chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Epistaxis, Haematocrit, Nasal crusting
Clinical narrative: Right nostril has bloody scab; Blow nose, blood comes out; Stomach is upset; Severe pain; Loose stools; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CRUSTING (Right nostril has bloody scab), EPISTAXIS (Blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHEA (Loose stools) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Spinal pain (Severe spinal pain/headache for 1-1/2 weeks starting March 3rd) on 03-Mar-2021.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CRUSTING (Right nostril has bloody scab), EPISTAXIS (Blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHEA (Loose stools). At the time of the report, NASAL CRUSTING (Right nostril has bloody scab), EPISTAXIS (Blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHEA (Loose stools) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haematocrit: low (Low) Low.         No concomitant medication reported. No treatment was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Right nostril has bloody scab; Blow nose, blood comes out; Stomach is upset; Severe pain; Loose stools; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CRUSTING (Right nostril has bloody scab), EPISTAXIS (Blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHEA (Loose stools) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Spinal pain (Severe spinal pain/headache for 1-1/2 weeks starting March 3rd) on 03-Mar-2021.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CRUSTING (Right nostril has bloody scab), EPISTAXIS (Blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHEA (Loose stools). At the time of the report, NASAL CRUSTING (Right nostril has bloody scab), EPISTAXIS (Blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHEA (Loose stools) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haematocrit: low (Low) Low.         No concomitant medication reported. No treatment was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Weakness; Fatigue; Feels feverish 99.1- 99.3; Difficulty breathing; Sorenesss in arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), PAIN IN EXTREMITY (arm), ASTHENIA, FATIGUE, and PYREXIA (Feels feverish 99.1- 99.3) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 002B214) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing) and PAIN IN EXTREMITY (arm). On 28-Apr-2021, the patient experienced ASTHENIA, FATIGUE, and PYREXIA (Feels feverish 99.1- 99.3). At the time of the report, DYSPNOEA (Difficulty breathing), PAIN IN EXTREMITY (arm), ASTHENIA, FATIGUE, and PYREXIA (Feels feverish 99.1- 99.3) had not resolved.            The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was not applicable.  Concomitant medications were not provided. Treatment information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; vaccination failure; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (vaccination failure) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ankylosing spondylitis.    No Medical History information was reported.   In February 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 and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (vaccination failure). At the time of the report, COVID-19 (COVID-19) was resolving and VACCINATION FAILURE (vaccination failure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Cough, Fatigue, Feeling abnormal
Clinical narrative: nasal drainage; Clammy; Sinus's bothered me; Cough; Felt like I was getting the flu; Chill; I had no energy and stayed in bed some; I felt bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt bad), RHINORRHOEA (nasal drainage), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me) and COUGH (Cough) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20I) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure and Cancer (allergic to chemicals, because of being sensitized when I had radiation for cancer in nineteen eighty -five, that those symptoms became intensified.) in 1995. Concurrent medical conditions included Allergy to chemicals (allergic to chemicals, because of being sensitized when I had radiation for cancer in nineteen eighty -five, that those symptoms became intensified).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I felt bad), RHINORRHOEA (nasal drainage), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me), COUGH (Cough), INFLUENZA LIKE ILLNESS (Felt like I was getting the flu), CHILLS (Chill) and FATIGUE (I had no energy and stayed in bed some). At the time of the report, FEELING ABNORMAL (I felt bad), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me), INFLUENZA LIKE ILLNESS (Felt like I was getting the flu), CHILLS (Chill) and FATIGUE (I had no energy and stayed in bed some) had resolved and RHINORRHOEA (nasal drainage) and COUGH (Cough) had not resolved.            No Concomitant Medication was provided.  Patient never had nasal drainage, before. After the injections, patient had them constantly. Nasal drainage have lessened but continued to happen.  No treatment  was provided.   This case was linked to MOD-2021-023021 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: follow up received, new event added
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rhinorrhoea, Sinus disorder
Clinical narrative: nasal drainage; Clammy; Sinus's bothered me; Cough; Felt like I was getting the flu; Chill; I had no energy and stayed in bed some; I felt bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt bad), RHINORRHOEA (nasal drainage), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me) and COUGH (Cough) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20I) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure and Cancer (allergic to chemicals, because of being sensitized when I had radiation for cancer in nineteen eighty -five, that those symptoms became intensified.) in 1995. Concurrent medical conditions included Allergy to chemicals (allergic to chemicals, because of being sensitized when I had radiation for cancer in nineteen eighty -five, that those symptoms became intensified).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I felt bad), RHINORRHOEA (nasal drainage), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me), COUGH (Cough), INFLUENZA LIKE ILLNESS (Felt like I was getting the flu), CHILLS (Chill) and FATIGUE (I had no energy and stayed in bed some). At the time of the report, FEELING ABNORMAL (I felt bad), COLD SWEAT (Clammy), SINUS DISORDER (Sinus's bothered me), INFLUENZA LIKE ILLNESS (Felt like I was getting the flu), CHILLS (Chill) and FATIGUE (I had no energy and stayed in bed some) had resolved and RHINORRHOEA (nasal drainage) and COUGH (Cough) had not resolved.            No Concomitant Medication was provided.  Patient never had nasal drainage, before. After the injections, patient had them constantly. Nasal drainage have lessened but continued to happen.  No treatment  was provided.   This case was linked to MOD-2021-023021 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: follow up received, new event added
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Magnetic resonance imaging, X-ray
Clinical narrative: Back Pain aggravated; This spontaneous case was reported by an other and describes the occurrence of BACK PAIN in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain, Rheumatoid arthritis, Abstains from alcohol, and Non-smoker. Concomitant products included RINVOQ and PLAQUENIL for Rheumatoid arthritis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN. At the time of the report, BACK PAIN had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Magnetic resonance imaging: unknown Inconclusive. In March 2021, X-ray: unknown Inconclusive.         No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04-JuN-2021 included no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: The worst night sweats; Shortness of breath; Lost to eat/and not eating like usual; Lost of taste with the lost to eat; Aching; Diarrhea; Nausea; Really bad chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat) and PAIN (Aching) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: VARICELLA ZOSTER VACCINE (Shingles first dose on 9 Mar 2021 and received second dose of Shingles vaccine on 27Mar2021) from 09-Mar-2021 to 27-Mar-2021, PNEUMOCOCCAL VACCINE (Pneumonia vaccines) on 09-Mar-2021 and FLU on 09-Mar-2021. Concomitant products included TAMSULOSIN, INSULIN DEGLUDEC (TRESIBA), EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY), SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL BISULFATE (PLAVIX), FUROSEMIDE (LASIX [FUROSEMIDE]), GLYBURIDE, ISOSORBIDE MONONITRATE, LISINOPRIL, METOPROLOL TARTRATE and FISH OIL for an unknown indication.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat), PAIN (Aching), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Really bad chills) and FATIGUE (Fatigue). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat), PAIN (Aching), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Really bad chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Night sweats, Pain
Clinical narrative: The worst night sweats; Shortness of breath; Lost to eat/and not eating like usual; Lost of taste with the lost to eat; Aching; Diarrhea; Nausea; Really bad chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat) and PAIN (Aching) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: VARICELLA ZOSTER VACCINE (Shingles first dose on 9 Mar 2021 and received second dose of Shingles vaccine on 27Mar2021) from 09-Mar-2021 to 27-Mar-2021, PNEUMOCOCCAL VACCINE (Pneumonia vaccines) on 09-Mar-2021 and FLU on 09-Mar-2021. Concomitant products included TAMSULOSIN, INSULIN DEGLUDEC (TRESIBA), EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY), SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL BISULFATE (PLAVIX), FUROSEMIDE (LASIX [FUROSEMIDE]), GLYBURIDE, ISOSORBIDE MONONITRATE, LISINOPRIL, METOPROLOL TARTRATE and FISH OIL for an unknown indication.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat), PAIN (Aching), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Really bad chills) and FATIGUE (Fatigue). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (The worst night sweats), DYSPNOEA (Shortness of breath), DECREASED APPETITE (Lost to eat/and not eating like usual), AGEUSIA (Lost of taste with the lost to eat), PAIN (Aching), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Really bad chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Stomatitis
Clinical narrative: mouth sores; fever; This spontaneous case was reported by an other and describes the occurrence of STOMATITIS (mouth sores) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Malignant neoplasm of head, face, and neck, Hypothyroidism, Malignant neoplasm of intrahepatic bile ducts, Malignant neoplasm of liver, specified as secondary and Adenoid cystic carcinoma. Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), DOCUSATE SODIUM (COLACE), PEMBROLIZUMAB (KEYTRUDA), LACTULOSE, MACROGOL 3350 (MIRALAX), LEVOTHYROXINE, PROBIOTICS NOS, SENNA ALEXANDRINA (SENNA PLUS [SENNA ALEXANDRINA]) and CHLORHEXIDINE GLUCONATE, METRONIDAZOLE (DENTAGEL [CHLORHEXIDINE GLUCONATE;METRONIDAZOLE]) for an unknown indication.   On 07-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. In April 2021, the patient experienced STOMATITIS (mouth sores) and PYREXIA (fever). At the time of the report, STOMATITIS (mouth sores) and PYREXIA (fever) outcome was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Erythema
Clinical narrative: After #2 dose Pain in joints including ankles, knees, arms; Large red area under blister remained; Blisters below left ankle bone lateral side; This spontaneous case was reported by a nurse and describes the occurrence of BLISTER (Blisters below left ankle bone lateral side), ARTHRALGIA (After #2 dose Pain in joints including ankles, knees, arms) and ERYTHEMA (Large red area under blister remained) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced BLISTER (Blisters below left ankle bone lateral side). On 09-Apr-2021, the patient experienced ERYTHEMA (Large red area under blister remained). On an unknown date, the patient experienced ARTHRALGIA (After #2 dose Pain in joints including ankles, knees, arms). At the time of the report, BLISTER (Blisters below left ankle bone lateral side) and ERYTHEMA (Large red area under blister remained) outcome was unknown and ARTHRALGIA (After #2 dose Pain in joints including ankles, knees, arms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   18 days later developed large blister below left ankle bone lateral side which drained clear liquid , med redness after blister drained. No obvious injury to foot or ankle.  The reported stated that patient received treatment medication of Antibiotic for blister, but didn't state what Antibiotic was used.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information received on 17-Jun-2021, ethnicity, race, occupation and event updated
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram
Clinical narrative: Severe pain behind left scapula; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe pain behind left scapula) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Severe pain behind left scapula). At the time of the report, ARTHRALGIA (Severe pain behind left scapula) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: CT scan was normal with no evidence of metastatic disease..         Treatment includes lidocaine patches
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Fatigue
Clinical narrative: Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypoglycemia (he has hypoglycemia for about 4 years).   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and FATIGUE (Tired). At the time of the report, CHILLS (Chills) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: (Low) hypoglycemia.         No concomitant drug information was provided by reporter.No treatment information was provided.      This case was linked to MOD-2021-015896 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24 Jun 2021 contains non- significant information On 14-Jul-2021: Added second dose information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt horrible; This spontaneous case was reported by an other and describes the occurrence of FEELING ABNORMAL (Felt horrible) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Panuveitis.    No Medical History information was reported.   On 27-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In February 2021, the patient experienced FEELING ABNORMAL (Felt horrible). At the time of the report, FEELING ABNORMAL (Felt horrible) outcome was unknown. Not Provided          No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: nerve pain worse in her heels; nerve pain worse in her heels; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (nerve pain worse in her heels) and NEURALGIA (nerve pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00156463) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Arthritis.    On 27-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 PAIN IN EXTREMITY (nerve pain worse in her heels) and NEURALGIA (nerve pain). At the time of the report, PAIN IN EXTREMITY (nerve pain worse in her heels) and NEURALGIA (nerve pain) outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information included Cancer medication and Arthritis Medication. No treatment medication information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Antibiotic level, Urinary tract infection
Clinical narrative: UTI; patient on antibiotics; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) and ANTIBIOTIC LEVEL (patient on antibiotics) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI) and ANTIBIOTIC LEVEL (patient on antibiotics). The patient was treated with CIPROFLOXACIN for Urinary tract infection, at a dose of 500 mg twice a day. At the time of the report, URINARY TRACT INFECTION (UTI) and ANTIBIOTIC LEVEL (patient on antibiotics) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided The patient reported UTI and the patient received a first round of antibiotic for 5 days, patient UTI was not covered in the first prescription of antibiotics.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Within four hours my tongue became numb like when you burn it from coffee; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Within four hours my tongue became numb like when you burn it from coffee) 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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (Within four hours my tongue became numb like when you burn it from coffee). At the time of the report, HYPOAESTHESIA ORAL (Within four hours my tongue became numb like when you burn it from coffee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: arm sore; arm swelling to elbow with rash; could not stay up; minor rash; nauseous; extreme fatigue, could not stay up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash) and NAUSEA (nauseous) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (extreme fatigue, could not stay up). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash), NAUSEA (nauseous) and FATIGUE (extreme fatigue, could not stay up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   This case was linked to MOD-2021-096933, MOD-2021-029359 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: arm sore; arm swelling to elbow with rash; could not stay up; minor rash; nauseous; extreme fatigue, could not stay up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash) and NAUSEA (nauseous) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (extreme fatigue, could not stay up). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (arm sore), PERIPHERAL SWELLING (arm swelling to elbow with rash), FEELING ABNORMAL (could not stay up), RASH (minor rash), NAUSEA (nauseous) and FATIGUE (extreme fatigue, could not stay up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   This case was linked to MOD-2021-096933, MOD-2021-029359 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Muscular weakness, Pyrexia
Clinical narrative: body and leg weakness; body and leg weakness; fever; chills; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (body and leg weakness), ASTHENIA (body and leg weakness), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     There was no reported medical history.     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 MUSCULAR WEAKNESS (body and leg weakness), ASTHENIA (body and leg weakness), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches). At the time of the report, MUSCULAR WEAKNESS (body and leg weakness), ASTHENIA (body and leg weakness), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no Concomitant medications provided. No treatment medication information was provided.  The patient noted the events felt like an MS relapse, but was not an MS relapse.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oral pain, Rash
Clinical narrative: Sore mouth; Rash; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Sore mouth), RASH, and FATIGUE 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 18-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 an unknown date, the patient experienced ORAL PAIN (Sore mouth), RASH, and FATIGUE. At the time of the report, ORAL PAIN (Sore mouth), RASH, and FATIGUE had resolved.            No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.    This case was linked to MOD-2021-030620, MOD-2021-030620.   Reporter did not allow further contact.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Rash; Upper arm hardness; Upper arm swelling to elbow; Upper arm swelling to elbow; Arm warmth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Upper arm swelling to elbow), VACCINATION SITE WARMTH, RASH, VACCINATION SITE INDURATION (Upper arm hardness), and VACCINATION SITE SWELLING (Upper arm swelling to elbow) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine since 1949, Drug allergy (Penciillin, Sulfa, erthymicin) and Pollen allergy. Concomitant products included BOTOX from 15-Jun-2020 to an unknown date for Chronic migraine, RIZATRIPTAN from 06-Jan-1995 to an unknown date for Migraine, VITAMIN D from 06-Jan-2017 to an unknown date and PROLIA from 06-Jan-2017 to an unknown date for Osteoporosis, LEVOTHYROXIN from 06-Mar-2000 to an unknown date for Thyroidectomy, VITAMIN B3, POTASSIUM, and CALCIUM for an unknown indication.    On 05-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PERIPHERAL SWELLING (Upper arm swelling to elbow), VACCINATION SITE WARMTH, VACCINATION SITE INDURATION (Upper arm hardness), and VACCINATION SITE SWELLING (Upper arm swelling to elbow). On 05-Feb-2021 at 5:00 PM, the patient experienced RASH. On 19-Feb-2021, PERIPHERAL SWELLING (Upper arm swelling to elbow), VACCINATION SITE WARMTH, RASH, VACCINATION SITE INDURATION (Upper arm hardness), and VACCINATION SITE SWELLING (Upper arm swelling to elbow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Doctor told to take L-lysine and Claritin for second dose.   This case was linked to MOD-2021-096853, MOD-2021-096853.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; Muscle aches; Fatigue; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA, CHILLS, MYALGIA, FATIGUE, and VACCINATION INJECTION SITE PAIN in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 0006M20A) for COVID-19 vaccination.     The patient's past medical history included Obesity on 20-Aug-1948 and Weight gain. Concurrent medical conditions included Hypertension since 15-Sep-1998, Chronic sinusitis on 01-Sep-2014, Arthritis since 20-Aug-2005, Seasonal allergy, and Fish allergy (Trout allergy). Concomitant products included MONTELUKAST from 15-Mar-2017 to an unknown date for Allergy, MELOXICAM from 15-Oct-2012 to an unknown date for Arthritis, SIMVASTATIN from 20-Oct-2010 to an unknown date for Hyperlipidemia, VALSARTAN & HCTZ from 14-Nov-2014 to an unknown date, and AMLODIPINE from 05-Oct-2020 to an unknown date for Hypertension, AMOXICLAV from 09-Sep-2017 to an unknown date for Sinusitis bacterial.   On 14-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 6:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA, CHILLS, MYALGIA, FATIGUE, and VACCINATION INJECTION SITE PAIN. At the time of the report, PYREXIA, CHILLS, MYALGIA, FATIGUE, and VACCINATION SITE PAIN had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2020, SARS-CoV-2 test: COVID-19 positive tested by nasal swab.         No treatment information was provided.   This case was linked to MOD-2021-018275.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; Chills; Muscle aches; Fatigue; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA, CHILLS, MYALGIA, FATIGUE, and VACCINATION INJECTION SITE PAIN in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 0006M20A) for COVID-19 vaccination.     The patient's past medical history included Obesity on 20-Aug-1948 and Weight gain. Concurrent medical conditions included Hypertension since 15-Sep-1998, Chronic sinusitis on 01-Sep-2014, Arthritis since 20-Aug-2005, Seasonal allergy, and Fish allergy (Trout allergy). Concomitant products included MONTELUKAST from 15-Mar-2017 to an unknown date for Allergy, MELOXICAM from 15-Oct-2012 to an unknown date for Arthritis, SIMVASTATIN from 20-Oct-2010 to an unknown date for Hyperlipidemia, VALSARTAN & HCTZ from 14-Nov-2014 to an unknown date, and AMLODIPINE from 05-Oct-2020 to an unknown date for Hypertension, AMOXICLAV from 09-Sep-2017 to an unknown date for Sinusitis bacterial.   On 14-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 6:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA, CHILLS, MYALGIA, FATIGUE, and VACCINATION INJECTION SITE PAIN. At the time of the report, PYREXIA, CHILLS, MYALGIA, FATIGUE, and VACCINATION SITE PAIN had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2020, SARS-CoV-2 test: COVID-19 positive tested by nasal swab.         No treatment information was provided.   This case was linked to MOD-2021-018275.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: vaccination site pain; headache; tiredness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and FATIGUE (tiredness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Colitis ulcerative.    No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and FATIGUE (tiredness) was resolving.        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.   On an unknown date, post vaccination, the patient reported that she experienced symptoms of headache, fatigue, and injection site pain.   No relevant concomitant medications were reported  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Email response
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Rash, Vaccination site pain
Clinical narrative: vaccination site pain; Cough; Rash over arms; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Cough), RASH (Rash over arms) and VACCINATION SITE PAIN (vaccination site pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 003B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    The patient's past medical history included Smoker (one pack per day) from 1975 to 2001. Concurrent medical conditions included Alcoholic (Beer one-two bottles per week) since 1975 and Rheumatoid arthritis. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disease, unspecified, FOLIC ACID for Rheumatoid arthritis, MULTIVITAMIN [VITAMINS NOS], VITAMIN D3 and VITAMIN B12 NOS for Vitamin supplementation, METHOTREXATE and LOSARTAN for an unknown indication.   In 2004, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) .4 ml. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced RASH (Rash over arms). On 15-Apr-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 18-Mar-2021, RASH (Rash over arms) had resolved. On 15-Apr-2021, COUGH (Cough) had resolved. At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RASH (Rash over arms) to be probably related and COUGH (Cough) to be not related. No further causality assessment was provided for VACCINATION SITE PAIN (vaccination site pain).    No corrective treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Pyrexia, Somnolence, Vomiting
Clinical narrative: sleepy; Made me really sick; Dizziness; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE, ILLNESS (Made me really sick), DIZZINESS, PYREXIA, and VOMITING 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE, ILLNESS (Made me really sick), DIZZINESS, PYREXIA, and VOMITING. At the time of the report, SOMNOLENCE, ILLNESS (Made me really sick), DIZZINESS, PYREXIA, and VOMITING outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-015191.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA had resolved.            This case was linked to MOD-2021-030618.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: Feeling unwell; This spontaneous case was reported by a physician and describes the occurrence of MALAISE in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA for Ulcerative colitis.    The patient's past medical history included No adverse event (no historical condition was reported).   On 12-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 and HUMIRA (Subcutaneous). On 12-Apr-2021, the patient experienced MALAISE. In April 2021, MALAISE had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rash, Vaccination site pain
Clinical narrative: vaccination site pain; Cough; rash over arms; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Cough), RASH (rash over arms) and VACCINATION SITE PAIN (vaccination site pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 003B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Arthritis rheumatoid.    no specified medical history was reported.  Concomitant products included LOSARTAN for Blood pressure, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder, METHOTREXATE and FOLIC ACID for Rheumatoid arthritis, MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], VITAMIN D3 and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for Supplementation therapy.   In 2004, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced RASH (rash over arms). On 15-Apr-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 18-Mar-2021, RASH (rash over arms) had resolved. On 15-Apr-2021, COUGH (Cough) had resolved. At the time of the report, VACCINATION SITE PAIN (vaccination site pain) 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 considered COUGH (Cough) and RASH (rash over arms) to be probably related. No further causality assessment was provided for VACCINATION SITE PAIN (vaccination site pain).    No treatment medication were reported.   This case was linked to MOD-2021-097090 (Patient Link).