chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTING POSITIVE FOR COVID BY BOTH A RAPID AND PCR TEST; This spontaneous report received from a patient concerned a 60-year-old White male of unspecified ethnic origin. 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: 1808609, and expiry: 07-SEP-2021) dose was not reported, dose number in series was 01, 01 in total administered on left arm on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  Following administration of covid-19 vaccine ad26.cov2.s, no events were reported (dose number in series was 01). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company vaccine as MRNA 1273 (moderna) (form of admin, route of admin were unknown, and batch number: 069f21a, expiry: unknown) dose was not reported, dose number in series was 02, administered on left arm on 15-NOV-2021 for prophylactic vaccination.  Following administration of vaccines, on an unspecified date the patient tested positive for covid by both rapid and polymerase chain reaction (PCR) test (dose number in series was 02). The action taken with MRNA 1273 was not applicable. The outcome of testing positive for covid by both a rapid and PCR test was not reported (dose number in series was 02). This report was non-serious. This report was associated with product quality complaint: 90000211870. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Depression, Suspected COVID-19, Unevaluable event, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ALMOST KILLED ME; DEPRESSION; This spontaneous report received from a patient via a social media via company representative concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 26-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown)1 total, for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose,1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection, almost killed me and depression (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost killed me, depression, suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000213039. The suspected regulatory authority has been confirmed to be voided (did not meet criteria) based on the RA evaluation/investigation performed.; Sender's Comments: V0: 20220137210 -COVID-19 VACCINE AD26.COV2.S-Suspected Clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: BREAST CANCER; This spontaneous report received from a consumer concerned multiple patients. It concerned two females of unspecified age. The patients' height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. The patient received injection left deltoid and unknown for other patient. No concomitant medications were reported.  On 09-JUL-2021, the patients experienced breast cancer on the same side they received the vaccine. The patients stated they were feeling like crap because they now had cancer. The diagnosis occurred about 1 week after the mammogram which was on 09-Jul-2021 and on unknown date, second patients mammogram showed more instances of enlarged lymph nodes. It was diagnosed by mammogram and an ultrasound, and biopsy. The diagnosis occurred about 1 week after the mammogram which was on 09-Jul-2021. On 14-Jul-2021, the one patient had biopsy done which confirmed cancer and unknown for other. On 28-Jul-2021, one patient had MRI of both breasts which showed that cancer was limited to the left breast. One patient had 16 consecutive days of radiation, and was currently taking medication which she would be on for 5 years and the other patient was also receiving radiation treatment at the same time as her who also recently had a covid-19 vaccine about 3-4 months ago. One patient also had a day surgery on 3-Aug-2021 at hospital. It was a lumpectomy and removal of 5 sentinel lymph nodes. The lymph nodes were clear but the actual lump showed cancer in it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breast cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220138438-covid-19 vaccine ad26.cov2.s-Breast cancer.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Tinnitus
Clinical narrative: HEADACHE; TINNITUS; NAUSEA; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (codeine), and patient had no medical history. The patient was previously received with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (form of admin, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination (dose number in series 1). It was unknown whether the patient had any adverse events following vaccination covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 15-JAN-2022 for prophylactic vaccination on left arm (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-JAN-2022 (following day after vaccination), the patient experienced some nausea, headaches, and tinnitus (dose number in series 2).The tinnitus was described as a high pitched electricity like buzz. The patient used some acetaminophen (paracetamol) to alleviate symptoms, however, they were still present as of 23-JAN-2022 (the day of report). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tinnitus, and nausea. This report was non-serious. unspecified manufacturer
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea
Clinical narrative: STOMACH UNCOMFORTABLE; FEELING NOT STRONG; DIARRHEA; This spontaneous report received from a consumer concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies, there was no drug abuse or illicit drug usage. The patient was previously received with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient received booster covid-19 vaccine ad26.cov2.s  (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-JAN-2022, the patient started having diarrhea. The patient seemed to be better now but mentioned that her stomach was uncomfortable and still not feeling strong (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 17-JAN-2022, and the outcome of stomach uncomfortable and feeling not strong was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age. 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: 042a21a, expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JAN-2022 after the 9 months of vaccination, the patient experienced covid-19 infection (coded to suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority.  .; Sender's Comments: V0; 20220145028-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: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: peg allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 36 year old female of unspecified ethnic origin. 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: 043A21A expiry: 19-SEP-2021) dose was not reported, 01 total administered in left arm on 09-APR-2021 for prophylactic vaccination.  After receiving vaccination on an unspecified date, the patient had tested positive for covid-19 with an at home test. Laboratory data included: COVID-19 virus test positive (dates unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was unknown. The patient additionally received non-company suspect vaccine MRNA 1273 (form of administration, route of administration, batch number: 071F21A, expiry: 28-JAN-2022), dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SYMPTOMS OF COVID; This spontaneous report received from a patient concerned a 21 year old male. 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: 211A21A and expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced symptoms of covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms of covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220150408 and 20220151154.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a female. 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 administration not reported and batch number: unknown, expiry: unknown ) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  After vaccination on an unspecified date, the patient experienced mild symptoms such as headache, runny nose and fatigue (suspected covid-19 infection). On 21-JAN-2022, she tested positive for coronavirus disease-19 (COVID-19) at home by using Abbott rapid antigen test (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered 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: 90000213827.; Sender's Comments: V0: 20220150238-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: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED VACCINE AFTER IT WAS RE-FROZEN AND THEN THAWED; INCORRECT PRODUCT STORAGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned multiple patients. 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: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced administered vaccine after it was re-frozen and then thawed, incorrect product storage, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine after it was re-frozen and then thawed, off label use and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: GREW ALL THE HAIR BACK; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced grew all the hair back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of grew all the hair back was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: PSORIASIS ON FEET; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Non-company suspect drugs included: risankizumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriasis. On an unspecified date, the patient experienced psoriasis on feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with risankizumab was withdrawn. The outcome of psoriasis on feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Pain, Respiratory tract congestion
Clinical narrative: BODYACHES; CONGESTION; HEAVY CHEST; HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. 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: 211A21A expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced bodyaches, congestion, heavy chest, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, bodyaches, congestion and heavy chest was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no prior health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20220150708.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: STIFF NECK; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the patient experienced stiff neck, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and headache. This report was non-serious This report was associated with product quality complaint: 90000214169
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Laboratory test, Rash, Skin discolouration
Clinical narrative: This spontaneous report received from a patient concerned a 40-year-old female patient (weight: 200 pounds; height: 61 inches). The patient's concurrent conditions included: seasonal allergy. No concomitant medications reported. The patient received the 1st dose of the COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 203A21A, expiry: Sep 21, 2021), on Jul 18, 2021 for immunization. On Jul 18, 2021, patient developed a big, red painful boil (right hip). On Jul 20, 2021, patient's skin was covered with dry, itchy black spots (all over entire body except for face). Rash started like raised, red patches that turned black. Laboratory data (dates unspecified) included: Lab test (NR: not provided). The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from a big, red painful boil (right hip); rash started like raised, red patches that turned black and skin covered with dry, itchy black spots (all over entire body except for face).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant and treatment product use was provided.    This case was linked to MOD-2022-462294, MOD-2022-462269 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Had a hard time sleeping; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INSOMNIA (Had a hard time sleeping) and PAIN IN EXTREMITY (Sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Grapes). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 12-May-2021 to an unknown date for an unknown indication.   On 11-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced INSOMNIA (Had a hard time sleeping) and PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, INSOMNIA (Had a hard time sleeping) and PAIN IN EXTREMITY (Sore arm) had resolved.      Treatment medications were not reported.   This case was linked to MOD-2021-015940 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Upon internal review on 28-Jan-2022, pregnancy details, assessment, batch number and event coding updated
Sex: M
Vaccine: COVID19
Symptoms: Colon cancer
Clinical narrative: Passed away from colon cancer in June after receiving the primary series from Moderna; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2022 and was forwarded to Moderna on 21-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (Passed away from colon cancer in June after receiving the primary series from Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer (Patient had colon cancer for one year and a half before passing away in June 2021) since July 2020.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced COLON CANCER (Passed away from colon cancer in June after receiving the primary series from Moderna) (seriousness criteria death and medically significant). The patient died in June 2021. The reported cause of death was Colon cancer. It is unknown if an autopsy was performed.            Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient did not had any side effects form the shots,he said it didn't bother him that much. Company comment:This case concerns a male patient of an unknown age with reported concurrent medical condition of Colon cancer since July 2020, who experienced the unexpected Fatal event of colon cancer (seriousness criteria death) which occurred in on unknown date in June 2021 after the second dose of mRNA-1273 vaccine(15-May-2021). The reported cause of death was Colon cancer. It is also unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with reported concurrent medical condition of Colon cancer since July 2020, who experienced the unexpected Fatal event of colon cancer (seriousness criteria death) which occurred in on unknown date in June 2021 after the second dose of mRNA-1273 vaccine(15-May-2021). The reported cause of death was Colon cancer. It is also unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Colon cancer
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lethargy, SARS-CoV-2 test, Urticaria
Clinical narrative: Lethargic; Hives; diagnosed with Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with Covid-19), LETHARGY (Lethargic) and URTICARIA (Hives) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (diagnosed with Covid-19). On an unknown date, the patient experienced LETHARGY (Lethargic) and URTICARIA (Hives). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, COVID-19 (diagnosed with Covid-19), LETHARGY (Lethargic) and URTICARIA (Hives) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: diagnosed with covid-19 (Positive) diagnosed with Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Birth control pills. Prednisone was mentioned as a treatment medication.  Company Comment: This is a spontaneous case concerning a 24-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 1 week after the first dose of mRNA-1273 vaccine administered on an unknown date in Feb-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 15-Jun-21 was positive. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-459639, MOD-2022-459640 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 24-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 1 week after the first dose of mRNA-1273 vaccine administered on an unknown date in Feb-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 15-Jun-21 was positive. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Myalgia, Rash, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (may be shingles), SWELLING FACE (right sided facial swelling), RASH PRURITIC (rash is itching and burning), SKIN BURNING SENSATION (rash is burning) and RASH (rash on the right side of their neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078J21A, 012M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in September 2021. Concurrent medical conditions included Latex allergy. Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM; COLECALCIFEROL]) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication. On 09-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. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, the patient experienced VACCINATION SITE PAIN (soreness of the site). 09-Jan-2022, the patient experienced FATIGUE (fatigue). In January 2022, the patient experienced HERPES ZOSTER (may be shingles), SWELLING FACE (right sided facial swelling), RASH PRURITIC (rash is itching and burning), SKIN BURNING SENSATION (rash is burning), RASH (rash got to their back, and all over their body, including knees, elbows and hands) and MYALGIA (muscle aches in both their upper arms). On 18-Jan-2022, the patient experienced RASH (rash on the right side of their neck). The patient was treated with PREDNISONE at a dose of high dose prednisone, 50; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itchy rash, at a dose of 10 milligram and FAMOTIDINE (PEPCID AC) at a dose of 20mg twice a day. At the time of the report, HERPES ZOSTER (may be shingles), SWELLING FACE (right sided facial swelling), RASH PRURITIC (rash is itching and burning), SKIN BURNING SENSATION (rash is burning), VACCINATION SITE PAIN (soreness of the site), FATIGUE (fatigue) and MYALGIA (muscle aches in both their upper arms) outcome was unknown and RASH (rash on the right side of their neck) and RASH (rash got to their back, and all over their body, including knees, elbows and hands) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2022-462296 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Swelling face, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (may be shingles), SWELLING FACE (right sided facial swelling), RASH PRURITIC (rash is itching and burning), SKIN BURNING SENSATION (rash is burning) and RASH (rash on the right side of their neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078J21A, 012M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in September 2021. Concurrent medical conditions included Latex allergy. Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM; COLECALCIFEROL]) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication. On 09-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. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, the patient experienced VACCINATION SITE PAIN (soreness of the site). 09-Jan-2022, the patient experienced FATIGUE (fatigue). In January 2022, the patient experienced HERPES ZOSTER (may be shingles), SWELLING FACE (right sided facial swelling), RASH PRURITIC (rash is itching and burning), SKIN BURNING SENSATION (rash is burning), RASH (rash got to their back, and all over their body, including knees, elbows and hands) and MYALGIA (muscle aches in both their upper arms). On 18-Jan-2022, the patient experienced RASH (rash on the right side of their neck). The patient was treated with PREDNISONE at a dose of high dose prednisone, 50; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itchy rash, at a dose of 10 milligram and FAMOTIDINE (PEPCID AC) at a dose of 20mg twice a day. At the time of the report, HERPES ZOSTER (may be shingles), SWELLING FACE (right sided facial swelling), RASH PRURITIC (rash is itching and burning), SKIN BURNING SENSATION (rash is burning), VACCINATION SITE PAIN (soreness of the site), FATIGUE (fatigue) and MYALGIA (muscle aches in both their upper arms) outcome was unknown and RASH (rash on the right side of their neck) and RASH (rash got to their back, and all over their body, including knees, elbows and hands) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2022-462296 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Active COVID-19  infection), DRUG INEFFECTIVE (Drug ineffective) and TINNITUS (Right ear ringing) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 032L20A and 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism, Chronic bronchitis, Penicillin allergy, Allergy to antibiotic (Ceclor), Allergy to vaccine (Pertussis Vaccine) and Fruit allergy (Avocado allergy). Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) from 2021 to an unknown date for Birth control, MONTELUKAST SODIUM (SINGULAIR) from 2020 to an unknown date for Chronic bronchitis, THYROID (ARMOUR THYROID) from 2021 to an unknown date for Hypothyroidism, ACYCLOVIR [ACICLOVIR] from 2010 to an unknown date for Prevention. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced COVID-19 (Active COVID-19  infection), DRUG INEFFECTIVE (Drug ineffective) and TINNITUS (Right ear ringing). On 08-Jan-2022, DRUG INEFFECTIVE (Drug ineffective) had resolved. At the time of the report, COVID-19 (Active COVID-19  infection) outcome was unknown and TINNITUS (Right ear ringing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. Treatment information was not provided. Company comment: This is a spontaneous case concerning a 38-year-old, female patient with no relevant medical history reported, who experienced the AESI event of COVID-19. The infection was diagnosed about 4 months after the 3rd dose and almost a year after the second dose of mRNA-1273. Lack of effect cannot be ruled out as patient received primary vaccination with Moderna vaccine as approved on the label. The benefit-risk relationship of mRNA-1273 in not affected by this report. This case was linked to MOD-2022-456216 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 38-year-old, female patient with no relevant medical history reported, who experienced the AESI event of COVID-19. The infection was diagnosed about 4 months after the 3rd dose and almost a year after the second dose of mRNA-1273. Lack of effect cannot be ruled out as patient received primary vaccination with Moderna vaccine as approved on the label. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was reported that after second vaccination, patient had a blood clot for 5 days which almost killed him.  Company Comment - This spontaneous case concerns a male patient of unknown age with no relevant medical history, who experienced the serious unexpected AESI event of thrombosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine, and the outcome was unknown. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no relevant medical history, who experienced the serious unexpected AESI event of thrombosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine, and the outcome was unknown. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke after he took his shot; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke after he took his shot) 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 CEREBROVASCULAR ACCIDENT (had a stroke after he took his shot) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (had a stroke after he took his shot) 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 reported. No treatment information was provided.  Company comment: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the serious (medically significant) AESI of CEREBROVASCULAR ACCIDENT. Onset date nor vaccination date were reported; hence, latency cannot be assessed. No further information has been provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the serious (medically significant) AESI of CEREBROVASCULAR ACCIDENT. Onset date nor vaccination date were reported; hence, latency cannot be assessed. No further information has been provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity, Road traffic accident
Clinical narrative: hit by a car and hospitalized for a week; arm soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of ROAD TRAFFIC ACCIDENT (hit by a car and hospitalized for a week) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). In March 2021, the patient experienced ROAD TRAFFIC ACCIDENT (hit by a car and hospitalized for a week) (seriousness criterion hospitalization). The patient was hospitalized for 7 days due to ROAD TRAFFIC ACCIDENT. At the time of the report, ROAD TRAFFIC ACCIDENT (hit by a car and hospitalized for a week) and PAIN IN EXTREMITY (arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: had testing showing antibodies that had persisted Had testing showing antibodies that had persisted up to this point..     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.   No concomitant drugs were reported.  Patient received the first dose of the moderna covid-19 vaccine by intramuscular injection on 17FEB2021 (lot number 029L20A, expiration date 30JUN2021). Patient had a little bit of arm soreness after receiving the vaccine but did not take any treatments for the symptoms. Prior to receiving the second dose of the vaccine patient was hit by a car and hospitalized for a week. Patient was placed on steroids as part of this hospitalization. The doctors were now recommending that the patient should receive additional doses of the Moderna vaccine. Patient had not received a second dose at that time, but had testing showing antibodies that have persisted up to this point.  Company comment: This case concerns a 75-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization) event of road traffic accident. The event occurred approximately 1 month after the first dose of mRNA-1273. The event has been assessed as not related to mRNA-1273 due to the nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 75-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization) event of road traffic accident. The event occurred approximately 1 month after the first dose of mRNA-1273. The event has been assessed as not related to mRNA-1273 due to the nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture and after exposure to room temperature for more than 24 hours) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2022 at 12:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022 at 12:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture and after exposure to room temperature for more than 24 hours). On 26-Jan-2022 at 12:25 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture and after exposure to room temperature for more than 24 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vial was initially stored in the refrigerator on 31-Dec-2021.The vial was first punctured on 25-Jan-2022 at 11:30 A.M and stored in RT (Refrigeration Tones). The vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius or 46 degree Fahrenheit to 77 degree Fahrenheit) for 24 hours and 55 minutes. The vial did not undergo any temperature excursions. Concomitant medications were not provided. Treatment information was not provided.