chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Bruise at the injection site; giver intravascularly by accident; Experienced immediate pain/pain/sharp stabbing pain; Bleeding; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding), PYREXIA (Fever), VACCINATION SITE BRUISING (Bruise at the injection site) and INCORRECT DOSE ADMINISTERED (giver intravascularly by accident) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding), PYREXIA (Fever) and INCORRECT DOSE ADMINISTERED (giver intravascularly by accident).   On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site). The patient was treated with ACETAMINOPHEN for Drug side effect, at an unspecified dose and frequency and IBUPROFEN for Drug side effect, at an unspecified dose and frequency.   On 25-Jan-2021, INCORRECT DOSE ADMINISTERED (giver intravascularly by accident) had resolved. On 28-Jan-2021, VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 102 f (High) Patient had fever of 102 F on the night when vaccinated.   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.   Patient's treatment included ice packs. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: New events added, accordingly outcome of the events updated. Treatment drug details added.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: itchy arm; inflamed arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchy arm), VACCINATION SITE INFLAMMATION (inflamed arm) and VACCINATION SITE ERYTHEMA (red arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 21-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 INJECTION SITE PRURITUS (itchy arm), VACCINATION SITE INFLAMMATION (inflamed arm) and VACCINATION SITE ERYTHEMA (red arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency.   At the time of the report, INJECTION SITE PRURITUS (itchy arm), VACCINATION SITE INFLAMMATION (inflamed arm) and VACCINATION SITE ERYTHEMA (red arm) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lip swelling, Swelling face, Vaccination site pain, Vaccination site swelling
Clinical narrative: Her lips, or near where that filler was put in, had some swelling; chills; arm was swollen; arm was really painful; her face has swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was really painful), SWELLING FACE (her face has swollen) and LIP SWELLING (Her lips, or near where that filler was put in, had some swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0421-20A (2nd dose)) for COVID-19 vaccination.     No Medical History was provided by the reporter.  The patient's past medical history included Dermal filler injection (Patient had filler put in lips.).   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 26-Jan-2021, the patient experienced CHILLS (chills), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was really painful) and SWELLING FACE (her face has swollen). On an unknown date, the patient experienced LIP SWELLING (Her lips, or near where that filler was put in, had some swelling).   At the time of the report, CHILLS (chills), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was really painful), SWELLING FACE (her face has swollen) and LIP SWELLING (Her lips, or near where that filler was put in, had some swelling) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased
Clinical narrative: INR increased to 5 after injection; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO INCREASED (INR increased to 5 after injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L208A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included WARFARIN for Clot blood.   On 27-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 INTERNATIONAL NORMALISED RATIO INCREASED (INR increased to 5 after injection).   At the time of the report, INTERNATIONAL NORMALISED RATIO INCREASED (INR increased to 5 after injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, International normalised ratio: 5 (High) Patient's INR is 5.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: Slept almost 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept almost 24 hrs) 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 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 HYPERSOMNIA (Slept almost 24 hrs). At the time of the report, HYPERSOMNIA (Slept almost 24 hrs) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site swelling
Clinical narrative: discomfort; swelling about an inch or so below injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (swelling about an inch or so below injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included Betablocker, medicine for eye: Lutein, MULTIVITAMINS & MINERALS PLUS LUTEIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and Heart med for an unknown indication.  On 19-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 DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (swelling about an inch or so below injection site).   At the time of the report, DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (swelling about an inch or so below injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and HEADACHE (Headaches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced PAIN (Body aches) and HEADACHE (Headaches). At the time of the report, PAIN (Body aches) and HEADACHE (Headaches) was resolving.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. The patient stated that she hasn't taken any medications for the events but her vaccination provider told her to take aspirin-acetaminophen-caffeine and Excedrin if the symptoms continue.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen). On 27-Jan-2021, PERIPHERAL SWELLING (arm was swollen) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Lymphadenopathy, Nausea
Clinical narrative: Swollen Lymph node Armpit; Tingly feeling left side of body; Nausea; Fatigue; Dizziness; Chills; Body Aches; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph node Armpit), PARAESTHESIA (Tingly feeling left side of body), NAUSEA (Nausea), FATIGUE (Fatigue) and DIZZINESS (Dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 21-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 LYMPHADENOPATHY (Swollen Lymph node Armpit), PARAESTHESIA (Tingly feeling left side of body), NAUSEA (Nausea), FATIGUE (Fatigue), DIZZINESS (Dizziness), CHILLS (Chills), PAIN (Body Aches) and PRURITUS (Itchiness).   At the time of the report, LYMPHADENOPATHY (Swollen Lymph node Armpit), PARAESTHESIA (Tingly feeling left side of body), NAUSEA (Nausea), FATIGUE (Fatigue), DIZZINESS (Dizziness), CHILLS (Chills), PAIN (Body Aches) and PRURITUS (Itchiness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus
Clinical narrative: Swollen Lymph node Armpit; Tingly feeling left side of body; Nausea; Fatigue; Dizziness; Chills; Body Aches; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph node Armpit), PARAESTHESIA (Tingly feeling left side of body), NAUSEA (Nausea), FATIGUE (Fatigue) and DIZZINESS (Dizziness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 21-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 LYMPHADENOPATHY (Swollen Lymph node Armpit), PARAESTHESIA (Tingly feeling left side of body), NAUSEA (Nausea), FATIGUE (Fatigue), DIZZINESS (Dizziness), CHILLS (Chills), PAIN (Body Aches) and PRURITUS (Itchiness).   At the time of the report, LYMPHADENOPATHY (Swollen Lymph node Armpit), PARAESTHESIA (Tingly feeling left side of body), NAUSEA (Nausea), FATIGUE (Fatigue), DIZZINESS (Dizziness), CHILLS (Chills), PAIN (Body Aches) and PRURITUS (Itchiness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: red dots around injection site; kinda bumpy; itchy;  A spontaneous report was received from a Consumer concerning a 2021- Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, red dots around injection site, kinda bumpy, itchy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the events, red dots around injection site. kinda bumpy, itchy. No treatment information was provided. Action taken with mRNA-1273 in response to the events, red dots around injection site, kinda bumpy, itchy was not reported.   On an unknown date the outcome of events include, red dots around injection site, kinda bumpy, itchy was not reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site reaction
Clinical narrative: pain; tightness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain) and VACCINATION SITE REACTION (tightness) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ARTHRALGIA (pain) and VACCINATION SITE REACTION (tightness). At the time of the report, ARTHRALGIA (pain) and VACCINATION SITE REACTION (tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment information not provided
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: Pain behind eyeballs; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Pain behind eyeballs) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 25-Jan-2021, the patient experienced EYE PAIN (Pain behind eyeballs). At the time of the report, EYE PAIN (Pain behind eyeballs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Is this one of the side effects? Ibuprofen taken as a treatment.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia, Pain in extremity
Clinical narrative: Sugar level was high; Sore in arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Sugar level was high) and PAIN IN EXTREMITY (Sore in arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain operation in November 2020. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HYPERGLYCAEMIA (Sugar level was high) and PAIN IN EXTREMITY (Sore in arm). At the time of the report, HYPERGLYCAEMIA (Sugar level was high) outcome was unknown and PAIN IN EXTREMITY (Sore in arm) 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.   No treatment details were provided.  Patient used the pen needle. Patient always get paranoid and Schedule for second shot on 20-Feb-2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: fever; sore arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and CHILLS (chills). On 29-Jan-2021, the patient experienced PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Fatigue, Ill-defined disorder, Pyrexia
Clinical narrative: feeling like i am crawling out of my skin; Restlessness; Clammy skin; Severe fatigue; Joint pain; Fever; This spontaneous case was reported by a nurse and describes the occurrence of ILL-DEFINED DISORDER (feeling like i am crawling out of my skin), RESTLESSNESS (Restlessness), COLD SWEAT (Clammy skin), FATIGUE (Severe fatigue) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis and Sarcoidosis.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-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 ILL-DEFINED DISORDER (feeling like i am crawling out of my skin), RESTLESSNESS (Restlessness), COLD SWEAT (Clammy skin), FATIGUE (Severe fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain). At the time of the report, ILL-DEFINED DISORDER (feeling like i am crawling out of my skin), RESTLESSNESS (Restlessness), COLD SWEAT (Clammy skin), FATIGUE (Severe fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) dropped below normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 01-JUL-2021 and contains information regarding phone number.
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, White blood cell count
Clinical narrative: feeling like i am crawling out of my skin; Restlessness; Clammy skin; Severe fatigue; Joint pain; Fever; This spontaneous case was reported by a nurse and describes the occurrence of ILL-DEFINED DISORDER (feeling like i am crawling out of my skin), RESTLESSNESS (Restlessness), COLD SWEAT (Clammy skin), FATIGUE (Severe fatigue) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis and Sarcoidosis.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-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 ILL-DEFINED DISORDER (feeling like i am crawling out of my skin), RESTLESSNESS (Restlessness), COLD SWEAT (Clammy skin), FATIGUE (Severe fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain). At the time of the report, ILL-DEFINED DISORDER (feeling like i am crawling out of my skin), RESTLESSNESS (Restlessness), COLD SWEAT (Clammy skin), FATIGUE (Severe fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) dropped below normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 01-JUL-2021 and contains information regarding phone number.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Headache, Pruritus
Clinical narrative: Headache; Diarrhea; Back pain; Itchy body; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIARRHOEA (Diarrhea), BACK PAIN (Back pain) and PRURITUS (Itchy body) 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 is provided. and concomitant drugs are provided.  Concomitant products included Medication for Bloodpressure for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (Headache), DIARRHOEA (Diarrhea), BACK PAIN (Back pain) and PRURITUS (Itchy body). At the time of the report, HEADACHE (Headache), DIARRHOEA (Diarrhea), BACK PAIN (Back pain) and PRURITUS (Itchy body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Injection site hot; Rash at the injection site; Injection site very itchy; Injection site red; Injection site a little swollen; Tenderness at the injection site; Injection site a little swollen; Injection site a little red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), the first episode of VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (Injection site a little red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L25A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 VACCINATION SITE PAIN (Tenderness at the injection site), the first episode of VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (Injection site a little red). On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Injection site very itchy), VACCINATION SITE ERYTHEMA (Injection site red) and the second episode of VACCINATION SITE SWELLING (Injection site a little swollen). On 22-Jan-2021, VACCINATION SITE PAIN (Tenderness at the injection site) and VACCINATION SITE ERYTHEMA (Injection site a little red) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Injection site very itchy), VACCINATION SITE ERYTHEMA (Injection site red) and the last episode of VACCINATION SITE SWELLING (Injection site a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications not provided by the reporter. Treatment drug, administered, but she didn't want to provide this information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site hot; Rash at the injection site; Injection site very itchy; Injection site red; Injection site a little swollen; Tenderness at the injection site; Injection site a little swollen; Injection site a little red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), the first episode of VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (Injection site a little red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L25A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 VACCINATION SITE PAIN (Tenderness at the injection site), the first episode of VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (Injection site a little red). On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Injection site very itchy), VACCINATION SITE ERYTHEMA (Injection site red) and the second episode of VACCINATION SITE SWELLING (Injection site a little swollen). On 22-Jan-2021, VACCINATION SITE PAIN (Tenderness at the injection site) and VACCINATION SITE ERYTHEMA (Injection site a little red) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Injection site very itchy), VACCINATION SITE ERYTHEMA (Injection site red) and the last episode of VACCINATION SITE SWELLING (Injection site a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications not provided by the reporter. Treatment drug, administered, but she didn't want to provide this information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; severely achy; headache the back of my head; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), PAIN (severely achy) and HEADACHE (headache the back of my head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     no medical history is provided and concomitant drugs are provided.  Concomitant products included BENRALIZUMAB (FASENRA).    On 26-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 CHILLS (chills), PAIN (severely achy) and HEADACHE (headache the back of my head). At the time of the report, CHILLS (chills), PAIN (severely achy) and HEADACHE (headache the back of my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Tylenol On 27-Jan-2021
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid after 1st dose; Very sick and thought it was a bad cold; Congested; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid after 1st dose), NASOPHARYNGITIS (Very sick and thought it was a bad cold), NASAL CONGESTION (Congested) and FATIGUE (Feeling tired) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Jan-2021.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced NASOPHARYNGITIS (Very sick and thought it was a bad cold), NASAL CONGESTION (Congested) and FATIGUE (Feeling tired). On 22-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid after 1st dose), NASOPHARYNGITIS (Very sick and thought it was a bad cold), NASAL CONGESTION (Congested) and FATIGUE (Feeling tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the site of injection after first dose; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (pain at the site of injection after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History 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, 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 VACCINATION SITE PAIN (pain at the site of injection after first dose). At the time of the report, VACCINATION SITE PAIN (pain at the site of injection after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Insomnia, Pain in extremity, Pruritus, Rash
Clinical narrative: have been waking up at 12 o'clock or 1 o'clock and be wide awake; red and rashy; the knot was still there; a rash down my arm; it got itchy; arm was sore; A spontaneous report  was received from a Consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, it got itchy, red and rashy, the knot was still there, 2-inch circle around it, a rash down my arm, have been waking up at 12 o'clock or 1 o'clock and be wide awake.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the events arm was sore . On 21 Jan 2021, the patient experienced the events it got itchy . On 22 Jan 2021, the patient experienced the events red and rashy. the knot was still there, 2-inch circle around it, a rash down my arm. On an unknown date, the patient experienced the events have been waking up at 12 o'clock or 1 o'clock and be wide awake.  Treatment details included Patient states using Benadryl ointment and putting ice pack on her arm.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, arm was sore, it got itchy, red and rashy, the knot was still there, 2-inch circle around it, a rash down my arm, have been waking up at 12 o'clock or 1 o'clock and be wide awake was not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: have been waking up at 12 o'clock or 1 o'clock and be wide awake; red and rashy; the knot was still there; a rash down my arm; it got itchy; arm was sore; A spontaneous report  was received from a Consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, it got itchy, red and rashy, the knot was still there, 2-inch circle around it, a rash down my arm, have been waking up at 12 o'clock or 1 o'clock and be wide awake.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the events arm was sore . On 21 Jan 2021, the patient experienced the events it got itchy . On 22 Jan 2021, the patient experienced the events red and rashy. the knot was still there, 2-inch circle around it, a rash down my arm. On an unknown date, the patient experienced the events have been waking up at 12 o'clock or 1 o'clock and be wide awake.  Treatment details included Patient states using Benadryl ointment and putting ice pack on her arm.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, arm was sore, it got itchy, red and rashy, the knot was still there, 2-inch circle around it, a rash down my arm, have been waking up at 12 o'clock or 1 o'clock and be wide awake was not reported.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pharyngitis
Clinical narrative: streptoccocal throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGITIS (streptoccocal throat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.    Co-suspect product included non-company product PENICILLIN NOS for an unknown indication.    No Medical History information was reported.   On 29-Dec-2020, 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PENICILLIN NOS (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced PHARYNGITIS (streptoccocal throat). At the time of the report, PHARYNGITIS (streptoccocal throat) outcome was unknown. 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.   Reporter did not allow further contact
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in left arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness in left arm). On 22-Jan-2021, INJECTION SITE PAIN (Soreness in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Reaction to the 1st dose that made her decide not to take the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Reaction to the 1st dose that made her decide not to take the 2nd dose) 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 ADVERSE EVENT (Reaction to the 1st dose that made her decide not to take the 2nd dose). At the time of the report, ADVERSE EVENT (Reaction to the 1st dose that made her decide not to take the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: tingling in face, arms, hands, legs, right foot, knees; burning in face, arms, hands, legs, right foot, knees; numbness in face, arms, hands, legs, right foot, knees; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (tingling in face, arms, hands, legs, right foot, knees), BURNING SENSATION (burning in face, arms, hands, legs, right foot, knees) and HYPOAESTHESIA (numbness in face, arms, hands, legs, right foot, knees) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (ESTROGEN) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 06-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PARAESTHESIA (tingling in face, arms, hands, legs, right foot, knees), BURNING SENSATION (burning in face, arms, hands, legs, right foot, knees) and HYPOAESTHESIA (numbness in face, arms, hands, legs, right foot, knees). The patient was treated with PREGABALIN (LYRICA) for Adverse event, at a dose of UNK dosage form and BACLOFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (tingling in face, arms, hands, legs, right foot, knees), BURNING SENSATION (burning in face, arms, hands, legs, right foot, knees) and HYPOAESTHESIA (numbness in face, arms, hands, legs, right foot, knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that around 5 PM left arm started tingling and burning then it went to right arm, then hands, felt numbness, tingling, burning, then to the knees, right foot, the face, had numbness in eat, forehead, chin. At the time of reporting, the patient still has all the symptoms, numbness and burning in arms, face, legs. After 3 and a half weeks, arms were a little bit better, they were not as tight, they were not burning that much, but her hands are, in the thumb, has no feeling in that part of her hand. Felt tingling, numbness, whole face feels like some had given her lidocaine, legs were numb.   Patient was treated with 3 doses of high IV (intravenous) steroids.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: PAIN; SWELLING; ITCHINESS; REDNESS; she has on her right arm what she describes as "mild symptoms": a rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (PAIN), SWELLING (SWELLING), PRURITUS (ITCHINESS), ERYTHEMA (REDNESS) and RASH (she has on her right arm what she describes as "mild symptoms": a rash) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (MULTIVIT [VITAMINS NOS]) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 21-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 PAIN (PAIN), SWELLING (SWELLING), PRURITUS (ITCHINESS), ERYTHEMA (REDNESS) and RASH (she has on her right arm what she describes as "mild symptoms": a rash). At the time of the report, PAIN (PAIN), SWELLING (SWELLING), PRURITUS (ITCHINESS), ERYTHEMA (REDNESS) and RASH (she has on her right arm what she describes as "mild symptoms": a rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No corrective treatment was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (severe nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 NAUSEA (severe nausea). At the time of the report, NAUSEA (severe nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye pain, Headache, Malaise
Clinical narrative: started getting sick; headache; muscle pain; joint pain; chills; throat is hurting bad; eyes hurt; urinating a lot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started getting sick), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure (High Blood Pressure) since an unknown date and Acid reflux (oesophageal) since an unknown date. Concurrent medical conditions included Drug allergy (Codeine allergy), Paracetamol (Tylenol allergy), Drug allergy (Morphine allergy) and Drug allergy (Statins Allergy). Concomitant products included OMEPRAZOLE (OMEPRAZOLE ACID REDUCER) and MELOXICAM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced MALAISE (started getting sick), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), OROPHARYNGEAL PAIN (throat is hurting bad), EYE PAIN (eyes hurt) and URINE OUTPUT INCREASED (urinating a lot). At the time of the report, MALAISE (started getting sick), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), OROPHARYNGEAL PAIN (throat is hurting bad), EYE PAIN (eyes hurt) and URINE OUTPUT INCREASED (urinating a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included blood pressure pills. The patients treatment information included Sumatriptan.