chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer and concerned a male of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had developed a Covid infection where he had a fever of 103 and extreme fatigue (suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103, and COVID-19 virus test (NR: not provided) positive (still testing positive). It was reported that, patient was feeling much better now. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211008860-covid-19 vaccine ad26.cov2. s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, frequency one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot after receiving vaccine and died from blood clot on an unspecified date. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211009196-COVID-19 VACCINE AD26.COV2.S-Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breast milk; This spontaneous case was reported by a physician and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a male neonate of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): On 04-JAN-2021, parent had Normal ultrasound, on 06-JAN-2021 Glucose test Normal 107.  Previously administered products included for Pregnancy: Prenatal vitamin (Daily via per oral route). Concurrent medical conditions included Exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on an unknown date and the estimated date of delivery was 19-Aug-2021. On an unknown date, the neonate was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). The mother had a cesarean delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, with an APGAR score of 7 and 8 at (1, 5 minutes). The outcome was reported as Term Birth NOS. Head circumference  34 cm. At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.  This report concerns a child who experienced the unexpected event of vaccine exposure via breast milk. The event occurred after an unknown duration following the mother's exposure to mRNA-1273 vaccine. The mother has no relevant past medical history. The patient was delivered by full time birth by cesarean section. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This report concerns a child who experienced the unexpected event of vaccine exposure via breast milk. The event occurred after an unknown duration following the mother's exposure to mRNA-1273 vaccine. The mother has no relevant past medical history. The patient was delivered by full time birth by cesarean section. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Gastric disorder, Intestinal obstruction, Pyrexia
Clinical narrative: potential bowel obstruction; gastric distress; low-grade fever spiking up to 104F; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (potential bowel obstruction), GASTRIC DISORDER (gastric distress) and PYREXIA (low-grade fever spiking up to 104F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 024M20A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease (has Crohn's disease and Colitis for 4 years.) and Colitis.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced INTESTINAL OBSTRUCTION (potential bowel obstruction) (seriousness criteria hospitalization and medically significant), GASTRIC DISORDER (gastric distress) (seriousness criterion hospitalization) and PYREXIA (low-grade fever spiking up to 104F) (seriousness criterion hospitalization). The patient was hospitalized on 17-Aug-2021 due to GASTRIC DISORDER, INTESTINAL OBSTRUCTION and PYREXIA. At the time of the report, INTESTINAL OBSTRUCTION (potential bowel obstruction), GASTRIC DISORDER (gastric distress) and PYREXIA (low-grade fever spiking up to 104F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 104 (High) low-grade fever spiking up to 104F..         No concomitant information was provided. Patient was hospitalized, and went to the ER, had CT Scan for potential bowel obstruction and gastric distress results were unknown. Then patient  was discharged along with heavy maintenance medication.  Company comment: This case concerns a  male of unknown age with relevant medical history of Crohn's disease and colitis who experienced serious unexpected event of intestinal obstruction, gastric disorder and pyrexia one day after the third dose of the Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a  male of unknown age with relevant medical history of Crohn's disease and colitis who experienced serious unexpected event of intestinal obstruction, gastric disorder and pyrexia one day after the third dose of the Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after use by date; 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication details were provided. No Treatment medication details were provided.  DOSE 1 was administered on 23Sep, 8am and DOSE 2 was administered 24Sep around 1:30pm.   On 24 Aug 2021,Vial went from freezer to refrigerator. At 6 am Vial from refrigerator, stored at the appropriate room temperature for 15 minutes before 1st puncture and administered to patient immediately after 1st puncture.   Neither vial went through a previous temperature excursion.  It was reported that the patient had no adverse events.   This case was linked to US-irms-MOD21-147703 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: follow up received with no new information. On 01-Oct-2021: Follow-up information added in I narrative supplement.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test, Sinusitis
Clinical narrative: lost her taste; lost her smell two weeks after; She also got a sinus infection but she gets them every year; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her taste), ANOSMIA (lost her smell two weeks after) and SINUSITIS (She also got a sinus infection but she gets them every year) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sinus infection (patient gets them every year). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost her taste), ANOSMIA (lost her smell two weeks after) and SINUSITIS (She also got a sinus infection but she gets them every year). At the time of the report, AGEUSIA (lost her taste) and ANOSMIA (lost her smell two weeks after) had not resolved and SINUSITIS (She also got a sinus infection but she gets them every year) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       After the first shot patient lost of taste and smell two weeks after. patient was tested for COVID-19 and it came up negative. patient said people  told her she might have gotten tested late though. She did not take any medications for this and still has no taste or smell. She also got a sinus infection but she gets them every year.   Patient  got the first and second Moderna COVID-19 vaccination at Pharmacy.   No treatment was reported by the reporter.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old got the first dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine) in a 16-year-old female patient 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna vaccine) outcome was unknown.            no concomitant or treatment medications were provided. patient wanted to get the second dose of the vaccine.   Reporter did not allow further contact
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Muscle discomfort
Clinical narrative: Slight muscular discomfort; Stomach discomfort / Abdomen discomfort; Stomach pain/ Abdomen pain; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0173NA, 038K20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Went through a series of cancer treatments).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-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 MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain). At the time of the report, MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient is on a number of different medications (name was unspecified).  No treatment information was provided.  The patient received third dose of vaccine and reports slight muscular discomfort, not severe with stomach and abdomen discomfort and pain. The patient had went through series of cancer treatments and considered as immunocompromised.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Allergy to animal, Dyspnoea
Clinical narrative: had a reaction to the cat/symptoms started within a couple of days after it was with the cat; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO ANIMAL (had a reaction to the cat/symptoms started within a couple of days after it was with the cat) and DYSPNOEA (trouble breathing) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergic to cats. Concomitant products included METHYLPREDNISOLONE ACETATE (DEPOMEDROL) for Allergy.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ALLERGY TO ANIMAL (had a reaction to the cat/symptoms started within a couple of days after it was with the cat) and DYSPNOEA (trouble breathing). The patient was treated with OLOPATADINE HYDROCHLORIDE (ALLERCHECK) for Adverse event, at a dose of 1 dosage form and TRIAMCINOLONE ACETONIDE (NASACORT) for Adverse event, at a dose of 1 dosage form. At the time of the report, ALLERGY TO ANIMAL (had a reaction to the cat/symptoms started within a couple of days after it was with the cat) and DYSPNOEA (trouble breathing) outcome was unknown.            The Patient stated on June travelled again and took the Depometrol and that time had it one week before and could stay with the cat.The patient said it's doctor told them that possibly travelled before the Deprometrol on Feb 10th acted the patient also stated that the it was a reaction to the cat because it was on lockdown and quarantine with the cat for 5 days   This case was linked to MOD-2021-335196 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 97 (normal) in the morning it is 97 and 100 (High) high. On 19-Jun-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 19-Jun-2021, SARS-CoV-2 test: negative (Negative) first dry blood spot test Reactive # of 8.52 with <1.41 index.. On 08-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 08-Sep-2021, SARS-CoV-2 test: negative (Negative) dry blood spot test showed a Reactive # of 2.93 with <1.41 index..         Concomitant medications were not provided.  Treatment information was not provided.  After the second one patient had a fever, normally in the morning  fever is 97. something did not remember how high was when took it but it went to 100°F and stopped taking it after that was perfectly fine. The test results show with the first dry blood spot test Reactive # of 8.52 with <1.41 index on June.19. Patient went for the 2nd antibody test and the dry blood spot test showed a Reactive # of 2.93 with <1.41 index .on Sept.8.   This case was linked to MOD-2021-335496 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: FU received on 04-OCT-2021. Lab results updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: right arm is itching; it has swelling around it/shocked that it was so swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen). At the time of the report, VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling at injection site after both vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at injection site after both vaccines) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at injection site after both vaccines). At the time of the report, VACCINATION SITE SWELLING (swelling at injection site after both vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-067360 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling abnormal, Insomnia
Clinical narrative: Vomit; Unable to sleep; Waking up soaking wet; Out of his mind; 101/104F fever; Major chills; Body aches; All joints of the body ache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever) and CHILLS (Major chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure abnormal. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), TESTOSTERONE, ASPIRIN [ACETYLSALICYLIC ACID] and CLONAZEPAM for an unknown indication.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever), CHILLS (Major chills), MYALGIA (Body aches) and ARTHRALGIA (All joints of the body ache). On an unknown date, the patient experienced VOMITING (Vomit). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever), CHILLS (Major chills), MYALGIA (Body aches), ARTHRALGIA (All joints of the body ache) and VOMITING (Vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Sep-2021, Body temperature: high (High) 101/104F fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants also include turmeric, cardecentin and pain medication. No treatment medication was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Night sweats, Pyrexia, Vomiting
Clinical narrative: Vomit; Unable to sleep; Waking up soaking wet; Out of his mind; 101/104F fever; Major chills; Body aches; All joints of the body ache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever) and CHILLS (Major chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure abnormal. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), TESTOSTERONE, ASPIRIN [ACETYLSALICYLIC ACID] and CLONAZEPAM for an unknown indication.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever), CHILLS (Major chills), MYALGIA (Body aches) and ARTHRALGIA (All joints of the body ache). On an unknown date, the patient experienced VOMITING (Vomit). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Unable to sleep), NIGHT SWEATS (Waking up soaking wet), FEELING ABNORMAL (Out of his mind), PYREXIA (101/104F fever), CHILLS (Major chills), MYALGIA (Body aches), ARTHRALGIA (All joints of the body ache) and VOMITING (Vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Sep-2021, Body temperature: high (High) 101/104F fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants also include turmeric, cardecentin and pain medication. No treatment medication was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sluggishness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of sluggishness (felt really sluggish) and fatigue (felt tired) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 060E21A) for COVID-19 immunization. The patient's past medical history included COVID-19. On Sep 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced sluggishness (felt really sluggish) and fatigue (felt tired). At the time of the report, sluggishness (felt really sluggish) and fatigue (felt tired) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Reportedly, her next dose will be Oct 26, 2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: started bleeding and has not stopped bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding). At the time of the report, VAGINAL HAEMORRHAGE (started bleeding and has not stopped bleeding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient a few months under 18 got the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine). On 28-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine) had resolved.        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 medications reported. No treatment information reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Headache, Hypersensitivity
Clinical narrative: Red; Swollen face; Palpitation; Dizziness; Injection iste hard; Allergic reaction on her legs; injection site is inflamed; Injection site painfull; headaches; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness) and VACCINATION SITE INDURATION (Injection iste hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Heart murmur, Skin cancer and Brain cancer metastatic (Brenign brain cancer). Concurrent medical conditions included Depression. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM for an unknown indication.    On 27-Aug-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 ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Swelling face, Vaccination site induration, Vaccination site inflammation
Clinical narrative: Red; Swollen face; Palpitation; Dizziness; Injection iste hard; Allergic reaction on her legs; injection site is inflamed; Injection site painfull; headaches; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness) and VACCINATION SITE INDURATION (Injection iste hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Heart murmur, Skin cancer and Brain cancer metastatic (Brenign brain cancer). Concurrent medical conditions included Depression. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM for an unknown indication.    On 27-Aug-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 ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Weight
Clinical narrative: Red; Swollen face; Palpitation; Dizziness; Injection iste hard; Allergic reaction on her legs; injection site is inflamed; Injection site painfull; headaches; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness) and VACCINATION SITE INDURATION (Injection iste hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Heart murmur, Skin cancer and Brain cancer metastatic (Brenign brain cancer). Concurrent medical conditions included Depression. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM for an unknown indication.    On 27-Aug-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 ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Vaccination site pain
Clinical narrative: He is feeling warm right now (today); The area of injection site started getting sore.; On same day after receiving 2nd dose, at night he started with chills.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (He is feeling warm right now (today)), VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.). On 29-Sep-2021, the patient experienced FEELING HOT (He is feeling warm right now (today)). At the time of the report, FEELING HOT (He is feeling warm right now (today)), VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unauthorized age group; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age group) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient's second dose was scheduled on 29-Sep-2021 at 09:45 am.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: feels like palpitation; mouth flu; sore arm; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (feels like palpitation), INFLUENZA (mouth flu), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included Tourette's syndrome and Bipolar disorder. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), AMITRIPTYLINE, FLUOXETINE HYDROCHLORIDE (PROZAC) and OMEPRAZOLE for an unknown indication.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (feels like palpitation), INFLUENZA (mouth flu), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills). At the time of the report, PALPITATIONS (feels like palpitation), INFLUENZA (mouth flu), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Patient was not allergic to food or medications Treatment medication were not reported.  Patient after getting the vaccine felt like palpitation, mouth flu, sore arm, fever and chills.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.  the patient received the third dose on 21Aug2021   This case was linked to MOD-2021-336417 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: Heart felt like it was coming out of her chest all day then it went away; felt as if she was about to die; Had a fever of 99.8°F/Keeping a low grade temperature; Felt odd; little sluggish; Slept from 12:00 noon-10:30 pm; Really didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well) and CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well) and PYREXIA (Had a fever of 99.8°F/Keeping a low grade temperature). On 10-Sep-2021, the patient experienced CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) and FEELING ABNORMAL (felt as if she was about to die). At the time of the report, FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well), FEELING ABNORMAL (felt as if she was about to die) and PYREXIA (Had a fever of 99.8°F/Keeping a low grade temperature) was resolving and CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 99.8°f (High) low grade temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Somnolence
Clinical narrative: Heart felt like it was coming out of her chest all day then it went away; felt as if she was about to die; Had a fever of 99.8°F/Keeping a low grade temperature; Felt odd; little sluggish; Slept from 12:00 noon-10:30 pm; Really didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well) and CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well) and PYREXIA (Had a fever of 99.8°F/Keeping a low grade temperature). On 10-Sep-2021, the patient experienced CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) and FEELING ABNORMAL (felt as if she was about to die). At the time of the report, FEELING ABNORMAL (Felt odd), SLUGGISHNESS (little sluggish), SOMNOLENCE (Slept from 12:00 noon-10:30 pm), MALAISE (Really didn't feel well), FEELING ABNORMAL (felt as if she was about to die) and PYREXIA (Had a fever of 99.8°F/Keeping a low grade temperature) was resolving and CHEST DISCOMFORT (Heart felt like it was coming out of her chest all day then it went away) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 99.8°f (High) low grade temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: second dose is pfizer; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (second dose is Pfizer) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 29-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (second dose is pfizer). On 29-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (second dose is pfizer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  On 29-Sep-2021, the patient received second dose of PFIZER  COVID-19 VACCINE in (lot 30155BA) in left deltoid.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received on 01-OCT-2021 Updated reporters more details and Vaccine route of administration.