chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Malaise, Pain in extremity, Paranoia
Clinical narrative: soreness of arm; anxiety; not feeling well; rash on left foot; really bad fatigue; paranoia; This spontaneous case was reported by a consumer and describes the occurrence of PARANOIA (paranoia), PAIN IN EXTREMITY (soreness of arm), ANXIETY (anxiety), MALAISE (not feeling well) and RASH (rash on left foot) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMITRIPTYLINE for Migraine.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PARANOIA (paranoia), ANXIETY (anxiety), MALAISE (not feeling well), RASH (rash on left foot) and FATIGUE (really bad fatigue). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jan-2021 for Pain in arm, at an unspecified dose and frequency. At the time of the report, PARANOIA (paranoia), PAIN IN EXTREMITY (soreness of arm), ANXIETY (anxiety), MALAISE (not feeling well), RASH (rash on left foot) and FATIGUE (really bad fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: soreness of arm; anxiety; not feeling well; rash on left foot; really bad fatigue; paranoia; This spontaneous case was reported by a consumer and describes the occurrence of PARANOIA (paranoia), PAIN IN EXTREMITY (soreness of arm), ANXIETY (anxiety), MALAISE (not feeling well) and RASH (rash on left foot) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMITRIPTYLINE for Migraine.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PARANOIA (paranoia), ANXIETY (anxiety), MALAISE (not feeling well), RASH (rash on left foot) and FATIGUE (really bad fatigue). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jan-2021 for Pain in arm, at an unspecified dose and frequency. At the time of the report, PARANOIA (paranoia), PAIN IN EXTREMITY (soreness of arm), ANXIETY (anxiety), MALAISE (not feeling well), RASH (rash on left foot) and FATIGUE (really bad fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Swelling
Clinical narrative: Swelling above her clavicle; Developed a nodule that was not there before; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling above her clavicle) and NODULE (Developed a nodule that was not there before) 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) (Intramuscular) 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 SWELLING (Swelling above her clavicle) and NODULE (Developed a nodule that was not there before). At the time of the report, SWELLING (Swelling above her clavicle) and NODULE (Developed a nodule that was not there before) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Excruciating pain in her whole left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Excruciating pain in her whole left arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Excruciating pain in her whole left arm). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Excruciating pain in her whole left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient could barely raise her arm to drive. It was also hard for her to sleep on the left side because of the pain.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Knot at the anterior of the elbow; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knot at the anterior of the elbow) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced JOINT SWELLING (Knot at the anterior of the elbow). At the time of the report, JOINT SWELLING (Knot at the anterior of the elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site that was about an inch in circumference), VACCINATION SITE SWELLING (Sweling at the injection site that was about an inch in circumference) and VACCINATION SITE ERYTHEMA (Redness at the injection site that was about an inch in circumference) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site that was about an inch in circumference), VACCINATION SITE SWELLING (Sweling at the injection site that was about an inch in circumference) and VACCINATION SITE ERYTHEMA (Redness at the injection site that was about an inch in circumference). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 20-Jan-2021 for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site that was about an inch in circumference), VACCINATION SITE SWELLING (Sweling at the injection site that was about an inch in circumference) and VACCINATION SITE ERYTHEMA (Redness at the injection site that was about an inch in circumference) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Patient reported events occurred approximately a week before his call on 27Jan2021; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in my right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my right shoulder) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25520-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in my right shoulder). At the time of the report, PAIN IN EXTREMITY (pain in my right shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that it was not acute pain but she had been feeling this pain since got the vaccination on 16-Jan-2021. It was a pain in right shoulder. She thought it would discontinue and go away. She did not get a similar pain left shoulder where she got vaccination. The pain has been persisting, but it was kind of annoying that it was there. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site became very red; itchy kind of like a bug bite; injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site became very red), VACCINATION SITE PRURITUS (itchy kind of like a bug bite) and VACCINATION SITE SWELLING (injection site swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site became very red), VACCINATION SITE PRURITUS (itchy kind of like a bug bite) and VACCINATION SITE SWELLING (injection site swollen). On 29-Jan-2021, VACCINATION SITE PRURITUS (itchy kind of like a bug bite) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site became very red) outcome was unknown and VACCINATION SITE SWELLING (injection site swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Event information updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Slight itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Slight itching at the injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Slight itching at the injection site). At the time of the report, INJECTION SITE PRURITUS (Slight itching at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       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.   Reporter did not allow further contact; 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: fatigue; dizziness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIZZINESS (dizziness) and ASTHENIA (weakness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (fatigue), DIZZINESS (dizziness) and ASTHENIA (weakness). At the time of the report, FATIGUE (fatigue), DIZZINESS (dizziness) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking unspecified medications. Treatment information was not reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: teeth chattering; A spontaneous report (United States) was received from a 18 years old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced teeth chattering.  The patient's medical history included allergies (unspecified). Concomitant medications included treatment (unspecified medication) to treat allergies.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced teeth chattering.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, teeth chattering was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: round red rash, below injection sight, the size of the donut; Itchy; round red circle, about the size of the donut; This spontaneous case was reported by a consumer and describes the occurrence of RASH (round red rash, below injection sight, the size of the donut), PRURITUS (Itchy) and ERYTHEMA (round red circle, about the size of the donut) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ERYTHEMA (round red circle, about the size of the donut). On 03-Feb-2021, the patient experienced RASH (round red rash, below injection sight, the size of the donut) and PRURITUS (Itchy). At the time of the report, RASH (round red rash, below injection sight, the size of the donut), PRURITUS (Itchy) and ERYTHEMA (round red circle, about the size of the donut) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Noticed two reactions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Noticed two reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History Information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Noticed two reactions). At the time of the report, VACCINATION COMPLICATION (Noticed two reactions) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Noticed two reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History Information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Noticed two reactions). At the time of the report, VACCINATION COMPLICATION (Noticed two reactions) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm has been little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm has been little sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) and VITAMIN D NOS for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm has been little sore). At the time of the report, PAIN IN EXTREMITY (Arm has been little sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain at injection first injection (R)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination.  No Medical History information was reported. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection first injection (R)). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PAIN (Pain at injection first injection (R)) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. This case was linked to MOD-2021-194165.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of diarrhea, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of diarrhea, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: round rash the size of a donut; Itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (round rash the size of a donut), INJECTION SITE PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red). On 03-Feb-2021, the patient experienced INJECTION SITE RASH (round rash the size of a donut) and INJECTION SITE PRURITUS (Itchy). At the time of the report, INJECTION SITE RASH (round rash the size of a donut), INJECTION SITE PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Hot; Didn't feel good; Arm was aching; Bigger, reaction was a pretty bad one; Ached; Swelled up; Red, redness was spreading real big; Injection site was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), FEELING ABNORMAL (Didn't feel good), VACCINATION SITE PAIN (Arm was aching), VACCINATION SITE REACTION (Bigger, reaction was a pretty bad one) and VACCINATION SITE PAIN (Ached) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 411.20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy). On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot), FEELING ABNORMAL (Didn't feel good), VACCINATION SITE PAIN (Arm was aching), VACCINATION SITE REACTION (Bigger, reaction was a pretty bad one), VACCINATION SITE PAIN (Ached), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE ERYTHEMA (Red, redness was spreading real big). On 15-Jan-2021, VACCINATION SITE PRURITUS (Injection site was itchy) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot), FEELING ABNORMAL (Didn't feel good), VACCINATION SITE PAIN (Arm was aching), VACCINATION SITE REACTION (Bigger, reaction was a pretty bad one), VACCINATION SITE PAIN (Ached) and VACCINATION SITE SWELLING (Swelled up) was resolving and VACCINATION SITE ERYTHEMA (Red, redness was spreading real big) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot; Didn't feel good; Arm was aching; Bigger, reaction was a pretty bad one; Ached; Swelled up; Red, redness was spreading real big; Injection site was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), FEELING ABNORMAL (Didn't feel good), VACCINATION SITE PAIN (Arm was aching), VACCINATION SITE REACTION (Bigger, reaction was a pretty bad one) and VACCINATION SITE PAIN (Ached) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 411.20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy). On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot), FEELING ABNORMAL (Didn't feel good), VACCINATION SITE PAIN (Arm was aching), VACCINATION SITE REACTION (Bigger, reaction was a pretty bad one), VACCINATION SITE PAIN (Ached), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE ERYTHEMA (Red, redness was spreading real big). On 15-Jan-2021, VACCINATION SITE PRURITUS (Injection site was itchy) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot), FEELING ABNORMAL (Didn't feel good), VACCINATION SITE PAIN (Arm was aching), VACCINATION SITE REACTION (Bigger, reaction was a pretty bad one), VACCINATION SITE PAIN (Ached) and VACCINATION SITE SWELLING (Swelled up) was resolving and VACCINATION SITE ERYTHEMA (Red, redness was spreading real big) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL and THYROID for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site induration, Vaccination site warmth
Clinical narrative: injection site is hot to touch; tinnitus; injection site is as hard as rock; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is hot to touch), TINNITUS (tinnitus) and VACCINATION SITE INDURATION (injection site is as hard as rock) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is hot to touch), TINNITUS (tinnitus) and VACCINATION SITE INDURATION (injection site is as hard as rock). At the time of the report, VACCINATION SITE WARMTH (injection site is hot to touch), TINNITUS (tinnitus) and VACCINATION SITE INDURATION (injection site is as hard as rock) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold-stimulus headache, Dizziness, Heart rate increased
Clinical narrative: Tingling Sensation in Head; Light Headed; Brain Fog; Increased Heart Rate - While Sleeping; Chills; Arm/Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of COLD-STIMULUS HEADACHE (Brain Fog), HEART RATE INCREASED (Increased Heart Rate - While Sleeping), PARAESTHESIA (Tingling Sensation in Head), DIZZINESS (Light Headed) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEART RATE INCREASED (Increased Heart Rate - While Sleeping), CHILLS (Chills) and ARTHRALGIA (Arm/Joint Pain). On 23-Jan-2021, the patient experienced COLD-STIMULUS HEADACHE (Brain Fog), PARAESTHESIA (Tingling Sensation in Head) and DIZZINESS (Light Headed). On 26-Jan-2021, HEART RATE INCREASED (Increased Heart Rate - While Sleeping), PARAESTHESIA (Tingling Sensation in Head), DIZZINESS (Light Headed), CHILLS (Chills) and ARTHRALGIA (Arm/Joint Pain) had resolved. At the time of the report, COLD-STIMULUS HEADACHE (Brain Fog) had not 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.   Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling Sensation in Head; Light Headed; Brain Fog; Increased Heart Rate - While Sleeping; Chills; Arm/Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of COLD-STIMULUS HEADACHE (Brain Fog), HEART RATE INCREASED (Increased Heart Rate - While Sleeping), PARAESTHESIA (Tingling Sensation in Head), DIZZINESS (Light Headed) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEART RATE INCREASED (Increased Heart Rate - While Sleeping), CHILLS (Chills) and ARTHRALGIA (Arm/Joint Pain). On 23-Jan-2021, the patient experienced COLD-STIMULUS HEADACHE (Brain Fog), PARAESTHESIA (Tingling Sensation in Head) and DIZZINESS (Light Headed). On 26-Jan-2021, HEART RATE INCREASED (Increased Heart Rate - While Sleeping), PARAESTHESIA (Tingling Sensation in Head), DIZZINESS (Light Headed), CHILLS (Chills) and ARTHRALGIA (Arm/Joint Pain) had resolved. At the time of the report, COLD-STIMULUS HEADACHE (Brain Fog) had not 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.   Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Dysuria, Fatigue, Headache
Clinical narrative: frequent and pain in urination; frequent and pain in urination; Lower abdominal cramps; headache; fatigue; Slight dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Slight dizziness), DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination), ABDOMINAL PAIN (Lower abdominal cramps) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Slight dizziness), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination) and ABDOMINAL PAIN (Lower abdominal cramps). At the time of the report, DIZZINESS (Slight dizziness), HEADACHE (headache) and FATIGUE (fatigue) was resolving and DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination) and ABDOMINAL PAIN (Lower abdominal cramps) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: frequent and pain in urination; frequent and pain in urination; Lower abdominal cramps; headache; fatigue; Slight dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Slight dizziness), DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination), ABDOMINAL PAIN (Lower abdominal cramps) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Slight dizziness), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination) and ABDOMINAL PAIN (Lower abdominal cramps). At the time of the report, DIZZINESS (Slight dizziness), HEADACHE (headache) and FATIGUE (fatigue) was resolving and DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination) and ABDOMINAL PAIN (Lower abdominal cramps) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Peripheral swelling, Vaccination site rash
Clinical narrative: Water blisters; Swelling in arm; red; Covid arm rash; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Water blisters), PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (red) and VACCINATION SITE RASH (Covid arm rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (Water blisters), PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (red) and VACCINATION SITE RASH (Covid arm rash). At the time of the report, BLISTER (Water blisters), PERIPHERAL SWELLING (Swelling in arm), ERYTHEMA (red) and VACCINATION SITE RASH (Covid arm rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up document was received. Reporter's middle name was updated. It contains Non-Significant information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Patient feeling real sick after vaccine; Tested positive for COVID after vaccine; A spontaneous report  was received from a consumer (patient mother) concerning a 59 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient feeling real sick after vaccine, tested positive for covid after vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date in Jan-2021,two weeks prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.  On an unknown date in Jan-2021, with in two weeks after first dose of administration, the patient felt real sick and tested positive for COVID after vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, patient feeling real sick after vaccine, positive for covid after vaccine was not reported.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of feeling sick and COVID-19, are assessed as unlikely related.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Pruritus
Clinical narrative: Redness on the shoulder; Itches; Feels heavy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on the shoulder), PRURITUS (Itches) and DISCOMFORT (Feels heavy) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced ERYTHEMA (Redness on the shoulder), PRURITUS (Itches) and DISCOMFORT (Feels heavy). At the time of the report, ERYTHEMA (Redness on the shoulder), PRURITUS (Itches) and DISCOMFORT (Feels heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal discomfort, Vaccination site erythema, Vaccination site pain
Clinical narrative: Caused my shoulder to droop a little bit; Shoulder pain; The area where I got the vaccine was red, tender; The area where I got the vaccine was red, tender; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Caused my shoulder to droop a little bit), ARTHRALGIA (Shoulder pain), VACCINATION SITE ERYTHEMA (The area where I got the vaccine was red, tender) and VACCINATION SITE PAIN (The area where I got the vaccine was red, tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (The area where I got the vaccine was red, tender). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Caused my shoulder to droop a little bit), ARTHRALGIA (Shoulder pain) and VACCINATION SITE ERYTHEMA (The area where I got the vaccine was red, tender). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Caused my shoulder to droop a little bit), ARTHRALGIA (Shoulder pain), VACCINATION SITE ERYTHEMA (The area where I got the vaccine was red, tender) and VACCINATION SITE PAIN (The area where I got the vaccine was red, tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait inability, Hyperhidrosis, Myalgia, Paraesthesia
Clinical narrative: Could barely walk; felt like she was being stuck with pins; Sweating; Bones were aching, body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could barely walk), PARAESTHESIA (felt like she was being stuck with pins), HYPERHIDROSIS (Sweating), MYALGIA (Bones were aching, body aches) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J2024) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced GAIT INABILITY (Could barely walk), PARAESTHESIA (felt like she was being stuck with pins), HYPERHIDROSIS (Sweating), MYALGIA (Bones were aching, body aches) and CHILLS (Chills). At the time of the report, GAIT INABILITY (Could barely walk), PARAESTHESIA (felt like she was being stuck with pins), HYPERHIDROSIS (Sweating) and CHILLS (Chills) had not resolved and MYALGIA (Bones were aching, body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: breastfeeding and got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and got the vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and got the vaccine). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and got the vaccine) had resolved. Not Provided      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.   Concomitant medications were not provided.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin discolouration
Clinical narrative: discolored; arm still has redness; a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (discolored), ERYTHEMA (arm still has redness) and PERIPHERAL SWELLING (a little swollen) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (discolored), ERYTHEMA (arm still has redness) and PERIPHERAL SWELLING (a little swollen). At the time of the report, SKIN DISCOLOURATION (discolored), ERYTHEMA (arm still has redness) and PERIPHERAL SWELLING (a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   No treatment medication information were provided.     Reporter did not allow further contact