chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Pain in extremity, Vaccination site pain
Clinical narrative: Sore left arm; Pain at the injection site; The patient received a fourth dose/ Pharmacist told the patient  that he was receiving a full 0.5ml dose /Pharmacist then proceeded to administer the 0.5ml dose instead of the 0.25ml dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), VACCINATION SITE PAIN (Pain at the injection site) and EXTRA DOSE ADMINISTERED (The patient received a fourth dose/ Pharmacist told the patient  that he was receiving a full 0.5ml dose /Pharmacist then proceeded to administer the 0.5ml dose instead of the 0.25ml dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 011D21A, 016M20A and 029o20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Jan-2022, the patient experienced PAIN IN EXTREMITY (Sore left arm) and EXTRA DOSE ADMINISTERED (The patient received a fourth dose/ Pharmacist told the patient  that he was receiving a full 0.5ml dose /Pharmacist then proceeded to administer the 0.5ml dose instead of the 0.25ml dose). 28-Jan-2022, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 28-Jan-2022, EXTRA DOSE ADMINISTERED (The patient received a fourth dose/ Pharmacist told the patient  that he was receiving a full 0.5ml dose /Pharmacist then proceeded to administer the 0.5ml dose instead of the 0.25ml dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore left arm) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient wanted to receive a booster dose of the Moderna Covid-19 vaccine. The Pharmacist told the patient that he was receiving a full 0.5ml dose. The Pharmacist then proceeded to administer the 0.5ml dose instead of the 0.25ml dose.   This case was linked to MOD-2022-465694, MOD-2022-465769, MOD-2022-465795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Follow-up received. Reporter Contact details updated. On 28-Jan-2022: Follow-up received contains No new information.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective
Clinical narrative: had the Moderna vaccine last year and had Omicron on January; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had the Moderna vaccine last year and had Omicron on January) and DRUG INEFFECTIVE (Lack of drug effect) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (had the Moderna vaccine last year and had Omicron on January) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (had the Moderna vaccine last year and had Omicron on January) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) Had a blood test and he had high volume antibodies.         No concomitant medications were reported.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 26-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, approximately 11 months after the second dose of mRNA- 1273 vaccine with an appropriate schedule of vaccination. Additionally, Drug ineffective was considered. Omicron variant was reported. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-464934 (Patient Link).; Sender's Comments: This spontaneous case concerns a 26-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, approximately 11 months after the second dose of mRNA- 1273 vaccine with an appropriate schedule of vaccination. Additionally, Drug ineffective was considered.  Omicron variant was reported. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: feel like im going to faint; nauseous; dizziness; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (feel like im going to faint) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (feel like im going to faint) (seriousness criterion medically significant), NAUSEA (nauseous) and DIZZINESS (dizziness). At the time of the report, SYNCOPE (feel like im going to faint), NAUSEA (nauseous) and DIZZINESS (dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had booster and feels nauseous and keep getting dizziness patient felt like patient was going to faint.  No concomitant medication details were provided by reporter.  No treatment medication details were provided by reporter.  This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the events of  syncope, nausea and dizziness. The events and the received third booster dose of mRNA  1273 vaccine was experienced on an unknown date. Syncope was reported as medically significant and at the time of report the outcome of all the events were still unknown. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the events of  syncope, nausea and dizziness. The events and the received third booster dose of mRNA  1273 vaccine was experienced on an unknown date. Syncope was reported as medically significant and at the time of report the outcome of all the events were still unknown. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: both of my legs hurt; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (both of my legs hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism (Patient had a PE in left lower lobe just a year ago).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (both of my legs hurt). At the time of the report, PAIN IN EXTREMITY (both of my legs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose > 35 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 032H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose). On 06-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure increased, Blood pressure measurement, Headache, Heart rate
Clinical narrative: pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there; pressure was still too high; headaches; throbbing at night/ throbbing; blood pressure is unstable since then it's still up and down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down), HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there), BLOOD PRESSURE INCREASED (pressure was still too high) and HEADACHE (headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down) and HEADACHE (headaches). On 26-Jan-2022, the patient experienced BLOOD PRESSURE INCREASED (pressure was still too high). On 27-Jan-2022, the patient experienced HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there). At the time of the report, PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down), HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there), BLOOD PRESSURE INCREASED (pressure was still too high) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood pressure measurement: abnormal (abnormal) blood pressure is unstable since then. The doctor changed her medications but it's still up and down.. On 26-Jan-2022, Blood pressure measurement: high (High) pressure was still too high. On 27-Jan-2022, Heart rate: pulse is racing (High) The pulse is racing on the right side of her neck..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  Patient reported that she took the first dose of Moderna COVID19 Vaccine on 01Nov2021, but since then she's having headaches, throbbing at night, and her blood pressure is unstable since then.The doctor changed her medications.  Last night 27Jan2022, it was throbbing. The pulse is racing on the right side of her neck. It's still pulsating. The pharmacist wouldn't give her the second dose of Moderna because they want to wait until her blood pressure is stable.  Patient got a test but nothing is wrong and She was going to do a blood test from the doctor and she was supposed to be doing a scan or ultrasound on 28-Feb-2022.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain
Clinical narrative: pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there; pressure was still too high; headaches; throbbing at night/ throbbing; blood pressure is unstable since then it's still up and down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down), HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there), BLOOD PRESSURE INCREASED (pressure was still too high) and HEADACHE (headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down) and HEADACHE (headaches). On 26-Jan-2022, the patient experienced BLOOD PRESSURE INCREASED (pressure was still too high). On 27-Jan-2022, the patient experienced HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there). At the time of the report, PAIN (throbbing at night/ throbbing), BLOOD PRESSURE FLUCTUATION (blood pressure is unstable since then it's still up and down), HEART RATE INCREASED (pulse is racing on the right side of my neck It's still pulsating racing of the pulse is still there), BLOOD PRESSURE INCREASED (pressure was still too high) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood pressure measurement: abnormal (abnormal) blood pressure is unstable since then. The doctor changed her medications but it's still up and down.. On 26-Jan-2022, Blood pressure measurement: high (High) pressure was still too high. On 27-Jan-2022, Heart rate: pulse is racing (High) The pulse is racing on the right side of her neck..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  Patient reported that she took the first dose of Moderna COVID19 Vaccine on 01Nov2021, but since then she's having headaches, throbbing at night, and her blood pressure is unstable since then.The doctor changed her medications.  Last night 27Jan2022, it was throbbing. The pulse is racing on the right side of her neck. It's still pulsating. The pharmacist wouldn't give her the second dose of Moderna because they want to wait until her blood pressure is stable.  Patient got a test but nothing is wrong and She was going to do a blood test from the doctor and she was supposed to be doing a scan or ultrasound on 28-Feb-2022.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Feeling abnormal, Rash erythematous
Clinical narrative: has a bad rash on his right wrist underneath his palm that looks like eczema; it feels like it wants to come out on his left wrist; It started after the 1st dose, looked like it was going away, then after the 2nd dose it got severely red & worse; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (has a bad rash on his right wrist underneath his palm that looks like eczema), FEELING ABNORMAL (it feels like it wants to come out on his left wrist) and RASH ERYTHEMATOUS (It started after the 1st dose, looked like it was going away, then after the 2nd dose it got severely red & worse) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A and 013H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ECZEMA (has a bad rash on his right wrist underneath his palm that looks like eczema), FEELING ABNORMAL (it feels like it wants to come out on his left wrist) and RASH ERYTHEMATOUS (It started after the 1st dose, looked like it was going away, then after the 2nd dose it got severely red & worse). At the time of the report, ECZEMA (has a bad rash on his right wrist underneath his palm that looks like eczema), FEELING ABNORMAL (it feels like it wants to come out on his left wrist) and RASH ERYTHEMATOUS (It started after the 1st dose, looked like it was going away, then after the 2nd dose it got severely red & worse) outcome was unknown.            No Concomitant medications were reported No Treatment medications were reported   This case was linked to MOD-2022-466161 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: lower dose volume administered; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (lower dose volume administered) 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.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced UNDERDOSE (lower dose volume administered). In January 2022, UNDERDOSE (lower dose volume administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported. Pharmacist states that 27 days ago she administered a Booster dose of the Moderna Covid-19 Vaccine by mistake, instead she should have administered the complete first dose.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: lightheaded/head is not right; head is not right, feels a little bad, and heads screwed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (head is not right, feels a little bad, and heads screwed) and DIZZINESS (lightheaded/head is not right) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for an unknown indication.     The patient's past medical history included Liver transplant in 2021. Concurrent medical conditions included Hepatic cancer since 2021.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced FEELING ABNORMAL (head is not right, feels a little shitty, and heads screwed). On 29-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (lightheaded/head is not right). At the time of the report, FEELING ABNORMAL (head is not right, feels a little bad, and heads screwed) and DIZZINESS (lightheaded/head is not right) outcome was unknown.            Patient had cancer in the liver and had a transplant a couple of months ago. Patient was asked to wait 6-7 weeks before getting booster dose. Patient had booster dose and Moderna vaccines shots before. Patient reports that after the booster shot, he experienced lightheaded or a little dizzy, head was not right, feels a little bad, and heads screwed.  He experienced dizziness form 29-Jan-2022 when he reached down and grabbed something.  Patient was on other medication for transplant and won't go through them all.  No Treatment information was reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Feeling abnormal
Clinical narrative: Has a bad rash on his right wrist underneath his palm that looks like eczema; It feels like it wants to come out on his left wrist; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Has a bad rash on his right wrist underneath his palm that looks like eczema) and FEELING ABNORMAL (It feels like it wants to come out on his left wrist) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-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 ECZEMA (Has a bad rash on his right wrist underneath his palm that looks like eczema) and FEELING ABNORMAL (It feels like it wants to come out on his left wrist). At the time of the report, ECZEMA (Has a bad rash on his right wrist underneath his palm that looks like eczema) had not resolved and FEELING ABNORMAL (It feels like it wants to come out on his left wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-466136 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received 0.5 ml for 4th shot booster instead of 0.25ml; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 0.5 ml for 4th shot booster instead of 0.25ml) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Jan-2022, the patient experienced EXTRA DOSE ADMINISTERED (Received 0.5 ml for 4th shot booster instead of 0.25ml). On 28-Jan-2022, EXTRA DOSE ADMINISTERED (Received 0.5 ml for 4th shot booster instead of 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Gait disturbance, Myalgia, Pain
Clinical narrative: negative side effects to the booster vaccine.; constant pain; joints, muscles, and skin have become achy; can't walk half a mile; m It feels like where you got hit by a truck / constantly feeling like that; joints, muscles, and skin have become achy; joints, muscles, and skin have become achy / whole body is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (negative side effects to the booster vaccine.), PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile) and FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile), ARTHRALGIA (joints, muscles, and skin have become achy) and MYALGIA (joints, muscles, and skin have become achy / whole body is sore). 08-Dec-2021, the patient experienced FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that). On an unknown date, the patient experienced VACCINATION COMPLICATION (negative side effects to the booster vaccine.). At the time of the report, VACCINATION COMPLICATION (negative side effects to the booster vaccine.), ARTHRALGIA (joints, muscles, and skin have become achy) and MYALGIA (joints, muscles, and skin have become achy / whole body is sore) outcome was unknown and PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile) and FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.   This case was linked to MOD-2022-467381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2022: Significant follow-up : Reporter added, Patient Details added, Events added, Email added, Primary reporters address added, Drug start date and Batch lot number added
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Vaccination complication
Clinical narrative: negative side effects to the booster vaccine.; constant pain; joints, muscles, and skin have become achy; can't walk half a mile; m It feels like where you got hit by a truck / constantly feeling like that; joints, muscles, and skin have become achy; joints, muscles, and skin have become achy / whole body is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (negative side effects to the booster vaccine.), PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile) and FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile), ARTHRALGIA (joints, muscles, and skin have become achy) and MYALGIA (joints, muscles, and skin have become achy / whole body is sore). 08-Dec-2021, the patient experienced FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that). On an unknown date, the patient experienced VACCINATION COMPLICATION (negative side effects to the booster vaccine.). At the time of the report, VACCINATION COMPLICATION (negative side effects to the booster vaccine.), ARTHRALGIA (joints, muscles, and skin have become achy) and MYALGIA (joints, muscles, and skin have become achy / whole body is sore) outcome was unknown and PAIN (constant pain), PAIN OF SKIN (joints, muscles, and skin have become achy), GAIT DISTURBANCE (can't walk half a mile) and FEELING ABNORMAL (m It feels like where you got hit by a truck / constantly feeling like that) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.   This case was linked to MOD-2022-467381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2022: Significant follow-up : Reporter added, Patient Details added, Events added, Email added, Primary reporters address added, Drug start date and Batch lot number added
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Allergic-Dermatologic reaction after 10 to 12 days of getting the Moderna Vaccine or Booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Allergic-Dermatologic reaction after 10 to 12 days of getting the Moderna Vaccine or Booster) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Allergic-Dermatologic reaction after 10 to 12 days of getting the Moderna Vaccine or Booster). At the time of the report, URTICARIA (Allergic-Dermatologic reaction after 10 to 12 days of getting the Moderna Vaccine or Booster) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller mention that was in a social media group with around 37,000 members support group were member manifested getting this allergic-dermatologic reaction after 10 to 12 days of getting the moderna or booster,also states that were many other places in the internet social media and support group that works as a connector to patients that had similar reactions. No concomitant and treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: extremely sore left injection site arm; swollen lymph nodes in her left arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (extremely sore left injection site arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in her left arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Immunosuppressed).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (extremely sore left injection site arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in her left arm). At the time of the report, VACCINATION SITE PAIN (extremely sore left injection site arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in her left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient received the first dose of vaccine in her right arm shoulder deltoid muscle. The patient had no adverse reactions after the first vaccine.  The patient received the second dose of vaccine in her left arm shoulder deltoid.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-466240 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Injection site inflammation, Injection site swelling, Pain
Clinical narrative: feeling a lot of pain; DIscomfort two days later; area is inflamed; Area is swolled; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (feeling a lot of pain), DISCOMFORT (DIscomfort two days later), INJECTION SITE INFLAMMATION (area is inflamed) and INJECTION SITE SWELLING (Area is swolled) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (feeling a lot of pain), DISCOMFORT (DIscomfort two days later), INJECTION SITE INFLAMMATION (area is inflamed) and INJECTION SITE SWELLING (Area is swolled). At the time of the report, PAIN (feeling a lot of pain), DISCOMFORT (DIscomfort two days later), INJECTION SITE INFLAMMATION (area is inflamed) and INJECTION SITE SWELLING (Area is swolled) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  It was reported that patient was vaccinated with the Moderna booster a few days ago and experienced symptoms.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: The patient also received a booster dose instead of a third full; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient also received a booster dose instead of a third full) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 041L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (The patient also received a booster dose instead of a third full). On 03-Dec-2021, ACCIDENTAL UNDERDOSE (The patient also received a booster dose instead of a third full) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.  The patient had no adverse reactions after the first vaccine and booster dose.   This case was linked to MOD-2022-466204 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Rash, Vaccination complication, Vaccination site warmth
Clinical narrative: hot to the touch; he almost shot out of his skin; not been able to sleep on his left arm; upper arm with a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION COMPLICATION (he almost shot out of his skin), LIMB DISCOMFORT (not been able to sleep on his left arm) and RASH (upper arm with a rash) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 078C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION COMPLICATION (he almost shot out of his skin), LIMB DISCOMFORT (not been able to sleep on his left arm) and RASH (upper arm with a rash). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION COMPLICATION (he almost shot out of his skin), LIMB DISCOMFORT (not been able to sleep on his left arm) and RASH (upper arm with a rash) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.  The patient woke up with his upper arm with a rash, and hot to the touch. He had not been able to sleep on his left arm.   This case was linked to MOD-2021-315913 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient received their 2nd Moderna vaccine dose 21 days after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received their 2nd Moderna vaccine dose 21 days after the 1st dose) in an adult patient of an unknown 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received their 2nd Moderna vaccine dose 21 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received their 2nd Moderna vaccine dose 21 days after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Reported that patient was over 18 years of age.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Influenza, Pain
Clinical narrative: They have the flu; can barely walk after having booster yesterday; are sore; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (They have the flu), GAIT DISTURBANCE (can barely walk after having booster yesterday) and PAIN (are sore) 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 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced INFLUENZA (They have the flu), GAIT DISTURBANCE (can barely walk after having booster yesterday) and PAIN (are sore). At the time of the report, INFLUENZA (They have the flu), GAIT DISTURBANCE (can barely walk after having booster yesterday) and PAIN (are sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-466436 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Sharp pain  in the left side of their chest, and hasn't gone away; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sharp pain  in the left side of their chest, and hasn't gone away) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced CHEST PAIN (Sharp pain  in the left side of their chest, and hasn't gone away). At the time of the report, CHEST PAIN (Sharp pain  in the left side of their chest, and hasn't gone away) was resolving.            Concomitant medications were not reported. Treatment details were not provided.  It was reported that the patient felt slightly better at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Influenza, Pain
Clinical narrative: Have the flu; Can barely walk; Sore; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (Have the flu), GAIT DISTURBANCE (Can barely walk) and PAIN (Sore) 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 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced INFLUENZA (Have the flu), GAIT DISTURBANCE (Can barely walk) and PAIN (Sore). At the time of the report, INFLUENZA (Have the flu), GAIT DISTURBANCE (Can barely walk) and PAIN (Sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-466357 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Headache, Hyperhidrosis, Vaccination complication
Clinical narrative: she started sweating; weakness in legs/weak; Couldn't walk; had a very bad headache; am having some side effects/I'm not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (am having some side effects/I'm not feeling well), HYPERHIDROSIS (she started sweating), ASTHENIA (weakness in legs/weak), GAIT DISTURBANCE (Couldn't walk) and HEADACHE (had a very bad headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08UJ21A, 042120A and 025520-2A) for COVID-19 vaccination.     The patient's past medical history included Spasms. Concomitant products included TIZANIDINE for Spasms, BUPROPION, DULOXETINE, AMLODIPINE and OLMESARTAN MEDOXOMIL for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (am having some side effects/I'm not feeling well). On 27-Jan-2022, the patient experienced HYPERHIDROSIS (she started sweating), ASTHENIA (weakness in legs/weak), GAIT DISTURBANCE (Couldn't walk) and HEADACHE (had a very bad headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for No adverse event, at an unspecified dose and frequency. On 29-Jan-2022, HYPERHIDROSIS (she started sweating), ASTHENIA (weakness in legs/weak), GAIT DISTURBANCE (Couldn't walk) and HEADACHE (had a very bad headache) was resolving. At the time of the report, VACCINATION COMPLICATION (am having some side effects/I'm not feeling well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that a few hours later, she started experiencing events sweating, felt weak, and couldn't walk and headache. Patient stated that she was still not 100% normal, but was getting back to feel like herself.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2022: Significant Follow Up Appended; Events added On 31-Jan-2022: Updated Reporter's details, dose details, concomitant medications, treatment medication, additional events and outcome were added and additional information added in I narrative
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: sore arm; sweated a lot; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweated a lot) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL, SIMVASTATIN, VITAMINS NOS, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ASPIRIN [ACETYLSALICYLIC ACID], PROBIOTICS NOS and CELECOXIB (CELEBREX) for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweated a lot) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweated a lot) and FATIGUE (tiredness) outcome was unknown.            No treatment information was provided. No medical history was provided by the reporter.   This case was linked to MOD-2022-466487, MOD-2022-466462 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Fatigue, Malaise
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of malaise (not feeling quite right), fatigue, chills (some chills) and extra dose administered in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 24, 2022, patient received the  fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 24, 2022, patient had an extra dose administered. On Jan 28, 2022, patient experienced malaise (not feeling quite right), fatigue and chills (some chills). On Jan 24, 2022, extra dose administered: resolved. At the time of the report, malaise (not feeling quite right), fatigue) and chills (some chills) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.