Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Drug ineffective, Herpes zoster, Injection site pain
Clinical narrative: mass on her lungs; lesion in the lungs metastasized to the brain / mass on her brain; blood clots in the shin to the hip; she passed /death; Covid-19 after 2 doses of the vaccine; Covid-19 after 2 doses of the vaccine; sore arm at the injection site for a day or two; a lot of pain from the lesions of the shingles; Shingles developed and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (she passed /death), PULMONARY MASS (mass on her lungs), METASTASES TO CENTRAL NERVOUS SYSTEM (lesion in the lungs metastasized to the brain / mass on her brain), THROMBOSIS (blood clots in the shin to the hip), HERPES ZOSTER (Shingles developed and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder) and COVID-19 (Covid-19 after 2 doses of the vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site for a day or two). In 2021, the patient experienced PULMONARY MASS (mass on her lungs) (seriousness criteria hospitalization and medically significant), METASTASES TO CENTRAL NERVOUS SYSTEM (lesion in the lungs metastasized to the brain / mass on her brain) (seriousness criteria hospitalization and medically significant), THROMBOSIS (blood clots in the shin to the hip) (seriousness criteria hospitalization and medically significant), HERPES ZOSTER (Shingles developed and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder) (seriousness criterion medically significant) and PAIN (a lot of pain from the lesions of the shingles). In February 2022, the patient experienced COVID-19 (Covid-19 after 2 doses of the vaccine) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Covid-19 after 2 doses of the vaccine). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at an unspecified dose and frequency. The patient died on 23-Mar-2022. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY MASS (mass on her lungs), METASTASES TO CENTRAL NERVOUS SYSTEM (lesion in the lungs metastasized to the brain / mass on her brain), THROMBOSIS (blood clots in the shin to the hip), HERPES ZOSTER (Shingles developed and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder), COVID-19 (Covid-19 after 2 doses of the vaccine), DRUG INEFFECTIVE (Covid-19 after 2 doses of the vaccine), PAIN (a lot of pain from the lesions of the shingles) and INJECTION SITE PAIN (sore arm at the injection site for a day or two) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that all hell broke loose after the 2nd dose. Caller reported that her bother who lived on and off with their mother noticed that she was having several falls. Her sister also noticed that when she spoke with her on the phone she was not making sense, could not complete her sentences, could not remember things, would mumble and not speak clearly and they were surprised because she was a very sharp lady. Everyone suspected that she might have a stroke. Her mother withheld this information from her until one day in Jul2021, she fell and no one was around to help her. Caller had to call the police to do a welfare check on her and they found her lying on the bathroom floor. She was taken to the hospital where they found a mass on her brain and her lungs. They were told that the mass needed to be removed immediately. They moved her to another state where caller would be able to take care of her. She was prescribed with Valacyclovir for Shingles developed around that time. The lesions on her left upper arm, shoulder and spread to her chest and back left upper shoulde were eventually scabbed over but she was still in a lot of pain. Brain surgery was done in another hospital. They were told that the lesion was from the mass in her lungs and it had metastasized to the brain. She underwent radiation after the brain surgery. This was somewhere in Sep2021 or Oct2021. She was hospitalized 3 more times due to blood clots that were seen on her shin to the hip. The patient spent more days in various hospitals than out after getting the 2nd dose of the vaccine. She did not have any concomitant vaccination with the Covid-19 vaccine. She contracted Covid-19 approximately 6 weeks (feb2022) before she passed on 23Mar2022 in a hospice across the hospital where she was confined last.  No concomitant product use was provided by the reporter. Company comment- This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced Fatal, unexpected, serious (Hospitalization) events of Pulmonary mass, Metastases to brain, unexpected, serious (Medically significant) event of Herpes zoster and unexpected, serious (Hospitalization, Medically significant) adverse event of special interest Thrombosis and unexpected, serious (Medically significant) adverse event of special interest Covid-19. After getting the 2nd dose of vaccination, the patient complained that she could not walk and talk. She was noted to have several falls, was not making sense when she speaks, could not complete her sentences, and could not remember things. She would mumble and could not speak clearly. In July 2021, the patient fell, and no one was around to help her. She was found lying on the bathroom floor. She was taken to the hospital where they found a mass on her brain and lungs. They were told that the mass needed to be removed immediately. Shingles developed around this time. It was severe and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder. She was prescribed with Valacyclovir, and it eventually scabbed over but she was still in a lot of pain due to the lesions. Brain surgery was done in another hospital  and they were told that the lesion was from the mass in her lungs and it had metastasized to the brain. She underwent radiation after the brain surgery. She was hospitalized 3 more times due to blood clots that were seen on her shin to the hip. The patient contracted Covid-19 approximately 6 weeks before she passed on in a hospice across the hospital where she was confined last. No autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-565162 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced Fatal, unexpected, serious (Hospitalization) events of Pulmonary mass, Metastases to brain, unexpected, serious (Medically significant) event of Herpes zoster and unexpected, serious (Hospitalization, Medically significant) adverse event of special interest Thrombosis and unexpected, serious (Medically significant) adverse event of special interest Covid-19. After getting the 2nd dose of vaccination, the patient complained that she could not walk and talk. She was noted to have several falls, was not making sense when she speaks, could not complete her sentences, and could not remember things. She would mumble and could not speak clearly. In July 2021, the patient fell, and no one was around to help her. She was found lying on the bathroom floor. She was taken to the hospital where they found a mass on her brain and lungs. They were told that the mass needed to be removed immediately. Shingles developed around this time. It was severe and the lesions were found on her left upper arm, shoulder and spread to her chest and back left upper shoulder. She was prescribed with Valacyclovir, and it eventually scabbed over but she was still in a lot of pain due to the lesions. Brain surgery was done in another hospital  and they were told that the lesion was from the mass in her lungs and it had metastasized to the brain. She underwent radiation after the brain surgery. She was hospitalized 3 more times due to blood clots that were seen on her shin to the hip. The patient contracted Covid-19 approximately 6 weeks before she passed on in a hospice across the hospital where she was confined last. No autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death