chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received the third dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received the third dose of Moderna vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A, 004M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received the third dose of Moderna vaccine). On 30-Apr-2021, EXTRA DOSE ADMINISTERED (Patient received the third dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information provided. No concomitant medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Non significant follow up
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got the first dose of the Moderna vaccine on 22Jan2021 and has not received the second dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 22Jan2021 and has not received the second dose yet.) in a 71-year-old male patient who received mRNA-1273 (batch no. 032L20B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 22Jan2021 and has not received the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 22Jan2021 and has not received the second dose yet.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: sore arm; itchy face; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included RISPERIDONE for an unknown indication.    On 07-Apr-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 PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face). At the time of the report, PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment medication was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Periarthritis
Clinical narrative: diagnosed with frozen shoulder; burning in left arm; horrible left shoulder and arm pain; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning in left arm), PERIARTHRITIS (diagnosed with frozen shoulder) and ARTHRALGIA (horrible left shoulder and arm pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (horrible left shoulder and arm pain). On 17-Mar-2021, the patient experienced BURNING SENSATION (burning in left arm). On an unknown date, the patient experienced PERIARTHRITIS (diagnosed with frozen shoulder). At the time of the report, BURNING SENSATION (burning in left arm) and PERIARTHRITIS (diagnosed with frozen shoulder) outcome was unknown and ARTHRALGIA (horrible left shoulder and arm pain) had not resolved.            Treatment medications provided by the reporter are Benadryl and Ibuprofen. Patient visit the Urgent care where  MRI of the neck was done and the results of this are pending. In ER Patient was advised to get an ultrasound. There was no blood clot detected in the ultrasound.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-105446 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Event added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 4 patients were given first dose in parts; first they were given 0.05ml by mistake and then remaining 0.45 ml given to them. 2 patients came within 8 hours and 2 came within 24 hours to take the remaining dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (4 patients were given first dose in parts; first they were given 0.05ml by mistake and then remaining 0.45 ml given to them. 2 patients came within 8 hours and 2 came within 24 hours to take the remaining dose) in a 38-year-old patient of an unknown gender who received mRNA-1273 (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (4 patients were given first dose in parts; first they were given 0.05ml by mistake and then remaining 0.45 ml given to them. 2 patients came within 8 hours and 2 came within 24 hours to take the remaining dose). On 29-Apr-2021, INCORRECT DOSE ADMINISTERED (4 patients were given first dose in parts; first they were given 0.05ml by mistake and then remaining 0.45 ml given to them. 2 patients came within 8 hours and 2 came within 24 hours to take the remaining dose) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: Eyes were like bananas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE DISORDER (Eyes were like bananas) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and AMLODIPINE for an unknown indication.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE DISORDER (Eyes were like bananas). On 02-May-2021, EYE DISORDER (Eyes were like bananas) had resolved.            Treatment information use unknown
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Emphysema, Cervical cancer (Stable), Lung cancer (Stable), Immunocompromised, Tiredness and Drug tolerance decreased (Low tolerance to medicines). Concomitant products included LISINOPRIL, SIMVASTATIN, ALPRAZOLAM, AMITRIPTYLINE and UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment reported.   This case was linked to MOD-2021-270114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: A follow up received on 22-JUL-2021 and contained No New Information. On 28-Jul-2021: A Significant follow up received on 28-JUL-2021, Action taken with suspect product was updated and second dose information was added.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breathe) in a male patient of an unknown age who received mRNA-1273 (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 2.  On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1.   On 28-Apr-2021, the patient experienced DYSPNOEA (shortness of breathe). At the time of the report, DYSPNOEA (shortness of breathe) had resolved.     Concomitant medication use was unknown.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: No specific follow-up information recorded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation, Nausea
Clinical narrative: Constipated very bad; stomach was not good; felt nauseas; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipated very bad), ABDOMINAL DISCOMFORT (stomach was not good) and NAUSEA (felt nauseas) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-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 CONSTIPATION (Constipated very bad), ABDOMINAL DISCOMFORT (stomach was not good) and NAUSEA (felt nauseas). At the time of the report, CONSTIPATION (Constipated very bad), ABDOMINAL DISCOMFORT (stomach was not good) and NAUSEA (felt nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098355 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: On !8-May-2021, follow up document was attached which contains Batch numbers of both the doses, Events ( Stomach problem, Stomach cramps, Constipated again after 2nd dose ) after second dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098355:2nd dose case
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of lingering fatigue in a 73-year-old male patient who received mRNA-1273 (batch# 026A21A and 019B21A) for COVID-19 immunization. No medical history reported. On Mar 9, 2021, patient received the first dose of mRNA-1273 intramuscular; 1 dosage form. On Apr 8, 2021, received the second dose of mRNA-1273 intramuscular; 1 dosage form. On Apr 8, 2021, patient experienced lingering fatigue. At the time of the report, lingering fatigue outcome: unknown. Concomitant product use and treatment information not provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age old had vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old had vaccine administered) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old had vaccine administered). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old had vaccine administered) 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 concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Rash
Clinical narrative: Cough; Rash; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (coughing), RASH (rash on chest) and HEADACHE (headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included Claritin for Seasonal allergy.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced COUGH (coughing), RASH (rash on chest) and HEADACHE (headache). At the time of the report, COUGH (coughing), RASH (rash on chest) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has used Benadryl and Sudafed as treatment medication
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: rash on the arm of the injection, which never went away completely; Fever which resolved shortly afterwards; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the arm of the injection, which never went away completely) and PYREXIA (Fever which resolved shortly afterwards) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash on the arm of the injection, which never went away completely) and PYREXIA (Fever which resolved shortly afterwards). At the time of the report, RASH (rash on the arm of the injection, which never went away completely) had not resolved and PYREXIA (Fever which resolved shortly afterwards) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications were not provided.  treatment medication was not given.   This case was linked to MOD-2021-100827 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site urticaria, Scar, Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: dark; It got itchy/ very very itchy; small bump pupping in her injection site, it got flat and speared out; rash some small and large as a penny; Nasty scars; This spontaneous case was reported by a consumer and describes the occurrence of SCAR, VACCINATION SITE DISCOLOURATION (dark), VACCINATION SITE PRURITUS, INJECTION SITE URTICARIA (small bump pupping in her injection site, it got flat and speared out) and INJECTION SITE RASH (rash some small and large as a penny) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported. No concomitant medication was reported.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SCAR, VACCINATION SITE PRURITUS (It got itchy/ very very itchy), INJECTION SITE URTICARIA (small bump pupping in her injection site, it got flat and speared out) and INJECTION SITE RASH (rash some small and large as a penny). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (dark). At the time of the report, SCAR, VACCINATION SITE DISCOLOURATION (dark), VACCINATION SITE PRURITUS, INJECTION SITE URTICARIA (small bump pupping in her injection site, it got flat and speared out) and INJECTION SITE RASH (rash some small and large as a penny) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment details included ice for itching.  No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: patient shared pictures describing the event.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Red rash on left arm; Warm rash on left arm; Itching on arm; Rash on face; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on left arm), SKIN WARM (Warm rash on left arm), RASH PRURITIC (Itching on arm) and RASH (Rash on face) in a 65-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on left arm), SKIN WARM (Warm rash on left arm), RASH PRURITIC (Itching on arm) and RASH (Rash on face). At the time of the report, RASH ERYTHEMATOUS (Red rash on left arm), SKIN WARM (Warm rash on left arm), RASH PRURITIC (Itching on arm) and RASH (Rash on face) outcome was unknown.            No concomitant medication was provided by the reporter. No treatmrnt medication were provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Shakiness; Feverish feeling; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakiness), PYREXIA (Feverish feeling) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 023M21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN for Diabetes.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced TREMOR (Shakiness), PYREXIA (Feverish feeling) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Shakiness and Pyrexia, at an unspecified dose and frequency. At the time of the report, TREMOR (Shakiness), PYREXIA (Feverish feeling) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Updated Outcome of Events to Recoverd and Reporter declined to further Follow Up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Adverse reaction
Clinical narrative: mild expected side effects; Nurse administered the 2nd dose and then noticed needle was dull and pulled it out and gave the 2nd dose with another needle; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Nurse administered the 2nd dose and then noticed needle was dull and pulled it out and gave the 2nd dose with another needle) and ADVERSE REACTION (mild expected side effects) in a 22-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunisation.     No medical history was provided by the reporter.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (Nurse administered the 2nd dose and then noticed needle was dull and pulled it out and gave the 2nd dose with another needle). On an unknown date, the patient experienced ADVERSE REACTION (mild expected side effects). On 30-Apr-2021, ACCIDENTAL OVERDOSE (Nurse administered the 2nd dose and then noticed needle was dull and pulled it out and gave the 2nd dose with another needle) had resolved. At the time of the report, ADVERSE REACTION (mild expected side effects) outcome was unknown.        For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04 JUNE 2021, email added- event updated as mild expected side effects
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Fatigue, Heart rate irregular
Clinical narrative: dizziness; weakness; Irregular and rapid heartbeat; hasn't been feeling well; extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue) in a 52-year-old female patient who received mRNA-1273 (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 85/67 (Low) Low.     The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   An electrocardiogram performed on 26-Apr-2021 did not reveal any findings.   No concomitant medications were reported.  No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: dizziness; weakness; Irregular and rapid heartbeat; hasn't been feeling well; extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue) in a 52-year-old female patient who received mRNA-1273 (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HEART RATE IRREGULAR (Irregular and rapid heartbeat), MALAISE (hasn't been feeling well) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 85/67 (Low) Low.     The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   An electrocardiogram performed on 26-Apr-2021 did not reveal any findings.   No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient missed his second dose (Second dose not administered within 42 days); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed his second dose (Second dose not administered within 42 days)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed his second dose (Second dose not administered within 42 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed his second dose (Second dose not administered within 42 days)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported. Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-026841 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Mobility decreased, Pain
Clinical narrative: nurse administered into her shoulder joint instead of deltoid muscle; arm  and fingers started tingling; redness at injection site; ridiculous pain; sore; puffy  at the injection site; arm was sore; arm was puffy; patient could not move her arm away from her body; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (nurse administered into her shoulder joint instead of deltoid muscle), PARAESTHESIA (arm  and fingers started tingling), INJECTION SITE ERYTHEMA (redness at injection site), PAIN (ridiculous pain) and ARTHRALGIA (sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (nurse administered into her shoulder joint instead of deltoid muscle), PARAESTHESIA (arm  and fingers started tingling), INJECTION SITE ERYTHEMA (redness at injection site), PAIN (ridiculous pain), ARTHRALGIA (sore), INJECTION SITE SWELLING (puffy  at the injection site), PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (arm was puffy) and MOBILITY DECREASED (patient could not move her arm away from her body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (nurse administered into her shoulder joint instead of deltoid muscle) had resolved. At the time of the report, PARAESTHESIA (arm  and fingers started tingling), INJECTION SITE ERYTHEMA (redness at injection site), PAIN (ridiculous pain), ARTHRALGIA (sore), INJECTION SITE SWELLING (puffy  at the injection site), PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (arm was puffy) and MOBILITY DECREASED (patient could not move her arm away from her body) outcome was unknown.             Action taken on mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: nurse administered into her shoulder joint instead of deltoid muscle; arm  and fingers started tingling; redness at injection site; ridiculous pain; sore; puffy  at the injection site; arm was sore; arm was puffy; patient could not move her arm away from her body; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (nurse administered into her shoulder joint instead of deltoid muscle), PARAESTHESIA (arm  and fingers started tingling), INJECTION SITE ERYTHEMA (redness at injection site), PAIN (ridiculous pain) and ARTHRALGIA (sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (nurse administered into her shoulder joint instead of deltoid muscle), PARAESTHESIA (arm  and fingers started tingling), INJECTION SITE ERYTHEMA (redness at injection site), PAIN (ridiculous pain), ARTHRALGIA (sore), INJECTION SITE SWELLING (puffy  at the injection site), PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (arm was puffy) and MOBILITY DECREASED (patient could not move her arm away from her body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (nurse administered into her shoulder joint instead of deltoid muscle) had resolved. At the time of the report, PARAESTHESIA (arm  and fingers started tingling), INJECTION SITE ERYTHEMA (redness at injection site), PAIN (ridiculous pain), ARTHRALGIA (sore), INJECTION SITE SWELLING (puffy  at the injection site), PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (arm was puffy) and MOBILITY DECREASED (patient could not move her arm away from her body) outcome was unknown.             Action taken on mRNA-1273 in response to the events was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Fatigue; a back pain around kidney areas; chills to hot to chills; headaches; joint pain; muscle pain; Up all night; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), INSOMNIA (Up all night), HEADACHE (headaches) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (Up all night). On 01-May-2021 at 11:00 PM, the patient experienced BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), HEADACHE (headaches), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 02-May-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 02-May-2021 at 7:00 AM, BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved. At the time of the report, INSOMNIA (Up all night) outcome was unknown and HEADACHE (headaches) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The action taken with the drug was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia
Clinical narrative: Fatigue; a back pain around kidney areas; chills to hot to chills; headaches; joint pain; muscle pain; Up all night; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), INSOMNIA (Up all night), HEADACHE (headaches) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (Up all night). On 01-May-2021 at 11:00 PM, the patient experienced BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), HEADACHE (headaches), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 02-May-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 02-May-2021 at 7:00 AM, BACK PAIN (a back pain around kidney areas), FEELING OF BODY TEMPERATURE CHANGE (chills to hot to chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved. At the time of the report, INSOMNIA (Up all night) outcome was unknown and HEADACHE (headaches) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The action taken with the drug was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: arm of injection hot to touch; site of injection has a bump; sore arm of injection; arm of injection has red area size of an orange; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of injection hot to touch), INJECTION SITE INDURATION (site of injection has a bump), VACCINATION SITE PAIN (sore arm of injection) and VACCINATION SITE ERYTHEMA (arm of injection has red area size of an orange) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), OMEPRAZOLE, FAMOTIDINE, METOPROLOL, BUPROPION, SERTRALINE HCL, TRAZODONE, SPIRONOLACTONE, ATORVASTATIN, LISINOPRIL and FLECAINIDE for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm of injection hot to touch), INJECTION SITE INDURATION (site of injection has a bump), VACCINATION SITE PAIN (sore arm of injection) and VACCINATION SITE ERYTHEMA (arm of injection has red area size of an orange). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm of injection hot to touch), INJECTION SITE INDURATION (site of injection has a bump), VACCINATION SITE PAIN (sore arm of injection) and VACCINATION SITE ERYTHEMA (arm of injection has red area size of an orange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Vaccination site reaction
Clinical narrative: Spot on the arm is getting bigger; Felt very sick; Awake at night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Spot on the arm is getting bigger), MALAISE (Felt very sick) and INSOMNIA (Awake at night) in a 69-year-old female patient who received mRNA-1273 (batch nos. 014C21A and 031B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced MALAISE (Felt very sick) and INSOMNIA (Awake at night). On an unknown date, the patient experienced VACCINATION SITE REACTION (Spot on the arm is getting bigger). The patient was treated with IBUPROFEN from 29-Apr-2021 to 30-Apr-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Spot on the arm is getting bigger) had not resolved and MALAISE (Felt very sick) and INSOMNIA (Awake at night) outcome was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had bad pain in her arm) and DIARRHOEA (diarrhea after first dose which relapsed after second dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (had bad pain in her arm) and DIARRHOEA (diarrhea after first dose which relapsed after second dose). At the time of the report, PAIN IN EXTREMITY (had bad pain in her arm) outcome was unknown and DIARRHOEA (diarrhea after first dose which relapsed after second dose) had resolved.            No concomitant medications were reported.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Non significant information was received on 31-MAY-2021 contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (vertigo) in a male patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS (Dizziness) and VERTIGO (vertigo) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-100611 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Bone pain, Chills, Erythema, Fatigue
Clinical narrative: Itchiness; Rash on foot and rash spread to her legs; Rash on her foot very red; Swelling of legs; Vulval rash; Tachycardia; Nausea; Fever; Tiredness; Lymph nodes of her armpit became swollen; Pain on her bones(big bones like her hips); Chills; Feeling cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Pain on her bones(big bones like her hips)), PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red) and PERIPHERAL SWELLING (Swelling of legs) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 037a21b) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced BONE PAIN (Pain on her bones(big bones like her hips)), FEELING COLD (Feeling cold) and CHILLS (Chills). On 23-Apr-2021, the patient experienced PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red), PERIPHERAL SWELLING (Swelling of legs), VULVOVAGINAL RASH (Vulval rash), TACHYCARDIA (Tachycardia), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Tiredness) and LYMPHADENOPATHY (Lymph nodes of her armpit became swollen). On 28-Apr-2021, BONE PAIN (Pain on her bones(big bones like her hips)), PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red), PERIPHERAL SWELLING (Swelling of legs), VULVOVAGINAL RASH (Vulval rash), FEELING COLD (Feeling cold), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Tiredness) and CHILLS (Chills) had resolved. At the time of the report, TACHYCARDIA (Tachycardia) and LYMPHADENOPATHY (Lymph nodes of her armpit became swollen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood pressure measurement: (High) High blood pressure.         Concomitant product use was not provided by the reporter. Treatment details included a self prescribed medication Benadryl cream & 2 Benadryl pills 25mg.Patient  called ER and went to hospital where she was given a cocktail:intravenous serum hexadrol 0.6mg benadryl advil 0.5mg pepsid 20mg 2ml Toradol, To be taken when she got back home:steroids prednisone 20mg twice a day and naproxen.  Action taken with mRNA-1273 in response to events were not applicable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Lymphadenopathy, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Itchiness; Rash on foot and rash spread to her legs; Rash on her foot very red; Swelling of legs; Vulval rash; Tachycardia; Nausea; Fever; Tiredness; Lymph nodes of her armpit became swollen; Pain on her bones(big bones like her hips); Chills; Feeling cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Pain on her bones(big bones like her hips)), PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red) and PERIPHERAL SWELLING (Swelling of legs) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 037a21b) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced BONE PAIN (Pain on her bones(big bones like her hips)), FEELING COLD (Feeling cold) and CHILLS (Chills). On 23-Apr-2021, the patient experienced PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red), PERIPHERAL SWELLING (Swelling of legs), VULVOVAGINAL RASH (Vulval rash), TACHYCARDIA (Tachycardia), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Tiredness) and LYMPHADENOPATHY (Lymph nodes of her armpit became swollen). On 28-Apr-2021, BONE PAIN (Pain on her bones(big bones like her hips)), PRURITUS (Itchiness), RASH (Rash on foot and rash spread to her legs), ERYTHEMA (Rash on her foot very red), PERIPHERAL SWELLING (Swelling of legs), VULVOVAGINAL RASH (Vulval rash), FEELING COLD (Feeling cold), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Tiredness) and CHILLS (Chills) had resolved. At the time of the report, TACHYCARDIA (Tachycardia) and LYMPHADENOPATHY (Lymph nodes of her armpit became swollen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood pressure measurement: (High) High blood pressure.         Concomitant product use was not provided by the reporter. Treatment details included a self prescribed medication Benadryl cream & 2 Benadryl pills 25mg.Patient  called ER and went to hospital where she was given a cocktail:intravenous serum hexadrol 0.6mg benadryl advil 0.5mg pepsid 20mg 2ml Toradol, To be taken when she got back home:steroids prednisone 20mg twice a day and naproxen.  Action taken with mRNA-1273 in response to events were not applicable.