLIC ACID;BUTALBITAL;CAFFEINE]) for Headache, HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]) for Sleep problem, BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light), INSOMNIA (Trouble sleeping/insomnia) and PRODUCT DOSE OMISSION ISSUE (Have not received the 2nd dose, because got neurological damage.). At the time of the report, NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light) and INSOMNIA (Trouble sleeping/insomnia) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Have not received the 2nd dose, because got neurological damage.) 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 treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Neurological damage; Left pupil is permanently dilated; have blurry vision; Extreme sensitivity to light; Trouble sleeping/insomnia; Have not received the 2nd dose, because got neurological damage.; This spontaneous case was reported by a nurse and describes the occurrence of NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light) and INSOMNIA (Trouble sleeping/insomnia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Allergy, ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (FIORINAL [ACETYLSALICYLIC ACID;BUTALBITAL;CAFFEINE]) for Headache, HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]) for Sleep problem, BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light), INSOMNIA (Trouble sleeping/insomnia) and PRODUCT DOSE OMISSION ISSUE (Have not received the 2nd dose, because got neurological damage.). At the time of the report, NERVOUS SYSTEM DISORDER (Neurological damage), MYDRIASIS (Left pupil is permanently dilated), VISION BLURRED (have blurry vision), PHOTOPHOBIA (Extreme sensitivity to light) and INSOMNIA (Trouble sleeping/insomnia) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Have not received the 2nd dose, because got neurological damage.) 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 treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Mobility decreased, Musculoskeletal discomfort, Polymyalgia rheumatica
Clinical narrative: pain increase in the shoulder with loss in mobility; hip tightness got worse where he could barely walk; hip tightness got worse where he could barely walk; Right shoulder pain; Polymyalgia rheumatica (PMR); This spontaneous case was reported by a physician and describes the occurrence of POLYMYALGIA RHEUMATICA in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tendinitis (patient done surgery for the same).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced POLYMYALGIA RHEUMATICA (seriousness criterion medically significant). On an unknown date, the patient experienced MOBILITY DECREASED (pain increase in the shoulder with loss in mobility), MUSCULOSKELETAL DISCOMFORT (hip tightness got worse where he could barely walk), GAIT DISTURBANCE (hip tightness got worse where he could barely walk), and ARTHRALGIA (Right shoulder). The patient was treated with CORTISONE for Adverse drug reaction, at an unspecified dose and frequency and DEXAMETHASONE for Adverse event, at a dose of 6 milligram. At the time of the report, POLYMYALGIA RHEUMATICA, MOBILITY DECREASED (pain increase in the shoulder with loss in mobility), MUSCULOSKELETAL DISCOMFORT (hip tightness got worse where he could barely walk), GAIT DISTURBANCE (hip tightness got worse where he could barely walk), and ARTHRALGIA (Right shoulder pain) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant medication reported.  This case concerns a 65-year-old, male patient with a relevant medical history of tendonitis, who experienced the unexpected serious events of polymyalgia rheumatica; unexpected non-serious events of mobility decreased, musculoskeleteal discomfort, and gait disturbance, expected non-serious event of arthralgia. The events developed approximately 2 months after receiving the second dose of Moderna mRNA-1273 vaccine. The re-challenge is not applicable as the events reported only occurred after the second dose. The reporter did not provide the causality assessment. The medical history, of tendonitis remains a confounder for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-330778 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nasal congestion, Pruritus, Pyrexia
Clinical narrative: Broke out in hives, has tremendous amount of hives; Congested; Entire body is itchy; Hasn't slept much, she's struggling; Some chills; Some fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives, has tremendous amount of hives), NASAL CONGESTION (Congested), PRURITUS (Entire body is itchy), INSOMNIA (Hasn't slept much, she's struggling) and CHILLS (Some chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Lyme disease (The patient used to be in a tremendous amount of antibiotics in the past). Concomitant products included VITAMINS NOS for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced CHILLS (Some chills) and PYREXIA (Some fever). On 21-Sep-2021, the patient experienced URTICARIA (Broke out in hives, has tremendous amount of hives), NASAL CONGESTION (Congested), PRURITUS (Entire body is itchy) and INSOMNIA (Hasn't slept much, she's struggling). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Broke out in hives, has tremendous amount of hives), NASAL CONGESTION (Congested), PRURITUS (Entire body is itchy), INSOMNIA (Hasn't slept much, she's struggling), CHILLS (Some chills) and PYREXIA (Some fever) outcome was unknown.            Treatment medicines include Prednisone and Benadryl