chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Malaise, Pain in extremity
Clinical narrative: felt miserable; arm very sore; chills; fever; headache; armpit sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003DR, 006C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and AXILLARY PAIN (armpit sore). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 16-Nov-2021, CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) had resolved. At the time of the report, MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore) and AXILLARY PAIN (armpit sore) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Lot number for booster dose was reported as 003DR?? (not readable).  This case concerns a 54-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Pain in Extremity and expected events of Chills, Pyrexia, Headache and Axillary Pain. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events of Chills, Pyrexia, Headache and Axillary Pain are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Pain in Extremity and expected events of Chills, Pyrexia, Headache and Axillary Pain. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events of Chills, Pyrexia, Headache and Axillary Pain are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt miserable; arm very sore; chills; fever; headache; armpit sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003DR, 006C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and AXILLARY PAIN (armpit sore). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 16-Nov-2021, CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) had resolved. At the time of the report, MALAISE (felt miserable), PAIN IN EXTREMITY (arm very sore) and AXILLARY PAIN (armpit sore) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Lot number for booster dose was reported as 003DR?? (not readable).  This case concerns a 54-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Pain in Extremity and expected events of Chills, Pyrexia, Headache and Axillary Pain. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events of Chills, Pyrexia, Headache and Axillary Pain are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Pain in Extremity and expected events of Chills, Pyrexia, Headache and Axillary Pain. The event occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events of Chills, Pyrexia, Headache and Axillary Pain are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: left supraclavicular (above the collar bone) lymph node is swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (left supraclavicular (above the collar bone) lymph node is swollen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 930676 and 067F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (left supraclavicular (above the collar bone) lymph node is swollen). At the time of the report, LYMPHADENOPATHY (left supraclavicular (above the collar bone) lymph node is swollen) had not resolved.            Concomitant medications include Synthroid for unknown indication  Company Comment : This is a spontaneous case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of supraclavicular lymphadenopathy. The event supraclavicular lymphadenopathy occurred 1 day after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of supraclavicular lymphadenopathy. The event supraclavicular lymphadenopathy occurred 1 day after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: left arm felt sore after second Covid-19 vaccine; stiff neck; Foggy feeling; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (left arm felt sore after second Covid-19 vaccine), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING ABNORMAL (Foggy feeling) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm felt sore after second Covid-19 vaccine), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING ABNORMAL (Foggy feeling). At the time of the report, PAIN IN EXTREMITY (left arm felt sore after second Covid-19 vaccine), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING ABNORMAL (Foggy feeling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant informations were reported.  No treatment informations were reported.   This case was linked to MOD-2021-391809, MOD-2021-391816 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history for patient was reported.  Concomitant products included ACYCLOVIR [ACICLOVIR] and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm after first dose). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment : This case concerns a 64-year-old female patient with no relevant medical history, who experienced the expected event of Vaccination Site Pain. The event occurred the same after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-391834 (Patient Link).; Sender's Comments: This case concerns a 64-year-old female patient with no relevant medical history, who experienced the expected event of Vaccination Site Pain. The event occurred the same after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Pharyngeal swelling, Throat tightness
Clinical narrative: throat is swollen and closing up; throat is swollen and closing up; they have a faster heart bit; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat is swollen and closing up), THROAT TIGHTNESS (throat is swollen and closing up) and HEART RATE INCREASED (they have a faster heart bit) 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 17-Nov-2021, the patient experienced PHARYNGEAL SWELLING (throat is swollen and closing up), THROAT TIGHTNESS (throat is swollen and closing up) and HEART RATE INCREASED (they have a faster heart bit). At the time of the report, PHARYNGEAL SWELLING (throat is swollen and closing up), THROAT TIGHTNESS (throat is swollen and closing up) and HEART RATE INCREASED (they have a faster heart bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter. Patient got a Moderna vaccine and they feel their throat is swollen and closing up and that they have a faster heart bit. They wonder if this may be related to the vaccine.   Company Comment: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious, unexpected, events of pharyngeal swelling, throat tightness and heart rate increased. The events occurred  1 day after unspecified dose of mRNA 1273 vaccine. The patient felt throat swelling and closing up and heart beat was faster, no information regarding treatment given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious, unexpected, events of pharyngeal swelling, throat tightness and heart rate increased. The events occurred  1 day after unspecified dose of mRNA 1273 vaccine. The patient felt throat swelling and closing up and heart beat was faster, no information regarding treatment given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: We had a store give Moderna shots past the BUD; Product moved from freezer to fridge on 9/20; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a store give Moderna shots past the BUD) and PRODUCT STORAGE ERROR (Product moved from freezer to fridge on 9/20) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Product moved from freezer to fridge on 9/20). On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a store give Moderna shots past the BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a store give Moderna shots past the BUD) and PRODUCT STORAGE ERROR (Product moved from freezer to fridge on 9/20) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious events of product storage error and expired product administered for mRNA-1273 vaccine (lot number 037F21A). The event product storage error occurred 56 days before the unknown dose number of mRNA-1273 vaccine administration while the event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 26 days past its 30-day use by date (initially placed in the refrigerator on 20 September 2021 and administered on 15 November 2021). The benefit-risk relationship of mRNA-1273 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 relevant medical history, who experienced the non serious events of product storage error and expired product administered for mRNA-1273 vaccine (lot number 037F21A). The event product storage error occurred 56 days before the unknown dose number of mRNA-1273 vaccine administration while the event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 26 days past its 30-day use by date (initially placed in the refrigerator on 20 September 2021 and administered on 15 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Unfortunately we did use this beyond the use date of 10/9/21.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Dyspnoea, Hyperhidrosis, Lethargy
Clinical narrative: Now she is starting to feel sweaty; Sometimes painful to breath; On Monday morning (15Nov2021), she started to have muscle cramps on left side of her abdomen where it was difficult to move; Lethargy; Next day, she had fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (On Monday morning (15Nov2021), she started to have muscle cramps on left side of her abdomen where it was difficult to move), HYPERHIDROSIS (Now she is starting to feel sweaty), DYSPNOEA (Sometimes painful to breath), LETHARGY (Lethargy) and PYREXIA (Next day, she had fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03TF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ATORVASTATIN, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) and GLIPIZIDE for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced LETHARGY (Lethargy), PYREXIA (Next day, she had fever) and CHILLS (Chills). On 15-Nov-2021, the patient experienced ABDOMINAL PAIN (On Monday morning (15Nov2021), she started to have muscle cramps on left side of her abdomen where it was difficult to move) and DYSPNOEA (Sometimes painful to breath). On 17-Nov-2021, the patient experienced HYPERHIDROSIS (Now she is starting to feel sweaty). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of UNK dosage form. On 15-Nov-2021, LETHARGY (Lethargy), PYREXIA (Next day, she had fever) and CHILLS (Chills) had resolved. At the time of the report, ABDOMINAL PAIN (On Monday morning (15Nov2021), she started to have muscle cramps on left side of her abdomen where it was difficult to move) and HYPERHIDROSIS (Now she is starting to feel sweaty) had not resolved and DYSPNOEA (Sometimes painful to breath) outcome was unknown.            Other treatments included Gatorade and Water. This case concerns a 57-year-old female patient with no relevant medical history, who experienced the unexpected events of Lethargy, Chills, Pyrexia, Abdominal Pain, Dyspnea and Hyperhidrosis. The events occurred 1-4 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old female patient with no relevant medical history, who experienced the unexpected events of Lethargy, Chills, Pyrexia, Abdominal Pain, Dyspnea and Hyperhidrosis. The events occurred 1-4 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Now she is starting to feel sweaty; Sometimes painful to breath; On Monday morning (15Nov2021), she started to have muscle cramps on left side of her abdomen where it was difficult to move; Lethargy; Next day, she had fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (On Monday morning (15Nov2021), she started to have muscle cramps on left side of her abdomen where it was difficult to move), HYPERHIDROSIS (Now she is starting to feel sweaty), DYSPNOEA (Sometimes painful to breath), LETHARGY (Lethargy) and PYREXIA (Next day, she had fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03TF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ATORVASTATIN, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) and GLIPIZIDE for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced LETHARGY (Lethargy), PYREXIA (Next day, she had fever) and CHILLS (Chills). On 15-Nov-2021, the patient experienced ABDOMINAL PAIN (On Monday morning (15Nov2021), she started to have muscle cramps on left side of her abdomen where it was difficult to move) and DYSPNOEA (Sometimes painful to breath). On 17-Nov-2021, the patient experienced HYPERHIDROSIS (Now she is starting to feel sweaty). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of UNK dosage form. On 15-Nov-2021, LETHARGY (Lethargy), PYREXIA (Next day, she had fever) and CHILLS (Chills) had resolved. At the time of the report, ABDOMINAL PAIN (On Monday morning (15Nov2021), she started to have muscle cramps on left side of her abdomen where it was difficult to move) and HYPERHIDROSIS (Now she is starting to feel sweaty) had not resolved and DYSPNOEA (Sometimes painful to breath) outcome was unknown.            Other treatments included Gatorade and Water. This case concerns a 57-year-old female patient with no relevant medical history, who experienced the unexpected events of Lethargy, Chills, Pyrexia, Abdominal Pain, Dyspnea and Hyperhidrosis. The events occurred 1-4 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old female patient with no relevant medical history, who experienced the unexpected events of Lethargy, Chills, Pyrexia, Abdominal Pain, Dyspnea and Hyperhidrosis. The events occurred 1-4 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use
Clinical narrative: Soreness; Received booster dose before approval; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received booster dose before approval) and MYALGIA (Soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 015M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Chronic kidney disease and Arthritis. Concomitant products included FUROSEMIDE (LASIX M), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, ATENOLOL, LISINOPRIL, MAGNESIUM OXIDE, AMLODIPINE, ATORVASTATIN and CLONIDINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced OFF LABEL USE (Received booster dose before approval). On an unknown date, the patient experienced MYALGIA (Soreness). On 17-Oct-2021, OFF LABEL USE (Received booster dose before approval) had resolved. At the time of the report, MYALGIA (Soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.  Company Comment: This is a case of off label use concerning a 76-year-old, female patient, with no relevant medical history, who experienced the non-serious, expected event of myalgia. The event occurred on unknown date after third dose of mRNA 1273 vaccine. The patient was given the booster dose, before it was approved and experienced soreness after the vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-391841.; Sender's Comments: This is a case of off label use concerning a 76-year-old, female patient, with no relevant medical history, who experienced the non-serious, expected event of myalgia. The event occurred on unknown date after third dose of mRNA 1273 vaccine. The patient was given the booster dose, before it was approved and experienced soreness after the vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: On 11/22/21 we gave a 17 year old a Pfizer booster, which is only approved for 18+. After getting ahold of the mother on 11/24, she explained that she thought her daughter was immunocompromised. Based on her conditions/meds, the dose should not have been given.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Gaze palsy, Loss of consciousness, Muscle rigidity
Clinical narrative: Within 1 minute he felt faint. Had a small seizure for about 10 seconds. Head rolled back. Eyes open but eyes rolled back. Body rigid and arm flailed and loud gasp. Regained consciousness and felt faint  for about 4 more minutes and passed out again. Regained consciousness and after 10 minutes ready to leave.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Within 1 minute he felt faint. Had a small seizure for about 10 seconds. Head rolled back. Eyes open but eyes rolled back. Body rigid and arm flailed and loud gasp. Regained consciousness and felt faint  for about 4 more minutes and passed out again. Regained consciousness and after 10 minutes ready to leave.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: Chest pains, shortness of breath and rapid heart rate. Went to the hospital at 10:30 PM. They did two EKG's, Catscan, chest xray, and blood work. They tried to lower her heart rate with medication, but that did not help.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased
Clinical narrative: Chest pains, shortness of breath and rapid heart rate. Went to the hospital at 10:30 PM. They did two EKG's, Catscan, chest xray, and blood work. They tried to lower her heart rate with medication, but that did not help.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness
Clinical narrative: About 5 minutes after receiving the shot on 11/24/21 at 5:45 pm, the patient's mom reported that her son passed out but was still alert and conscious. I went to check on the patient and realized that he was still alert and conscious but seemed to be very tired and could barely open his eyes so I told the front store staff to call emergency. EMTs arrived, tendered to the patient and took him to a nearby hospital.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Immobile, Musculoskeletal stiffness, Pain, Peripheral swelling, Pruritus
Clinical narrative: COVID arm Swelling in arm, itching, intense pain, tight shoulder muscle, immobility
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Inappropriate schedule of product administration, Musculoskeletal pain
Clinical narrative: First night I had headache and chills, some muscle soreness during the night.   10 days later I got the Influenza vaccine.   Day after influenza vaccine I started to get severe pain in lower back (near coccyx), both glutes and legs.  I could not sleep as lying down or putting my legs up made it worse.  The next moring I took dexketoprofen  and at night cyclobenzaprine with lysine cloxinate, but the pain barely subsided.  I had to go to the emergency room the pain was so severe (9 or 10) I had to sleep sitting down that night.  At the ER they took an xray, said they could find nothgin wrong there- They gave me an injection of tramadol with ketorolac, and told me to see a neurologist the next day.  Next morning I went to a neurologist and he diagnosed sacroileitis (I had gone bike riding 5 days before).  I asked if it might be because of the covid and influenza vaccines recently, but he attributed the pain more to the bike ride.  The bike seat was hard and I was sore in genital area from that, but I felt no muscle soreness nor discomfort day after the ride. (I had not ridden a bike for over 30 years though)  .   The neurologist gave me an injection of diprospan (betamethasone) and prescribed Celebrex and the Lysine and ciclobenzaprine.   The pain has subsided a bit, but still I feel tingling in feet and at night the back pain and glute pain keeps me up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia, Sacroiliitis, Sleep disorder
Clinical narrative: First night I had headache and chills, some muscle soreness during the night.   10 days later I got the Influenza vaccine.   Day after influenza vaccine I started to get severe pain in lower back (near coccyx), both glutes and legs.  I could not sleep as lying down or putting my legs up made it worse.  The next moring I took dexketoprofen  and at night cyclobenzaprine with lysine cloxinate, but the pain barely subsided.  I had to go to the emergency room the pain was so severe (9 or 10) I had to sleep sitting down that night.  At the ER they took an xray, said they could find nothgin wrong there- They gave me an injection of tramadol with ketorolac, and told me to see a neurologist the next day.  Next morning I went to a neurologist and he diagnosed sacroileitis (I had gone bike riding 5 days before).  I asked if it might be because of the covid and influenza vaccines recently, but he attributed the pain more to the bike ride.  The bike seat was hard and I was sore in genital area from that, but I felt no muscle soreness nor discomfort day after the ride. (I had not ridden a bike for over 30 years though)  .   The neurologist gave me an injection of diprospan (betamethasone) and prescribed Celebrex and the Lysine and ciclobenzaprine.   The pain has subsided a bit, but still I feel tingling in feet and at night the back pain and glute pain keeps me up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: First night I had headache and chills, some muscle soreness during the night.   10 days later I got the Influenza vaccine.   Day after influenza vaccine I started to get severe pain in lower back (near coccyx), both glutes and legs.  I could not sleep as lying down or putting my legs up made it worse.  The next moring I took dexketoprofen  and at night cyclobenzaprine with lysine cloxinate, but the pain barely subsided.  I had to go to the emergency room the pain was so severe (9 or 10) I had to sleep sitting down that night.  At the ER they took an xray, said they could find nothgin wrong there- They gave me an injection of tramadol with ketorolac, and told me to see a neurologist the next day.  Next morning I went to a neurologist and he diagnosed sacroileitis (I had gone bike riding 5 days before).  I asked if it might be because of the covid and influenza vaccines recently, but he attributed the pain more to the bike ride.  The bike seat was hard and I was sore in genital area from that, but I felt no muscle soreness nor discomfort day after the ride. (I had not ridden a bike for over 30 years though)  .   The neurologist gave me an injection of diprospan (betamethasone) and prescribed Celebrex and the Lysine and ciclobenzaprine.   The pain has subsided a bit, but still I feel tingling in feet and at night the back pain and glute pain keeps me up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Heart rate irregular
Clinical narrative: 2 days after receiving my booster Pfizer vaccine I had mild chest pain that lasted 3 days (I'm currently on day 3 and symptom has improved but still noticeable).  Also had fatigue and  the exact sensation is hard to explain but felt lightheaded at times and like my heart wasn't beating normally.  Like a slowed heartbeat or less effective that corresponded to a throbbing sensation in my heart and head and fatigue.  It was somewhat mild pain but concerning since it affected what seemed like my heart. I haven't seen a medical professional about it, though I did think it was concerning enough to report here
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Laboratory test normal, Pain in extremity, Rash erythematous, Ultrasound Doppler normal
Clinical narrative: I am reporting these reactions only as associations and possible adverse events, most certainly definative. The event I'm reporting are in response to the booster - third, partial dose, of Moderna. (I responded to second Moderna dose with chills and unwell feeling duration one day) Possible Association with booster: 1.  First time appearance or red, painless, flat pin prick-like mark on forearms dorsal side or wrists. These by internet search look something like senile purpuras.  First appearance 1 week following vaccine. Next occurance today. 2. Pain in upper right quadrant in area of liver or gall bladder, sensitive to touch.  Ultrasound and blood work showed no abnormalities. 3. Vaccinated arm remains very sore.  (Person administering shot appeared unskilled.) Upper R quadrant pain has resolved.  Lasted weeks. I also developed a uti, and antibiotics eased symptoms of both. Pin prick rash ( senile purpura?) appeared again today - second time.  Upper arm pain persists.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I am reporting these reactions only as associations and possible adverse events, most certainly definative. The event I'm reporting are in response to the booster - third, partial dose, of Moderna. (I responded to second Moderna dose with chills and unwell feeling duration one day) Possible Association with booster: 1.  First time appearance or red, painless, flat pin prick-like mark on forearms dorsal side or wrists. These by internet search look something like senile purpuras.  First appearance 1 week following vaccine. Next occurance today. 2. Pain in upper right quadrant in area of liver or gall bladder, sensitive to touch.  Ultrasound and blood work showed no abnormalities. 3. Vaccinated arm remains very sore.  (Person administering shot appeared unskilled.) Upper R quadrant pain has resolved.  Lasted weeks. I also developed a uti, and antibiotics eased symptoms of both. Pin prick rash ( senile purpura?) appeared again today - second time.  Upper arm pain persists.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Delayed urticaria- began 10 days after vaccination. Is ongoing. Rashes and hives on moving spots all over the body. Also had "COVID arm" beginning the day after vaccination and lasting a few days-- rash around injection site.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Oropharyngeal pain, Pulmonary congestion
Clinical narrative: This report involves the Pfizer booster shot, which I received 8.5 months after my second Pfizer dose.  My symptoms, which started the morning following the booster shot and have gradually gotten worse, are runny nose, sore throat, slight cough, nasal congestion, slight chest congestion, and headache. It has been four days since my booster shot, and today (11/24/2021) is the worst day for my symptoms. It's like I have a bad cold.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: This report involves the Pfizer booster shot, which I received 8.5 months after my second Pfizer dose.  My symptoms, which started the morning following the booster shot and have gradually gotten worse, are runny nose, sore throat, slight cough, nasal congestion, slight chest congestion, and headache. It has been four days since my booster shot, and today (11/24/2021) is the worst day for my symptoms. It's like I have a bad cold.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Arthralgia, Blood test, Cough, Dizziness
Clinical narrative: -Headaches, dizziness, yellow discharge, nausea, painful throat, pain behind my eyes, pain near my cerebral cortex and spin, knee pain, etc.  -I started to become more sensitive to irritants -cough that lasted for a good 2 months and at times would skip a day -3 months of extreme cramping for period, and abnormally heavy flow survived on iron pills and even went home early the first time. need to change pads every hour/hour and a half -My normal seasonal allergies started acting weird then I sneezed twice and both my eyes felt warm and were completely red looked like Subconjunctival hemorrhaging  (3 witness) didn't take picture because I was freaking the out on the inside and was at work. It lasted for about 40 minutes off and on after antihistamine.  -Throughout the first 3 weeks, I could feel the vaccines path from my throat to nose to behind eyes back down toward my lungs but never went that far (though had a 2 month cough).  -Find the times, dates and more information in initial health check-in by v-safe after vaccination health checker. The program will time out before I can finish typing it all. You have my permission or call me if you want a voice statement.  Don't know if there are any permanent damage yet for me I'll figure it out 4-7 years from know.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Eye pain, Headache, Heavy menstrual bleeding, Hypersensitivity
Clinical narrative: -Headaches, dizziness, yellow discharge, nausea, painful throat, pain behind my eyes, pain near my cerebral cortex and spin, knee pain, etc.  -I started to become more sensitive to irritants -cough that lasted for a good 2 months and at times would skip a day -3 months of extreme cramping for period, and abnormally heavy flow survived on iron pills and even went home early the first time. need to change pads every hour/hour and a half -My normal seasonal allergies started acting weird then I sneezed twice and both my eyes felt warm and were completely red looked like Subconjunctival hemorrhaging  (3 witness) didn't take picture because I was freaking the out on the inside and was at work. It lasted for about 40 minutes off and on after antihistamine.  -Throughout the first 3 weeks, I could feel the vaccines path from my throat to nose to behind eyes back down toward my lungs but never went that far (though had a 2 month cough).  -Find the times, dates and more information in initial health check-in by v-safe after vaccination health checker. The program will time out before I can finish typing it all. You have my permission or call me if you want a voice statement.  Don't know if there are any permanent damage yet for me I'll figure it out 4-7 years from know.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mucosal discolouration, Ocular hyperaemia, Oropharyngeal pain, Sensory disturbance, Sneezing
Clinical narrative: -Headaches, dizziness, yellow discharge, nausea, painful throat, pain behind my eyes, pain near my cerebral cortex and spin, knee pain, etc.  -I started to become more sensitive to irritants -cough that lasted for a good 2 months and at times would skip a day -3 months of extreme cramping for period, and abnormally heavy flow survived on iron pills and even went home early the first time. need to change pads every hour/hour and a half -My normal seasonal allergies started acting weird then I sneezed twice and both my eyes felt warm and were completely red looked like Subconjunctival hemorrhaging  (3 witness) didn't take picture because I was freaking the out on the inside and was at work. It lasted for about 40 minutes off and on after antihistamine.  -Throughout the first 3 weeks, I could feel the vaccines path from my throat to nose to behind eyes back down toward my lungs but never went that far (though had a 2 month cough).  -Find the times, dates and more information in initial health check-in by v-safe after vaccination health checker. The program will time out before I can finish typing it all. You have my permission or call me if you want a voice statement.  Don't know if there are any permanent damage yet for me I'll figure it out 4-7 years from know.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: -Headaches, dizziness, yellow discharge, nausea, painful throat, pain behind my eyes, pain near my cerebral cortex and spin, knee pain, etc.  -I started to become more sensitive to irritants -cough that lasted for a good 2 months and at times would skip a day -3 months of extreme cramping for period, and abnormally heavy flow survived on iron pills and even went home early the first time. need to change pads every hour/hour and a half -My normal seasonal allergies started acting weird then I sneezed twice and both my eyes felt warm and were completely red looked like Subconjunctival hemorrhaging  (3 witness) didn't take picture because I was freaking the out on the inside and was at work. It lasted for about 40 minutes off and on after antihistamine.  -Throughout the first 3 weeks, I could feel the vaccines path from my throat to nose to behind eyes back down toward my lungs but never went that far (though had a 2 month cough).  -Find the times, dates and more information in initial health check-in by v-safe after vaccination health checker. The program will time out before I can finish typing it all. You have my permission or call me if you want a voice statement.  Don't know if there are any permanent damage yet for me I'll figure it out 4-7 years from know.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: My right side temple and right eye haven began twitching. My right side of the mouth also chatters sometimes at the same time the twitching is happening. Sometimes it?s two of the three issues at once or sometimes it?s individually reacting.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Hypersomnia, Pain
Clinical narrative: Severe headache, chills, fever, chest pain, body aches.  Slept over 16 hours waking only to drink.  Symptoms lasted for 18 hours.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe headache, chills, fever, chest pain, body aches.  Slept over 16 hours waking only to drink.  Symptoms lasted for 18 hours.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Computerised tomogram, Dizziness
Clinical narrative: Elevated HR, Fever of 103.7, chills, extreme muscle pain and weakness, dizziness, lethargy
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Lethargy, Muscular weakness, Myalgia
Clinical narrative: Elevated HR, Fever of 103.7, chills, extreme muscle pain and weakness, dizziness, lethargy
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Elevated HR, Fever of 103.7, chills, extreme muscle pain and weakness, dizziness, lethargy
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: Within 5 minutes: Throat tightness; headache; face numbness; tongue numbness. After 40-minutes: Extreme sensitivity to light; loss of vision clarity; headache worsening. Face and tongue numbness cleared. 2-3 days: Flu-like symptoms; pain/stiffness in neck; loss of clear distance vision (could no longer read street signs). July 2021: Distance vision still not restored requiring PRK surgery to aid in regaining some of the vision.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Photophobia, Photorefractive keratectomy, Throat tightness, Vision blurred
Clinical narrative: Within 5 minutes: Throat tightness; headache; face numbness; tongue numbness. After 40-minutes: Extreme sensitivity to light; loss of vision clarity; headache worsening. Face and tongue numbness cleared. 2-3 days: Flu-like symptoms; pain/stiffness in neck; loss of clear distance vision (could no longer read street signs). July 2021: Distance vision still not restored requiring PRK surgery to aid in regaining some of the vision.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Within 5 minutes: Throat tightness; headache; face numbness; tongue numbness. After 40-minutes: Extreme sensitivity to light; loss of vision clarity; headache worsening. Face and tongue numbness cleared. 2-3 days: Flu-like symptoms; pain/stiffness in neck; loss of clear distance vision (could no longer read street signs). July 2021: Distance vision still not restored requiring PRK surgery to aid in regaining some of the vision.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Pain in extremity
Clinical narrative: Arm pain began approximately 6 hours after shot; fatigue approximately seven hours after. SEVERE joint pain woke me up approximately 11-12 hours after shot, along with headache. Headache was minimal roughly twelve hours after that (24 hours after shot), SEVERE joint pain, fatigue, and injection site pain lasted about two days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Arm pain began approximately 6 hours after shot; fatigue approximately seven hours after. SEVERE joint pain woke me up approximately 11-12 hours after shot, along with headache. Headache was minimal roughly twelve hours after that (24 hours after shot), SEVERE joint pain, fatigue, and injection site pain lasted about two days.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Paraesthesia, Spinal X-ray
Clinical narrative: About 1 week after first injection, swelling and bruising at injection site. Shoulder pain in that shoulder. Sometimes fingers will tingle in left hand. Is not continuous but does still come up. After 3rd dose similar pain in right shoulder.