chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (positive for COVID-19) and inappropriate schedule of product administration (second dose may be greater than 36 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040B21A) for COVID-19 immunization. No medical history reported. On Apr 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 29, 2021, patient had COVID-19 (positive for COVID-19). On an unknown date, patient experienced inappropriate schedule of product administration (second dose may be greater than 36 days). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; and ibuprofen, at an unspecified dose and frequency. At the time of the report, COVID-19 (positive for COVID-19) and inappropriate schedule of product administration (second dose may be greater than 36 days) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has not received her second dose/Second vaccine not scheduled for more than 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received her second dose/Second vaccine not scheduled for more than 42 days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 PRODUCT DOSE OMISSION ISSUE (Patient has not received her second dose/Second vaccine not scheduled for more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received her second dose/Second vaccine not scheduled for more than 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of "broke-out with a rash" in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced "broke-out with a rash." At the time of the report, "broke-out with a rash" outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. No concomitant medication or treatment information provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: N/V/D; N/V/D; N/V/D; Muscle aches; Joint pains; Mild fever; chills; fatigue/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (N/V/D), NAUSEA (N/V/D), VOMITING (N/V/D), MYALGIA (Muscle aches) and ARTHRALGIA (Joint pains) in a 64-year-old female patient who received mRNA-1273 (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 08-Apr-2021. Concomitant products included PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (N/V/D), NAUSEA (N/V/D), VOMITING (N/V/D), MYALGIA (Muscle aches), ARTHRALGIA (Joint pains), PYREXIA (Mild fever), CHILLS (chills) and FATIGUE (fatigue/tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (N/V/D), NAUSEA (N/V/D), VOMITING (N/V/D), MYALGIA (Muscle aches), ARTHRALGIA (Joint pains), PYREXIA (Mild fever), CHILLS (chills) and FATIGUE (fatigue/tiredness) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       The patient reported that she was exposed to Covid-19 on 01-Apr-2021. On 08-Apr-2021, the patient got tested for Covid-19 due to her symptoms. The patient was tested positive on 11-Apr-2021 and finished her quarantine on 18-Apr-2021.   The patient stated that after getting the vaccination, she felt exactly same as when she had Covid-19. The patient also mentioned that when she had Covid-19 she did not have diarrhea.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: N/V/D; N/V/D; N/V/D; Muscle aches; Joint pains; Mild fever; chills; fatigue/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (N/V/D), NAUSEA (N/V/D), VOMITING (N/V/D), MYALGIA (Muscle aches) and ARTHRALGIA (Joint pains) in a 64-year-old female patient who received mRNA-1273 (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 08-Apr-2021. Concomitant products included PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (N/V/D), NAUSEA (N/V/D), VOMITING (N/V/D), MYALGIA (Muscle aches), ARTHRALGIA (Joint pains), PYREXIA (Mild fever), CHILLS (chills) and FATIGUE (fatigue/tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (N/V/D), NAUSEA (N/V/D), VOMITING (N/V/D), MYALGIA (Muscle aches), ARTHRALGIA (Joint pains), PYREXIA (Mild fever), CHILLS (chills) and FATIGUE (fatigue/tiredness) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       The patient reported that she was exposed to Covid-19 on 01-Apr-2021. On 08-Apr-2021, the patient got tested for Covid-19 due to her symptoms. The patient was tested positive on 11-Apr-2021 and finished her quarantine on 18-Apr-2021.   The patient stated that after getting the vaccination, she felt exactly same as when she had Covid-19. The patient also mentioned that when she had Covid-19 she did not have diarrhea.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash, Urticaria
Clinical narrative: Hives; Itching; Rash; Pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itching), RASH (Rash) and MYALGIA (Pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VALACYCLOVIR [VALACICLOVIR], THYROID (ARMOUR THYROID), LORAZEPAM and PEPPERMINT [MENTHA X PIPERITA] for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced URTICARIA (Hives), PRURITUS (Itching), RASH (Rash) and MYALGIA (Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), PRURITUS (Itching), RASH (Rash) and MYALGIA (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication includes Omega 3 fatty acid of esters. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Dose received in parts 0.05ml and then 0.45 ml; This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml). At the time of the report, INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was informed by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product dose omission issue
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of off-label use (missed scheduled second dose/45 days since first one) and product dose omission issue (missed second dose due to it raining badly outside) in a female patient, of an unknown age, who received mRNA-1273 (batch# 012A21A) for COVID-19 immunization. No medical history reported. On Mar 17, 2021, patient received the first dose of mRNA-1273, (intramuscular); 1 dosage form. On May 1, 2021, patient experienced product dose omission issue (missed second dose due to it raining badly outside). On an unknown date, patient experienced off-label use (missed scheduled second dose/45 days since first one). On May 1, 2021, product dose omission issue (missed second dose due to it raining badly outside) resolved. At the time of the report, off-label use (missed scheduled second dose/45 days since first one) resolved. The action taken with mRNA-1273, intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Patient missed the 2nd dose; Patient is likely to get the 2nd shot beyond the interval of 42 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is likely to get the 2nd shot beyond the interval of 42 days.) in a patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is likely to get the 2nd shot beyond the interval of 42 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is likely to get the 2nd shot beyond the interval of 42 days.) had resolved.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed a rash on her chest called shingles; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Developed a rash on her chest called shingles) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A 21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Developed a rash on her chest called shingles). At the time of the report, HERPES ZOSTER (Developed a rash on her chest called shingles) was resolving.            Concomitant medications were not reported.  No treatment details were provided
Sex: U
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal
Clinical narrative: patient contracted strep throat approx 2 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGITIS STREPTOCOCCAL (patient contracted strep throat approx 2 weeks after first dose) in a  patient of an unknown age and gender who received mRNA-1273 (batch no. unknown) for COVID-19 vaccine.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGITIS STREPTOCOCCAL (patient contracted strep throat approx 2 weeks after first dose). At the time of the report, PHARYNGITIS STREPTOCOCCAL (patient contracted strep throat approx 2 weeks after first dose) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medication includes unknown antibiotic.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: injection site turned pink; hives appeared at the site of the injection; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE URTICARIA (hives appeared at the site of the injection) and VACCINATION SITE ERYTHEMA (injection site turned pink) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included CLL (Chronic lymphocytic leukaemia).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itching). On 25-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (hives appeared at the site of the injection). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site turned pink). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (injection site turned pink) was resolving and VACCINATION SITE URTICARIA (hives appeared at the site of the injection) had resolved.            No relevant concomitant medications were provided. Treatment activities for event was also done with Triple antibiotic ointment. The action taken for mRNA-1273 was not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medication include Augmentin(Amoxicillin/Clavulanate) prescribed by her doctor. She is still having the infection. She has not yet started taking the prescribed drug.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose Bleeds; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nose Bleeds) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis and Cholesterol. Concurrent medical conditions included Hypertension.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced EPISTAXIS (Nose Bleeds). At the time of the report, EPISTAXIS (Nose Bleeds) outcome was unknown.            Treatment includes Ice and pressure locally to slow bleeding   Reporter did not allow further contact
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Skin depigmentation
Clinical narrative: spot under my armpit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN DEPIGMENTATION (spot under my armpit) in a 54-year-old male patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SKIN DEPIGMENTATION (spot under my armpit). The patient was treated with DOXYCYCLINE at a dose of UNK, q2wk. At the time of the report, SKIN DEPIGMENTATION (spot under my armpit) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       no concomitant medications reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Pain in extremity, Wheezing
Clinical narrative: wheezing; severe dry cough/coughs so much that she is on the brink of vomiting; chest tightness; arm soreness; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm soreness), CHEST DISCOMFORT (chest tightness), WHEEZING (wheezing), COUGH (severe dry cough/coughs so much that she is on the brink of vomiting) and FATIGUE (fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Asthma.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and FATIGUE (fatigue). On 22-Apr-2021, the patient experienced CHEST DISCOMFORT (chest tightness). On an unknown date, the patient experienced WHEEZING (wheezing) and COUGH (severe dry cough/coughs so much that she is on the brink of vomiting). The patient was treated with AMOXICILLIN SODIUM, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANIC ACID]) at a dose of 875 mg and METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), CHEST DISCOMFORT (chest tightness), WHEEZING (wheezing), COUGH (severe dry cough/coughs so much that she is on the brink of vomiting) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Wound haemorrhage
Clinical narrative: Wound wont stop bleeding on hand; This spontaneous case was reported by a consumer and describes the occurrence of WOUND HAEMORRHAGE (Wound wont stop bleeding on hand) in a 32-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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced WOUND HAEMORRHAGE (Wound wont stop bleeding on hand). At the time of the report, WOUND HAEMORRHAGE (Wound wont stop bleeding on hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient stated that the wound would not stop bleeding and it has been over an hour and they have tried everything.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: massive headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in a 68-year-old male patient who received mRNA-1273 for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications included unspecified blood pressure medications. Treatment information was not provided.   This case was linked to MOD-2021-100546 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered the second dose of Moderna COVID-19 vaccine from a vial that have been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the second dose of Moderna COVID-19 vaccine from a vial that have been punctured for more than 12 hours) in a 36-year-old female patient who received mRNA-1273 (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the second dose of Moderna COVID-19 vaccine from a vial that have been punctured for more than 12 hours). On 30-Apr-2021, EXPIRED PRODUCT ADMINISTERED (administered the second dose of Moderna COVID-19 vaccine from a vial that have been punctured for more than 12 hours) 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 drugs and treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Muscle spasms
Clinical narrative: undertake a covid19 test and he tested positive; Chills; Headache; Muscle Cramps; Dry cough; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 01-May-2021. The most recent information was received on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle Cramps), COUGH (Dry cough), COVID-19 (undertake a covid19 test and he tested positive), CHILLS (Chills) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MUSCLE SPASMS (Muscle Cramps), COUGH (Dry cough), CHILLS (Chills) and HEADACHE (Headache). On 02-May-2021, the patient experienced COVID-19 (undertake a covid19 test and he tested positive). On 01-May-2021, MUSCLE SPASMS (Muscle Cramps), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, COUGH (Dry cough) had not resolved and COVID-19 (undertake a covid19 test and he tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Reporter information, additional events and lab data were updated On 02-May-2021: No new information was provided.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: undertake a covid19 test and he tested positive; Chills; Headache; Muscle Cramps; Dry cough; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 01-May-2021. The most recent information was received on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle Cramps), COUGH (Dry cough), COVID-19 (undertake a covid19 test and he tested positive), CHILLS (Chills) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MUSCLE SPASMS (Muscle Cramps), COUGH (Dry cough), CHILLS (Chills) and HEADACHE (Headache). On 02-May-2021, the patient experienced COVID-19 (undertake a covid19 test and he tested positive). On 01-May-2021, MUSCLE SPASMS (Muscle Cramps), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, COUGH (Dry cough) had not resolved and COVID-19 (undertake a covid19 test and he tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Reporter information, additional events and lab data were updated On 02-May-2021: No new information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: massive headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in a 68-year-old male patient who received mRNA-1273 for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Treated with blood pressure medications.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) outcome was unknown.        mRNA-1273 (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-100543.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Pyrexia, Somnolence, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling good), SOMNOLENCE (Wants to sleep all the time), DECREASED APPETITE (Did not eat anything today) and PYREXIA (low grade fever of 99 degree) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 021B21A) for COVID-19 vaccination.     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, 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 VACCINATION COMPLICATION (Not feeling good) and SOMNOLENCE (Wants to sleep all the time). On 02-May-2021, the patient experienced DECREASED APPETITE (Did not eat anything today). In May 2021, the patient experienced PYREXIA (low grade fever of 99 degree). At the time of the report, VACCINATION COMPLICATION (Not feeling good), SOMNOLENCE (Wants to sleep all the time), DECREASED APPETITE (Did not eat anything today) and PYREXIA (low grade fever of 99 degree) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Body temperature: 99 (High) 99 degree.         No relevant concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache, Neck pain
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes an episode of dizziness, dizziness/headaches, back and neck pain in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 immunization. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 7, 2021, patient had an episode of dizziness. On Apr 8, 2021, patient experienced back pain and neck pain. On Apr 18, 2021, patient experienced dizziness/headaches. The patient treated with Advil (ibuprofen), at an unspecified dose; and frequency and Tylenol (paracetamol), at an unspecified dose and frequency. On Apr 20, 2021, back pain and neck pain resolved. On Apr 30, 2021, dizziness/headaches resolved. At the time of the report, an episode of dizziness outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported. The patient stated Apr 30, 2021 was the first day he did not have any side effects. The patient went to chiropractor. Treated with Advil and Tylenol for 13 to 14 days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of relaxation, Headache, Pyrexia, Vaccination site erythema
Clinical narrative: Feeling calmly; Injection site is swollen; Injection site is red; Having headaches; Felt tired; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION (Feeling calmly), HEADACHE (Having headaches), FATIGUE (Felt tired), PYREXIA (Had fever) and VACCINATION SITE SWELLING (Injection site is swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A0 and 0020B20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-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 HEADACHE (Having headaches), FATIGUE (Felt tired) and PYREXIA (Had fever). On 30-Apr-2021, the patient experienced FEELING OF RELAXATION (Feeling calmly), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, FATIGUE (Felt tired) had resolved. At the time of the report, FEELING OF RELAXATION (Feeling calmly), HEADACHE (Having headaches), PYREXIA (Had fever), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.            This case was linked to MOD-2021-100857 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Feeling calmly; Injection site is swollen; Injection site is red; Having headaches; Felt tired; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION (Feeling calmly), HEADACHE (Having headaches), FATIGUE (Felt tired), PYREXIA (Had fever) and VACCINATION SITE SWELLING (Injection site is swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A0 and 0020B20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-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 HEADACHE (Having headaches), FATIGUE (Felt tired) and PYREXIA (Had fever). On 30-Apr-2021, the patient experienced FEELING OF RELAXATION (Feeling calmly), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, FATIGUE (Felt tired) had resolved. At the time of the report, FEELING OF RELAXATION (Feeling calmly), HEADACHE (Having headaches), PYREXIA (Had fever), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.            This case was linked to MOD-2021-100857 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Dyspnoea, Pain in extremity
Clinical narrative: an adverse reaction; severe chills; Severe shortness of breath; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Severe shortness of breath), PAIN IN EXTREMITY (arm soreness), ADVERSE REACTION (an adverse reaction) and CHILLS (severe chills) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DYSPNOEA (Severe shortness of breath), PAIN IN EXTREMITY (arm soreness) and CHILLS (severe chills). On an unknown date, the patient experienced ADVERSE REACTION (an adverse reaction). On 02-Apr-2021, DYSPNOEA (Severe shortness of breath), PAIN IN EXTREMITY (arm soreness) and CHILLS (severe chills) had resolved. At the time of the report, ADVERSE REACTION (an adverse reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient almost could not breathe, which subsided in about 30 but for a while he thought he might had to rush to the emergency room.  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.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: No specific follow-up information recorded.; 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: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Vaccination complication
Clinical narrative: Weird side effect; pressure on her head; More intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Weird side effect), HEAD DISCOMFORT (pressure on her head) and HEADACHE (More intense headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoarthritis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (More intense headaches). On 04-May-2021, the patient experienced HEAD DISCOMFORT (pressure on her head). On an unknown date, the patient experienced VACCINATION COMPLICATION (Weird side effect). At the time of the report, VACCINATION COMPLICATION (Weird side effect), HEAD DISCOMFORT (pressure on her head) and HEADACHE (More intense headaches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was noted that after the second dose, the patient experienced more intense headaches than with the first one. These lasted six days. Patient noted she never had a headache before. On 01May2021, the headache came back. She noticed that the pain started when she read or used the computer, no matter for how long, but it would go away if she stopped. On 02May2021, the pain was described as "pretty intense" and this time, she didn't read or used the computer. On 04May2021, she woke up with a headache again. The patient noted it was the same kind of pain that she felt after both doses, in the top of the back of her head, and that if she laid down, it was worse. She described it as pressure on her head.   This case was linked toMOD-2021-102984 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Events and out come of the events updated; Sender's Comments:  INC.-MOD-2021-102984:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Malaise, Pain in extremity
Clinical narrative: not feeling good; shoulder of the injection site down to the elbows and wrist became sore; like whole brain was being shorted out; shoulder of injection site down to elbows and wrist became sore; electrical current running through head,felt like whole brain was being shorted out; pain in left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore) and HEADACHE (electrical current running through head,felt like whole brain was being shorted out) in a 74-year-old female patient who received mRNA-1273 (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis and Parkinson's disease.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore), HEADACHE (electrical current running through head,felt like whole brain was being shorted out) and ARTHRALGIA (pain in left shoulder). At the time of the report, MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore), HEADACHE (electrical current running through head,felt like whole brain was being shorted out) and ARTHRALGIA (pain in left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Patient stated that the pain is on-going and does cause her to wake up in the middle of the night with pain in the left shoulder and left arm. Treatment was reported as Tylenol extra strength and ibuprofen. No concomitant medications were reported.; Sender's Comments:  MOD-2021-100608:Husband's case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: not feeling good; shoulder of the injection site down to the elbows and wrist became sore; like whole brain was being shorted out; shoulder of injection site down to elbows and wrist became sore; electrical current running through head,felt like whole brain was being shorted out; pain in left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore) and HEADACHE (electrical current running through head,felt like whole brain was being shorted out) in a 74-year-old female patient who received mRNA-1273 (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis and Parkinson's disease.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore), HEADACHE (electrical current running through head,felt like whole brain was being shorted out) and ARTHRALGIA (pain in left shoulder). At the time of the report, MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore), HEADACHE (electrical current running through head,felt like whole brain was being shorted out) and ARTHRALGIA (pain in left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Patient stated that the pain is on-going and does cause her to wake up in the middle of the night with pain in the left shoulder and left arm. Treatment was reported as Tylenol extra strength and ibuprofen. No concomitant medications were reported.; Sender's Comments:  MOD-2021-100608:Husband's case
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle soreness at the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness at the injection site arm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     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 03-Apr-2021, the patient experienced MYALGIA (Muscle soreness at the injection site arm). At the time of the report, MYALGIA (Muscle soreness at the injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not reported. Treatment information was not reported.   This case was linked to MOD-2021-101306 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: on dialysis when received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (on dialysis when received the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Dialysis since an unknown date.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (on dialysis when received the vaccine). At the time of the report, NO ADVERSE EVENT (on dialysis when received the vaccine) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received contains significant  information  with regards to dose-2
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Pruritus, Rash
Clinical narrative: eyes and around the eyes looked like swollen; felt itchy; full body rash; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (eyes and around the eyes looked like swollen), PRURITUS (felt itchy), RASH (full body rash) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRURITUS (felt itchy), RASH (full body rash) and HEADACHE (headache). On 01-May-2021, the patient experienced EYE SWELLING (eyes and around the eyes looked like swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (eyes and around the eyes looked like swollen), PRURITUS (felt itchy), RASH (full body rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient took the BJ's generic of Benadryl (antihistamine) medication to help with the sign and symptoms.