Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
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I wanted to urinate I couldn't reach my penis because it was covered by my scrotum; my groin area swelled up; scrotum swelled up to the size of a baseball and it is hard; the skin in my thighs is hard; My weight went up to 235; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (I wanted to urinate I couldn't reach my penis because it was covered by my scrotum), SWELLING (my groin area swelled up), SCROTAL SWELLING (scrotum swelled up to the size of a baseball and it is hard), INDURATION (the skin in my thighs is hard) and WEIGHT INCREASED (My weight went up to 235) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) DOSAGE#1. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to DOSAGE#2. On an unknown date, the patient experienced DYSURIA (I wanted to urinate I couldn't reach my penis because it was covered by my scrotum), SWELLING (my groin area swelled up), SCROTAL SWELLING (scrotum swelled up to the size of a baseball and it is hard), INDURATION (the skin in my thighs is hard) and WEIGHT INCREASED (My weight went up to 235). At the time of the report, DYSURIA (I wanted to urinate I couldn't reach my penis because it was covered by my scrotum), SWELLING (my groin area swelled up), SCROTAL SWELLING (scrotum swelled up to the size of a baseball and it is hard), INDURATION (the skin in my thighs is hard) and WEIGHT INCREASED (My weight went up to 235) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. . Patient could not find lot number, and gave this number: MBC80777-0273-99 Regular med blood boost Herbal supplement to enhance circulation, little bit of aspirin, cardiac pill. First shot on 10Feb2021, left non-dominant arm. Lot number: Not available. Patient could not find lot number, and gave this number: MBC80777-0273-99. Second shot on 10Mar2021, left non-dominant arm. Lot number: Not available. Side effects occurred after the first shot a week into it and it was very gradual. 4-5 days after injection (I can't tell when it actually started because it was not bothering me. I noticed because when I wanted to urinate I couldn't reach my penis because it was covered by my scrotum), my groin area swelled up. Primarily my scrotum swelled up to the size of a baseball and it is hard. And the skin in my thighs is hard as well. The swelling subsided a few days ago, Monday-Tuesday (08-09Mar2021) or something. But then, it picked up again a few days later. I saw my urologist and he said "if you can walk, and if you are not in pain, you should not do anything". My weight went up to 235 but it is back down now. Regular med: blood boost Herbal supplement to enhance my circulation because I have circulation problems in my left hand, but I stopped taking that. I've also been taking diuretic for 3.5 - 4 years now. a little bit of aspirin, cardiac pill. This case was linked to MOD-2021-051528 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: FollowUp received. Information regarding dose 2 and its event was reported
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 2 | COVID19 | MODERNA | OT | LA |
| RECVDATE: | 08-23-2021 | RPT_DATE: |
| CAGE_YR: | 89 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | ASPIRIN [ACETYLSALICYLIC ACID] |
| CUR_ILL: | |
| HISTORY: | Comments: No medical history was reported. |
| PRIOR_VAX: | |
| SPLTTYPE: | USMODERNATX, INC.MOD20210 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 08-22-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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