chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Coating in mouth, Fatigue, Hyperhidrosis, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Sweats; Coating in mouth; Permanent crick in the neck from the injection site up to the neck; Tender injection site; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (Sweats), COATING IN MOUTH (Coating in mouth), MUSCULOSKELETAL STIFFNESS (Permanent crick in the neck from the injection site up to the neck), VACCINATION SITE PAIN (Tender injection site) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     Concomitant products included TRIAMTERENE for Blood pressure, ROSUVASTATIN for Cholesterol, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced HYPERHIDROSIS (Sweats), COATING IN MOUTH (Coating in mouth), MUSCULOSKELETAL STIFFNESS (Permanent crick in the neck from the injection site up to the neck), VACCINATION SITE PAIN (Tender injection site) and FATIGUE (Fatigue). At the time of the report, HYPERHIDROSIS (Sweats), COATING IN MOUTH (Coating in mouth), MUSCULOSKELETAL STIFFNESS (Permanent crick in the neck from the injection site up to the neck), VACCINATION SITE PAIN (Tender injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood test, Chills, Magnetic resonance imaging
Clinical narrative: Pain all over his body; Arthritis Pain as if he was a 60 years old  (After 2nd Dose); Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose); Joint Pain; High Fever (After 2nd Dose); Chills (After 2nd Dose); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)), ARTHRALGIA (Joint Pain (After 2nd Dose)), MYALGIA (Pain all over his body) and PYREXIA (High Fever (After 2nd Dose)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 06-Apr-2021, the patient experienced PYREXIA (High Fever (After 2nd Dose)) and CHILLS (Chills (After 2nd Dose)). On 11-Apr-2021, the patient experienced ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)) and ARTHRALGIA (Joint Pain (After 2nd Dose)). On an unknown date, the patient experienced MYALGIA (Pain all over his body). On 08-Apr-2021, PYREXIA (High Fever (After 2nd Dose)) and CHILLS (Chills (After 2nd Dose)) had resolved. At the time of the report, ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)), ARTHRALGIA (Joint Pain (After 2nd Dose)) and MYALGIA (Pain all over his body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: unknown (normal) normal. In April 2021, Magnetic resonance imaging: unknown (normal) normal.         No treatment information provided by the reporter. No other concomitant medical  provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pyrexia
Clinical narrative: Pain all over his body; Arthritis Pain as if he was a 60 years old  (After 2nd Dose); Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose); Joint Pain; High Fever (After 2nd Dose); Chills (After 2nd Dose); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)), ARTHRALGIA (Joint Pain (After 2nd Dose)), MYALGIA (Pain all over his body) and PYREXIA (High Fever (After 2nd Dose)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 06-Apr-2021, the patient experienced PYREXIA (High Fever (After 2nd Dose)) and CHILLS (Chills (After 2nd Dose)). On 11-Apr-2021, the patient experienced ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)) and ARTHRALGIA (Joint Pain (After 2nd Dose)). On an unknown date, the patient experienced MYALGIA (Pain all over his body). On 08-Apr-2021, PYREXIA (High Fever (After 2nd Dose)) and CHILLS (Chills (After 2nd Dose)) had resolved. At the time of the report, ARTHRITIS (Arthritis Pain as if he was a 60 years old  (After 2nd Dose)), NECK PAIN (Pain starts at his Neck and Cervical, then moves down to all joints  (After 2nd Dose)), ARTHRALGIA (Joint Pain (After 2nd Dose)) and MYALGIA (Pain all over his body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: unknown (normal) normal. In April 2021, Magnetic resonance imaging: unknown (normal) normal.         No treatment information provided by the reporter. No other concomitant medical  provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: For the second shot I was delayed getting the shot by 2 weeks, a total of 6 weeks 2 days since first shot; I had an allergic reaction to mango sap and waited until symptoms plus one week had past; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (For the second shot I was delayed getting the shot by 2 weeks, a total of 6 weeks 2 days since first shot) and HYPERSENSITIVITY (I had an allergic reaction to mango sap and waited until symptoms plus one week had past) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history reported.     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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (For the second shot I was delayed getting the shot by 2 weeks, a total of 6 weeks 2 days since first shot) and HYPERSENSITIVITY (I had an allergic reaction to mango sap and waited until symptoms plus one week had past). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (For the second shot I was delayed getting the shot by 2 weeks, a total of 6 weeks 2 days since first shot) and HYPERSENSITIVITY (I had an allergic reaction to mango sap and waited until symptoms plus one week had past) had resolved.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain, Pruritus, Urticaria
Clinical narrative: itchy all over his body; hives on his arms and palms; low energy level; pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy all over his body), URTICARIA (hives on his arms and palms), ASTHENIA (low energy level) and PAIN (pain) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced ASTHENIA (low energy level) and PAIN (pain). On 20-May-2021, the patient experienced PRURITUS (itchy all over his body) and URTICARIA (hives on his arms and palms). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 25-Apr-2021, ASTHENIA (low energy level) and PAIN (pain) had resolved. At the time of the report, PRURITUS (itchy all over his body) and URTICARIA (hives on his arms and palms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Pruritus, Rash
Clinical narrative: itching spread to her chest, back, and other arm, term It looks like somebody burned my arm or something; Spots on her arm that look like dried out little pimples; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching spread to her chest, back, and other arm, term It looks like somebody burned my arm or something), RASH (rash) and ACNE (Spots on her arm that look like dried out little pimples) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching spread to her chest, back, and other arm, term It looks like somebody burned my arm or something), RASH (rash) and ACNE (Spots on her arm that look like dried out little pimples). The patient was treated with ACETYLSALICYLIC ACID (ASPRIN) for Arthritis, at a dose of UNK, qd and MULTIVITAMIN [VITAMINS NOS] at a dose of UNK, qd. At the time of the report, PRURITUS (itching spread to her chest, back, and other arm, term It looks like somebody burned my arm or something), RASH (rash) and ACNE (Spots on her arm that look like dried out little pimples) outcome was unknown.            treatment information includes Ceravia Cream, Wrapping up the areas at night Stopped using soap, perfumes, and laundry soap. No concomitant medications were reported.    This case was linked to MOD-2021-162442 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Muscle/ligament stiffness lasting a couple months,From waist to knees.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle/ligament stiffness lasting a couple months,From waist to knees.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle/ligament stiffness lasting a couple months,From waist to knees.). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle/ligament stiffness lasting a couple months,From waist to knees.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Diarrhea; Loss of appetite; Body Aches; Fever; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body Aches), PYREXIA (Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body Aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), MYALGIA (Body Aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment medication was not provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            No concomitant medication provided by the reporter No treatment information reported by the reporter
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: itching; tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and FATIGUE (tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Disability. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Arthritis, VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and FATIGUE (tired). At the time of the report, PRURITUS (itching) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-162433 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: follow-up information received on 30-jun-2021 contain No new information.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site reaction
Clinical narrative: A magnet can now stick to her arm and is very concerned about it; Vaccine administered to 17-year old patient; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (A magnet can now stick to her arm and is very concerned about it) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION SITE REACTION (A magnet can now stick to her arm and is very concerned about it) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year old patient). At the time of the report, VACCINATION SITE REACTION (A magnet can now stick to her arm and is very concerned about it) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year old patient) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No allergies, current illness, lab data and medical history was reported by patient.  No concurrent and treatment medication was reported by patient.   Patient reported that it was her 1 dose and her 2 dose was due on tomorrow. Patient reported that she was very concerned about it. Patient was not pregnant.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient received half a dose of the vaccine at the time of the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received half a dose of the vaccine at the time of the first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 001B21A) for COVID-19 vaccination.     no medical history was provided by the reporter.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient received half a dose of the vaccine at the time of the first dose). At the time of the report, ACCIDENTAL UNDERDOSE (patient received half a dose of the vaccine at the time of the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO Concomitant products were provided. no treatment medications were provided. HCP inquires that  the patient should receive a third dose of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: over a month since first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over a month since first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over a month since first shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over a month since first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Sinus disorder
Clinical narrative: Chronic infections; Sinus problems; This spontaneous case was reported by a pharmacist and describes the occurrence of INFECTION (Chronic infections) and SINUS DISORDER (Sinus problems) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 020B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced INFECTION (Chronic infections) and SINUS DISORDER (Sinus problems). At the time of the report, INFECTION (Chronic infections) had resolved and SINUS DISORDER (Sinus problems) outcome was unknown.        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. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up Appended
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Pyrexia
Clinical narrative: some people had "reactions"; fever; cold chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (some people had "reactions"), PYREXIA (fever) and CHILLS (cold chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (some people had "reactions"), PYREXIA (fever) and CHILLS (cold chills). At the time of the report, ADVERSE DRUG REACTION (some people had "reactions"), PYREXIA (fever) and CHILLS (cold chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had second vaccine 6hrs ago and arm really hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had second vaccine 6hrs ago and arm really hurts) 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 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced VACCINATION SITE PAIN (had second vaccine 6hrs ago and arm really hurts). At the time of the report, VACCINATION SITE PAIN (had second vaccine 6hrs ago and arm really hurts) outcome was unknown.            No lab results/concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was administered > 42 days after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose). On 21-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-162467 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162467:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Maternal exposure during pregnancy, Myalgia, Pain in extremity
Clinical narrative: ¨going trough a small Flu illness with  : tearing, sneezing , mucus¨; Fatigue; Muscle pain; Pain in the arm of the injection ( Left) for almost 2 days; pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (¨going trough a small Flu illness with  : tearing, sneezing , mucus¨), PAIN IN EXTREMITY (Pain in the arm of the injection ( Left) for almost 2 days), MATERNAL EXPOSURE DURING PREGNANCY (pregnant), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     no medical history was reported.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 23-Mar-2021 and the estimated date of delivery was 28-Dec-2021. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection ( Left) for almost 2 days) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (¨going trough a small Flu illness with  : tearing, sneezing , mucus¨), FATIGUE (Fatigue) and MYALGIA (Muscle pain). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  The patient was treated with ACETAMINOPHEN for Pain, at a dose of 1 dosage form and PARACETAMOL for Pain, at a dose of 1 dosage form. On 23-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (¨going trough a small Flu illness with  : tearing, sneezing , mucus¨), PAIN IN EXTREMITY (Pain in the arm of the injection ( Left) for almost 2 days), FATIGUE (Fatigue) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications include pregnancy medications daily   This case was linked to US-MODERNATX, INC.-MOD-2021-161014 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Internal review on 28- JUL-2021, resulted in the updates of pregnancy details; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-161014:Husband's case
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain in my body) and HEADACHE (Pain in my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 MYALGIA (Pain in my body) and HEADACHE (Pain in my head). At the time of the report, MYALGIA (Pain in my body) and HEADACHE (Pain in my head) outcome was unknown. Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was administered > 42 days after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose). On 21-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered > 42 days after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-162457 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information received provided no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162457:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had my first Moderna vaccine on 3/21/21 and did not get my second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first Moderna vaccine on 3/21/21 and did not get my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first Moderna vaccine on 3/21/21 and did not get my second dose).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experienced a situation after receiving the second dose vaccination in feb, which i still suffering still today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced a situation after receiving the second dose vaccination in feb, which i still suffering still today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced a situation after receiving the second dose vaccination in feb, which i still suffering still today). At the time of the report, VACCINATION COMPLICATION (Experienced a situation after receiving the second dose vaccination in feb, which i still suffering still today) outcome was unknown.            No relevant concomitant medications reported. Treatment information were not provided. The action taken with mRNA-1273 with the events was considered as not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) 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 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 CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: cough; soar throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and OROPHARYNGEAL PAIN (soar throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 COUGH (cough) and OROPHARYNGEAL PAIN (soar throat). At the time of the report, COUGH (cough) and OROPHARYNGEAL PAIN (soar throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Palpitations
Clinical narrative: Heart palpitations; Body cramps; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (Body cramps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (Body cramps). At the time of the report, PALPITATIONS (Heart palpitations) and MUSCLE SPASMS (Body cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm on site of injection with first Moderna Covid-19  injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm on site of injection with first Moderna Covid-19  injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 020B21A) for COVID-19 vaccination.     Concomitant products included DIAZEPAM (VALIUM) and PREDNICARBATE (TOPIMAX [PREDNICARBATE]) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm on site of injection with first Moderna Covid-19  injection). At the time of the report, VACCINATION SITE PAIN (Sore arm on site of injection with first Moderna Covid-19  injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes Tylenol, Hydroxyzine, Phenergan,Hyoscyamine.125 and 10mg .Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: Second dose was on day 40; allergies and asthma flare up; allergies and asthma flare up; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was on day 40), HYPERSENSITIVITY (allergies and asthma flare up) and ASTHMA (allergies and asthma flare up) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022c21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was on day 40), HYPERSENSITIVITY (allergies and asthma flare up) and ASTHMA (allergies and asthma flare up). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was on day 40), HYPERSENSITIVITY (allergies and asthma flare up) and ASTHMA (allergies and asthma flare up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-162670 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: swelling of upper lip; Swelling of cheeks; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of cheeks) and LIP SWELLING (swelling of upper lip) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Blood pressure medicine..    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced SWELLING FACE (Swelling of cheeks). On an unknown date, the patient experienced LIP SWELLING (swelling of upper lip). At the time of the report, SWELLING FACE (Swelling of cheeks) and LIP SWELLING (swelling of upper lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Pain; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and NAUSEA (Nausea) 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 PAIN (Pain) and NAUSEA (Nausea). At the time of the report, PAIN (Pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Asthma
Clinical narrative: Allergies and asthma flare up; Allergies and asthma flare up; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Allergies and asthma flare up) and ALLERGY TO VACCINE (Allergies and asthma flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included albuterol inhaler for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Allergies and asthma flare up) and ALLERGY TO VACCINE (Allergies and asthma flare up). The patient was treated with albuterol inhaler at an unspecified dose and frequency. At the time of the report, ASTHMA (Allergies and asthma flare up) and ALLERGY TO VACCINE (Allergies and asthma flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-162612 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Hot flush, Nausea, Salivary hypersecretion
Clinical narrative: hives today on neck and face/2 hives on face and neck; felt her cheeks getting tight, red, and hot; felt her cheeks getting tight, red, and hot; felt her cheeks getting tight, red, and hot; Same as 1st/Metallic taste in mouth; same as 1st/extra salivating; taste metallic; nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot) and DYSGEUSIA (Same as 1st/Metallic taste in mouth) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042821A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for an unknown indication.    Previously administered products included for an unreported indication: SHINGRIX (fever 100.4 for 4 days) on 15-Oct-2020. Concurrent medical conditions included Urticaria. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-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 started CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot), DYSGEUSIA (Same as 1st/Metallic taste in mouth), SALIVARY HYPERSECRETION (same as 1st/extra salivating), DYSGEUSIA (taste metallic) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 19-Apr-2021 for Antihistamine therapy, at a dose of 25 mg and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot), DYSGEUSIA (Same as 1st/Metallic taste in mouth), SALIVARY HYPERSECRETION (same as 1st/extra salivating), DYSGEUSIA (taste metallic) and NAUSEA (nausea) had resolved.            This case was linked to MOD-2021-080179, MOD-2021-080179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up was received on 24 may 2021 contact information, patient demographics,  date and new events of the second dose, patient concomitant medication,  and event outcome was updated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: hives today on neck and face/2 hives on face and neck; felt her cheeks getting tight, red, and hot; felt her cheeks getting tight, red, and hot; felt her cheeks getting tight, red, and hot; Same as 1st/Metallic taste in mouth; same as 1st/extra salivating; taste metallic; nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot) and DYSGEUSIA (Same as 1st/Metallic taste in mouth) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042821A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for an unknown indication.    Previously administered products included for an unreported indication: SHINGRIX (fever 100.4 for 4 days) on 15-Oct-2020. Concurrent medical conditions included Urticaria. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-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 started CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot), DYSGEUSIA (Same as 1st/Metallic taste in mouth), SALIVARY HYPERSECRETION (same as 1st/extra salivating), DYSGEUSIA (taste metallic) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 19-Apr-2021 for Antihistamine therapy, at a dose of 25 mg and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, URTICARIA (hives today on neck and face/2 hives on face and neck), SWELLING FACE (felt her cheeks getting tight, red, and hot), ERYTHEMA (felt her cheeks getting tight, red, and hot), HOT FLUSH (felt her cheeks getting tight, red, and hot), DYSGEUSIA (Same as 1st/Metallic taste in mouth), SALIVARY HYPERSECRETION (same as 1st/extra salivating), DYSGEUSIA (taste metallic) and NAUSEA (nausea) had resolved.            This case was linked to MOD-2021-080179, MOD-2021-080179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up was received on 24 may 2021 contact information, patient demographics,  date and new events of the second dose, patient concomitant medication,  and event outcome was updated