chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Sitting disability
Clinical narrative: bruising behind the left knee; unable to move; "cannot stand up sleep and sit"; "cannot stand up sleep and sit"; "cannot stand up sleep and sit"; muscle pain; This spontaneous case was reported by a physician and describes the occurrence of CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit") and INSOMNIA ("cannot stand up sleep and sit") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit"), INSOMNIA ("cannot stand up sleep and sit") and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, CONTUSION (bruising behind the left knee), MOBILITY DECREASED (unable to move), DYSSTASIA ("cannot stand up sleep and sit"), SITTING DISABILITY ("cannot stand up sleep and sit"), INSOMNIA ("cannot stand up sleep and sit") and MYALGIA (muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Pulmonary oedema
Clinical narrative: Boody pink fluid built up in his lungs; Bloody pink fluid built up around his heart; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (Boody pink fluid built up in his lungs) and PERICARDIAL EFFUSION (Bloody pink fluid built up around his heart) 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 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 PULMONARY OEDEMA (Boody pink fluid built up in his lungs) (seriousness criteria death and medically significant) and PERICARDIAL EFFUSION (Bloody pink fluid built up around his heart) (seriousness criteria death and medically significant). The reported cause of death was boody pink fluid built up in his lungs and bloody pink fluid built up around his heart. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was died 15 weeks after taking the vaccine.  Company Comment: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected events of Pulmonary Edema and Pericardial Effusion. The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine)  and had a fatal outcome, with death occurring approximately 15 weeks after the dose. It's unclear if it was the first or second dose. The rechallenge was not applicable, as the event happened after a dose and resulted in death. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected events of Pulmonary Edema and Pericardial Effusion. The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine)  and had a fatal outcome, with death occurring approximately 15 weeks after the dose. It's unclear if it was the first or second dose. The rechallenge was not applicable, as the event happened after a dose and resulted in death. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Boody pink fluid built up in his lungs; Bloody pink fluid built up around his heart
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in the arm/pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the arm/pain in her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A., 031L20A and 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in the arm/pain in her arm). On 11-Feb-2021, VACCINATION SITE PAIN (soreness in the arm/pain in her arm) had resolved.            Concomitant medication was not provided. Treatment information was not provided.    This case was linked to MOD-2021-387051 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral herpes, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: largest fever blister on their upper lips; very sore arm lasted for 2 weeks; swelling in their lymph node under their arm area on the side tissue that lasted for 2 weeks/swollen lymph nodes after flu vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (largest fever blister on their upper lips), PAIN IN EXTREMITY (very sore arm lasted for 2 weeks) and LYMPHADENOPATHY (swelling in their lymph node under their arm area on the side tissue that lasted for 2 weeks/swollen lymph nodes after flu vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Swollen lymph nodes with Flu vaccine. Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (largest fever blister on their upper lips), PAIN IN EXTREMITY (very sore arm lasted for 2 weeks) and LYMPHADENOPATHY (swelling in their lymph node under their arm area on the side tissue that lasted for 2 weeks/swollen lymph nodes after flu vaccine). The patient was treated with DOCOSANOL (ABREVA) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) at an unspecified dose and frequency. At the time of the report, ORAL HERPES (largest fever blister on their upper lips), PAIN IN EXTREMITY (very sore arm lasted for 2 weeks) and LYMPHADENOPATHY (swelling in their lymph node under their arm area on the side tissue that lasted for 2 weeks/swollen lymph nodes after flu vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.         Patient took Vitamin [Melaleuca peak performance total health 50+] as concomitant drug product with an unknown date and unknown indication.   This case was linked to MOD-2021-387016 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Pierced vial more than 20 times to administer booster doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Pierced vial more than 20 times to administer booster doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Pierced vial more than 20 times to administer booster doses). At the time of the report, PRODUCT ADMINISTRATION ERROR (Pierced vial more than 20 times to administer booster doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.   No treatment information provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm/pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm/pain in her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soreness in the arm/pain in her arm). On 11-Feb-2021, PAIN IN EXTREMITY (soreness in the arm/pain in her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment information were provided.   This case was linked to MOD-2021-387051, MOD-2021-387066 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Dyspnoea, Pain in extremity
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of pain in extremity (sore arm after 3rd full dose), anger and dyspnea (shortness of breath after 3rd full dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939904) for COVID-19 immunization. The patient's past medical history included cancer/chemotherapy/surgery (post cancer and chemotherapy, half her lungs removed due to cancer prior to vaccination). On Oct 27, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 27, 2021, patient experienced pain in extremity (sore arm after 3rd full dose) and dyspnea (shortness of breath after 3rd full dose). On Nov 15, 2021, patient experienced anger. At the time of the report, pain in extremity (sore arm after 3rd full dose): not resolved; anger and dyspnea (shortness of breath after 3rd full dose) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient visited the doctor and they are running tests.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue, Vaccination site pain
Clinical narrative: is kind of Sick; arm sore from first dose; Did not receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (is kind of Sick), VACCINATION SITE PAIN (arm sore from first dose) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A214) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetes (The patient is diabetic, and was kind of sick.). Concomitant products included METFORMIN for Diabetes, GABAPENTIN for an unknown indication.    On 09-Mar-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 ILLNESS (is kind of Sick), VACCINATION SITE PAIN (arm sore from first dose) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). At the time of the report, ILLNESS (is kind of Sick) and VACCINATION SITE PAIN (arm sore from first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had put cold to relieve the symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Patient face is swelling up in one specific zone in the same side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Patient face is swelling up in one specific zone in the same side of the injection) 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 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Patient face is swelling up in one specific zone in the same side of the injection). At the time of the report, SWELLING FACE (Patient face is swelling up in one specific zone in the same side of the injection) outcome was unknown.            No concomitant medications are provided. No treatment medications are provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: My whole body is sore is that normal; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (My whole body is sore is that normal) 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 MYALGIA (My whole body is sore is that normal). At the time of the report, MYALGIA (My whole body is sore is that normal) 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.   Concomitant medications were not reported.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Three crazy rashes) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Three crazy rashes). At the time of the report, RASH (Three crazy rashes) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-387460, MOD-2021-387461 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: starts having pain-left arm / radiates down to left arm; pain starts at injection site-left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (starts having pain-left arm / radiates down to left arm) and VACCINATION SITE PAIN (pain starts at injection site-left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (starts having pain-left arm / radiates down to left arm) and VACCINATION SITE PAIN (pain starts at injection site-left arm). At the time of the report, PAIN IN EXTREMITY (starts having pain-left arm / radiates down to left arm) and VACCINATION SITE PAIN (pain starts at injection site-left arm) had not resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Excruciating Headache; Nausea; Vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Excruciating Headache), NAUSEA (Nausea) and VOMITING (Vomiting) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced HEADACHE (Excruciating Headache), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, HEADACHE (Excruciating Headache), NAUSEA (Nausea) and VOMITING (Vomiting) 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 details was given.   No Treatment drug details was given by reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received booster instead of 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose). On 11-Nov-2021, ACCIDENTAL UNDERDOSE (received booster instead of 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. An Immunocompromised patient received a booster dose instead of the 3rd dose.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Family members having covid right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Family members having covid right now) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COVID-19 (Family members having covid right now). At the time of the report, COVID-19 (Family members having covid right now) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No relevant concomitant medications was reported. Treatment information was not provided.  Family members had COVID on 7,8,9,10 November 2021.  Company comment: This is a spontaneous case concerning a male patient of an unknown age,with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19 . The patient received dose of mRNA-1273 on an unknown date and the event occurred in November 2021. Reporter don´t know the manufacturer of vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age,with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19 . The patient received dose of mRNA-1273 on an unknown date and the event occurred in November 2021. Reporter don´t know the manufacturer of vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little bit more of pain than what I had for the other two) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included VITAMIN D NOS and LORATADINE (CLARITINE) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Little bit more of pain than what I had for the other two). At the time of the report, PAIN (Little bit more of pain than what I had for the other two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Patient takes blood pressure medicine   This case was linked to MOD-2021-387844, MOD-2021-387845 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) 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.   Patient used concomitant medications for High blood pressure and thyroid  No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Pain in extremity
Clinical narrative: Hair falling out/Receiving hairline in the right side of her head; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling out/Receiving hairline in the right side of her head) and PAIN IN EXTREMITY (Sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (twice but not enough to be hospitalize), Cough (Patient state for 3 straight months she was cough badly), Taste abnormality and Smell change. Concomitant products included METOPROLOL for an unknown indication.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Oct-2021, the patient experienced ALOPECIA (Hair falling out/Receiving hairline in the right side of her head). At the time of the report, ALOPECIA (Hair falling out/Receiving hairline in the right side of her head) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that The first shot made hair fall out and supposed to get the second. As a woman, don't want to be bald.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: followup document contains non-significant information
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: After the second dose, patient had a lot of soreness in left arm; Achy all over for a couple of days; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the second dose, patient had a lot of soreness in left arm), PAIN (Achy all over for a couple of days) and FATIGUE (Very tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 024M20A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (After the second dose, patient had a lot of soreness in left arm), PAIN (Achy all over for a couple of days) and FATIGUE (Very tired). At the time of the report, PAIN IN EXTREMITY (After the second dose, patient had a lot of soreness in left arm), PAIN (Achy all over for a couple of days) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-387428 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Pain, Pain in extremity
Clinical narrative: Muscles are so bad I can't even lift a dish or stretch  arm"; However, about five days later, pain came back on both arms and shoulders, and has been still since beginning of November; next morning after the booster dose, patient woke up with "terrible pain in whole entire body, like a train run over me"; except in her arm, which she couldn't lift up for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (except in her arm, which she couldn't lift up for a few days), HYPOKINESIA (Muscles are so bad I can't even lift a dish or stretch  arm"), PAIN (next morning after the booster dose, patient woke up with "terrible pain in whole entire body, like a train run over me") and ARTHRALGIA (However, about five days later, pain came back on both arms and shoulders, and has been still since beginning of November) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 038A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (except in her arm, which she couldn't lift up for a few days). On 27-Oct-2021, the patient experienced PAIN (next morning after the booster dose, patient woke up with "terrible pain in whole entire body, like a train run over me"). In November 2021, the patient experienced HYPOKINESIA (Muscles are so bad I can't even lift a dish or stretch  arm") and ARTHRALGIA (However, about five days later, pain came back on both arms and shoulders, and has been still since beginning of November). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 28-Oct-2021, PAIN (next morning after the booster dose, patient woke up with "terrible pain in whole entire body, like a train run over me") had resolved. At the time of the report, PAIN IN EXTREMITY (except in her arm, which she couldn't lift up for a few days) and ARTHRALGIA (However, about five days later, pain came back on both arms and shoulders, and has been still since beginning of November) had not resolved and HYPOKINESIA (Muscles are so bad I can't even lift a dish or stretch  arm") outcome was unknown.            No concomitant medications were reported   This case was linked to MOD-2021-387389 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 3 crazy rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (3 crazy rashes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (3 crazy rashes). At the time of the report, RASH (3 crazy rashes) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2021-387097, MOD-2021-387461 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 3 crazy rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (3 crazy rashes) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 RASH (3 crazy rashes). At the time of the report, RASH (3 crazy rashes) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-387460, MOD-2021-387097 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Vaccination complication
Clinical narrative: bad reactions to the Moderna vaccine; she was so itchy; She felt like she was going to die; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reactions to the Moderna vaccine), PRURITUS (she was so itchy) and FEELING ABNORMAL (She felt like she was going to die) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reactions to the Moderna vaccine), PRURITUS (she was so itchy) and FEELING ABNORMAL (She felt like she was going to die). At the time of the report, VACCINATION COMPLICATION (bad reactions to the Moderna vaccine), PRURITUS (she was so itchy) and FEELING ABNORMAL (She felt like she was going to die) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications are provided by the reporter. patient stated that after the first dose, the caregiver was in the hospital.   This case was linked to MOD-2021-387480 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Headache, Myalgia, Vaccination site pain
Clinical narrative: has been having trouble to concentrate; vertigo; dizzyness; body aches; headache; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizzyness), DISTURBANCE IN ATTENTION (has been having trouble to concentrate), MYALGIA (body aches) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) 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 METFORMIN, EMPAGLIFLOZIN (JARDIANCE), INSULIN GLARGINE (BASAGLAR) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced DIZZINESS (dizzyness), MYALGIA (body aches), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the injection site). On 11-Nov-2021, the patient experienced VERTIGO (vertigo). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (has been having trouble to concentrate). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) had not resolved and DIZZINESS (dizzyness), DISTURBANCE IN ATTENTION (has been having trouble to concentrate), MYALGIA (body aches), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: has been having trouble to concentrate; vertigo; dizzyness; body aches; headache; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizzyness), DISTURBANCE IN ATTENTION (has been having trouble to concentrate), MYALGIA (body aches) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) 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 METFORMIN, EMPAGLIFLOZIN (JARDIANCE), INSULIN GLARGINE (BASAGLAR) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced DIZZINESS (dizzyness), MYALGIA (body aches), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the injection site). On 11-Nov-2021, the patient experienced VERTIGO (vertigo). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (has been having trouble to concentrate). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) had not resolved and DIZZINESS (dizzyness), DISTURBANCE IN ATTENTION (has been having trouble to concentrate), MYALGIA (body aches), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: family members having covid right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (family members having covid right now) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COVID-19 (family members having covid right now). At the time of the report, COVID-19 (family members having covid right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  The reporter reported that lot of family members having covid right now, on 2021 November 7,8,9,10. There are 4 family members- 2 males and 2 females. All patients are vaccinated but caller don't know the manufacturer of vaccine.  This case concerns a male patient of unknown age with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred on an unknown date after mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred on an unknown date after mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a booster dose of 0.25mL instead of 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who was immunocompromised received a  booster dose of 0.25mL instead of a 3rd dose of 0.5mL/6 months gap between the 2nd dose and the booster dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHOTREXATE and PREDNISONE for an unknown indication.   On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. 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) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received a booster dose of 0.25mL instead of 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who was immunocompromised received a  booster dose of 0.25mL instead of a 3rd dose of 0.5mL/6 months gap between the 2nd dose and the booster dose). On 13-Nov-2021, INCORRECT DOSE ADMINISTERED (Received a booster dose of 0.25mL instead of 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who was immunocompromised received a  booster dose of 0.25mL instead of a 3rd dose of 0.5mL/6 months gap between the 2nd dose and the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist stated that the patient signed up for the additional dose for immunocompromised people but got the half dose of 0.25mL instead of 0.5mLThe HCP asked, does the patient need a 2nd booster dose shot as they did not get a 3rd dose while being immunocompromised?  No Treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 expired doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported.   This case was linked to MOD-2021-387476 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 expired doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-386799, MOD-2021-387476 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 with 3 days of symptoms) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19 with 3 days of symptoms). At the time of the report, COVID-19 (COVID-19 with 3 days of symptoms) had resolved. Not Provided          No concomitant medication were reported.  No treatment medication were reported.  Patient had unspecified vaccine booster on an unspecified date in August or September 2021 also has a mild case of COVID-19 with 3 days of symptoms and didn't specify when was diagnosed with COVID-19 or when symptoms began.  This case concerns a male patient with unknown age with no reported medical history, who experienced non-serious , unexpected , AESI event  Covid 19 which occurred on an unknown date after vaccination with 2 dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event has not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.; Sender's Comments: This case concerns a male patient with unknown age with no reported medical history, who experienced non-serious , unexpected , AESI event  Covid 19 which occurred on an unknown date after vaccination with 2 dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the event has not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was temperature excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  No treatment medications were provided y the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up document was received on 15-NOV-2021 and it includes patient demographics and dose number and the lot number was updated.