chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: left shoulder slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (left shoulder slightly sore) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (sulfa - suspected), Cancer (SLL cancer, bladder cancer) since 2013, Arrhythmia (heart rhythm problems) since 2013, Hypertension (blood pressure hypertension) since 2013 and Arthritis (old age arthritis) since 2006. Concomitant products included DIGOXIN from 14-Dec-2016 to an unknown date, APIXABAN (ELIQUIS) from 02-Dec-2016 to an unknown date and METOPROLOL from 03-Dec-2016 to an unknown date for Arrhythmia, ATORVASTATIN from 20-Aug-2014 to an unknown date for Cholesterol, LATANOPROST from 09-Sep-2011 to an unknown date for Glaucoma, AMLODIPINE from 03-Jul-2013 to an unknown date, CHLORTHALIDONE from 24-Jun-2014 to an unknown date and LOSARTAN from 30-May-2013 to an unknown date for Hypertension, METHENAMINE from 10-Aug-2018 to an unknown date and TAMSULOSIN from 19-Aug-2018 to an unknown date for UTI, BPH and Urinary retention, MULTIVITAMINS;MINERALS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRALGIA (left shoulder slightly sore). At the time of the report, ARTHRALGIA (left shoulder slightly sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided   This case was linked to MOD-2021-101196, MOD-2021-101196 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: The Significant follow up received in which patient demographic details were added. Medical history information is added. Concomitant drugs were added. On 13-Jul-2021: Follow up received does not contain any new information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Induration, Pain, Pruritus
Clinical narrative: Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under; Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under; Noticed arm is red and itchy and has a hard spot; Noticed arm is red and itchy and has a hard spot; Noticed arm is red and itchy and has a hard spot; Had chills, fever, and felt achy; Had chills, fever, and felt achy; Had chills, fever, and felt achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had chills, fever, and felt achy), ERYTHEMA (Noticed arm is red and itchy and has a hard spot), PRURITUS (Noticed arm is red and itchy and has a hard spot), INDURATION (Noticed arm is red and itchy and has a hard spot) and RASH PRURITIC (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Had chills, fever, and felt achy), CHILLS (Had chills, fever, and felt achy) and PYREXIA (Had chills, fever, and felt achy). On 28-Feb-2021, the patient experienced ERYTHEMA (Noticed arm is red and itchy and has a hard spot), PRURITUS (Noticed arm is red and itchy and has a hard spot) and INDURATION (Noticed arm is red and itchy and has a hard spot). On 01-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under) and RASH (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under). At the time of the report, PAIN (Had chills, fever, and felt achy), RASH PRURITIC (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under), RASH (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under), CHILLS (Had chills, fever, and felt achy) and PYREXIA (Had chills, fever, and felt achy) had not resolved and ERYTHEMA (Noticed arm is red and itchy and has a hard spot), PRURITUS (Noticed arm is red and itchy and has a hard spot) and INDURATION (Noticed arm is red and itchy and has a hard spot) outcome was unknown.            No concomitant medications were reported. Treatment details included Aloe vera. She used some Aloe Vera cream to alleviate the discomfort   This case was linked to MOD-2021-035780 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under; Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under; Noticed arm is red and itchy and has a hard spot; Noticed arm is red and itchy and has a hard spot; Noticed arm is red and itchy and has a hard spot; Had chills, fever, and felt achy; Had chills, fever, and felt achy; Had chills, fever, and felt achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had chills, fever, and felt achy), ERYTHEMA (Noticed arm is red and itchy and has a hard spot), PRURITUS (Noticed arm is red and itchy and has a hard spot), INDURATION (Noticed arm is red and itchy and has a hard spot) and RASH PRURITIC (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Had chills, fever, and felt achy), CHILLS (Had chills, fever, and felt achy) and PYREXIA (Had chills, fever, and felt achy). On 28-Feb-2021, the patient experienced ERYTHEMA (Noticed arm is red and itchy and has a hard spot), PRURITUS (Noticed arm is red and itchy and has a hard spot) and INDURATION (Noticed arm is red and itchy and has a hard spot). On 01-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under) and RASH (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under). At the time of the report, PAIN (Had chills, fever, and felt achy), RASH PRURITIC (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under), RASH (Itchy rash all over neck, face, jaw, eyes, head - under neck and eyes were really itchy , under), CHILLS (Had chills, fever, and felt achy) and PYREXIA (Had chills, fever, and felt achy) had not resolved and ERYTHEMA (Noticed arm is red and itchy and has a hard spot), PRURITUS (Noticed arm is red and itchy and has a hard spot) and INDURATION (Noticed arm is red and itchy and has a hard spot) outcome was unknown.            No concomitant medications were reported. Treatment details included Aloe vera. She used some Aloe Vera cream to alleviate the discomfort   This case was linked to MOD-2021-035780 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: low-grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low-grade fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low-grade fever) and CHILLS (chills). At the time of the report, PYREXIA (low-grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Paraesthesia; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Paraesthesia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Paraesthesia). At the time of the report, PARAESTHESIA (Paraesthesia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products are reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness everywhere on her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness everywhere on her body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical information was reported.  Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Acid reflux (esophageal), OMEPRAZOLE for GERD, LEVOTHYROXINE and AZATHIOPRINE for an unknown indication.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (itchiness everywhere on her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (itchiness everywhere on her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Feeling abnormal, Headache
Clinical narrative: stomach cramping; brain fog; headache; joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy and Hay fever.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD21-085094 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Contact Information Updated; Sender's Comments:  MOD21-085094:follow up - contact information updated - name , email , address.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stomach cramping; brain fog; headache; joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy and Hay fever.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD21-085094 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Contact Information Updated; Sender's Comments:  MOD21-085094:follow up - contact information updated - name , email , address.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: It was injected into their fatty tissue instead of the muscle; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was injected into their fatty tissue instead of the muscle) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was injected into their fatty tissue instead of the muscle). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was injected into their fatty tissue instead of the muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: No new information received.; Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 029A21A) with no associated AEs reported
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site warmth, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site warmth; Itch around the injection site; Injection site immediately turned red; Injection site immediately began to swell; vaccination site pain; Vaccine was given subcutaneously; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) from 01-Jan-2016 to an unknown date for Seasonal allergy.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously) had resolved.            Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: updated new events , vaccination site erythema, vaccination site pruritus, vaccination site pain, vaccination site warmthReporter contact details updated In product tab, second dose details of mRNA 1273 was updated. concomitant drug was updated patient demographics was updated; Sender's Comments: This report refers to a case of Inappropriate route of vaccination for mRNA-1273, lot # 029A21A with no associated AEs.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: injection site warmth; Itch around the injection site; Injection site immediately turned red; Injection site immediately began to swell; vaccination site pain; Vaccine was given subcutaneously; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) from 01-Jan-2016 to an unknown date for Seasonal allergy.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subcutaneously) had resolved.            Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: updated new events , vaccination site erythema, vaccination site pruritus, vaccination site pain, vaccination site warmthReporter contact details updated In product tab, second dose details of mRNA 1273 was updated. concomitant drug was updated patient demographics was updated; Sender's Comments: This report refers to a case of Inappropriate route of vaccination for mRNA-1273, lot # 029A21A with no associated AEs.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Invalid dosing, received less than half dose,needle pooped out during administration; A spontaneous report was received from a nurse concerning a Consumer, 74 years- old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) with accidental underdose, received less than half dose.  The patient's medical history included Hypertension,Diabetes Mellitus, Cholesterol, Hypothyroidism, and Acid Reflux.  The concomitant medications included Labetalol hydrochloride , Amlodipine 5mg, Metformin, Empagliflozin for Diabetes Mellitus, Losartan For Hypertension, Rosuvastatin for Cholesterol, Levothyroxine For Hypothyroidism, Omeprazole For Acid Reflux.  On 06 Mar 2021, prior to the onset of the events, the patient received the unknown of the two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.  On 06 Mar 2021, the patient received accidental underdose, received less than half dose.  No Laboratory investigations were provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The event, accidental underdose, received less than half dose was considered resolved on 06 Mar 2021.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 001A21A  with no associated AEs.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever; headache; Fatigue; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; headache; Fatigue; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Dyspnoea, SARS-CoV-2 test negative
Clinical narrative: Had mild shortness of breath; Annoying cough that sounded like bronchitis cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had mild shortness of breath) and COUGH (Annoying cough that sounded like bronchitis cough) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Flu vaccination (Over 20 years ago she had mild reaction to a flu vaccine; mid tingling of lip and tongue and rapid heart beat).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (Had mild shortness of breath) and COUGH (Annoying cough that sounded like bronchitis cough). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for  and COVID-19 vaccination, at a dose of 25mg an hour before the vaccine. On 04-Mar-2021, DYSPNOEA (Had mild shortness of breath) and COUGH (Annoying cough that sounded like bronchitis cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Chest X-ray: normal (normal) normal. On 02-Mar-2021, SARS-CoV-2 test negative: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was available. Patient was prescribed an Inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Contact details updated On 09-Jul-2021: Non-Significant follow up
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Same reaction in arm; nausea; chills; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Same reaction in arm), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Same reaction in arm), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On 02-Mar-2021, NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) had resolved. On 05-Mar-2021, VACCINATION SITE PAIN (Same reaction in arm) had resolved.            Treatment medication was not provided. Concomitant medication was not reported.   This case was linked to MOD-2021-035798 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fibula fracture, X-ray
Clinical narrative: Slipped and hurt ankle, fractured mildly displace fibula; This spontaneous case was reported by a consumer and describes the occurrence of FIBULA FRACTURE (Slipped and hurt ankle, fractured mildly displace fibula) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FIBULA FRACTURE (Slipped and hurt ankle, fractured mildly displace fibula). At the time of the report, FIBULA FRACTURE (Slipped and hurt ankle, fractured mildly displace fibula) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) fractured mildly displace fibula.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Vaccination site pain
Clinical narrative: dizziness; nausea; left arm pain at the site of the injection; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), VACCINATION SITE PAIN (left arm pain at the site of the injection), CHILLS (chills) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and LEVOTHYROXINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea), VACCINATION SITE PAIN (left arm pain at the site of the injection), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) and NAUSEA (nausea) was resolving and VACCINATION SITE PAIN (left arm pain at the site of the injection), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site, felt like someone hit it with a baseball bat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site, felt like someone hit it with a baseball bat) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site, felt like someone hit it with a baseball bat). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site, felt like someone hit it with a baseball bat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Bed rest, Illness, Vaccination complication
Clinical narrative: adverse reactions; quite ill for 3 to 4 days; in bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reactions), ILLNESS (quite ill for 3 to 4 days) and BED REST (in bed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reactions), ILLNESS (quite ill for 3 to 4 days) and BED REST (in bed). At the time of the report, VACCINATION COMPLICATION (adverse reactions), ILLNESS (quite ill for 3 to 4 days) and BED REST (in bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash 4inch below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash 4inch below the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided.  Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE, METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN and LEVOTHYROXINE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE RASH (rash 4inch below the injection site). At the time of the report, VACCINATION SITE RASH (rash 4inch below the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness and Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness and Pain in arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness and Pain in arm). At the time of the report, PAIN IN EXTREMITY (soreness and Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications were provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm of the injection hurt as hell; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm of the injection hurt as hell) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm of the injection hurt as hell). At the time of the report, VACCINATION SITE PAIN (Arm of the injection hurt as hell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  The reporter stated that she would normally take a pain relief, but she heard that if you took pain relievers on the same 24 hours when the vaccine was administered, the pain relievers could interfere with the vaccine and the immune system.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Non significant information On 03-May-2021: Non-significant follow up (Contact information updated)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Eructation, Fatigue
Clinical narrative: Hives; Belching and gas; Gas; Woke up with no appetite; Chills; Fatigue; Felt like was going to black out; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), URTICARIA (Hives), ERUCTATION (Belching and gas) and FLATULENCE (Gas) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D3, BIOTIN and ACETYLSALICYLIC ACID (ST. JOSEPH ASPIRIN ADULT CHEWABLE) for an unknown indication.   On 26-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 24-Feb-2021, the patient experienced PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), ERUCTATION (Belching and gas), FLATULENCE (Gas), DECREASED APPETITE (Woke up with no appetite), CHILLS (Chills) and FATIGUE (Fatigue). On 28-Feb-2021, the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Feb-2021 for Hives, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), URTICARIA (Hives), ERUCTATION (Belching and gas), FLATULENCE (Gas), DECREASED APPETITE (Woke up with no appetite), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            This case was linked to MOD-2021-029450 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Presyncope, Urticaria
Clinical narrative: Hives; Belching and gas; Gas; Woke up with no appetite; Chills; Fatigue; Felt like was going to black out; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), URTICARIA (Hives), ERUCTATION (Belching and gas) and FLATULENCE (Gas) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D3, BIOTIN and ACETYLSALICYLIC ACID (ST. JOSEPH ASPIRIN ADULT CHEWABLE) for an unknown indication.   On 26-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 24-Feb-2021, the patient experienced PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), ERUCTATION (Belching and gas), FLATULENCE (Gas), DECREASED APPETITE (Woke up with no appetite), CHILLS (Chills) and FATIGUE (Fatigue). On 28-Feb-2021, the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Feb-2021 for Hives, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), URTICARIA (Hives), ERUCTATION (Belching and gas), FLATULENCE (Gas), DECREASED APPETITE (Woke up with no appetite), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            This case was linked to MOD-2021-029450 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: he keeps tripping with his right foot; sometimes things slip from his right hand; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (he keeps tripping with his right foot) and MUSCULAR WEAKNESS (sometimes things slip from his right hand) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced GAIT DISTURBANCE (he keeps tripping with his right foot) and MUSCULAR WEAKNESS (sometimes things slip from his right hand). At the time of the report, GAIT DISTURBANCE (he keeps tripping with his right foot) and MUSCULAR WEAKNESS (sometimes things slip from his right hand) outcome was unknown.            No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Feeling tired and constantly sleeping; Feeling tired and constantly sleeping; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feeling tired and constantly sleeping) and FATIGUE (Feeling tired and constantly sleeping) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SOMNOLENCE (Feeling tired and constantly sleeping) and FATIGUE (Feeling tired and constantly sleeping). At the time of the report, SOMNOLENCE (Feeling tired and constantly sleeping) and FATIGUE (Feeling tired and constantly sleeping) 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.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Injection site it's filling up and another spot that's hard; Underneath the injection site it's itching, 3 inches long; Arm is still swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site it's filling up and another spot that's hard), VACCINATION SITE PRURITUS (Underneath the injection site it's itching, 3 inches long) and INJECTION SITE SWELLING (Arm is still swelled) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX), LAMOTRIGINE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), LEVOTHYROXINE, PANTOPRAZOLE and TRAZODONE for an unknown indication.    On 01-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 VACCINATION SITE INDURATION (Injection site it's filling up and another spot that's hard), VACCINATION SITE PRURITUS (Underneath the injection site it's itching, 3 inches long) and INJECTION SITE SWELLING (Arm is still swelled). At the time of the report, VACCINATION SITE INDURATION (Injection site it's filling up and another spot that's hard), VACCINATION SITE PRURITUS (Underneath the injection site it's itching, 3 inches long) and INJECTION SITE SWELLING (Arm is still swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: TCR report
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Red blotches; Itches like crazy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches) and PRURITUS (Itches like crazy) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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 02-Mar-2021, the patient experienced RASH MACULAR (Red blotches) and PRURITUS (Itches like crazy). At the time of the report, RASH MACULAR (Red blotches) and PRURITUS (Itches like crazy) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Mar-2021 at 10:30 AM, the patient experienced ACCIDENTAL OVERDOSE (administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml). On 06-Mar-2021 at 10:30 AM, ACCIDENTAL OVERDOSE (administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-035775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035775:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 16-May-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. It was unknown whether the patient had any complications or acute illness during this pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received contains non-significant information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue
Clinical narrative: had explosive diarrhea; tired; feel a little shaky; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had explosive diarrhea), FATIGUE (tired) and CHILLS (feel a little shaky) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included TRAZODONE, FENOFIBRATE, TRAMADOL and GABAPENTIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (had explosive diarrhea), FATIGUE (tired) and CHILLS (feel a little shaky). At the time of the report, DIARRHOEA (had explosive diarrhea), FATIGUE (tired) and CHILLS (feel a little shaky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included None.