chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Knee deformity
Clinical narrative: big painful lump on her left knee, the lump is still there but the pain is going down; Swollen knee like an abscess; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of KNEE DEFORMITY (big painful lump on her left knee, the lump is still there but the pain is going down) and JOINT SWELLING (Swollen knee like an abscess) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced KNEE DEFORMITY (big painful lump on her left knee, the lump is still there but the pain is going down) and JOINT SWELLING (Swollen knee like an abscess). At the time of the report, KNEE DEFORMITY (big painful lump on her left knee, the lump is still there but the pain is going down) and JOINT SWELLING (Swollen knee like an abscess) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment details were not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: chills; extreme fatigue; low grade fever; redness at the injection site; soreness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PAIN (soreness at the injection site), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (low grade fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 12-Dec-2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). On 05-Mar-2021, the patient experienced CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Low grade fever, at an unspecified dose and frequency. On 04-Mar-2021, VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) had resolved. On 06-Mar-2021, CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The patient reported that the next day of vaccination, she felt like she had COVID all over again with "COVID like symptoms" including extreme fatigue, low grade fever, and chills that lasted around 24 hours.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: Underneath the injection site was pink; Sore arm; Rash at different part of his body; Underneath the injection site was itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Underneath the injection site was pink), PAIN IN EXTREMITY (Sore arm), RASH (Rash at different part of his body) and VACCINATION SITE PRURITUS (Underneath the injection site was itchy) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Underneath the injection site was pink), PAIN IN EXTREMITY (Sore arm), RASH (Rash at different part of his body) and VACCINATION SITE PRURITUS (Underneath the injection site was itchy). The patient was treated with TRIAMCINOLONE ACETONIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (Underneath the injection site was pink), PAIN IN EXTREMITY (Sore arm), RASH (Rash at different part of his body) and VACCINATION SITE PRURITUS (Underneath the injection site was itchy) outcome was unknown.            No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the second dose out of the allowed window of time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose out of the allowed window of time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose out of the allowed window of time). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose out of the allowed window of time) had resolved.            Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No new information; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot# 030L20A, with no associated adverse events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Myalgia, Spinal pain, Vaccination site swelling
Clinical narrative: Felt like her spine was going to break in half; injection site swelling; muscle pain all over body; Joint pain all over body; A spontaneous report was received from a consumer concerning a 60-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site swelling, muscle pain all over body, joint pain all over body, felt like her spine was going to break in half.  The patient's medical history include cancer . Concomitant medications included Blood pressure meds, Diabetic meds, Astrovle.  Lab test include Covid 19 test with positive result on 20-1-2021.  On 6 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 0010a21a) intramuscularly for prophylaxis of COVID-19 infection.  On 7 Mar 2021, the patient experienced the event(s) injection site swelling. muscle pain all over body, joint pain all over body, felt like her spine was going to break in half.  Treatment medications included Tylenol 500, Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), injection site swelling, muscle pain all over body,joint pain all over body,felt like her spine was going to break in half was unknown.; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her first dose did not hurt as much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her first dose did not hurt as much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis since an unknown date. Concomitant products included GABAPENTIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her first dose did not hurt as much). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 800 mg and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg. At the time of the report, PAIN IN EXTREMITY (Her first dose did not hurt as much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-036972 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her first dose did not hurt as much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis since an unknown date. Concomitant products included GABAPENTIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her first dose did not hurt as much). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 800 mg and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg. At the time of the report, PAIN IN EXTREMITY (Her first dose did not hurt as much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-036972 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Trigeminal nerve disorder
Clinical narrative: Trigeminal neuropathy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TRIGEMINAL NERVE DISORDER (Trigeminal neuropathy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 TRIGEMINAL NERVE DISORDER (Trigeminal neuropathy). At the time of the report, TRIGEMINAL NERVE DISORDER (Trigeminal neuropathy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  The treatment information was unknown.  The action taken with the drug was Not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Dyspnoea, Gait disturbance, Myalgia
Clinical narrative: Having troubles walking; Having troubles inhaling/Having troubles exhaling; The pain in the muscles around her stomach makes it difficulty breath; Nausea; Myalgia; Really bad back pain; Vomiting; Bad weakness; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling), MYALGIA (The pain in the muscles around her stomach makes it difficulty breath), NAUSEA (Nausea) and MYALGIA (Myalgia) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Feb-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Myalgia), BACK PAIN (Really bad back pain), VOMITING (Vomiting) and ASTHENIA (Bad weakness). On 01-Mar-2021, the patient experienced GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling) and MYALGIA (The pain in the muscles around her stomach makes it difficulty breath). At the time of the report, GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling), MYALGIA (The pain in the muscles around her stomach makes it difficulty breath), NAUSEA (Nausea), MYALGIA (Myalgia), BACK PAIN (Really bad back pain), VOMITING (Vomiting) and ASTHENIA (Bad weakness) outcome was unknown.            Treatment included Advil and Tylenol. no concomitant medications reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Having troubles walking; Having troubles inhaling/Having troubles exhaling; The pain in the muscles around her stomach makes it difficulty breath; Nausea; Myalgia; Really bad back pain; Vomiting; Bad weakness; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling), MYALGIA (The pain in the muscles around her stomach makes it difficulty breath), NAUSEA (Nausea) and MYALGIA (Myalgia) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Feb-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Myalgia), BACK PAIN (Really bad back pain), VOMITING (Vomiting) and ASTHENIA (Bad weakness). On 01-Mar-2021, the patient experienced GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling) and MYALGIA (The pain in the muscles around her stomach makes it difficulty breath). At the time of the report, GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling), MYALGIA (The pain in the muscles around her stomach makes it difficulty breath), NAUSEA (Nausea), MYALGIA (Myalgia), BACK PAIN (Really bad back pain), VOMITING (Vomiting) and ASTHENIA (Bad weakness) outcome was unknown.            Treatment included Advil and Tylenol. no concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: Ill; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Ill) and PYREXIA (Temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ILLNESS (Ill) and PYREXIA (Temperature). At the time of the report, ILLNESS (Ill) and PYREXIA (Temperature) outcome was unknown.            No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Illness
Clinical narrative: felt sick for 8 days; Very Dizzy; Hot to the touch Injection Site; Redness Injection Site bigger 3" diameter; Swollen Injection Site; Hurts Injection Site Red Area; Itching Injection Site; Tired and Fatigue; Chills (No Fever); Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick for 8 days), DIZZINESS (Very Dizzy), INJECTION SITE WARMTH (Hot to the touch Injection Site), FATIGUE (Tired and Fatigue) and CHILLS (Chills (No Fever)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Tired and Fatigue), CHILLS (Chills (No Fever)) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced DIZZINESS (Very Dizzy), INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE ERYTHEMA (Redness Injection Site bigger 3" diameter), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE PAIN (Hurts Injection Site Red Area) and INJECTION SITE PRURITUS (Itching Injection Site). On an unknown date, the patient experienced ILLNESS (felt sick for 8 days). On 27-Feb-2021, CHILLS (Chills (No Fever)) and HEADACHE (Headache) had resolved. On 28-Feb-2021, FATIGUE (Tired and Fatigue) had resolved. At the time of the report, ILLNESS (felt sick for 8 days) had resolved and DIZZINESS (Very Dizzy), INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE ERYTHEMA (Redness Injection Site bigger 3" diameter), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE PAIN (Hurts Injection Site Red Area) and INJECTION SITE PRURITUS (Itching Injection Site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided by reporter.  Per report, after receiving the first dose of the covid-19 vaccine in 26-FEB-2021, the patient felt sick for 8 days, which she attributed to a delayed site reaction.   This case was linked to MOD-2021-252892.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: 2nd Dose information is updated
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: felt sick for 8 days; Very Dizzy; Hot to the touch Injection Site; Redness Injection Site bigger 3" diameter; Swollen Injection Site; Hurts Injection Site Red Area; Itching Injection Site; Tired and Fatigue; Chills (No Fever); Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick for 8 days), DIZZINESS (Very Dizzy), INJECTION SITE WARMTH (Hot to the touch Injection Site), FATIGUE (Tired and Fatigue) and CHILLS (Chills (No Fever)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Tired and Fatigue), CHILLS (Chills (No Fever)) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced DIZZINESS (Very Dizzy), INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE ERYTHEMA (Redness Injection Site bigger 3" diameter), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE PAIN (Hurts Injection Site Red Area) and INJECTION SITE PRURITUS (Itching Injection Site). On an unknown date, the patient experienced ILLNESS (felt sick for 8 days). On 27-Feb-2021, CHILLS (Chills (No Fever)) and HEADACHE (Headache) had resolved. On 28-Feb-2021, FATIGUE (Tired and Fatigue) had resolved. At the time of the report, ILLNESS (felt sick for 8 days) had resolved and DIZZINESS (Very Dizzy), INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE ERYTHEMA (Redness Injection Site bigger 3" diameter), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE PAIN (Hurts Injection Site Red Area) and INJECTION SITE PRURITUS (Itching Injection Site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided by reporter.  Per report, after receiving the first dose of the covid-19 vaccine in 26-FEB-2021, the patient felt sick for 8 days, which she attributed to a delayed site reaction.   This case was linked to MOD-2021-252892.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: 2nd Dose information is updated
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: low grade fever; chills; body ache; joint pain; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), MYALGIA (body ache), ARTHRALGIA (joint pain) and PYREXIA (low grade fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (body ache) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, CHILLS (chills), MYALGIA (body ache), ARTHRALGIA (joint pain) and PYREXIA (low grade fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As concomitant medication she reported consuming Thyroid medicine. No information regarding corrective treatment was reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome updated as report and patient took second dose without adverse reaction and doesnot consent to further fUs.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site pain, Vaccination site pruritus
Clinical narrative: soreness; itching rash at the injection site; itching rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness), VACCINATION SITE PRURITUS (itching rash at the injection site) and INJECTION SITE RASH (itching rash 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness), VACCINATION SITE PRURITUS (itching rash at the injection site) and INJECTION SITE RASH (itching rash at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness), VACCINATION SITE PRURITUS (itching rash at the injection site) and INJECTION SITE RASH (itching rash at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported for mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessment.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non significant follow up
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: quite significant pain in the right arm/arm throbbing; redness from wrist to elbow; rash from elbow to wrist; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (quite significant pain in the right arm/arm throbbing), ERYTHEMA (redness from wrist to elbow) and RASH (rash from elbow to wrist) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Arthritis. Concomitant products included FUROSEMIDE for Blood pressure high, POTASSIUM and VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (quite significant pain in the right arm/arm throbbing), ERYTHEMA (redness from wrist to elbow) and RASH (rash from elbow to wrist). The patient was treated with CORTISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (quite significant pain in the right arm/arm throbbing), ERYTHEMA (redness from wrist to elbow) and RASH (rash from elbow to wrist) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration
Clinical narrative: a hard raised lump developed that has grown a bit; itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (a hard raised lump developed that has grown a bit), INJECTION SITE PRURITUS (itchy) and INJECTION SITE ERYTHEMA (red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE INDURATION (a hard raised lump developed that has grown a bit), INJECTION SITE PRURITUS (itchy) and INJECTION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE INDURATION (a hard raised lump developed that has grown a bit), INJECTION SITE PRURITUS (itchy) and INJECTION SITE ERYTHEMA (red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Injection site erythema, Injection site pain, Injection site rash, Maternal exposure during breast feeding
Clinical narrative: very distressful; her breast milk dried up; Maternal exposure during breast feeding; "horrible hives"  raised up everywhere on body; rash at injection site; Felt like a bee sting at injection site; Arm looked red at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA ("horrible hives"  raised up everywhere on body), EMOTIONAL DISTRESS (very distressful), SUPPRESSED LACTATION (her breast milk dried up), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and INJECTION SITE RASH (rash at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE RASH (rash at injection site), INJECTION SITE PAIN (Felt like a bee sting at injection site) and INJECTION SITE ERYTHEMA (Arm looked red at injection site). On 08-Mar-2021, the patient experienced URTICARIA ("horrible hives"  raised up everywhere on body). On an unknown date, the patient experienced EMOTIONAL DISTRESS (very distressful), SUPPRESSED LACTATION (her breast milk dried up) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA ("horrible hives"  raised up everywhere on body), EMOTIONAL DISTRESS (very distressful), SUPPRESSED LACTATION (her breast milk dried up), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), INJECTION SITE RASH (rash at injection site), INJECTION SITE PAIN (Felt like a bee sting at injection site) and INJECTION SITE ERYTHEMA (Arm looked red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. The patient had seen the allergist twice and treatment to the events included antihistamines and steroids for nearly a month.   This case was linked to MOD-2021-128724 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Added new events (urticaria, emotional distress and suppressed lactation), treatment information. On 21-Jun-2021: Follow-up document received contains Non-significant information
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Suppressed lactation, Urticaria
Clinical narrative: very distressful; her breast milk dried up; Maternal exposure during breast feeding; "horrible hives"  raised up everywhere on body; rash at injection site; Felt like a bee sting at injection site; Arm looked red at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA ("horrible hives"  raised up everywhere on body), EMOTIONAL DISTRESS (very distressful), SUPPRESSED LACTATION (her breast milk dried up), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and INJECTION SITE RASH (rash at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE RASH (rash at injection site), INJECTION SITE PAIN (Felt like a bee sting at injection site) and INJECTION SITE ERYTHEMA (Arm looked red at injection site). On 08-Mar-2021, the patient experienced URTICARIA ("horrible hives"  raised up everywhere on body). On an unknown date, the patient experienced EMOTIONAL DISTRESS (very distressful), SUPPRESSED LACTATION (her breast milk dried up) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA ("horrible hives"  raised up everywhere on body), EMOTIONAL DISTRESS (very distressful), SUPPRESSED LACTATION (her breast milk dried up), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), INJECTION SITE RASH (rash at injection site), INJECTION SITE PAIN (Felt like a bee sting at injection site) and INJECTION SITE ERYTHEMA (Arm looked red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. The patient had seen the allergist twice and treatment to the events included antihistamines and steroids for nearly a month.   This case was linked to MOD-2021-128724 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Added new events (urticaria, emotional distress and suppressed lactation), treatment information. On 21-Jun-2021: Follow-up document received contains Non-significant information
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dyspnoea, Myalgia, Tachycardia
Clinical narrative: diarrhea; sore stomach; sore injection site; heart started to beat like crazy; started to get harder to breath; A spontaneous report was received from a consumer who is a 73-year-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site soreness, difficulty breathing, increased heart beat, diarrhea, and stomach soreness.  The patient's medical history was not provided. Concomitant medications included losartan, acetylsalicylic acid, hydrochlorothiazide, pravastatin, amlodipine, and combination of amoxicillin trihydrate, clarithromycin, esomeprazole magnesium.  On 15-Feb- 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 15-Feb-2021, the patient experienced the events injection site soreness, difficulty breathing, and increased heart beat. On 16-Feb-2021, the patient experienced the events, diarrhea and sore stomach.  Treatment details included bismuth subsalicylate.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events injection site soreness, difficulty breathing, increased heart beat, diarrhea, and stomach soreness was considered resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Hypokinesia, Insomnia, Pain, Rash erythematous
Clinical narrative: A rash in her belly on her left side, now it's just steadily all over her belly, now it's just steadily all over her back/bloody red, big as her hand; she can't move; Very painful, she thought it was shingles, it hurts like shingles; It's awful, can't wear a top; Can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (A rash in her belly on her left side, now it's just steadily all over her belly, now it's just steadily all over her back/bloody red, big as her hand), HYPOKINESIA (she can't move), PAIN (Very painful, she thought it was shingles, it hurts like shingles), DISCOMFORT (It's awful, can't wear a top) and INSOMNIA (Can't sleep) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included METOPROLOL, RIVAROXABAN and PREDNISONE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH ERYTHEMATOUS (A rash in her belly on her left side, now it's just steadily all over her belly, now it's just steadily all over her back/bloody red, big as her hand), HYPOKINESIA (she can't move), PAIN (Very painful, she thought it was shingles, it hurts like shingles), DISCOMFORT (It's awful, can't wear a top) and INSOMNIA (Can't sleep). At the time of the report, RASH ERYTHEMATOUS (A rash in her belly on her left side, now it's just steadily all over her belly, now it's just steadily all over her back/bloody red, big as her hand), HYPOKINESIA (she can't move), PAIN (Very painful, she thought it was shingles, it hurts like shingles), DISCOMFORT (It's awful, can't wear a top) and INSOMNIA (Can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information regarding corrective treatment was reported by the patient.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Incorrect route of product administration
Clinical narrative: Cough; Administered the shot in the upper arm. It was below his shoulder, toward the triceps in the lower deltoid muscle.; This spontaneous case was reported by an other caregiver and describes the occurrence of COUGH (Cough) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered the shot in the upper arm. It was below his shoulder, toward the triceps in the lower deltoid muscle.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced COUGH (Cough) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered the shot in the upper arm. It was below his shoulder, toward the triceps in the lower deltoid muscle.). At the time of the report, COUGH (Cough) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered the shot in the upper arm. It was below his shoulder, toward the triceps in the lower deltoid muscle.) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event, included thyroid medication.  Vaccine was administered below patient's shoulder, toward the triceps, in the lower deltoid muscle.  Treatment information was not provided.   This case was linked to MOD-2021-037146 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Illness, Influenza, Pyrexia
Clinical narrative: had loss of smell; had loss of taste; she had the flu; she was sick; fever 101 and 103; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (she had the flu), ILLNESS (she was sick), PYREXIA (fever 101 and 103), ANOSMIA (had loss of smell) and AGEUSIA (had loss of taste) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced INFLUENZA (she had the flu), ILLNESS (she was sick) and PYREXIA (fever 101 and 103). On 07-Mar-2021, the patient experienced ANOSMIA (had loss of smell) and AGEUSIA (had loss of taste). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 400 mg 2 doses. On 07-Mar-2021, INFLUENZA (she had the flu), ILLNESS (she was sick) and PYREXIA (fever 101 and 103) had resolved. At the time of the report, ANOSMIA (had loss of smell) and AGEUSIA (had loss of taste) had resolved.            No concomitant medications provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Peripheral swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: migraines; arm swollen; arm hot; itchy; red; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and DIZZINESS (Dizzy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and DIZZINESS (Dizzy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were BP medicine for drug use for unknown indication
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: migraines; arm swollen; arm hot; itchy; red; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and DIZZINESS (Dizzy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and DIZZINESS (Dizzy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were BP medicine for drug use for unknown indication
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test, Urticaria
Clinical narrative: missed 2 dose; my legs (below my knees) itched and ankles swelled; my legs (below my knees) itched and ankles swelled; hives; burning; prickling all over; itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (burning), PARAESTHESIA (prickling all over), PRURITUS (itching), URTICARIA (hives) and PRURITUS (my legs (below my knees) itched and ankles swelled) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN, OMEPRAZOLE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and ASCORBIC ACID, BORAGO OFFICINALIS OIL, FISH OIL, MAGNESIUM, NICOTINAMIDE, PYRIDOXINE, ZINC (OMEGA-3 & -6 COMPLEX) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced BURNING SENSATION (burning), PARAESTHESIA (prickling all over) and PRURITUS (itching). On 05-Mar-2021, the patient experienced URTICARIA (hives). On 07-Apr-2021, the patient experienced PRURITUS (my legs (below my knees) itched and ankles swelled) and JOINT SWELLING (my legs (below my knees) itched and ankles swelled). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2 dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Burning skin, Prickling of hand and Itching, at a dose of bed time; LORATADINE (CLARITINE) for Hives, at a dose of 14 days at bed time; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 22-Mar-2021 for Itching and Burning skin, at a dose of 20 mg twice a day and FAMOTIDINE on 22-Mar-2021 for Hives and Itching, at a dose of 20 mg twice a day. At the time of the report, BURNING SENSATION (burning), PARAESTHESIA (prickling all over), PRURITUS (itching), URTICARIA (hives), PRURITUS (my legs (below my knees) itched and ankles swelled) and JOINT SWELLING (my legs (below my knees) itched and ankles swelled) had resolved and PRODUCT DOSE OMISSION ISSUE (missed 2 dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative. On an unknown date, SARS-CoV-2 antibody test: other IgG: Positive IgM: Positive IgA: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is feeling good now.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional AE added, updated AE outcome, doctor's info updated